U.S. patent application number 13/926424 was filed with the patent office on 2014-03-27 for system and method for communicating product recall information, product warnings or other product-related information to users of products.
This patent application is currently assigned to GeeLux Holdings, Ltd.. The applicant listed for this patent is GeeLux Holdings, Ltd.. Invention is credited to Marcio Marc Abreu.
Application Number | 20140089006 13/926424 |
Document ID | / |
Family ID | 22666693 |
Filed Date | 2014-03-27 |
United States Patent
Application |
20140089006 |
Kind Code |
A1 |
Abreu; Marcio Marc |
March 27, 2014 |
System and Method for Communicating Product Recall Information,
Product Warnings or Other Product-Related Information to Users of
Products
Abstract
An automated system and method for communicating product
information to consumers through a central computer using a
distributed computer network. The central computer is connected to
a plurality of public health and product recall information sources
through a public network such as the Internet. Consumers purchasing
or otherwise linked with products submit product information to the
central computer. The central computer establishes a link between
the user and associated product information and stores the data in
a database. User medical information is also submitted to and
retained by the central computer. Upon receipt of product update
information, which may include recall notification or other product
warnings from the public health or product recall information
sources, the central computer accesses the database and identifies
user-product links impacted by the product update information and
automatically initiates electronic or other communications to
affected users.
Inventors: |
Abreu; Marcio Marc; (North
Haven, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
GeeLux Holdings, Ltd. |
Tortola |
|
VG |
|
|
Assignee: |
GeeLux Holdings, Ltd.
|
Family ID: |
22666693 |
Appl. No.: |
13/926424 |
Filed: |
June 25, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12591779 |
Dec 1, 2009 |
8473313 |
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13926424 |
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09778762 |
Feb 8, 2001 |
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12591779 |
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60182000 |
Feb 11, 2000 |
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Current U.S.
Class: |
705/3 |
Current CPC
Class: |
G06Q 30/016 20130101;
G06Q 30/02 20130101; A61B 5/4848 20130101; G06K 7/10861 20130101;
G06Q 30/014 20130101; Y02A 90/10 20180101; G16H 40/67 20180101 |
Class at
Publication: |
705/3 |
International
Class: |
G06Q 30/00 20060101
G06Q030/00; A61B 5/00 20060101 A61B005/00 |
Claims
1. A computer-implemented method of transferring information
between a user and a third party through a centralized computer,
comprising the steps of: receiving, at the centralized computer,
user identification information including biometric data from a
user; storing the user identification information in a database;
receiving, at the centralized computer, user dynamically changing
biometric information transmitted by the user from a remote
location at different points in time, the biometric information
being measured by health monitoring devices; linking and storing
the user dynamically changing biometric information in a user
information database; comparing, by the centralized computer, the
user dynamically changing biometric information with normal values
and notifying the user of a comparison result; reviewing, by the
centralized computer, the user dynamically changing biometric
information; transmitting, on an automated basis, in response to
any abnormal variations to said user dynamically changing biometric
information and a stored health condition, an automated message to
said user; said database including a plurality of databases, said
plurality of databases including at least one of a user database, a
product database, a product information database, an interaction
database, a product usage database and a biological variables
database; and electronically receiving said user biometric
information from the health monitoring devices including at least
one of blood glucose, temperature, eye pressure and blood pressure
devices.
2. The method as set forth in claim 1, further comprising a step of
transmitting said user abnormal biometric information to a third
party, the third party includes at least one of a doctor, a
pharmacy, a laboratory, an insurance company, hospital, and
emergency medical services.
3. The method as set forth in claim 1, wherein the biometric
reading is potentially harmful and said electronic message includes
a warning and instruction regarding the abnormal biometric
readings.
4. A computerized information distribution system comprising: a
remote terminal for receiving user identification information and
for registering a user; a central server for storing biometric data
corresponding to the user; a communications network for receiving
dynamically changing biometric information from a plurality of
third party computers transmitted by the user from a remote
location at different points in time, the biometric information
variables being measured by health monitoring devices; means for
storing said dynamically changing biometric information at said
central server; means for generating a message corresponding to
abnormal biometric data; and means for transmitting said message to
the user over said communications network; said remote terminal
being an IECLD including a display, data entry means, memory means,
processing means and communication means.
5. The system as set forth in claim 4, wherein the data entry means
includes at least one of a keypad, a keyboard and a bar code
scanner.
6. The system as set forth in claim 4, wherein the communications
means includes a modem.
7. The system as set forth in claim 4, wherein said means for
storing is a plurality of databases.
8. The system as set forth in claim 4, wherein said plurality of
databases includes at least one of a user database, a product
database, a product information database, an interaction database,
a product usage database and a biological variables database.
9. The system as set forth in claim 4, wherein the user is at least
one of a doctor, a pharmacy, a laboratory and a patient.
Description
RELATED APPLICATIONS
[0001] This application is a Continuation of application Ser. No.
12/591,779 filed Dec. 1, 2009, now U.S. Pat. No. 8,473,313, which
is a Continuation of application Ser. No. 09/778,762 filed Feb. 8,
2001, which in turn claims priority from, and the benefit of, U.S.
provisional application Ser. No. 60/182,000 filed Feb. 11, 2000,
hereby incorporated in its entirety by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a system and method for
communicating product recall information, product warnings, or
other product-related information to users of such products, and
more specifically, relates to a system and method that facilitate
implementation of an electronic and network-based recall and
notification system that is product-driven and/or biological
variable-driven, to assist the users of the system in timely
identifying a health hazard or any other hazardous situation or
difficulties due to unintended harmful effects and adverse
consequences of a variety of products and/or biological variable,
and to prevent the occurrence of such harmful effects.
BACKROUND
[0003] The world, especially the United States, is now facing a
challenging rise in health care costs. Health care expenditures are
rising rapidly. Contributing to this rise, there has been with a
rapid increase in the number and spread of preventable illnesses
and injury that are attributable to the unintended harmful effects
of a variety of products and/or changes in the health status of an
individual interacting with such products. According to projections
by the Health Care Financing Administration of the United States
Department of Health and Human Services, health care spending as a
share of US gross domestic product (GDP) is estimated to increase
from 13 percent to close to 20% of the United States GDP after the
year 2000. This clearly demonstrates how unwise health care
spending can affect the overall economy of a nation. The World
Health Organization reported in 1995 that the percentage of total
spending on health by various governments clearly indicated that
health care costs are a serious global problem and an important
factor concerning the overall utilization of public money. Public
spending on health by the United States government was about 47%,
by the United Kingdom was 84%, by France was 81%, by Japan was 78%,
by Canada was 71%, by Italy was 70%, by Mexico was 56%.
[0004] The United States Department of Agriculture has estimated
that the medical costs of illnesses caused by the unintended
harmful effect of food alone amounted to over $34 billion dollars
in 1998 (more than the combined global revenues in 1998 of
Coca-Cola and Microsoft). It is easy to appreciate the threat to a
nation's economy that such a situation presents. This, however, is
only a fraction of the total medical cost created by the unintended
harmful effect of products. The unintended harmful effect of
prescription drugs, for example, resulted in an astonishing annual
cost of $136 billion dollars in the United States. This is greater
than all of the costs incurred as a result of heart disease (the
number one cause of death in the United States). The above medical
costs attributable to the unintended harmful effects of
prescription drugs is more than the combined global revenues of all
major airlines in the United States, England, Germany, Japan,
France and Spain, which totaled $120 billion U.S. dollars in 1998.
The situation is much more serious and inconceivably far more
costly when the harmful effects of other consumer products are
considered. This ultimately imposes a tremendous burden on the
income tax payer and average worker, who at the end is the one
paying for the vast majority of the costs associated with health
care services. The fastest and most effective way to protect the
public from an unsafe product and thus decrease such outrageous and
unwise medical expenditures would be to timely and reliably
identify, locate, and instruct the users of such unsafe products.
Due to the seriousness of the harm and the rapidly increasing
number of occurrences of harm and death caused by a variety of
products, the government, private enterprises and medical
organizations have an urgent need to find means and technology to
prevent the spread and occurrences of illnesses and injuries that
result from a failure to timely identify, locate, and treat users
of harmful products. The ability to satisfy this need is critical
to the containment of health care spending, not only in the United
States, but also globally.
[0005] The development and use of a variety of medications (drugs)
is essential to promoting health and treating a great number of
disorders, while substantially increasing life expectancy. There
are many benefits to the development of medications. Certain
antibiotics, for example, have saved millions of lives.
Antihypertensive drugs likewise have helped reduce the number of
occurrences of strokes and heart disease, by controlling high blood
pressure. The use of cholesterol lowering agents also have helped
decrease the mortality rate associated with heart disease, the use
of anti-depressants have helped millions of individuals better
enjoy life, and the use of anti-glaucoma medications have helped
millions of patients preserve their sight. The exhaustive process
and laborious research involved with drug development have created
many other breakthroughs and formidable drug discoveries which, in
turn, have led to the control of previously untreatable diseases
and a decrease in morbidity, while enhancing the quality of life
and increasing life expectancy for millions of people across the
world. However, these great benefits are associated with serious
and costly problems due to the astonishing fact that not only
thousands, but actually hundreds of thousands of patients die every
year in the United States alone, as a result of drug reaction or
unexpected and unintended adverse effects and reactions caused by
prescription drugs.
[0006] Adverse drug reactions resulting from correctly administered
FDA-approved drugs alone are responsible for the shocking figure of
over 106,000 deaths per year in the United States alone. Adverse
drug reactions are the fourth leading cause of death in the United
States, immediately after heart disease, cancer, and stroke. The
number of deaths caused by the harmful unintended effects of
prescription drugs is amazingly more than the annual totals for
AIDS, suicide, and homicide combined, and amount to more than twice
the number of deaths due to accidents (which is about 40,000 per
year). A person is more likely to die from an adverse effect of
prescription medication than from accidents, diabetes, or lung
disease. The staggering number of close to 300 deaths per day
resulting from prescription drug adverse reactions remains
unchanged due to the difficulties in timely identifying, locating,
preventing use of the medication by, and treating the individuals
at risk. In addition to the fatal events, there are typically over
2.2 million annual occurrences of non-fatal, but serious,
reactions, and millions of complications and disabilities related
to unexpected effects of drugs, chemical compounds and a variety of
products which are responsible for some of the staggering health
care spending that the world faces today. Unfortunately, this
alarming picture will continue to worsen in the future, with
devastating consequences to the economy, tax-payers and society as
a whole if appropriate measures for prevention and the timely
identification and location of the harmful products and affected
individuals is not instituted to avoid spreading of potentially
preventable injuries and disease.
[0007] The above catastrophic picture is even more grim and
astonishing since the above figures exclude drugs which were
improperly prescribed or improperly administered, as well as drug
abuse and drug overdose and adverse effects caused by
non-prescription drugs (over-the-counter medications), devices and
other chemical compounds which are injected, ingested, or placed in
or on the human body. If the adverse effects and fatal reactions
related to the use of over-the-counter drugs (non-prescription
drugs) and other products such as cosmetics were included the
numbers would prove to be even more staggering. The risks, injury,
and death caused by unintended adverse drug reactions and defective
products could be substantially reduced if appropriate technology
were implemented to provide the requisite notification, guidance,
treatment, or the like.
[0008] The misuse of prescription and non-prescription drugs due to
the inability to understand or identify a potential hazardous
effect is also a critical cause of morbidity and mortality related
to the utilization of a variety of products, devices, and chemical
compounds. The ability to understand information about drugs,
chemical compounds or devices is central to the prevention of some
of the aforementioned devastating consequences. The U.S. Department
of Education estimated that 47% of all adult Americans had poor
reading and comprehension skills. Large amounts of medical material
therefore can exceed the reading abilities of many American adults.
Although there is information printed on the packages and product
inserts that accompany prescription and over-the-counter drugs, as
well as many other products, the majority of the population has
difficulty understanding, interpreting, or using the information
provided. As a result, many individuals suffer adverse effects due
to their inability to understand the content of the information
provided by the manufacturer and its relationship to his/her
individual health status. It is important to remember that the
health status of an individual is a dynamic process with continuous
change over time. Such changes in the health status are quite
capable of potentially interacting with chemical compounds and
devices used by the patient and causing serious and even fatal
effects and reactions. New technology is surely needed that will
assist the user in safely using a drug despite his/her lack of
knowledge regarding medical terminology and the interaction of
drugs and products with the human body's continuously changing
biological variables.
[0009] The prior art has provided several important home-testing
technologies. Examples include several devices developed by the
Applicant hereof. Such devices can be used by patients to
self-administer measurements of eye pressure and perform a complete
non-invasive blood analysis that includes evaluation of a variety
of biological variables. Heretofore, there has been no convenient
and reliable way of associating such home-testing devices with a
notification, guidance, and/or treatment system, to provide a
complete system of preventing negative interaction between chemical
compounds used by the patient and changing biological variables of
the patient. There is consequently a need for such a system. A
brief example demonstrates the situation. Patients using some
medications for the common cold or flu or products containing
steroids may be at risk for damaging their eyes or even blindness
if one biological variable, in this case, eye pressure is
significantly increased. The increase in eye pressure can be
silent, without any symptoms that would otherwise indicate that the
individual may have glaucoma. The packet insert of the common cold
pill and some skin lotions with steroids may have a warning against
use of such products by those with glaucoma. Unfortunately,
however, the person taking the pills or using the skin lotion
typically does not know what glaucoma means, even after reading the
packet insert, and will continue to use the product not knowing
that there is a risk of eye damage. There is consequently a need
for a system that will alert patients about such risks, regardless
of the patient's knowledge of the meaning of the medical
terminology in the packet insert and/or potential interaction with
their health status and current biological variables.
[0010] The rapid rise in health care costs also relates to the
disturbing fact that millions of patients suffer from severe
complications, permanent disability, and death as a result of
untimely identification of a health problem or untimely arrival at
the medical provider or hospital. The medical costs associated with
such untimely treatment cannot be overstated. There is consequently
a need for a system that, in addition to preventing the harmful
event from occurring, also can alert the user to seek treatment and
arrange for treatment when such treatment becomes necessary as a
result of injury or illness caused by a harmful product and/or
changing biological variables.
[0011] Many adverse effects and reactions resulting from the use of
chemical compounds and/or devices occur after the chemical
compounds or devices are already in the marketplace and being used
by potentially millions of consumers. The pre-marketing trials
conducted during the evaluation process of drugs and devices
frequently are not sufficient to reliably detect adverse effects
and reactions and lack the requisite length of follow-up which is
needed to evaluate the delayed consequences that manifest
themselves only after chronic use or wide spread administration of
drugs and devices. In addition to the limits associated with
pre-marketing evaluation by the United States Food and Drug
Administration (FDA) of drugs and devices, these trials do not
include evaluation of the interaction of drugs with a variety of
biological variables, nor do they involve evaluation of the result
of use by special population groups that can be at a higher risk
for adverse effects or reactions, when compared to the general
population. Furthermore, the inability to identify the changes that
occur in the healthy status of an individual such as changes in
blood pressure, eye pressure, blood glucose, blood cholesterol,
weight, and the like, make it virtually impossible to identify and
prevent adverse reactions or effects that occur with the
utilization of drugs and/or devices interacting with changing
biological variables.
[0012] In order to identify and thus prevent the catastrophic
complications due to the adverse effects of drugs, chemical
compounds and devices that were not identified during pre-marketing
evaluation, a post-marketing surveillance system has been
instituted by the FDA. The sample size of the typical pre-marketing
trial is small, with a short follow-up, when compared to the use of
the drug by the general population in which thousands and even
millions of patients will use the drug or devices for a long period
of time with the consequent development of drug reactions. The
post-marketing surveillance represents an attempt to address this
limitation and relies on spontaneous reporting by health care
providers and companies of adverse effects or reactions which were
associated with the use of the chemical compounds, devices,
cosmetics, or the like. The post-marketing surveillance system,
however, includes no system or method adapted to directly alert the
patients at risk. The post-marketing surveillance system instead
relies basically on the physician informing patients on an
individual basis. This is accomplished at the doctor's discretion
and using his/her available resources. The primary objective of the
post-marketing surveillance is to alert the health care provider
and companies, but no system is in effect to directly address the
individual user and all users of the harmful product.
[0013] The adverse events or reactions that result from the use of
drugs, devices, cosmetics, or the like can occur during different
stages of use (e.g., shortly after initiation of use, after long
term use, and even much later, after the drug, chemical compound or
device has been discontinued and/or recalled). Moreover, for each
one report received by the FDA, it is estimated that there may be
over 100 actual reactions. This demonstrates that the
post-marketing surveillance reporting system used by health care
providers substantially underestimates the actual number of adverse
reactions and effects. Unfortunately, the most common way for a
patient to discover that a product is harmful is after they have
suffered injury or even death caused by the harmful product.
[0014] Besides the unintended detrimental effects caused by drugs
and/or devices, the use of medications or devices may be associated
with unintended beneficial effects. The post-marketing surveillance
system also attempts to identify those beneficial effects and was
key in identifying that hormonal therapy in post-menopausal women
reduces death from cardiovascular disease, and that oral
contraceptive users have a lower risk of ovarian cancer. There is
consequently a need for a system and method that individually
informs all of the users of a beneficial effect related to the
particular drugs they are using.
[0015] The post-marketing surveillance system and prior art
currently used suffer from many limitations and drawbacks, and is
unable to efficiently identify, locate, prevent, and treat the
unintended harmful effects of a variety of products after the
product has been identified as harmful, as the above numbers
clearly show and some of the following examples will further
demonstrate.
[0016] A drug that was widely advertised on television by the name
Loratadine and which is used to treat allergies, was found during
post-marketing surveillance to cause esophagus rupture with even
potentially fatal complications. The unexpected reason for this
complication was identified as the size of the tablet for a
particular formulation. The tablet was too large and caused
blockages and subsequent potential rupture of the gastrointestinal
tract. As a result of rupture, caustic gastrointestinal contents
poured into the mediastinum and the surface of the heart,
potentially leading to the demise of the patient. Although there
was a great effort by the government and manufacturer to notify
doctors and patients about this catastrophic event, many patients
had no way of learning that their particular formulation of
Loratadine could cause these completely unexpected complications,
unless they were informed by their doctors or, in a few occasions,
through the media. Due to the widespread use of this drug and the
obvious difficulties in locating and alerting patients,
astonishingly even after the announcement to doctors and the public
by the FDA and the manufacturer about these devastating
complications, patients unfortunately still were using the
drug.
[0017] Another similar situation occurred with the antihistaminic
drug called Terfenadine, which was subsequently found to cause
potentially fatal arrhythmia when taken with certain antibiotics.
In many cases, even after a drug has been discontinued and/or
recalled, patients still use the recalled drug and are injured
because it is virtually impossible for doctors, companies, and even
the government to locate and inform all users of a particular drug
about the complications. Drugs used by patients are usually
manually written onto patients' charts. It would be necessary to
manually review the thousands of charts for every medical
practitioner and subsequently identify written information on the
chart regarding different medications used by each patient. Since
in most cases there is no indication about the date that a certain
patient was started on a particular medication, this chart review
would have to include the hundreds of pages that each chart may
have. Of course this would have to be done any time a new adverse
effect was identified for the drug as well as a new harmful drug
was identified. Naturally, this is an insurmountable task. The data
for each patient to be identified, located, and warned about the
potential hazardous situation is impossible to retrieve in any
practical manner. Sometimes the product does not need a
prescription which makes the direct identification and location of
the user impossible using existing record-keeping techniques. The
problem is further demonstrated by a situation involving a shampoo
capable of treating dandruff. That shampoo was later found to cause
fatal reactions, blindness, diabetes, and other severe
complications because of certain ingredients in its composition.
Since this product was being sold over-the-counter without the need
for a prescription, there is no way to identify who is using this
extremely dangerous shampoo, even though it has been recalled and
removed from the market. Users therefore continue to perish and
suffer because they do not have access to the information on the
hazards posed by the shampoo.
[0018] Unfortunately, the most common way that a user finds out
about the potential harmful effects of product is by suffering the
illness, injury or death caused by the harmful product. The above
are only a few examples of real events that occurred in connection
with such products. There are many other products causing harm and
being recalled every year.
[0019] The picture is unfortunately more shocking and alarming when
we consider the fact that defective products cause a similar amount
of injury as described above, and even deaths as the following
example will show. On May 12, 1998, a 17-month-old toddler died
when his portable crib collapsed and strangled him at a licensed
day-care facility in Chicago. The loss of a young child is surely
irreparable, but more difficult to accept is the fact that it could
have been prevented. Most astonishing is the fact that the portable
crib that killed the young child had been recalled in 1993, five
years earlier, by the United States Consumer Product Safety
Commission (CPSC) and by the manufacturer. Neither the parents nor
the day-care provider were aware of the recall. The crib collapsed
wedging the toddler's neck inside the folded V of the rails and
killing the child in one of the most horrifying ways, the inability
to breath. The child was prevented from breathing and could not cry
for help during the last minutes of his life. This same type of
crib had already strangled and killed many children, but the
available notification methods and system were inefficient and
incapable of tracking, identifying, locating, and alerting the user
about a potentially harmful and even deadly product. Although the
recall was publicized several times, primarily through the news
media, ads and other conventional, printed means, the message
reached a very limited portion of the population and, even today,
this deadly product is still present in many homes. It is important
to remember that strangulation if not fatal, can lead to brain
damage and a lifetime of nursing and institutional care for those
unfortunate toddlers. There is consequently an increase in health
care costs associated with these defective products, not to mention
the emotional toll.
[0020] The following illustration will further demonstrate the
inefficiency of existing systems and methods in recalling,
tracking, and locating already known harmful drugs and other
consumer products. Within weeks of the death of the aforementioned
child, his parents began an urgent and massive e-mail campaign
"Prevent death of next child" warning of the danger of the recalled
portable cribs with the message being forwarded all over the U.S.
and the world. The parents founded "Kids In Danger", a charitable
organization that warned millions of people in the U.S. and abroad
about the dangers of recalled juvenile products by granting
interviews to print, radio and television media and through E-mail
and printed warning campaigns. The message reached various
organizations, such as the American Academy of Pediatrics and other
major medical and public organizations. Many of the respondents had
a recalled crib but were not aware of the danger. Some of the
responses to the e-mail posted by "Kids in Danger" demonstrate the
magnitude of this alarming problem. The following are examples of
such responses:
[0021] 1). "The dissemination of recall information is horribly
lacking. We have called all of the manufacturers of the equipment
we use with our children and discovered that the carrier of our
stroller has been recalled because it flips children out of the
seat; we returned the warranty card over a year ago, when we
purchased the stroller, and still were not notified of the recall.
It is certainly clear now that parents and child care providers and
state agencies need to be proactive in chasing this information
down"
[0022] 2). "I think it's bad that we have to really research in
order to find out if a product we bought is considered safe. That
safety seems to be an ever-changing line, does it not? I grieve
with the families that have suffered; it is senseless."
[0023] 3). "I read the newspaper every day. I never heard about
this danger to my children until now."
[0024] This outstanding organization, "Kids in Danger", issued a
press release urging a far-reaching advertising campaign and began
a nationwide television and print media campaign and also
distributed public safety announcements to radio and television
stations nationwide, encouraging consumers to call the CPSC to
verify whether products in their possession have been recalled for
safety problems. The massive nationwide and international e-mail
campaign as well as massive media announcement, associated with
extensive government actions that occurred after the death of the
above-mentioned child were important and helpful, but unfortunately
inefficient and limited by the existing systems and techniques for
notification. Even after all of those efforts, the same needless
tragedy happened again, On Aug. 19, 1998 (only 3 months after the
aforementioned death), another innocent baby was killed by the same
product in Fair Haven, N.J. The second baby was killed in the same
terrifying manner. He was strangled to death when the same model of
portable crib collapsed and crushed his throat. Unfortunately, the
potentially life-saving recall information about the deadly crib
never reached this innocent child's parents. It is clear that the
commonly used systems and methods of notifying consumers suffer
from severe limitations. It is incapable of reliably recalling
and/or locating harmful products and the users of such harmful
products.
[0025] Interestingly state inspectors had visited the day-care a
week before one of the foregoing children died. The day care
center's manager also had no idea the crib had been recalled.
Despite a recall initiative by the City of Chicago, and the efforts
of others, only about 15% of the 1.5 million portable cribs and
play yards that were recalled, were actually accounted for. Thus,
more than 1.2 million defective cribs remain in circulation. This
further demonstrates the inefficiency and limitations of the
existing notification and recall methods and systems.
[0026] According to Consumer Reports 99Buying Guide "the odds of
your hearing about an unsafe product are slim. Manufacturers are
reluctant to issue a recall in the first place because they can be
costly. And getting the word out to consumers can be haphazard."
Likewise, according to the Kids in Danger organization, the only
way to be certain that you are not using a recalled product is to
check for yourself and periodically check with these government and
private agencies about new recalls. Unfortunately, there is no
commonly available method or system that actively searches and
notifies individually and privately the user for all of the unique
products that such users utilize and that informs the user about
warnings/recalls for all the products being used by that individual
user.
[0027] There are also web-sites that send undiscriminating and
random recall information for virtually all recalled products, but
it is obviously impossible and absolutely inappropriate to randomly
send thousands of e-mails every day for each user with the user
having to waste an incredible amount of time every day to sort
through all of the thousands of daily messages received in order to
identify a potentially harmful product that the particular user
happens to be using. Furthermore, even if the user identifies among
the thousands of daily messages the name of one product being used,
the user would have to know if that particular product being used
came from the plant or lot or section or processing area that
corresponds to the product being recalled. The user then would have
to check each package individually to try to find out if he/she has
obtained a recalled product. There is consequently a need for a
system or method that actively searches for the user and
individually informs the user about a recalled product according to
precise identification characteristics of the product such as
processing plant, section, and the like. Since it is not practical
or even appropriate to send thousands of daily messages to each of
the millions of users, existing notification schemes select and
send one message randomly to the user. There are clear limits and
drawbacks to such a scheme. The individual user, for example,
cannot afford the significant time, effort, and expense needed to
sort through the millions of recalled products to find out which
products being used by that user were actually previously recalled
and to seek the warning information for each and every product
being used by that user. Moreover, the user does not want to be
inundated with the millions of recalls and warnings that do not
correspond to the products being used by that user. Moreover, this
indiscriminate e-mailing has proven to be unable to reach the user
of a harmful product in a timely fashion, as the situation with the
deadly crib demonstrated, with the tragic death of a second
innocent child.
[0028] Notably, the existing notification systems tend to be
user-based. That is, the user ultimately has to actively search for
the recall and warning information about the products being used.
Such systems therefore are not product-based and product-driven.
There is a need, however, for a product-based and product-driven
system and method, wherein an active search is conducted for all of
the individual users of a particular product and the specific user
of the unique product passively waits for the information about
used products to reach him/her. In this regard, there is also a
need for a method and system that provides such information to the
user as soon as it becomes available.
[0029] In 1998 alone, the CPSC recalled more than 38 million
individual units concerning harmful children's products. However,
because most people never hear about these recalls, the majority of
the recalled harmful products are still being used. CPSC usually
relies on the media, printed material and manufacturers to recall
harmful products voluntarily and most of the manufacturers
cooperated. This, however, falls well short of guaranteeing
effective results. During the past decade, 622 children have died
in defective cribs, a rate of 57 children per year. In addition, at
least 137,000 children were hurt. This translates to a rate of
almost 400 child injuries per day. CPSC uses various means to
inform the public. These include local and national media coverage,
publication of numerous booklets and product alerts, a web site, a
telephone Hotline, a Fax-On-Demand service, the National Injury
Information Clearinghouse, and the CPSC's Public Information
Center. There also are several web-sites and other means that
publicly announce recalled products. However, they are not
sufficient as the figures show. There is consequently a need for
new means and technology capable of preventing those tragic
events.
[0030] According to a CPSC spokesman, recalls also depend heavily
on the cooperation of the news media. In the case of the
aforementioned crib, the agency issues new press releases every
time a child dies in the crib. The crib is also included in the
agency's "recall roundup," an annual news release that lists some
of the most dangerous recalled products. The CPSC issues hundreds
of press releases every year, including video news releases for
television stations. This further demonstrates the long-standing
need for a system capable of alerting users of potentially harmful
products and thereby preventing injury.
[0031] Companies also are trying desperately to track and identify
the recalled products as can be seen by another press release
issued by the manufacturer of the deadly crib, after the death of
the second baby in August of 1998. "This is a terrible tragedy we
had hoped to prevent when we voluntarily recalled the Playskool
Travel-Lite crib in 1993 and immediately began extensive public
awareness efforts to urge consumers to stop using the products", an
officer of the company said in his written statement. The
manufacturer said that they franticly have done everything possible
to recall the cribs after the death in May 1998. The company has,
in fact, extensively advertised using all means, written directly
to pediatricians and to all J. C. Penney catalog customers; mailed
posters to stores that carried the cribs; set up a toll-free
telephone hot line; and offered consumers $60 for the return of
each crib (the cribs originally sold for about $89 each). Of
course, all of that was not enough and one more child, among the
many who died, was strangled to death, and the tragedy
repeated.
[0032] Another critical issue related to the recall system
currently used is the negative impact on the general reputation of
business. This indirectly discourages companies from putting forth
their best efforts to recall defective products. According to the
United States CPSC, underreporting products that could cause injury
or death is a very serious problem. This business concern, however,
arises primarily because of the means by which both the CPSC and
manufacturers inform the public. Typically, the news media and
other forms of mass public disclosure are used. The bad publicity
through the media has a devastating financial impact on the
manufacturer of the recalled product. According to studies by Paul
Rubin, former chief economist for the CPSC and professor of
economics at Emory University, a company loses 7% of its revenues
after each recall. It is easy to recognize the financial disaster
faced by companies and the economy of the nation in general when
the current, public means are used to alert users of potentially
harmful products. There is consequently a need for a system and
method capable of privately and individually alerting the user
about a recalled and/or harmful product.
[0033] The current way of recalling also is very expensive. It
therefore is difficult for companies to exert aggressive recall
efforts. The federal government likewise is reluctant to impose too
many restrictions on manufacturers because it could put hundreds if
not thousands of companies out of business with the consequent
uncontrolled increase in unemployment and the catastrophic effect
on the economy of the nation. Although the government is to some
extent charged with the responsibility of ensuring safety and
protecting the population, the government is faced with a complex
and perplexing challenge. It must balance the interest of safety on
the one hand, against its interest in avoiding the consequences of
forcing companies to spend money to recall products and to publicly
advertise more aggressively their recalls of potentially harmful
products (which could lead to increases in bankruptcy and the
consequent irreparable damage to the economy of the nation). There
is consequently a need to solve these problems associated with
conventional recall techniques, by providing a system and method
capable of privately and individually identifying, locating, and
informing all users of a recalled product.
[0034] To find 10 deadly products that were sold to 10 out of 100
million potential purchasers is a daunting and currently virtually
impossible task. Thus, 10 people can die because of the deadly
effect of the harmful recalled products. Thus, there is a need for
a system and method capable of individually identifying each
particular product that is being recalled and the particular users
of the product, and providing a warning to such users. This need
for a system of identifying and warning all users of such
potentially harmful products extends to one that, in addition to
the savings in terms of lives, injury and costs provided thereby,
can be implemented in a cost-efficient manner.
[0035] Recently, there has been an increase in the number of foods
and other products that are imported and that are more likely to
cause unintended harmful effects. Moreover, public sector spending
on the consequences of adverse drug reactions is expected to
accelerate since prescription drugs grew at double-digit rates
during the last few years. This acceleration in prescription drug
use can be attributed, at least in part, to the number of new
life-saving drugs entering the marketplace, increased consumer
demand induced by drug manufacturer advertising, and an increase in
the number of prescriptions filled. It is expected that, in the
year 2000, each American will use an average of 8 to 9 drugs. This
will increase life expectancy and enhance quality of life, but also
will cause unintended harmful effects. Besides rising utilization
(number of prescriptions), there also will be an increase in
intensity (including changes in size and mix of prescriptions)
that, in turn, will lead to a greater risk for reactions. It will
be virtually impossible to slow the growth on national health
expenditures if there is no way to efficiently, privately, and
timely identify, locate, prevent and provide guidance regarding
potential injury and illness due to unintended harmful effects of
products. For extended care, both nursing home and home health
expenditures are expected to grow, as more people become disabled
due to the unintended harmful effects of a variety of products.
Left uncorrected, the number of injuries, illnesses and deaths due
to the lack of timely identification and location of users of
defective, contaminated products, and drug reactions, as well as
illnesses caused by food, will boost the demand for medical
services, exponentially increase health care costs, and cause
significant increases in income tax to compensate for the rising
cost of health care. There is consequently an urgent and vital need
for technology that can privately, individually, timely,
continuously, confidentially, reliably and/or cost-effectively
track, identify, locate, inform and alert all of the users of
potentially harmful products. It is also extremely desirable to
have a system that returns only specific information relevant to
the individual user of a unique product, and not random and/or mass
information about a variety of products that do not relate to the
user, thus avoiding the unnecessary transfer of information and
documents that are not relevant to the user, and making it more
practical and convenient (therefore more likely) for the user to
become consciously aware of the warning.
SUMMARY
[0036] It is a primary object of the present invention to overcome
at least one of the foregoing problems by providing a system and
method for communicating product recall information, product
warnings, or other product-related information to users of such
products. The present invention facilitates implementation of an
electronic and network-based recall and information system that is
product-driven and/or biological variable-driven, to assist the
user of the system in timely identifying a health hazard or any
other hazardous situation or difficulties due to unintended harmful
effects and adverse consequences of a variety of products and/or
biological variables, and to prevent the occurrence of such harmful
effects. In this regard, the present invention can provide a way of
preventing the spread and continuation of such harmful effects, for
example, by tracking, identifying, and locating dangerous products,
and/or by tracking, identifying, and locating the adverse reactions
and adverse effects of drugs, medical devices, food, cosmetics and
other consumer products. The present invention therefore allows
appropriate action and preventive measures to be taken with respect
to the potentially hazardous situation. It can do this by
privately, timely, individually, and cost-efficiently locating and
alerting the users at risk and/or by providing guidelines to assist
such users before any difficulties, damage or injury occurs.
According to the present invention, this can be achieved using a
portable device into which data is entered using, for example,
bar-code technology. The portable device can be associated with a
computer-based system in which the information on harmful products
is continuously updated by recall and information sources and is
automatically transmitted over a public network and/or the
Internet. The transmission of such information on harmful products
can be performed using a server that receives, retrieves, stores
and sends the information on recalled products to a user identified
as being a user of such recalled products. The server also can
store the information for later retransmission to other users who
subsequently enter data indicating that they are users of such
recalled products.
[0037] Advantages and objects of the present invention can be
achieved by providing a completely automatic, electronic, and
network-based recall and information system for a variety of
products, for interaction among products and/or biological
variables adapted to prevent and control any harmful effects of
products by providing electronic data communications of such
recalls and information. The communication system preferably
includes an electronic hand-held portable terminal and a network
information system. The portable terminal can include a device
capable of acquiring product identifiers and/or biological
variables. The network information system can be adapted to assist
the user in timely identifying a health hazard or any other
hazardous situation or complications due to unintended harmful
effects and adverse consequences of a variety of products and/or
biological variables, as well as to prevent the occurrence of the
harmful effects and to prevent the spread and continuation of such
harmful effects. It can do this by tracking, identifying and
locating potentially harmful products and the users of such harmful
products, and by alerting and informing such users about the
adverse reactions and adverse effects of drugs, medical devices,
food, cosmetics, other consumer products, and the like. This allows
the users of such products to take appropriate action with respect
to a possible unintended harmful effect of such products,
preferably using a system that can privately, individually, timely,
continuously, confidentially, reliably and cost-effectively track,
identify, locate and alert all of the users of potentially harmful
products with a very low cost, electronically-based
arrangement.
[0038] The apparatus and methods of the present invention can
include an electronic and Internet-based recall system comprising
hardware, firmware and software. The system can utilize a database
of potentially harmful product utilization and variables such as
objective biological variables, and/or objective factors which
alter a biological variable, with the objective data, as well as
product usage information, being acquired, processed, and
transmitted using a computer-based system integrated with a public
network such as the Internet, for purposes of precisely locating a
user exposed to a hazardous situation in a timely manner, and
delivering information/instructions regarding such a hazardous
situation or potentially hazardous situation. Preferably, an
automated and automatically adjusted and updated system is provided
in a reliable and cost-effective manner and is capable of timely
and precisely locating and warning a user at risk or exposed to a
potentially hazardous situation.
[0039] According to a preferred embodiment, the present invention
provides a product-based and product-driven system in which
reliable product information is used to actively search for all of
the individual users of a unique product and all users of products
acquire information on each and every product they use, preferably
in a passive manner (i.e., the users need not actively seek the
information), wherein the acquired information comprises recall
information, information regarding potentially harmful effects,
and/or information regarding beneficial effects for each and every
product used. The product information preferably is delivered
instantaneously as soon as the information becomes available. The
product recall and warning information for all of the products
utilized by each user, in this regard, searches for and finds the
user, rather than requiring the user to find the recall and warning
information through his/her own efforts.
[0040] In accordance with another preferred embodiment, the
invention provides a product-based and biological variable-based
system having a location, information and recall system that
preferably provides electronic transmission of data via the
Internet. The product-based and biological variable-based system
includes a portable hand-held device (or otherwise portable unit)
that can be carried by the user. The portable hand-held unit
preferably stores data related to unique product identifications.
This data can be acquired, for example, from optically encoded
symbols and then can be transmitted to a remotely located central
server that is adapted to receive and store the user's product data
and a username and also is adapted to receive and store information
from remote recall and information sources such as government
agencies, private institutions such as medical institutions,
manufacturing companies, and the like. The system allows a
plurality of users who have product information stored in a
database of the central server on their behalf to update and
transmit information to the database using a public network, such
as the Internet, and to receive feedback information on the
products stored in the database. The computer server can send
information and warnings about the products for which data is
stored in the database, as soon as such information or warnings are
received, to all of the users of the products. These warnings or
information can be sent via electronic communication means,
preferably through the Internet. The hand-held device carried by
the user provides a record of all of the products being utilized by
that user and biological variables, which record can be transmitted
to the central server by the hand-held device. The system is
described herein using the terms username, IP (Internet protocol)
address, domain name address, and full Internet address
interchangeably to denote a specific confidential address of a user
of a product. The combination of the various networks, computer
units, users, server(s), and recall and information sources that
defines the location, communication and information system
according to the principles of the invention is referred to herein
as a GPI System (General Product Information System) or Intelligent
Systems for Recall and Notification. Any variable that can be
measured in a living tissue, for the purpose of the description, is
referred to herein as a biological variable or biometric
information. Factors which alter biological variables include any
physical or chemical action or interaction with/to living tissue
that causes any change in, on, or surrounding the living tissue.
Any chemical compound that alters any biological variable or any
living tissue is referred to herein as a drug. Any network of
computers, for the purpose of the description, may be referred
herein as the Internet. User, consumer, customer and patient, for
the purpose of the description, herein are used interchangeably and
denote a living being at risk of harm or death caused by the
unintended harmful effect of a product.
[0041] It is another object and advantage of the invention to
provide a novel electronic recall system that can precisely
identify all of the users of a harmful product.
[0042] It is still another object and advantage of the invention to
provide a novel electronic recall system based on electronic
communications via the Internet.
[0043] Yet another object and advantage of the invention is to
provide an electronic information and location system that can
privately and confidentially locate and alert the users of a
harmful product.
[0044] It is still another object and advantage of the invention to
provide an electronic and network-based information and location
system that can individually locate and alert the user of a harmful
product.
[0045] It is still another object and advantage of the invention to
provide an electronic and network-based information and location
system that can timely locate and alert a user of one or more
harmful products.
[0046] It is a further object and advantage of the invention to
provide a system in which a recall database is continuously updated
and items of the database are automatically transmitted
electronically.
[0047] Still another advantage and object of the invention is to
provide a system in which the user of the harmful product can be
located and informed about the potential hazard, but the user can
remain anonymous throughout the process of tracking and locating
the user, and receiving and using the information.
[0048] A further advantage and object of the present invention is
to provide a system that is continuously updated with the latest
product-related information available to the users of potentially
harmful products.
[0049] It is yet a further advantage and object of the present
invention to provide a system that provides only proven information
from reliable sources about the products utilized by the user or
biological variables acquired by the user.
[0050] It is another advantage and object of the invention to
provide an alert system in regards to the interaction between
dynamically changing biological variables and products as well as
product-to-product interaction, with timely identification of the
hazard and subsequent institution of treatment or prevention
measures specifically tailored for the individual user of a
particular product.
[0051] Yet another advantage and object of the present invention is
to provide guidelines and instructions to assist the user of a
potentially harmful product before any insult, illness or injury
occurs.
[0052] It is also an advantage and object of the present invention
to provide an information system not only about the newly found
harmful features of products, but also the newly found beneficial
features of products.
[0053] It is also another advantage and object of the invention to
provide an electronically-based cost-effective system for recalling
harmful products.
[0054] It is still another advantage and object of the invention to
provide a reporting system in which the users can report any
harmful event that occurred with the use of the product and/or any
product contamination, labeling concerns, or questionable product
stability.
[0055] It is yet another object and advantage of the preset
invention to provide a confidential alert system that protects
against the financial disaster that invariably occurs to companies
which rely on publicly announced recalls.
[0056] It is also an object and advantage of the present invention
to provide an economically practical way for government agencies
and private companies to implement their recall programs.
[0057] Another object and advantage of the present invention is to
provide a system that can assist the user in identifying substances
that the user should avoid without requiring the user to read all
of the chemical ingredients described in the label of a
product.
[0058] It is still another advantage and object of the invention to
provide a system that informs the user of the existence of
alternative products which do not interact with drugs being used
and/or the biological variables of the user, and to inform the user
about alternative products which may be beneficial to the user
according to the information about the user.
[0059] It is still a further advantage and object of the invention
to provide a system that offers an opportunity for the user to
replace or purchase an alternative product as a replacement to the
recalled product.
[0060] It is yet a further advantage and object of the invention to
provide a system that interfaces with credit card clearing houses
and/or retailer's product information storage and processing
medium.
[0061] It is yet a further object to provide a system with a bar
code-based or magnetic-based Safety Card.
[0062] It is still a further object of the invention to provide a
system that automatically informs credit card users or swipe card
users about recalled products purchased using said cards.
[0063] It is still a further object and advantage of the invention
to provide a system capable of assisting government agencies in
their efforts to locate plants that potentially do not have good
manufacturing practices, so that such plants can be inspected.
[0064] It is yet a further object and advantage of the invention to
provide a system to assist government agencies in identifying and
locating imported products for collection of samples and
inspection.
[0065] It is still a further object and advantage of the invention
to provide a time-efficient and orderly system of the types
described above, using optically encoded symbology.
[0066] It is still another advantage and object of the invention to
provide a low-cost and simple to use hand-held portable unit that
can be universally and unrestrictedly utilized.
[0067] It is yet another advantage and object of the invention to
provide a novel electronic recall and information system with a
hand-held portable unit that can be used by hearing impaired or
visually impaired users.
[0068] It is still another object and advantage of the invention to
provide a system with information cards and smart cards with
extended storage capabilities for the tracking, identification and
location of a user of a potentially harmful product.
[0069] It is another object and advantage of the invention to
provide a communication and information system in which the user
communicates with a server and receives instantaneous information
as to whether such a user is utilizing a recalled product and what
level of hazard is presented to the user by exposure to or use of
such a product.
[0070] Another object and advantage of the present invention is to
provide a system in which the users who seek warning or recall
information receive only information about the specific products
being used, to thereby avoid being inundated with meaningless
and/or random product warning information.
[0071] Another object and advantage of the present invention is to
provide a system that can electronically receive not only text but
also image data related to information about the harmful product
being used.
[0072] Another object and advantage of the present invention is to
provide a system that is coupled with the most reliable and updated
information sources including government agencies, manufacturers,
and the like.
[0073] It is a further object and feature of the invention to
provide a system for the complete delivery of health care in
response to the effects of harmful products, for example, by
contacting and dispatching emergency medical services, scheduling
an appointment, laboratory testing, and/or other diagnostic
testing, prescribing and delivering drugs, and providing insurance
approval.
[0074] Another object and advantage of the present invention is to
provide a system that optimizes the interaction among the pharmacy,
insurance agencies, and the user.
[0075] Another object and advantage of the present invention is to
provide a system that uses non-subjective biological, medical,
treatment, and diagnostic data and variables.
[0076] It is still a further advantage and object of the invention
to provide a tracking, location and identification system that
allows specifically tailored information to be delivered to the
user.
[0077] It is a further object and feature of the invention to
provide a system in which a hand-held portable device can
communicate with another hand-held portable device.
[0078] It is still another object and advantage of the present
invention to provide a system that allows the timely intervention
and treatment of diseases before complications or/and unintended
harmful effects occur.
[0079] It is a further object and feature of the invention to
provide an interactive system for home monitoring and
self-measuring devices.
[0080] It is still a further object and advantage of the invention
to provide a system capable of incorporating data entry peripheral
devices and coupling with various home-use data acquisition and
transmission devices, as well as home-monitoring devices, and to
provide a system that can communicate with a variety of processing
devices.
[0081] Another object and advantage of the preset invention is to
provide a completely paperless system for recalling harmful
products.
[0082] It is also an object and advantage of the preset invention
to alternatively provide a system that can receive handwritten
input data and voice input data, in addition to data that
preferably is optically encoded.
[0083] It is still a further object and advantage of the present
invention to provide a system with an acoustic coupling arrangement
that couples the hand-held device with telephone lines to establish
a direct connection with a central server and create a two-way
telephone communication link.
[0084] It is still another object and advantage of the present
invention to provide a hand-held device of the type described above
that can be attached to a second module, such as a home measuring
device.
[0085] It is yet another object and advantage of the present
invention to provide a system wherein the hand-held device can
communicate directly with the central server by telephone lines,
optical means, radio frequency links and the like, in order to
locate, identify, and inform the user of a harmful product.
[0086] The above and other objects and advantages will become more
readily apparent when reference is made to the following
description taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0087] FIG. 1 is a schematic diagram of one exemplary embodiment of
a data processing system according to the present invention.
[0088] FIG. 2 depicts in more detail a computer system in
accordance with the embodiment in FIG. 1.
[0089] FIGS. 3A and 3B are a perspective view and a block diagram,
respectively, of a portable unit according to an exemplary
embodiment of the present invention.
[0090] FIG. 3C is a front view of an exemplary keypad of the
portable unit illustrated in FIGS. 3A and 3B.
[0091] FIG. 4 is a schematic view of an exemplary embodiment of the
portable unit when provided with a wireless connection to health
monitoring devices, according to a preferred embodiment of the
present invention.
[0092] FIG. 5A is a block diagram of an exemplary general product
information system according to the present invention.
[0093] FIG. 5B is a block diagram of a general product information
system similar to that of FIG. 5A but implemented using a portable
unit, instead of a desk-top personal computer, and showing an
exemplary screen that can be displayed by the portable unit.
[0094] FIGS. 5C through 5J are schematic views of exemplary
implementations of point-of-transaction systems for gathering
product data using a swipe card or smart card, according to the
principles of the invention.
[0095] FIG. 5K is a block diagram depicting an exemplary embodiment
of a point-of-transaction system.
[0096] FIGS. 5L through 5N are flow charts illustrating an
exemplary sequence of operating steps that can be used when
transferring product identifiers and acquiring information related
to such product identifiers, according to a preferred embodiment of
the present invention.
[0097] FIGS. 5P and 5Q are block diagrams of an exemplary
connection between a third party server and the central server
according to preferred embodiments of the present invention.
[0098] FIG. 6 is a block diagram depicting an exemplary embodiment
of a central server according to the present invention.
[0099] FIGS. 7A and 7B are a menu diagram illustrating exemplary
product recall and information menus that can be displayed in an
open display window on a user's personal computer in accordance
with the embodiment depicted in FIG. 6.
[0100] FIGS. 8A through 8C are schematic views of an exemplary
memory arrangement according to the principles of the
invention.
[0101] FIG. 9 is a block diagram showing an exemplary embodiment of
a central server in accordance with the embodiment shown in FIG.
8.
[0102] FIG. 10 is a flow chart illustrating initial processing
according to the principles of the invention.
[0103] FIGS. 11A through 11L are flow charts illustrating an
exemplary sequence of operating steps that can be used when
transferring product identifiers and acquiring information related
to such product identifiers.
[0104] FIGS. 12A through 12E are flow charts illustrating an
exemplary sequence of operating steps that can be used when
transferring biological variables and acquiring information related
to such biological variables.
[0105] FIGS. 13A and 13B are flow charts illustrating an exemplary
sequence of operating steps that can be used when acquiring
information from remote computers according to the principles of
the invention.
[0106] FIGS. 14A and 14B are flow charts illustrating another
exemplary sequence of operating steps that can be used when
acquiring information from remote computers according to the
principles of the invention.
[0107] FIGS. 15A and 15B are flow charts illustrating another
exemplary sequence of operating steps that can be used when
acquiring information from remote computers according to the
principles of the invention.
[0108] FIG. 16 is a flow chart illustrating steps that can be
performed when data is acquired by the portable unit.
[0109] FIGS. 17A through 17C are flow charts illustrating exemplary
steps that can be performed when acquiring, deleting or using
product data provided by the portable unit.
[0110] FIGS. 18A through 18C are flow charts illustrating exemplary
steps that can be performed when acquiring, deleting or using
biological variable data provided by the portable unit.
[0111] FIGS. 19A and 19B are flow charts illustrating exemplary
steps that can be performed when removing data via the portable
unit.
[0112] FIGS. 20A and 20B are flow charts illustrating an exemplary
sequence of operating steps that can be performed when removing
data via the central server according to the principles of the
invention.
[0113] FIG. 21 is a block diagram illustrating a system adapted to
acquire data and transmit data between IECLD units, according to an
exemplary embodiment of the invention.
DETAILED DESCRIPTION
[0114] With reference to FIG. 1, a preferred embodiment of the
present invention provides an electronic communication,
information, and locating system, generally designated by the
reference numeral 1, for recalls and information on products and
biological variables. The system 1 is capable of preventing and
controlling the unintended harmful effects of products. The
electronic communications provided by the system 1 preferably are
carried out using packet technology via the Internet 100. The
system 1 preferably includes a main central server 10 connected to
a variety of entities and computers via the Internet 100 (or via
any other suitable network such as telephone lines 19, wired means
18 and wireless means 16 including private virtual networks). The
central server 10 also can be coupled to one or more
microprocessor-based hand-held portable units 40. The portable
unit(s) 40 preferably are implemented with bar code reading
capabilities.
[0115] The embodiment depicted in FIG. 1 includes a central
computer that serves as the central server 10 and that is
associated with a plurality of remote computers, generally
designated by the reference numeral 20, and as well as a plurality
of computer systems 30. Some or all of the computer systems 30 can
be associated with respective ones of the portable units 40 via
wired 18a or wireless 16a means. Each portable unit 40 preferably
is implemented using a hand-held, programmable,
microprocessor-based unit. The microprocessor-based portable units
40 can be coupled to health monitoring devices 50. The combination
of the foregoing units with their respective functions provides an
exemplary embodiment of a General Product Information (GPI) system
1 according to the present invention. The system 1 thus can include
Recall and Information Sources (RIS) computing units 60, Providers
of Health Care (PHC) computing units 70, the aforementioned
computer systems 30 (e.g., provided as personal computers),
portable computer units 40, home-measuring devices 50, the Internet
100, and data input and output devices such as keyboard(s) 15,
display(s) 22, and the like (collectively referred to as
interactive devices 15,22). The user 90 may be human, but also can
be another computer application which interacts with interactive
devices 15,22 or the like, to send information and/or receive
information to/from the central server 10. The RIS units 60 and PHC
units 70 preferably connect to the Internet 100 using high-speed T1
or T3 connections. Each portable unit 40 or computer system 30 can
connect to the Internet 100 using a conventional communications
interface (e.g. a modem with suitable software, and the like).
[0116] The computer system 30 can be physically embodied in a
workstation or a computer terminal, as well as conventional
personal computers, such as desk-top computers, lap-top computers,
hand-held computers, Personal Digital Assistants, electronic
organizers, cellular phones, television units, web-based TV or
virtually any suitably configured computation or electronic
equipment that can be connected to the Internet 100 or telephone
lines 19, or wired means 18 or wireless means 16 for the transfer
of information to the user 90, which information includes data
regarding uniquely identified products and/or biological variables
according to the principles of the invention. As mentioned above, a
cellular phone as well as a watch can be used to receive automatic
updates about recalled and/or harmful products and can act as the
computer system 30 of the invention. While the Internet-based
system is preferred, the portable unit 40 and the computer system
30 also can consist of any computation or electronic means capable
of transferring and receiving information on uniquely identified
products and/or biological variables according to the principles of
the invention
[0117] The hand-held portable unit 40 will be described hereinafter
as an Individual Electronic Communicator and Locator Device (IECLD
40). According to an exemplary embodiment of the IECLD 40, the
IECLD 40 is connected by the Internet 100 to a main central server
10 that is protected by a suitable firewall 23. The IECLD 40 shown
in FIG. 1 comprises a portable hand-held microprocessor-based unit
with a keypad 12 for selection of product categories and a bar code
reader wand 14. The IECLD 40 is adapted to acquire, process, and
transfer data. It is understood, however, that the IECLD 40 can
operate while coupled with a computer system 30, preferably of the
type described above. The IECLD 40, in addition to having the
keypad 12, can be provided with a wireless input device 16b for use
when inputting or entering a unique identifier code for individual
products used by uniquely identified users 90. The unique product
codes preferably are optically encoded (e.g., as a bar code element
150). Although the preferred embodiment includes the IECLD 40 for
purposes of acquiring and entering information, it is understood
that the users 90 of the product can enter the product data and
user data directly into their computer systems 30 using a keyboard
15 for subsequent transmission to the central server 10.
[0118] In this disclosure, the central server 10 will be referred
to as the General Product Information (GPI) and the source and
information entities will be referred to as remote computers 20 or
more particularly as Recall and Information Sources (RIS) 60
whereas the providers of health care entities are referred to as
Providers of Health Care (PHC) 70.
[0119] The system 1 includes the central server 10 (or GPI). The
central server 10 can be located remotely from the computer system
30. The central server 10 acquires, receives, retrieves, stores,
searches, processes, transfers and connects the data and/or
information on products and/or biological variables to/from the
user 90 and/or to/from other RIS entities 60 and PHC entities 70.
Preferably, this is accomplished via the Internet 100. The central
server 10 can establish communication channels with the RIS 60 and
PHC 70. The central server 10 also is programmed to handle
electronic transfer of data, including conventional e-mail, and has
data storage and processing capabilities for storing and processing
the pertinent data. To facilitate this process, the server 10 can
be provided with multiple modems and telephone lines coming into it
through which data is transferred. It is understood, however, that
other physically wired telephone lines, or wireless communication
links, such as cable, satellite transmission, radio transmission,
optical transmission, and the like, as well as conventional
telephone phone lines or digital telephone lines, and other
electronic transmission means or any electronic transmission over
the Internet 100 or any high-speed Internet connection can be used
by the central server 10 (or GPI) as a communications medium. The
central server 10 (or GPI) preferably contains software, firmware
and hardware capable of carrying out any requisite protocols, such
as search applications that are well known. The other units of the
system 1 preferably comprise devices (such as modems and the like)
that enable communications with other units, as well as programs
that facilitate implementation of protocols according to the
principles of the invention. The GPI system 1 includes information
retrieval engines for text and multi-media files and is capable of
performing searches through the stored database. The GPI system 1
also can include search engines that search the World Wide Web and
equipment to connect the user to web sites related to the search
topic. It is understood that the invention is not limited to any
particular types of hardware and software, nor is it limited to any
particular method of communication, inasmuch as there are virtually
endless combinations of technology that can be employed to carry
out the present invention.
[0120] While the central server 10 (or GPI) is shown schematically
in the drawings as one single unit, it is understood that a
plurality of networked computers can be employed. This, in turn,
allows continuation of service in the event of a hardware failure
of a server 10. It also allows the use of larger storage and
processing capabilities. The central server 10 (or GPI) operates as
the central database where all the unique usernames, unique product
identifier codes, biological variables, product and user
information, recall/warning information, harmful effects of
products, beneficial effects of products, and product-to-biological
variable interaction information and product-to-product interaction
information are maintained. The stored information can be made
available to the user 90 electronically via the Internet 100 or by
conventional, physically wired means 18, wireless means 16, or the
like.
[0121] In the embodiment shown in FIG. 1, the user 90 inputs
product identifying information regarding products that are being
used, preferably by acquiring the product identifying information
from optically encoded symbols (e.g., using a bar code reader 14),
and electronically transmits this information to the central server
10 (or GPI), preferably through the Internet 100. The product
identifying information can be transmitted as a unique identifier
for that individual product, along with an indication of the unique
particular user 90 who is or will be using the identified product.
The latter indication can be provided using a unique username. The
central server 10 (or GPI) transfers information to/from Recall and
Information Sources (RIS) 60 and to/from the users 90 of the
product while acquiring information from the RIS 60 on products.
This information is acquired based on the transmitted product
identifier. As shown in FIG. 1, the product identifier preferably
is derived from a unique bar code number 150 that is applied to or
otherwise associated with each product. The search of the RIS 60
can be performed using automated processors according to
applications described hereinafter, which applications interact
with and search the Internet 100 and remote computers 20 according
to the product identifier. The user 90 thus can provide the unique
product identifiers, as well as values for biological variables, to
the central server 10 by way of a communication medium such as the
Internet 100. The values or other data indicative of the biological
variables and product identifiers can be stored in the central
server 10 (e.g., in a database of the server 10, as will be
described hereinafter) according to the principles of the
invention.
[0122] When the invention is implemented using the IECLD 40, the
unique bar code number 150 for the particular product being used is
acquired using the bar code reader 14 present on the IECLD 40. The
bar code number 150 representing a unique product identifier then
can be converted to a binary number and transmitted using a
suitable communication interface to one of the computer systems 30.
The binary number derived from the bar code number 150 can be
stored at the computer system 30. The product identifying
information then can be transmitted to the central server 10 (or
GPI), where it can be stored in a memory device (or database) of
the central server 10 (or GPI) under the user's name (e.g. under a
username with a full Internet address being used to identify the
user). Alternatively, the binary number can be transmitted directly
from the portable unit 40 (or IECLD) to the central server 10 (or
GPI). Every time a new product is used, the data on the product is
acquired, transmitted, and stored in the database of the central
server 10 under the username of the individual who is submitting
the individual product code.
[0123] FIG. 1 also shows the various entities and sources that can
be connected to the central server 10 (or GPI) via a communications
network. Preferably, as shown in FIG. 1, the central server 10 (or
GPI) is connected to remote computers 20, which include RIS, at
government and private agencies/institutions in the U.S. and
abroad, such as, the United States FDA 130 (Food and Drug
Administration), the United States CSPC 132 (Consumer Safety
Product Commission), the United States EPA 134 (Environment
Protection Agency), the United States CDC 136 (Centers for Disease
Control), the United States Department of Agriculture (USDA) 138,
United States National Institutes of Health (NIH) 140, United
States Department of Health and Human Services (HHS) 142, the World
Health Organization (WHO) 144 as well as international and domestic
agencies and institutions 146 (such as, for example, but not
limited to the Japanese Ministry of Health and Welfare, Canadian
Food Inspection Agency, German Federal Institute for Drugs and
Medical Devices, French Agency for Medicine, the Pharmaceutical
Inspectorate in Belgium, the "Secretariat de Salud" in Mexico, the
Ministry of Health in Brazil) as well as the U.S. Department of
Energy, the U.S. Department of Transportation, and the like. The
central server 10 (or GPI) also is connected to other RIS remote
computers 60, for example, computers operated by the
manufacturers/distributors 148 of the products for which
information is stored in the database of the central server 10 (or
GPI), medical institutions 152, research facilities 154, public
computer terminals (PCT) 156, pharmacies 151, the Federal Trade
Commission 153, hospitals 155, and the like. The above named
various entities relate to the sources for recall and information
relating to the products stored in the memory medium of the central
server 10 (or GPI). For purposes of this description, such entities
are collectively referred to herein as Recall and Information
Sources 60 (RIS). The RIS computers 60 connected to the central
server 10 (or GPI) facilitate implementation of the present
invention by providing a reliable source of proven information
about the products being used. The PCT 156 or Public Computer
Terminal mentioned above, for the purpose of the invention, is a
computer system located in a public place through which anyone can
transfer data on products being used to the central server 10 (or
GPI).
[0124] FIG. 1 shows the central server 10 (or GPI) connected to the
computers for the various RIS 60 via particular links to a
communications network (e.g., the Internet 100). The central server
10 (or GPI) also is connected via the Internet 100 to a personal
computer 30 of a user 90 or to the portable IECLD 40 of the user
90, with the central server 10 (or GPI) acquiring up-to-the-minute
updates on the products stored in the central server 10 database
from the institutions and agencies described above as RIS 60.
Although each block is labeled as a particular entity/entities or
user, the present invention can be implemented using any computing
device that performs the computations and communications that are
carried out by the entity/entities and/or users. FIG. 1 also shows
the central server 10 (or GPI) as being connected to remote
computers 20 which include the various providers of health care 70
(i.e., PHC entities). The PHC 70 include one or more insurance
companies 71, one or more emergency medical services (EMS) 72, one
or more medical institutions (MI) 73, one or more doctor's offices
(DR) 74, one or more laboratories (LAB) 75, and/or one or more
pharmacies (PH) 76. It is understood that the central server 10 (or
GPI) can operate as a web server for both receiving and
transmitting product identifiers and/or product information to/from
the user 90 and to/from the RIS 60 and to/from the PHC 70 including
searching/retrieval for both text and multimedia files related to
the product identifier and/or biological variable.
[0125] An exemplary embodiment of the system also includes
home-monitoring devices herein described as health monitoring
devices (HMD) 50 interfaced with the IECLD 40. The interface
preferably is a wireless interface 16 through which data can be
transmitted. Examples of the home-measuring devices 50 include
those patented and/or developed by the Applicant hereof, as well as
other devices that are known in the art of home health monitoring
and/or doctor's office monitoring. More specific examples of such
devices are a self-tonometer for home-measurement of eye pressure
52, a non-invasive blood analysis device 53, a continuous
temperature monitoring device 54, a conventional electronic,
at-home, blood-pressure monitoring device 55, and a conventional
electronic scale 56. In addition, the HMD 50 can include a
microfluidics-based intelligent contact lens 57, and/or as shown in
FIG. 4, a heart rate and/or rhythm monitor 58. It is understood
though that any device that measures any biological variable,
physical variable, chemical variables or any device, method, or
system used for the delivery of health care including evaluation,
diagnosis, monitoring or treatment of patients can be used in the
invention as an HMD 50, including any device that has a unique
identification and interacts with patients during the process of
providing health care, such as diagnosis, monitoring and treatment
(e.g., infusion pumps, catheters, ventilators, electrocardiogram
(EKG) machines, and the like). The data acquired by such HMD 50 can
be transmitted to the central server 10 (or GPI) and can be stored
in the central server 10 (or GPI) for further processing and
transmission of information back to the user 90 according to the
principles of the invention.
[0126] Preferably, the electronic information communication system
between the central server 10 (or GPI) and the various RIS 60 and
also between the central server 10 (or GPI) and the user 90
provides electronic communications using packets of data that are
transmitted via the Internet 100. These electronic communications
can be performed using hypertext markup language (HTML) or any
other electronic communication techniques, using a public or
private network as well as direct point-to-point communication 19
via a direct log-in by the user 90 (via his/her portable unit 40
(e.g., an IECLD 40) or his/her computer system 30) into the central
server 10, and/or by other electronic or conventional communication
means between the central server 10 (or GPI) and the user 90 (e.g.,
via a private communications network, such as a local area network
(LAN), a wide area network (WAN), and the like). The user 90
therefore can communicate electronically with the central server 10
(or GPI) via the Internet 100 or via other ones of the
aforementioned connections for information exchange using
electronic or conventional communication means. The HMD 50 can
communicate with the central server 10 (or GPI) directly by wired
or wireless means, via the Internet 100, via the computer system 30
or via the IECLD 40.
[0127] The central server 10 (or GPI) also is connected to various
PHC computers 70 to enable such PHC to deliver health care
according to information received from the various RIS 60 and/or
directly provided by the central server 10 (or GPI) with respect to
a potentially harmful product. Thus, if a harmful product is known
to cause a life-threatening situation that, in turn, requires
emergency treatment, the EMS 72 can be contacted and a team
dispatched to the residence of the particular user 90 of that
harmful product (assuming that user has elected to submit his/her
address or other location indicative information to the system 1).
If a harmful product is known to cause a medical condition that
requires less urgent medical attention, then a doctor's office 74
or medical institution 73 can be contacted and an appointment and
transportation arrangements can be made for that particular user of
a potentially harmful product. If a harmful product is known to
cause a medical condition that requires laboratory testing or
further testing, then the type of tests and laboratories 75 where
the tests should be done are identified and the information sent to
the particular user 90 at risk of injury from use of the harmful
product. If the harmful product is known to require treatment with
a medication or antidote, then the necessary prescription can be
issued by the doctor's office 74 and the appropriate pharmacy 76
can be contacted for delivery of the medications needed by the user
90 of the harmful product.
[0128] If information about a uniquely identified harmful or
recalled product is received/acquired by the central server 10 (or
GPI) from a source such as the FDA 130, CPSC 132 or USDA 138, then
the central server 10 (or GPI) searches and retrieves the usernames
of all of the users 90 of the harmful or recalled products and
preferably electronically sends this information by e-mail to all
of the users 90 of such products. This information can include
interaction information. The communications involving the central
server 10 (or GPI), the RIS 60, and users 90 preferably are carried
out automatically by appropriately programmed processors according
to the principles of the invention.
[0129] An autodialing or paging system 160 also is activated if the
user 90 of a product is identified as using a product that requires
immediate attention, without the need for emergency equipment and
EMS 72. The decisions on what services, if any, are needed can be
based on the requisite treatment and/or methods of preventing the
harmful effect of a product and can be based on a recommendation
from the relevant RIS 60 or the central server 10 (or GPI). A
variety of other means can be used to alert the user 90 about an
urgent message, such as paging, audio and/or light signal in the
computer system 30 or in the IECLD 40, and the like. These can be
used in addition to, or as an alternative to, autodialing.
Autodialing can include dialing of either a conventional telephone
device or a cellular phone with the "Alert" message appearing on
the screen of said telephone devices. In this embodiment, either
the GPI server 10 does the autodialing or an authorized phone
service company does the autodialing. The GPI server 10 or the
phone service company can then send the "Alert" message to the
screen of a cellular phone as well as to a personal computer or the
IECLD 40. The GPI server 10 can be connected to the phone company
which then sends the alert message received from the GPI server
10.
[0130] As illustrated in FIG. 1, multiple users can be connected to
the central server 10 (or GPI). These users can be located in
virtually any part of the world. They include domestic users 31,
international users 32, as well as one or more web-supported sites
33 of the central server 10 (or GPI). These can be used by anyone
to enter and send to the central server 10 (or GPI) via the
Internet 100 information regarding the harmful effects encountered
with products, thus creating an additional collection system for
identifications of potentially harmful products. When appropriate,
this information on harmful effects can be sent to the various RIS
60 by the central server 10 (or GPI).
[0131] The central server 10 (or GPI), besides receiving
information from the various RIS 60, also can be provided with
application programs that are adapted to search for information on
the products which are stored in the various RIS 60, as well as
applications adapted to search for the product identifications and
usernames stored in the database defined in the memory of the
central server 10 (or GPI). If a product is found to be harmful, or
is recalled based on information transmitted or acquired by the
central server 10 (or GPI), then the central server 10 (or GPI) can
identify and retrieve information concerning all of the users 90 of
such harmful product(s). This retrieval can be based on the brand
name of the product, or preferably, according to the product's
unique code identification number. If there are any matches between
usernames and the brand name or unique code number of the product
being recalled, then the central server 10 (or GPI) automatically
retrieves the relevant usernames or code numbers of all of such
users 90 of the harmful product, and attaches the information about
the hazards and instructions related to the harmful product to an
"Alert" message. The central server 10 (or GPI) then electronically
transmits to all of the users 90 of the harmful product the alert
and information about the product, preferably utilizing
conventional bulk e-mail software or via other electronic and
conventional communication means. In addition, or alternatively,
the central server 10 (or GPI) can transmit the information to the
user's web-based e-mail address when the web-based e-mail is
supported by the central server 10 (or GPI). The information
transmitted to the user 90 can include textual and/or multimedia
documents stored in the central server 10 (or GPI) and also can
include the information/documents that can be accessed via the
overall system 1 and stored at one or more remotely located
computers 20. Likewise, the information can relate to a file that
connects to another web site when that web site has the information
concerning the harmful product.
[0132] Whenever the user 90 sends information to the central server
10 (or GPI), as part of an application and registration process,
the user 90 is automatically registered with the central server 10
(GPI) web-based e-mail. Preferably, any product identifications or
values of biological variables that are sent by any user 90
automatically causes that user to become registered with the
central server 10 (or GPI) and its web-based e-mail, and allows the
user 90 to have immediate and confidential access to the
information on the potentially harmful or beneficial effects of the
unique products being used. Any time information on a harmful
product is sent to the central server (or GPI) from the various RIS
60, the information is checked against the database of the central
server 10, and if any user 90 is identified as utilizing the
harmful product, the warning message and/or instructions about that
harmful product are sent to the users 90 via conventional
electronic mail, or via the web-based e-mail of the central server
10 (or GPI), and/or is sent via a web site supported by the central
server 10 (or GPI) when the user logs onto that web site and proper
identification is established. In addition, autodialing or paging
or other conventional communication means may be used, in case of
critical life-threatening situations and/or in the event that no
connection can be achieved via the Internet. The central server 10
(or GPI) also uses conventional keyword, natural language, fuzzy
logic, text engines, and other conventional searching tools to find
information requested by a user 90 who transmits data to the
central server 10 (or GPI) about a particular product and/or
biological variable, as well as to find the information on products
for which information is stored in the central server 10 (or GPI)
and which can be located in the various RIS 60 databases (e.g., FDA
130, CPSC 132, EPA 134, manufacturers 148, and the like). Whenever
the central server 10 (or GPI) is configured as a web server,
conventional web browsers can be used to transmit product
identifiers and biological variables. The system of the invention
can use a hypermedia and graphic medium system as information
provided via the World Wide Web, with the user 90 of the invention
being able to access updated recall information on the drugs and
products being utilized by that user 90 from around the world, from
any computer terminal with direct communication with the central
server 10 (or GPI), via the Internet by logging onto the central
server 10 (or GPI) web site, by retrieving his/her e-mail in a
conventional manner, or any other means to retrieve electronic data
or electronic data transfer, as well as verbal messaging and e-mail
with a text-to-speech electronic voice synthesizer, and the like.
The central server 10 (or GPI) can be accessed in a variety of ways
by the user 90 including via a web site on the Internet, Internet
service providers, on-line networks, direct link, and the like. The
information from/to the user 90, to/from the central server 10 (or
GPI), as well as from/to the central server 10 (or GPI), to/from
the remote computers (RIS) 60 preferably uses packet technology. It
also is understood that other current and emerging network protocol
technologies can be used to carry out the invention according to
the principle of the present invention.
[0133] The present invention provides a very cost-efficient way of
sending and receiving recall and product data using electronic
information transfer. The user 90 of the GPI system 1 receives
information related solely to the product(s) being used by or
otherwise linked with the user 90. This facilitates better and
safer utilization of the product. Government and private
institutions can send any relevant information to the central
server 10 (or GPI), or alternatively, the central server 10 (or
GPI) can actively search for the information in the databases. The
information about potentially harmful products thus is compared and
matched to the current data stored in the database of the central
server 10 (or GPI), and the user(s) 90 of that particular product
are identified and notified. Whenever the government or the
manufacturer issues any information, warnings, or life-threatening
alert about a drug or product, bulk web pages and bulk e-mail are
transmitted by the central server 10 (or GPI) to all of the users
90 of the unique product related to the warning. This can be
accomplished using conventional bulk mailing software with the
lists of the users of the products being derived from the database
of the central server 10 (or GPI) which, in turn, is the data
transmitted by the plurality of users 90 using and otherwise linked
with the product identifier. This allows appropriate measures to be
taken by all of the users 90 of the unique harmful product. All of
the warning messages sent to the user(s) 90 preferably include
detailed instructions on what to do and not do concerning the
product, including web site information related to the product as
well as address, and emergency telephone numbers in case of
life-threatening issues, as well as information and/or guidance in
regards to their medical condition and how to proceed, including
appointment scheduling and laboratory work-ups.
[0134] The user 90 also can manually check and/or interrogate the
central server 10 (or GPI) for information in regards to alert
messages that are stored in the database of the central server 10
(or GPI) as well as factors related to biological functions or
factors which alter such biological functions related to products
being used, as identified by a suitable product identifier that is
transmitted to the central server 10 (or GPI) by a user 90.
[0135] Any medical information of an individual is an extremely
sensitive and confidential matter, and although encryption means
and other applications to protect against attackers can be used
when transmitting the medical data of a user, there are few, if
any, ways to provide full protection and confidentiality. One of
the features of the invention includes a system that keeps the name
of the user of the medications and products confidential at all
times by using an ID, as can be conventionally done when
transmitting information over the Internet. Mr. XYZ, for example,
can be used instead of Mr. Jones when registering with the central
server 10 (or GPI). A medication "X" therefore is NOT associated
with Mr. Gerald M. Jones who lives at 111 Main Street, but with
Mr.XYZ@GPI.org. Mr. Jones' identity as the user of the drug thereby
is protected. The system of the present invention preferably uses
the conventional Domain Name System which allows the user of the
potentially harmful product to remain anonymous. The sensitive
matter of what type of drugs or products a user is utilizing thus
can be kept confidential. Instead of disclosing the user's name,
the information about the hazard associated with a certain drug is
sent to the user's Internet address under the user's Internet name
and address, substantially assuring that any required security and
confidentiality is maintained throughout the process of using the
product, retrieving information about the user of the product,
retrieving information on the recalled products, and sending the
information to the user about the recalled products. The
information on the recalled product is converted to the appropriate
Internet communications protocol for transmission to the user of
the harmful product. The system 1 uses the terms IP (Internet
protocol) address, domain name address, username, and full Internet
address interchangeably to denote a specific confidential address
of a user of a product. Each user of any product which has its
information stored in the database of the central server 10 (or
GPI) has, for example, a specific address such as the IP address
and has a username combined with the IP address as it is
conventionally done, creating a full Internet address. For example,
Mr. Gerald M. Jones is the user of drug "X2", his username is Mr.
XYZ, and his full Internet address is Mr.XYZ@GPI.org. The GPI part
of the domain name in the present example preferably corresponds to
the central server 10 (or GPI) attached to the Internet which
receives the information on drugs being used. It is understood,
however, that any IP address as a four-part number or any domain
name or code can be used according to the invention, as long as it
uniquely and preferably confidentially identifies the user of the
various products and drugs. The full Internet address is stored in
the GPI database of the central server 10 (or GPI), preferably as a
username or under a code associated with the full Internet address,
and for description herein, each is preferably referred to as
username. All of the codes and names of the products used are
acquired according to the principles of the invention, then
transmitted and stored under the username's code, meaning the
user's full Internet address. It is also intended for the purpose
of the description herein that the terminology IP address or domain
name or full Internet address means the username combined to the IP
address or the username combined to the domain name or any other
means which uniquely identifies the user 90 of a product, though
each may represent a different form of that username.
[0136] The central server 10 (or GPI) can be continuously updated
on drug "X" by government agencies such as the FDA 130, the
manufacturer 148 of the drug, and the like. Thus, information can
be received relating to marketing surveillance by the FDA on drug
"X". Whenever there is a recall or relevant information by the FDA
concerning drug "X", this information is actively or passively
transferred to the central server 10 (or GPI) which then searches
and identifies all of the anonymous users of drug "X" for whom
information is stored in the database of the central server 10 (or
GPI). The central server 10 (or GPI) then electronically sends the
information and instructions on how to proceed in regards to the
use of drug "X" to the user Mr.XYZ@GPI.org, and to all of the other
users linked with drug "X", without even the central server 10 (or
GPI) or any third parties knowing the true identity of the user.
Thus, all of the users are reliably and privately identified,
located, and instructed regarding drug "X", or drug "X2" if lot X2
is the one being recalled.
[0137] Although the description above involves a person as the
user, it is understood that an entity can be considered a user. In
this case a business concern, a hospital or a doctor's office are
notified about a recalled or harmful product. For instance if a EKG
(electrocardiogram) was recalled, the GPI system 1 then will send
the notification and information to the hospital and doctor's
office which registered the EKG machine with the GPI system 1.
[0138] While the system 1 can be implemented using many different
components, FIG. 2 shows a preferred implementation that includes a
computer system 30, an IECLD 40, and at least one home-monitoring
device 50. The user's computer system 30 includes a display device
30A, a display screen 30B, a housing 30C that encloses standard
computer components, interactive devices such as a keyboard 15, and
a microphone (not shown), as well as a mouse 30D and a built-in or
external modem 30F. The IECLD 40, as shown in FIGS. 2 and 3A to 3C,
preferably includes a touch screen 40A (or other display 40AA), a
built-in barcode reader 14, a keypad 40B, a housing 40C (that
encloses standard computer components), an external antenna 40D
(shown in FIG. 3C), an optical transceiver 40E, and a modem 40F.
The home monitoring devices 50 can include any of the
aforementioned home-monitoring components and structure (e.g., as
described by U.S. Pat. No. 5,830,139; No. 6,120,460 and pending
applications to Abreu directed to systems and methods for measuring
eye pressure or blood sugar by patients at home and other
diagnostic and monitoring systems).
[0139] FIG. 2 also illustratively shows the flow of data and
information to and from the computer systems 30, portable units 40,
RIS computers 60, and the central server 10 (or GPI), with the flow
of data preferably being controlled by the central server 10 (or
GPI) and being routed over the Internet 100.
[0140] The central server 10 (or GPI) keeps track of all of the
recall information provided and/or retrieved from the various RIS
computers 60 and then locates the unique user(s) 90 of a particular
product. The central server 10 (or GPI) uses standard applications
to search for recalled products and/or receives information about
recalled products from the various RIS 60. If a recalled product or
a harmful or beneficial effect is found, the central server 10 (or
GPI) retrieves and stores the name or preferably the code number
for that harmful product in its database, and then searches for
usernames associated with people who are using the harmful product.
It also matches the code sent by the RIS 60 with the code of the
products being used under the username. If there are harmful
product codes under one or more usernames, then the usernames are
retrieved, and the level of severity or risk of the hazard is
evaluated. Hazard degrees preferably are identified by a code of 1
to 5. If hazard degree codes 1 to 3 are found in the warning
information received (1=minimal, 2=moderate, and 3=high), and an
affected username(s) has (have) an active Internet address, then
conventional bulk e-mail software is used to electronically send
the warning message and/or web pages on the harmful product to all
of the people with usernames associated with the code for the
harmful product. If hazard degree code 4 (4=critical) is found in
the warning information received, then e-mail with a warning
message and/or web pages on the harmful product are sent, and an
autodialing or paging terminal which dials all of the users of the
potentially deadly product is activated to inform the users by
conventional computerized voice messaging techniques about the
potentially fatal reactions or other problems associated with the
harmful product. In this manner, the user is advised to check the
GPI web site and the GPI e-mail. If emergency care with risk for
fatal reaction is present (hazard degree code=5), then the EMS 72
is contacted and dispatched, assuming the user has enabled the
system 1 to obtain his/her address.
[0141] It is understood that depending on the level of severity, a
variety of audible and/or visible signals can be used, each of
which corresponds to the respective level of severity. Such signals
can be displayed on the screen of the computer systems 30 including
the screen of a telephone or IECLD 40. When the RIS 60 transfers
warning information via the Internet to the central server 10 (or
GPI) concerning a newly found recalled product or harmful product,
then the central server (or GPI) can immediately send a request to
check its database for any usernames that are associated with the
harmful product code number. When the username(s) associated with
the harmful product is identified, the central server 10 (or GPI)
matches the usernames with the alert message and/or web pages and
sends the resulting compilation to all of the users represented by
the matching usernames, and according to the level of severity as
previously described (hazard degree 1 to 5). Alternatively, if only
the names of the products are used (e.g., in the case of a
comprehensive recall) or when no hazard codes are available, then
the central server 10 (or GPI) uses the name of the product and
warning information, without a hazard code, in order to identify,
locate and warn the users of the product in the same manner as
described above.
[0142] The information about products (codes and/or names) being
used and stored in the central server 10 (or GPI), can be accessed
only by the users of such products. They preferably are required to
enter a proper identification and password. To further assure the
confidentiality of the information about products being used,
biometric identification devices such as iris scanners, retinal
scanners, fingerprint readers, voice recognition systems, and the
like can be used to verify the identity of the user before
accessing the database of the central server 10 or using the IECLD
40. The biometric data system also can be used by users who are
visually or hearing impaired. The central server 10 (or GPI) can
continuously receive and/or acquire updates on products, with the
new information about the harmful products immediately being
transmitted to the unique user of such harmful products. A
menu-type message can be generated with the most critical hazard
placed first and with a decreasing order of severity presented when
the message/warning is transmitted. Certain information, such as
the cardiac effects of products being used, can be stored and thus
the user has the option to store and index the particular
information in the database of the central server 10 (or GPI) under
his/her username, which enables the user to review products which
are or were used that affect the heart, and this information can be
transferred to the user's doctor as well.
[0143] The central server 10 (or GPI) also checks the presence
and/or values of the biological variables of the user and
determines whether any abnormal values have been detected and/or
whether the user has failed to comply with a prescribed schedule
for monitoring of biological variables (i.e., determining whether
there has been an episode of non-compliance with timely monitoring
of biological variables). If the user has, for instance, not sent
or has not recorded blood sugar levels in the last week and the
user is diabetic, then the central server 10 (or GPI) sends a
message to the user to inform and encourage the user to monitor
his/her blood sugar according to the time criteria set by the
doctor.
[0144] The acquisition and transmission of signals corresponding to
biological data or factors which alter the biological data is
accomplished utilizing the hand-held portable unit 40 (or IECLD
40), with electronic data being communicated over a public network
such as the Internet to the central server 10 (or GPI). This
provides feedback information according to the biological and/or
product data electronically received. The electronic feedback data
is automatically transmitted back to the user's computer system 30
and/or the user's IECLD 40. It is understood, however, that any
computer terminal connected to the Internet can be used by the user
90 to receive the information on biological variables according to
the principle of the invention.
[0145] A preferred IECLD 40 will now be described. It is understood
that the IECLD 40 is preferably a portable device with bar code
reading capabilities for the input and output of data. Other forms
of inputting/outputting data, however, can be used such as a
personal computer keyboard and the like, in accordance with the
present invention. In addition, or alternatively, data input/output
can be accomplished using RF or optical input, or an on-screen
keyboard with the data being entered by a medical practitioner,
health care professionals, clerks, or the users 90 themselves.
[0146] Referring to FIGS. 3A-3C and 4, a preferred embodiment of
the portable Individual Electronic Communicator and Locator Device
40 (IECLD 40) comprises a portable unit 40 which can be carried by
the user and utilized by a particular individual to acquire,
process, transmit and receive information on biological variables
and products being used by the particular individual. The IECLD 40
can include a housing 40C that contains a conventional, programmed
microprocessor 40G with data processing and storage units, and
which controls the operation of the portable unit 40. Communication
interfaces and communication ports 40I can be provided with the
IECLD 40, as well as a built-in bar code reader 14, warning lights
40H, optical transceiver 40E (e.g., exposed through the housing 40C
and preferably working in the infrared wavelength), and a numerical
keypad 40B. A modified keypad 40BB may also be provided, designed
for the five main types of products that can be recalled and
enabling manual selection of the type of product being scanned. The
five main types of products are drugs, medical devices, toys and
baby products, cosmetics, and food. A miscellaneous key 40BBB is
also provided. The IR optical transceiver 40E receives/transmits
signals, such as biological data acquired from home monitoring
devices 50. It also is coupled with other interfaces (e.g., 40D and
40I) to transmit signals, such as biological variables or/and
product identifiers to a computer system 30.
[0147] The computer system 30 preferably is connected to the
Internet. The portable unit 40 preferably is provided with a
variety of software applications and decoding elements for
optically encoded symbology, with a system configuration including
a scanner module for bar code reading. Alternatively, the hand-held
terminal IECLD 40 may be provided with voice input and/or voice
synthesizer modules and/or means for handwritten input data and/or
typed input data and/or manual data entry with an electronic
keypad. It is understood that any type of product group such as,
for example, household items could be used, but these are less
likely to cause substantial and frequent harm and increased health
care costs as compared with the above main five categories
preferably used (drugs, cosmetics, food, baby/toy products, medical
devices,), and such other types of products are included under
miscellaneous. It is intended that any variations or group products
could be selected with keypads or using a touch screen addressing
other group products, or the device preferably may have all
products stored by product, according to their identifier numbers.
Alternatively, the device can be programmed to address particular
groups of products such as, but not limited to, automotives,
appliances, furniture, lighting products, outdoor products,
clothing, electronic devices, electrical devices, environmental
products such air conditioners, household products,
sports/exercise, and so forth.
[0148] The block diagram of FIG. 3B shows an exemplary IECLD 40
comprising communication ports 40I, a power source 40J, a
conventional modem 40F which can be connected to the central server
10 via electronic or conventional communication means, an RF
transceiver/modem 40L coupled to an antenna 40D for wireless
transfer of data, non-volatile RAM memory 40M, I/O ports 40N, an
optical transceiver 40E, an optical sensor/bar code reader 14 with
decoding devices 14B, visual indicators (e.g., warning lights 40H)
and audible indicators (e.g., speaker 40R), a microphone 40P, and a
display 40A or 40AA, At least one output from the microprocessor
40G is supplied to the display 40A,40AA through a conventional LCD
driver circuit that conventionally decodes and multiplexes the data
to be applied to the display 40A,40AA as well as known parts of a
computer arrangement, such as random access memory (RAM), read-only
memory (ROM), and the like.
[0149] The bar code reader (BCR) apparatus 14 includes a decoding
device 14B, a code reader device 14BB and an optical sensor 14BBB.
The BCR apparatus 14 preferably is used because of its low-cost and
low-power requirements. It can include an LED bar code reader with
low-light levels and preferably is implemented using a direct
contact type of bar code reader. While it is understood that
non-contact types of bar code readers, such as laser-based ones,
can be used with the invention, they tend to be more expensive and
tend to consume more power. Virtually any bar code reading
technology can be used with the present invention including, but
not limited to, imaging technology, CCDs, and the like. The system
1 also allows for direct wired and wireless communication and duple
transmission with the central server 10 (or GPI). While the input
of product identification information preferably is accomplished
using the bar code reader, manual entry using the keypad or RF
wireless input of product identification or any conventional wired
or wireless input of product identification also can be used. The
IECLD 40 also has conventional encoding and decoding programs which
allow the IECLD 40 user to read messages as well as to view
multimedia files related to products used by the user 90, using the
information transferred from the central server (or GPI).
[0150] In an exemplary embodiment, data such as drugs used by a
patient is entered by scanning a newly created bar code element
preferably separated from the conventional UPC code. The new
product identifier of the present invention encodes information
about the name and characteristics of the drug, date of
manufacturing, plant location, serial number, and lot number, into
what will be called hereinafter BarCodeData (BCD) or unique product
identifier (UPI). Although UPI is used in the description, it is
understood that the conventional NDC (National Drug Code) bar code
can be used. The NDC has eleven digits corresponding to the
following: first five digits provide information on the
manufacturer, next four digits indicate the name and type of drug,
and the last two digits provide packaging information. BCD or UPI
is a unique identifier of the product and the characteristics of
the product, such as concentration and strength, expiration date,
serial number, plant number, date of manufacturing, and lot number.
The UPI can be optically encoded in a PDF417 format which, due to
the high information density and capacity, can include all of the
information regarding the individual product, including even test
summaries, components, ingredients and parts used, personnel
involved in the manufacturing of the product, manufacturing
process, color additive(s) used when coating pills, and so forth.
Thus, the UPI when optically encoded gives all of the information
necessary for the recall of any particular individual and single
product or ingredient of that product such as color additives
present in drugs and foods. It is important to note that the
conventional UPC codes consist of a Universal Product Code which is
universal and does not encode detailed characteristics of the
product, as might be needed for certain recalls of individual and
single products or of a certain number of units of the product from
a lot with the same UPC code. Thus, the currently used UPC does not
allow a single and individual recalled product to be located. If a
company, for example, has sold five million units of a certain
over-the-counter drug, and 5,000 units from three lots were
contaminated, then a recall of only the 5000 units is difficult to
perform using the conventional UPC code. Instead, the recall
probably would involve identifying and notifying all of the 5
million users. Using the UPI system according to a preferred
embodiment of the present invention, it is possible to limit the
recall to the 5,000 users who actually bought the product from the
tampered lots. Thus, while the system 1 is generally effective when
implemented based on the conventional UPC code, additional benefits
can be realized using the UPI system of the present invention.
Using the aforementioned UPI, only the 5,000 users at risk would be
located and warned, thus creating a significantly more
cost-effective recall system for the users, the companies, and the
government.
[0151] The BCD or UPI may be used separately but also possibly in
combination with the conventional UPC code. For instance the
addition and/or substitution of a few encoded symbol or numbers to
the UPC could provide the needed unique identifier data as
described above, and thus could be easily implemented to provide a
modified UPC, which also would fall within the definition of UPI
for the purposes of this disclosure. This modified UPC is easier to
implement and thus represents the preferred embodiment. It should
be emphasized that the "U" of UPI stands for Unique, which is
completely contrary to "U" of UPC, which stands for Universal. The
UPI arrangement provided by the present invention therefore
distinguishes from the UPC arrangement, at least because it
uniquely identifies a product utilizing optically encoded symbology
in an unique manner.
[0152] The UPI system allows a variety of potentially hazards
elements to be encoded, including color additives. All drugs or/and
food that contain certain potentially dangerous additives could be
identified in this fashion. For instance, color additive Red
FD&C No. 2 was shown to significantly cause tumors in female
rats and has been banned as unsafe. Color additive Red FD&C No.
3 has been found to cause thyroid tumors in male rats but has not
yet been considered unsafe and removed from the market. As soon as
the information is available, the user at risk is informed, before
the product is removed from the market by authorities. For
instance, if the user has a family history of thyroid cancer, the
user would have the opportunity to make an educated choice and
avoid food and drugs that contain Red FD&C No. 3 based on the
alert with respect to foods and drugs that can be provided by the
central server 10 (or GPI) according to the principles of the
invention. The information preferably is sent only to users with a
personal or family history of thyroid cancer according to
information stored in the users' personal information database 700
(as will be described hereinafter), and not randomly, thus
optimizing the use of electronic data transfer. It is very
difficult for the average individual to be aware of harmful
products including harmful color additives. Although the additives
are printed in the label, the information is often meaningless for
the average user. Furthermore, even when the user has knowledge of
additives, the user most likely would still not know the latest
information in regards to harm caused by such additives. Since the
system 1 is continuously updated with respect to this type of
information about harmful products, the user has the advantage of
passively receiving this updated information without being required
to read the label and/or be knowledgeable about the barely
publicized effects of chemicals that are present in products being
used.
[0153] For the purposes of this description, the UPI can be a
modified UPC, a separate bar code from the UPC, a two-dimensional
bar code with or without the UPC, or any other machine readable
format that uniquely identifies a product according to the
principles of the invention. There are some situations in which the
conventional UPC could be used. For example, if the total number of
units sold is similar to the number of units tampered with, for
instance according to the above example, if 5,000 units are
recalled, but the total number of units sold is less than 6,000, or
if the recalled units pose an immediate and 100% fatal threat, then
a comprehensive recall using the UPC code could be used. The UPC
can also be used in association with the date of purchase to
minimize or eliminate the return of any good products. In this
embodiment, the date of purchase is used and, based on the standard
"first in first out" approach used by business concerns, the GPI
system 1 can identify the harmful products in a more precise
manner. For example, a non-perishable product (UPC 12345) with
defective units arrived at the point-of-sale on January 2. A second
lot with non-defective products but with the same UPC 12345 arrived
on April 1.sup.st. Only on April 30.sup.th was it noted that the
lot delivered in January contained defective harmful product. Good
products could have been sold with defective products in the month
of April. Thus to minimize return of good products, the GPI system
1 sends two different "Alert" messages according to the date of
purchase. Purchase dates up to April 1.sup.st identify the consumer
as acquiring a defective product. Purchase dates between April
1.sup.st and 30.sup.th identify the consumer as likely acquiring a
defective harmful product and state "Please check lot number; if
11A, please stop using it and return it to vendor". It is most
likely that, due to "first in first out", purchases around April
30.sup.th do not include defective harmful products and in 60 days
most products are out of the inventory. The above method and system
also applies to perishable items but since those items have
expiration dates, there is less risk of harm arising from long term
storage or use of the product. As can be seen, although UPC can be
used to practice the invention, the preferred way is to use the UPI
(Unique Product Identifier).
[0154] The bar code element UPI is a unique identifier of, for
example, drug "X". The UPI is then converted to binary data and is
transmitted using a communication interface to the central server
10 and stored as a binary number (e.g., 0100 . . . 0110 for drug
"X"). The information on drug "X" is stored in the memory of the
portable unit 40 with the data regarding drug "X" being
automatically electronically transmitted over the Internet to the
central server 10 (or GPI). If, for instance, the user Mr. Gerald
M. Jones starts using a drug "X" that came from a different lot,
for example, one that included a new coating with a new color
additive, then a new unique bar code element for that product is
used, and the new data is stored as for instance "X1" with a
binary-converted UPI No. of 0100 . . . 0111. If Mr. Gerald M. M.
Jones starts using a drug "X" which comes with a tablet of larger
size, then a new unique bar code element is used to identify the
product and is stored, for instance, as "X2" (e.g., using a binary
UPI number of 0100 . . . 0112), and then "X3" (UPI 0100 . . . 0113)
for a formula manufactured abroad, and so on. Data entry using
optically encoded symbology provides a virtually error-free entry
system and a time-efficient and cost-efficient mode contrary to
written and/or manually entered or typed data. The large amount of
data on the characteristics of medication "X" is conveniently and
automatically acquired as a bar code number, and then processed,
and transmitted over a public network such as the Internet to the
central server 10 (or GPI). The computer system 30 or portable unit
40 of the user and/or the GPI central server 10 can contain the
name equivalent data that can be used to generate the name of the
products scanned according to their UPI.
[0155] The bar code reader 14 acquires the information on the
characteristics of the product which are necessary for precise
identification in case of a recall, with the data preferably being
transferred directly from the portable unit IECLD 40 to the GPI
central server 10. Alternatively, the identification data on the
products can be transmitted later to the user's computer system 30
via IR means 40E, RF means 40L and/or 40D, or via conventional
physically-wired downloading means with the processor executing the
programs in the memory 40M necessary to carry out the function. The
IECLD 40 includes a memory that stores the data about the product,
and communications port(s) 40I, for downloading the data to the
user's computer system 30, with the user's computer system 30
having capabilities to connect with the GPI central server 10 via
the Internet. Preferably, the portable unit 40 or IECLD 40 includes
computer terminal components having capabilities to directly
connect with the Internet, thus bypassing the user's computer
system 30 (e.g., a personal computer or desktop computer). The
IECLD 40 also provides for duplex communication to and from the GPI
central server 10 using conventional direct communication via
telephone lines or wireless communication via the RF transceiver
40L. The bar code data related to the precise identification of the
product and biological variables acquired by the portable hand-held
device 40 is uploaded to the central server 10 (or GPI) for storage
via conventional or electronic communication devices. The
processing and transmission of data can be performed by the
microprocessor 40G, using conventional applications. The data
generated by the microprocessor 40G also, or alternatively, can be
supplied to the user's computer system 30 using a typical wireless
transmission.
[0156] The portable IECLD 40 provides means for entry, storage,
processing and transmission of the unique characteristics of a
product and biological variables to or into the central server 10
(or GPI). The central server 10 then checks its database in order
to update and/or generate information according to the data
transmitted by the portable IECLD 40. According to the principles
of the invention, if there is any information stored that
corresponds to a recalled product or the product identifiers
transferred are indicative of a product that can cause a harmful or
life-threatening event, the information is retrieved and is sent
immediately as an "Alert" message which is then transferred back to
the individual user of the product, as previously described. Since
the IECLD 40 is portable, hand-held and compact, the IECLD 40 can
be easily carried to different places and during trips and thus can
have applications in virtually any environment including, but not
limited to, doctor's offices, hospitals, pharmacies,
grocery-stores, department stores, hotels, and the like, allowing
easy acquisition of information on products being used as well as
easy retrieval of information by directly connecting the IECLD 40
with the Internet and directly accessing the central server 10 (or
GPI) for the information about recall in regards to the products
being utilized by the user. The IECLD 40 can also include GPS
(global positioning system). This can be used to locate the user in
case said user is exposed to fatal injury/illness by using a
harmful product and does not respond (there is no read
receipt).
[0157] FIG. 3C shows a frontal view of the housing 40C with a
modified keypad 40BB, for selection of product groups before
product information is entered. FIG. 4 shows the IECLD 40 coupled
to home-measuring devices 50, such as a self-tonometer 52 to
measure eye pressure at home, as previously described by Abreu, a
non-invasive self-measurement system for blood glucose 53, as
described by Abreu; a continuous temperature measuring device 54
(shown in FIG. 1) as described by Abreu; a heart rate and rhythm
monitor 59; as well as a conventional electronic blood pressure
measuring device 55, electronic scale 57, and a microfluidics-based
intelligent contact lens 57. It is understood, however, that any
other device capable of measuring any physical or chemical
biological variable can be used in the present invention. An
optical transceiver 40E mounted in the housing 40C of the IECLD 40
establishes communication with the various home-monitoring devices
and receives and stores the information on the values of the many
biological variables, such as eye pressure, blood glucose,
temperature, blood pressure, weight, and the like. Data is
transmitted and received by the microprocessor 40G through the
optical transceiver 40E by conventional means of transmitting light
signals. It is understood that the values of the biological
variables can be entered manually into the IECLD 40 or by RF
transmission (e.g. using RF transceiver 40L) as described by Abreu,
but a more cost-efficient system involves the optically automated
transmission of the biological variable values. The optical
transceiver 40E establishes data communication in bit serial format
between the IECLD 40 and the user's computer system 30. The user's
computer system 30 is connected to the central server 10 (or GPI).
It is understood that the IECLD 40 preferably acts as the user
computer system 30 with a direct connection between the IECLD 40
and the central server 10 (or GPI), without the need for the user's
computer system 30. In this regard, the IECLD 40 can acquire and
transmit to the central server 10 both biological variables and
product identification information. The acquisition, storage and
transmission of data preferably are performed via programming
within the IECLD 40, for example, using standard techniques. It
also is understood that any means for transferring biological
variables via a network such as the Internet 100 can be employed by
the present invention. The biological variables can be analyzed
against the product identification information stored in the
database of the central server 10 (or GPI) for the evaluation of
potential interaction of the products with the biological variables
or potential harm caused by abnormal values of biological
variables.
[0158] Although the IECLD 40 is preferably designed to be used by
one person, more than one user can have his/her individual data in
the microprocessor-based portable IECLD 40. Naturally the user can
select what products or type of products the user is interested in
receiving recall or warning information concerning, and thus if the
user does not purchase or use baby products, the user has the
option of not acquiring the information or/and not transmitting the
information and/or selecting not to receive recall/warnings on the
particular product. The user can at its sole discretion cancel or
add any products or group of products and/or biological variables
to the main GPI database at any time. Besides the user actively
deleting items, the principle of the invention also includes an
expiration date for some of the products entered such as
perishables and ready-to-consume items as certain foods, drugs,
cosmetics, and so on, so that the stored database for the user does
not grow too large and products are not kept in the database for an
excessive period of time.
[0159] Furthermore if a user brings his/her IECLD 40 to the
doctor's office, a drug being prescribed may be entered and if
there is a medical reason for the drug not to be prescribed or a
drug interaction, then an alert will be displayed in the display
before the patient buys or starts using the drug, and subsequent to
that the GPI gives alternative drugs for the condition. For
example, a general practitioner may prescribe a drug to control
heart rhythm, such as amiodarone, to a patient. This patient has
stored in his IECLD 40 medical information which includes
measurement of his biological variables with a record of elevated
eye pressure which put that patient at risk for optic nerve injury.
Now considering that amiodarone was found to cause optic neuropathy
as an adverse reaction, then the system identifies the potential
harmful interaction between the drug being prescribed (amiodarone)
and the biological variable measured (elevated eye pressure) and
alerts the user and the doctors. The GPI system 1 then sends
alternative drugs that treat arrhythmia but without any adverse
effect considering the user health status according to the
biological variables transferred. Naturally the patient also could
be made aware of the harmful interaction drug-biological variable
at the point-of-sale or in the pharmacy by sending the information
to the GPI server 10, or at home by uploading the information to
the GPI server 10 and thus receiving the warning.
[0160] The apparatus and methods of the present invention allow
acquisition, storage, transmission, and processing of objective
biological function and variables, as well as objective factors
that can alter the biological variables, such as the use of a
variety of products. The system of the invention provides a display
of the alert information needed by the previously located user, as
well as information on how to manage the hazardous situation. Also
provided are automatic updates of information and guidance
according to chronological changes of the biological variables that
would be otherwise undetected, thereby permitting the user to take
timely appropriate action and establish control over the hazardous
situation.
[0161] The system 1 of the invention provides not only display and
guidance/instructions on currently known hazardous situations, but
also may predict and warn the user of the potential for a hazardous
situation to occur before it takes place by continuously analyzing
the data that is transmitted for the purpose of intermittently
providing information and alerting the user about potential
imminent hazardous situations. The system 1 sets the criteria
according to the data received from the user and the criteria is
continuously adjusted in a graded manner, in accordance with the
updated data that is transmitted by the user and RIS 60. If the
criteria are met, the user automatically receives a
warning/information about the potentially hazardous situation
and/or guidance/instruction without interference from subjective
considerations, nor the need for a human observer to select the
information. The system 1 of the invention also provides and
displays information to the user about transmitted biological
variables, or factors that alter such biological variables, with
the purpose of improving understanding and comprehension regarding
the biological variables, disease states or factors that may alter
biological variables, such as interactions with drugs and other
products.
[0162] Referring now to FIG. 5A, there is depicted a simplified
version of the system 1. The simplified version includes, for the
user 90, an input device for manual entry such as the keyboard 15
of a computer system 30, a communications interface 25, a central
server 10 (or GPI), and the RIS 60 and/or PHC 70. The computer
system 30 can be implemented using a typical personal computer
having input means such as a keyboard 15, a microphone, a mouse,
and/or the like, a processor, a display element, and a network
interface. The computer system 30 likewise can include a CPU, ROM,
RAM, input device, memory device, video driver, video monitor,
clock and modem. While FIG. 5A shows a desk-top computer system 30,
it is understood that a hand-held computer 30, as shown in FIG. 5B,
can be used instead of a traditional desk-top computer. The
personal digital assistant 30 can have an electronic architecture
similar to that of the desk-top computer system depicted in FIG. 5A
and can work in a similar manner. The computer system 30 in FIG.
5B, however, preferably includes a touch-screen display 30B that
facilitates manual entry of product information or other
information. Also shown in FIG. 5B are the communications interface
25, a central server 10, and the RIS 60.
[0163] With reference to FIGS. 5C-5F, transaction terminal
equipment, generally designated by the reference numeral 39, can be
used at a point-of-transaction (e.g., a point-of-sale) to connect
the point-of-transaction to the central server 10. Using this
equipment 39, it is possible to transfer unique product identifiers
to the central server 10, without the need for duplicating the
entry of product information or double-scanning of the product,
i.e., once at the point-of-transaction to consummate the
transaction and then again at home or elsewhere when data is to be
entered into the system 1. Thus, a single scan at the
point-of-transaction will suffice for both purposes. While the user
can provide a user identification number or other identifier that
is manually keyed into the equipment 39, it is more desirable to
provide the user with a card 39A, that is swiped or otherwise read
electronically at the point-of-transaction to provide the equipment
39 with a user identification. The unique product identifiers 39B
scanned at the point-of-transaction then can be associated with the
user identification as read from the card 39A, and the resulting
combination of data can be transferred to the central server 10.
The data from the product identifiers 39B being scanned in this
manner, can be automatically transferred to the GPI server 10
according to criteria set forth for each individual user.
[0164] The exemplary point-of-transaction equipment 39 in FIG. 5E
includes a transaction terminal 39C, a display 68, a card swipe
device 39D such as a credit card reader through which a
magnetically encoded GPI card that carries a user name can be read,
a flat card reader or smart card slot 39E equipped to read at least
the user name from the smart card 39A, a keyboard 58, and a bar
code reader 14 adapted to read bar-coded product information in the
product identifiers 39B. As shown in FIG. 5E, the equipment 39 at
the point-of-transaction can further include data communications
means 49, and a printer 39F that prints the bar codes 39G
conveniently on a single piece of paper 39H, e.g., if the
connection to the GPI central server 10 is not available, so that
these can be scanned later at home.
[0165] FIG. 5C is an enlarged view of the card swipe device 39D.
FIG. 5D is an enlarged view of the exemplary bar code reader 14.
The credit card reader 39D reads binary coded data recorded
magnetically along a length of a credit card. The bar code reader
14 reads optically encoded symbols. The credit card reader 39D
preferably includes a slot 51. The consumer or salesperson inputs
the data by swiping the credit card through the slot 51.
[0166] In the alternative embodiment of FIG. 5F, a smartcard 39A is
shown at a more portable version of the point-of-transaction
equipment 39. With the arrangements shown in FIGS. 5C-5F, the user
can acquire a variety of UPIs 39B and then swipe the card 39A
through the appropriate one of the readers 39D or 39E. The card
39A, preferably, has a memory medium 39I that stores the user
identification, along with encoded data capable of opening a
connection with the central server 10 (or GPI). The
point-of-transaction thus has a card reader 39D, 39E communicating
with the central server 10 (or GPI). When the UPI codes are scanned
using a conventional bar code reader at the point-of transaction,
the UPI data is automatically transferred to the GPI server 10 and
stored under the username.
[0167] Referring to FIGS. 5C to 5J, the embodiment related to the
use of point-of-sale for acquisition of consumer identification and
product identifier for recall and warning includes
point-of-transaction terminal equipment 39 and preferably remotely
located Card Central Computers 80 (CCC). Data on products
associated with a credit card sale or the like is collected and
transmitted to said CCC 80 for storage of said product information
and card holder identification, with said product information
including the elements necessary for identification of a recalled
product and the consumer using such product(s) according to the
principles of the invention. The smart card 39A or other card such
as a credit card which is used for payment, can also be used to
identify the consumer as "registered" and as being qualified to use
the GPI system.
[0168] The CCC 80 can include central credit card computers,
computerized credit card authorization or validation centers,
computerized insurance company centers, the GPI server 10, or any
central computer capable of receiving and storing product
identifiers and consumer identification according to the principles
of the invention. The card 39A, for the purposes of this
description, can include conventional credit cards, the GPI
SafetyCard, smart cards, debit cards, store payment card, gas
payment cards, telephone cards, insurance cards, courtesy cards,
other magnetically or optically encoded cards, programming cards,
CD cards, and the like. Point of sale for the purpose of the
description includes any place in which a consumer can acquire a
product which can cause harm to the user or be recalled. For
example, but not by way of limitation, point-of-sale can include
stores, malls, supermarket, pharmacies, dealerships, retailers, any
business concern, and the like. Although point-of-sale is
described, any point at which goods are acquired, regardless of
payment for such goods, can be used and such goods covered by the
GPI system, which is also referred to herein at the GPI Safety
Program.
[0169] The GPI Safety Program is a free-of-charge recall and
warning notification system to users of products as disclosed in
the present invention. The user receives a GPI SafetyCard such as
card 39A when registering with the GPI system 1 and the GPI Safety
Program. One exemplary means of registering occurs when the
consumer fills out a conventional credit card form. The consumer
checks the GPI SafetyCard box on the form, reads the respective
information on the GPI Safety Program for Recall and Warning, and
signs the form authorizing collection of product identifiers. Blank
credit card forms may be found in stores or such forms may be
received through the mail or electronically. Similarly, the
consumer may receive GPI Safety Program forms and apply for a GPI
SafetyCard in the same fashion as applying for a conventional
credit card. However, contrary to credit card companies that can
deny issuance of a card due to poor credit history, in the case of
the GPI Safety Program everybody can be accepted and each eligible
consumer that enrolls free-of-charge in the Safety Program for
Recall and Warning will receive a GPI SafetyCard.
[0170] The GPI SafetyCard 39A is a unique customer card issued to
the customer after appropriate registration with the GPI Safety
Program for Recall and Warning Notification. The GPI SafetyCard 39A
has magnetically encoded data similar to a credit card, but said
SafetyCard has no purchasing function. The GPI SafetyCard 39A has
preferably a thin magnetic strip 41 with an identification number
stored thereon. The GPI SafetyCard 39A is used to identify the
consumer as registered with the GPI system 1 and GPI Safety
Program. The GPI SafetyCard 39A can have identification and
information data encoded in a dual face format, the front having
magnetically encoded data in a strip 41 similar to credit cards,
and the back having optically encoded data such as a bar-code 43.
The GPI SafetyCard 39A can also be used as a key ring card, CD
card, or by any other suitable means to store the registration code
with the GPI Safety Program. The encoded information in the GPI
SafetyCard 39A can include customer identification number (GPI
Safety Program number), username, name, address, and the like. An
authorized GPI credit card 39A means a credit card which the card
holder is registered with the GPI Safety Program as described
above. The authorized GPI credit card 39A contains in one of its
tracks a few extra bits of information such as the GPI
identification number or any other means to identify the consumer
as "registered with GPI". At least one of the tracks of card 39A
includes information on registration with GPI Safety Program and
preferably the arrangement conforms to the specifications found in
the American National Standard for magnetic stripe encoding and
interchange message, and in accordance with standards by the
American National Standards Institute. Each authorized GPI credit
card 39A or the GPI SafetyCard 39A is unique in that it contains a
code unique to the GPI Safety Program in its track. The GPI
SafetyCard 39A can also have other information embossed on the card
for further identification.
[0171] Besides using a conventional stripe credit card, the system
can include a GPI SafetyCard 39A which uses only a bar code 43 or
other optical symbols as means for identification of the consumer.
If the consumer uses a bar coded GPI SafetyCard 39A, then the
consumer presents said SafetyCard at the point-of-transaction
terminal 39C which is then scanned by conventional means for bar
code reading. Subsequently, products purchased with their
respective product identifiers are scanned. If the consumer is
registered with the GPI Safety Program and has the encoded
authorization code to store product identifiers, then said product
identifiers are stored in the point-of-transaction terminal 39C
under said consumer identification which can include a username or
Internet address. The information stored is then transmitted to the
CCC 80 when connection with said central credit card computer is
established, or may be stored for later transmission in accordance
with the principles of the invention. It is understood that the bar
coded GPI SafetyCard 39A can be scanned at the end of the
transaction by the point-of-transaction terminal equipment 39. In
this instance after the products purchased are scanned, then the
said bar coded GPI SafetyCard 39A is scanned and the operation
proceeds as described above.
[0172] The point-of-transaction terminal equipment 39 includes
credit card data input devices which in the preferred embodiment
include a credit card reader 39D. For the purpose of the
description, the credit card reader can be considered to be a
device capable of identifying the consumer as registered with the
GPI Safety Program which then allows acquisition and transmission
to the CCC 80 of product identifiers related to that consumer. The
credit card readers 39D generate digital output signals indicative
of the magnetically encoded GPI Safety Program registration
information.
[0173] The point-of-transaction terminals can function as the entry
point for the product identifiers and consumer identification. The
point-of-transaction terminal equipment 39 can include wired or
wireless cash registers, check out stations, and the like. In the
case of wireless transmission, the point-of-transaction terminal
39C transmits to the CCC 80 data packets over a radio frequency
communication network. When a registered consumer purchases
products using an authorized GPI credit card 39A, then the product
information and user identification is transmitted by conventional
means to the CCC 80. Once the point-of-transaction terminal 39C
actuates, automatically or manually, the transmitting means, the
product identifiers scanned are then transmitted to the CCC 80,
either concurrently with the transaction or later on in a batch
form. Preferably, the product identifiers transmitted and stored
identify products that could be recalled and that are most likely
to cause harm to the consumer. This approach avoids transmission
and storage of information on products that are less likely to
cause harm to the consumer. In one preferred embodiment the product
identifiers collected and transmitted concern drugs or medical
products purchased at a pharmacy. However, any consumer acquiring
any product can be protected against harm or death in accordance
with the principles of the invention.
[0174] As shown in FIG. 5K, the point-of-transaction terminal
equipment 39 includes within the terminal 39C processing means 110
and memory 61 (RAM and ROM) for controlling operations of said
terminal 39C with said processing means 110 interconnected to the
other parts of the point-of-transaction terminal equipment 39 and
being programmed so as to provide suitable control over the
individual operational elements described herein. The
point-of-transaction terminal equipment 39 will preferably have
communication means and data communication means 49 providing for a
suitable telephone line connection, cable, wireless, and the like,
so as to enable communication with the CCC 80 over conventional
telephone lines, the Internet, wireless, and the like. Data
communication means 49 is operatively interconnected with the
central processor 110 for communicating data between the central
processor 110 of the point-of-transaction terminal 39C and the CCC
80. The memory 61 at the point-of-transaction terminal 39C can be
used for storing product identifiers concerning products which were
scanned or entered by the point-of-transaction terminal equipment
39, and includes sufficient data storage so as to enable storage of
product identifiers and consumer identification. The processing
means 110 at the point-of-transaction terminal 39C can be
programmed to permit storage and transmission of product
identifiers and consumer identification to the CCC 80, either by
downloading at a later time or by transmission at the time of
purchase. Various storage compartments (not shown) might be
included with the point-of-transaction terminal equipment 39 to
provide for storage of data (product identifiers, consumer
identification, transaction documents, and the like). The data
storage can be located at the point-of-transaction terminal 39C or
other suitable electronic data storage at the point-of-sale.
[0175] For example, but not byway of limitation, the product
identifiers are preferably encoded as optical symbols suitable for
reading by a bar code reader 39D at the point-of-transaction
terminal 39C. It is understood that other means to identify
products being purchased or to read merchandise identification
tags, whether currently available or developed in the future, can
be used according to the principles of the invention. Exemplary
other means to identify products at a checkout counter can include
radio frequency tags, magnetic tags, other optical symbols,
transponder means, and the like. It is understood that the
principles of the invention apply to an environment where there is
no check-out station as well as where products are not entered by a
clerk nor have a bar code for merchandise identification. For
instance there is no need for check-out stations when using certain
radio frequency tags for merchandise identification. The radio
frequency contains the information related to merchandise
identification and product identifiers, with said information being
linked to local store computers 39N which can further transmit the
product identifiers to the CCC 80 either real time or in batch
format at a later time. The method and type of payment identifies
the user and links the user with the product identifiers being
wirelessly transmitted to the CCC 80. When a product has various
parts, such as in a machine or vehicle, which can individually pose
danger to the user, said individual parts can be identified in the
same fashion as has been described, or collectively identified with
a unique product identifier that includes identifiers for each part
of the product.
[0176] When the point-of-transaction terminal equipment 39 is
connected to a CCC 80 and product purchases occur, the
point-of-transaction terminal equipment 39 is used to read the
identification on the card 39A and establish communications with
the CCC 80. The consumer or salesperson inputs the data by swiping
the credit card or GPI SafetyCard 39A through the slot 51 in the
credit card reader 39D. The information provided by the credit card
reader 39D to the central processor 110 about the card holder
identification is transmitted to the CCC 80. Upon receipt of the
information, the CCC 80 checks the identification of the card
holder and advises the central processor 110 at the
point-of-transaction terminal 39C as to whether this card holder is
registered with the GPI system 1 and if there is proper consumer
authorization to use the credit card for collection of product
identifiers in accordance to the GPI Safety Program for Recall and
Warning Notification. If the card holder is a registered GPI user,
then the CCC 80 transmits electronically an appropriate response to
the central processor 110 at the point-of-transaction terminal 39C
which permits transmission of product identifiers stored at said
point-of-transaction terminal 39C to said CCC 80. The product
information transmitted can include product identifier, date of
purchase, lot number, and other related information according to
the principles herein described. If any product identifier is
recognized as recalled, then the CCC 80 automatically sends the
"Alert" message which may actuate the printing device 39F at the
point-of-transaction causing it to print said "Alert" message. The
transmission of product identifiers can occur during the
transaction or, if the transaction occurs during peak or high
traffic hours, the point-of-transaction terminal 39C can retain and
store product identifiers in the point-of-sale memory medium such
as local store computers 39N which also includes memory area 39M in
the point-of-transaction terminal 39C. The point-of-transaction
terminal 39C or other suitable computer system at the point-of-sale
then transmits to the CCC 80 product identifiers for the various
registered users collected over time. These transmissions can be
scheduled to occur during off-peak access times and using a batch
format. Besides linking with CCC 80, those point-of-transaction
terminals 39C can be linked to other computers (not shown) through
conventional telephone lines, the Internet, wireless means, or the
like.
[0177] The merchant, point of sale, or any point of transaction for
purchasing any product verifies with the CCC 80 whether the card
holder is registered with GPI and thus whether the card holder has
authorized the collection of information on products purchased. In
the credit card transaction industry, there are completely
computerized credit card verification services that verify credit
cards in real time. The point-of-transaction terminal equipment 39
disclosed herein can electronically connect with one of these
credit card verification services or any computerized center
referred to herein as CCC 80, and obtain verification of
registration with the GPI Safety Program before completing the
second part of the transaction conventionally used in the credit
card industry. The point-of-transaction terminal equipment 39 can
be configured to interface with the CCC 80 to receive a code for
capturing and transmitting or storing product identifiers prior to
completing the remainder of the credit card purchase transaction.
Alternatively, the point-of-transaction terminal equipment can be
configured to interface with the CCC 80 to receive a conventional
approval code for credit card purchases prior to completing the
capture and transmission or storage of product identifiers. In this
embodiment, while the receipt is being printed and signed by the
consumer, the product identifiers are transferred to the CCC
80.
[0178] As an illustration, the preferred embodiment described can
be accomplished by the point-of-transaction terminal equipment 39
calling the CCC 80 so as to obtain information on consumer
registration with the GPI Safety Program. In accordance, after
selection of products by a customer, the products are scanned using
the point-of-transaction terminal equipment 39 and product
identifiers obtained. The point-of-transaction terminal 39C places
this information into memory 61 and holds this information until
receiving a code from the CCC 80. The card 39A then is swiped and
the point-of-transaction terminal equipment 39 forwards a stream of
information as a single data transmission to the CCC 80 which
includes GPI Identification number, the credit card number,
expiration date, and date of purchase. The date of purchase can,
for example, be used as means to identify a particular recalled
product. The CCC 80 reviews its database files to determine if the
card holder is registered with the GPI Safety Program. Thereafter,
the CCC 80 identifies the card as registered or non-registered. If
registered, the CCC sends, via the data communications link, a
capture code which permits product identifiers stored at the
point-of-transaction terminal 39C to be transmitted to the CCC or
other data storage locally. The point-of-transaction terminal 39C
then accepts the code and transmits the product identifiers to the
CCC 80 or stores said product identifiers locally for later
transmission. The operation then proceeds in the customary fashion
for a validation of a credit card, as is well known in the credit
card industry.
[0179] Alternatively, the point-of-transaction terminal equipment
39 may have interface means to locally identify whether the
consumer is registered with the GPI Safety Program. Upon inputting
the credit card data or the GPI SafetyCard data by swiping the card
39A, the interface electronics within the point-of-transaction
terminal equipment 39 performs a local registration check to
identify whether the card holder is registered with the GPI Safety
Program. This local verification at the point-of-transaction
includes checking for the encoded data in the credit card that
identifies the consumer as registered. The GPI SafetyCard format
can be confirmed against a memory check at the point-of-transaction
terminal 39C.
[0180] In a further alternative embodiment, the
point-of-transaction terminal equipment 39 is not used as an entry
point or for transmission of product identifiers to the CCC 80, but
is used as a collection site for the consumer. In this embodiment,
after the products are scanned at the point-of-transaction, the
consumer uses the credit card reader 39D to write information onto
an information bearing stripe 41 such as the one present on the GPI
SafetyCard 39A. Consumers can then download the product identifiers
and transmit the data to the CCC 80 at their convenience.
[0181] A yet further alternative embodiment includes swiping the
credit card 39A in the card reader 39D in the usual fashion and
then entering a special registration code or command into the card
reader keypad (not shown) or other point-of-transaction terminal
equipment 39. In this embodiment any regular credit card, even one
without a Safety Program registration encoded thereon, can be used.
This manually-entered special code or command identifies the
consumer as registered. At least two methods of operation may then
be undergone. In a first method, data is not sent to the CCC but
instead the manually-entered approval code executes the operation
for storage of the product identifiers locally at the
point-of-transaction. In this case, the whole operation of
acquisition of product identifiers is done locally at the
point-of-transaction. According to the second method, the
registration data is transmitted to the CCC 80 and operations occur
as previously described. The approval code serves as the consumer
identification as registered with the Safety Program, with said
approval code being transmitted to the CCC 80. It is also
understood that alternatively the user can simply enter a code at
the point-of-transaction terminal 39C without using any card 39A.
The code indicates to the clerk that the user is registered with
the GPI Safety Program. The clerk then can store the product
identifiers for that user locally or transfer this information to
the CCC 80. In this embodiment the whole operation can be done
without the credit card reader 39D.
[0182] According to an exemplary operation, the consumer purchases
products at a point of sale. The products are then scanned and
product information is temporarily stored in the
point-of-transaction terminal equipment 39. The consumer or store
clerk swipes the credit card 39A in the usual fashion. After the
credit card 39A is validated as registered with the GPI Safety
Program locally (at the point-of-transaction terminal 39C), or
preferably through a verification computer such as CCC 80, then if
the consumer is registered with GPI the first message that appears
indicates that the consumer is registered and that the product
identifiers are captured and either transmitted to the CCC 80 or
stored locally. Subsequently, the point-of-transaction terminal
display 68 displays the approval code for the purchase in the usual
fashion for credit card approval well known in the credit card
industry. If the consumer has two cards, for instance, such as a
conventional credit card and the GPI SafetyCard, the consumer first
swipes his GPI SafetyCard 39A and receives the "registered"
message, and then swipes his regular credit card in the
conventional fashion. If the user is not using a credit card or the
like and decides to pay with cash or check, the principles of the
invention still apply. In this situation, after the products have
been scanned in the usual fashion, the consumer swipes the GPI
SafetyCard 39A in the slot 51 of the regular credit card reader 39D
and waits for the response from the CCC 80 or terminal equipment
39. The card in this case is not used for purchase but only for
verification of registration with GPI.
[0183] If the user is registered, the operation proceeds as
previously described. The user then pays with cash in the usual
fashion. As briefly mentioned, it is understood that the
point-of-transaction terminal equipment 39 can identify if the user
is registered and thus avoid extra transmission of data and
response to/from the CCC 80. When this embodiment is used, as soon
as the user swipes his/her card 39A, the point-of-transaction
terminal equipment 39 identifies the user as registered and stores
the product identifiers for the consumer according to the
principles of the invention. In the event that the consumer has
forgotten the GPI SafetyCard 39A, the consumer can manually enter
the GPI identification at the credit card reader keypad, and the
operation will proceed as previously described. Although it was
disclosed that the card 39A was swiped after the products were
scanned, it is understood that the consumer can first swipe his/her
card 39A which would identify the consumer as registered. Then each
product scanned is automatically stored for either transmission to
the CCC 80 or further storage locally at the point of sale.
[0184] Cell phone, personal digital assistants, computers, and many
other devices can have built-in credit card readers and said card
readers can be used to identify the consumer as registered with the
GPI Safety Program and allow acquisition and transmission to the
CCC of product identifiers related to the consumer.
[0185] FIG. 5G shows schematically an exemplary bar code-based GPI
SafetyCard 39A using a key ring arrangement being scanned by a bar
code reader 14. FIG. 5H shows a list of products 39L with the
respective product identifiers L.sub.1-L.sub.n which were scanned
after the GPI SafetyCard 39A was scanned. The product identifiers
L.sub.1-L.sub.n can then be transmitted to a temporary storage area
39M at the point-of-transaction terminal 39C, or at the inventory
storage area 39N of the point-of-sale, or directly to the CCC 80.
FIG. 51 shows the interconnections between the temporary storage
area 39M, inventory storage area 39N at the point of sale, such as
local store computers, and the CCC 80. Data can be sent from the
temporary storage area 39M to the inventory storage area 39N at the
point-of-sale for subsequent transmission to the CCC 80 or may be
sent directly to the CCC 80. Data from the inventory storage area
39N of the point-of-sale can be sent directly to the CCC 80. The
point-of-transaction terminal 39C can generate real-time data for
re-stocking merchandise inventories as well as providing data to
the CCC 80 for tracking recalled products.
[0186] Now referring to FIG. 5J, the system can also include a
central processing station 42 connected to a plurality of
point-of-transaction terminals 44 such as cash registers. All of
the information on product identifiers and user identification are
transferred to the central processing station 42 and said central
station transmits the data to the CCC 80 real-time by modem or
wirelessly, either real time or in batch format at a later time.
The communications between the point of sale and the CCC 80 can
include the use of secured XML tunnels. In addition, packetized or
serial data can be communicated. The GPI SafetyCard 39A can have in
its tracks the code to call the GPI server 10 when said GPI
SafetyCard 39A is swiped through the credit card reader.
[0187] Another embodiment includes the use of a GPI SafetyCard 39A
or a credit card to transmit data directly to the GPI server 10. If
the user is registered, then the point-of-transaction terminal
equipment 39 can assemble the data on product identifiers and
username into packets and send the data wirelessly or by modem
directly to the GPI server 10. In this case the GPI server 10 acts
as the CCC 80 and the point-of-transaction terminal verifies GPI
registration locally without sending any stream of data via
interface with the credit card reader.
[0188] FIG. 5K shows a block diagram of the basic features and
interconnection of the major components of exemplary
point-of-transaction credit card terminal equipment 39. The
point-of-transaction terminal 39C is governed by the CPU or central
processor 110. The CPU 110 can be programmed to perform the
functions necessary to carry out the operations according to the
principles of the invention. The CPU 110 receives input from the
credit card reader 39D, credit card keypad 63, keyboard 58, scanner
72, and memory means 61. The data communication means 49 is
bi-directional. CPU 110 receives data transmitted to the
point-of-transaction terminal 39C via communication means 49 such
as a modem. CPU 110 generates a number of outputs including printer
control and data signals to printer 39F, data signal to speakers
66, output data or information to the display 68 including messages
such as "registered" or "non-registered", and data output for
storage in memory 61. CPU 110 by its communication means 49
transmits data to the CCC 80 over communication medium 74 such as
telephone lines, wireless means, Internet, or the like.
Transmission of data can be implemented using EDI (Electronic Data
Interchange) such as X12 or EDIFACT and communication means such as
EDI VAN (value-added network)
[0189] FIGS. 5L and 5M are a flow diagram of the basic operation of
the exemplary point-of-transaction terminal equipment 39 according
to the present invention and serve to illustrate an exemplary basic
cycle of operation thereof. As indicated in FIG. 5L when a consumer
purchases goods, step 120, product identifiers are scanned or
manually entered and product identifiers are obtained. At step 122
product identifiers are stored in an electronic data storage 61 at
the point-of-transaction terminal 39C and displayed on screen 68.
The product identifier data stored in the point-of-transaction
terminal 39C represents the data obtained by entering or scanning
information on the products purchased by the consumer. Next the
operation determines whether the user card 39A is available, step
124. If no card is available, step 126, the operator enters card
information using keypad 63 and the information is stored in memory
61, step 132. When the consumer uses a credit card 39A for payment,
step 128, the operator (sales clerk) or user swipes the credit card
39A in a magnetic stripe credit card reader 39D. At step 130,
credit card swiping results in the credit card reader 39D reading
the card information which includes user identification and code
for registration with the GPI Safety Program. At step 132, card
information is stored in memory at the point-of-transaction
terminal 39C and, at step 134, user identification is displayed.
Step 136 then establishes connection with CCC 80 and electronically
transmits a stream of encoded data to CCC 80 including GPI
identification number, if present. Upon receipt the encoded data,
step 138, CCC 80 checks its database to identify the consumer as
registered or non-registered.
[0190] Referring to FIG. 5M, the method continues at step 140, with
the point-of-transaction terminal 39 receiving code for
"registered"or "non-registered". A determination is then made
whether the consumer is registered or non-registered, step 142. If
the user is using a GPI SafetyCard or an authorized GPI credit card
with a valid start of data bit, then the user is identified as
registered and the code authorizes capture and storage of product
identifiers for that user. Accordingly, if the user is registered
then operation executes step 144, to determine whether the
transaction is occurring during peak hours. If the transaction is
occurring during peak hours or high traffic, the
point-of-transaction terminal 39C retains and stores product
identifiers and consumer identification in the point-of-transaction
data storage medium, step 146 for later transmission of the data.
This alternative mode can be automatically chosen during high
traffic hours at the point-of-transaction terminals, allowing
efficient transmission of data during such peak hours. At the end
of the day, for example, the point-of-sale terminal computers batch
the record data for all consumers and submit the data to the CCC 80
for storage. In accordance, at step 148 the terminal transmits to
the CCC product identifiers for the various registered users
collected over time and using a batch format, and the operation
ends.
[0191] If the transaction is not occurring during peak hours, step
150, the product identifiers are transmitted to and stored in the
CCC 80 under the user identification which can include the username
or Internet address. At step 152, the product identifier(s) are
then checked against the CCC 80 database to determine whether there
are any product identifiers transferred which were recalled. At
step 154, the point-of-transaction terminal equipment 39 receives
code "recalled" or "non-recalled". Step 156 then determines whether
the product has been recalled. If no, step 158, the terminal
displays "non-recalled" and the operation ends. If yes, step 160,
the point-of-transaction terminal equipment 39 displays the product
identifier for the recalled product and prints an "Alert" Message
related to said product identifier, step 162, and ends
operation.
[0192] If, at step 142, it is determined that the user is not
registered, then no product identifiers are stored and the terminal
displays "non-registered" at step 164, the operation ends, and the
processing occurs as with conventional credit card validation for
payment of goods and approval for sales. After any step in which
the operation ends, then conventional processing for credit card
automatically occurs and authorization for payment is conducted in
the conventional fashion for credit card use for purchasing goods
and obtaining approval for sales which is well known in the credit
card industry. When the system for recall and notification is
implemented using multiple point-of-transaction terminals 44, then
a plurality of terminals with a central processor are in
communication with the CCC 80. In this instance CCC 80 can be
linked to all point-of-transactions terminals 44. A further
alternative embodiment includes reprogramming credit card terminal
equipment 39 to tag each transaction with the username prior to
transmission to the CCC 80.
[0193] If a product is purchased over the Internet 100, then the
product identifier can be automatically transferred to the GPI
server 10 during the transaction. Purchases can include e-commerce,
m-commerce, or any electronic acquisition of products over the
Internet including e-business with acquisition of products by a
business concern from another business concern. For example, a GPI
agent can be downloaded to an authorized user's computer and used
to capture the purchase data from the user's computer 30 and
transmit to the GPI server 10 using a secured XML tunnel. A special
web browser can be used to capture data related to acquisition of a
product. FIG. 5N shows exemplary steps for acquisition of product
identifiers over the Internet. At step 121 products (items) are
selected and product identifiers appear on the screen of a
computer. At step 123 the user accepts, purchasing items displayed
in the line of items. Step 125 shows a bill of materials invoice or
line of items invoice on the screen of a computer related to items
purchased. Step 127 captures data displayed. Step 129 transmits
data to GPI server 10, and the operation ends.
[0194] Besides using a conventional computer device for receiving
and displaying alert information, the display of a cellular enabled
device can be used. FIG. 5P shows an exemplary block diagram of the
connection between the GPI server 10 and a communications company
300 and user 90. The GPI server 10 can be connected to
communications company 300 by physical or wireless means. Likewise,
communications company 300 can be connected to the user 90 by
physical or wireless means. The GPI server 10 transmits the alert
information to a communications company 300 which subsequently
transmits the alert information to the user, for example to the
screen of a cellular telephone. As shown in FIG. 5Q, user 90 may
transfer over the Internet the line of items purchased to
supplier's server 350. Supplier's server 350 may then transmit the
line of items to the GPI server 10 over a secured XML (extensible
markup language) tunnel or virtual private network. User 90 can
also transfer the line of items directly to GPI server 10.
[0195] Although the point-of-transaction terminal equipment 39 can
have means to select what products to choose and transfer data for,
in some cases, it is more cost-effective to have information for
all products or at least all products of a certain group (which
were identified by proper code) sent to the GPI server 10. If all
products purchased by every user 90 are scanned and the data
transferred to the GPI server 10, it may create a potential data
overload. It is therefore preferred that the user has the option to
select the products for which information will be transferred and
stored in the GPI database e.g., typically those products that are
most likely to cause significant harm and increased health care
costs. Although technically possible, it would be difficult if, for
example, at the point-of-transaction a first user only wants one
item transferred, then a second user wants one item from the D2
(over-the-counter drugs) group and four items from the C
(cosmetics) group, and none from the F (food) group, and then a
third user purchases items in all of the groups but wants two
individual products of the Mi (Miscellaneous) group, one out of ten
in the F group, two out of eight in the C group, and so forth.
Under these circumstances, it would be possible but cumbersome to
implement the invention in that fashion. It is therefore preferable
for the user to transfer all of the identifiers or select only the
products he/she is interested in receiving information about, by
acquiring the UPI using the aforementioned IECLD 40 or GPI
SafetyCard 39A only for the selected items.
[0196] Alternatively the user can acquire data on all the products
purchased at the point-of-transaction, and store the data in the
smartcard 39A. The smartcard 39A then is read in a suitable reader
and information on the items selected by the user 90 is transferred
to the GPI central server 10 for storage. Naturally, the user 90
during registration or at any time thereafter has the option to
select and/or block the information to be sent about harmful,
beneficial, or recalled products at the user's discretion. For
example, the user 90 may only want to know about recalled products,
or only recalled drugs and harmful effects of drugs, or recalls and
beneficial information on cosmetics, or recalled baby/toy products
and recalled drugs and cosmetics, and so on. Thus, even if all UPIs
are transferred, the system 1 can be tailored to the individual
need of each user so that only the data that is meaningful to that
user is transferred.
[0197] Although the preferred embodiment concerns the electronic
transfer of information, the invention can be carried out using
conventional communication means as previously mentioned. In those
alternative illustrative embodiments, the user 90 can utilize a
conventional telephone line to communicate with the central server
10 (or GPI) which can direct the user to a human attendant who then
registers the user 90 and collects the personal information, the
UPI data, and any biological variables data if applicable. The
attendant then converts the data into binary elements and transmits
and stores the data in the GPI central server 10 in the manner
previously described, or alternatively, digitized and faxed
information could be acquired and processed in a similar manner.
Once the user 90 is registered, the whole entering of data can be
done automatically without human interference since the data
consists of numbers for either the UPIs or the biological
variables. This consequently can be performed using a telephone
keypad and conventional Interactive Voice Response (IVR) Unit. The
user 90 then can contact the GPI central server 10 to receive
feedback information on the products being used. The GPI central
server 10 can convert text into audio with standard electronic
voice synthesizers.
[0198] Although less preferable, it is intended that the current
invention also can be carried out using printed medium which is
converted into binary elements and used in accordance with the
principles of the invention previously described. Although the
preferred way to carry out the invention involves data transfer in
electronic mail format, it is understood that other electronic data
transfers including automatic transfer to a computer, without the
user necessarily having to open and read an e-mail, can be used.
For instance, if a company is registered with the GPI system 1, the
information can be transmitted using electronic data transfer and
interface with the alert information appearing directly on the
computer screen of a designated human attendant. For users who
cannot receive electronic transmissions or have no connection with
the Internet, an automated print out sheet with the information can
be made and mailed to the user by conventional means to the user's
regular mailing address, thereby allowing potentially life-saving
information about recalled products to reach any user. In addition,
a recall message and information can be sent to a telephone device
and displayed on the screen of said telephone device. Although
printed means and conventional telephone means are not the
preferred way, the critical information about recalled products can
be made available to anyone regardless of their electronic
capabilities. As mentioned above, any user 90 of a product can
register freely using the PCT stations 156 and transfer product
identifiers. Such users 90 are subsequently informed by mail or
phone messaging when they do not have Internet capabilities. When
using electronic means, the preferred output means includes a
computer screen, whether portable, conventional, or other as
previously described, but for elderly patients a more friendly
interface such as a television screen is a desirable alternative
way carrying out the invention. In this regard, the IECLD 40,
besides its regular functions described, can work as the remote
control for the television and/or VCR.
[0199] With reference to FIG. 6, a preferred embodiment of the
central server 10 will now be described. The exemplary central
server 10 includes a CPU 500 and an exemplary memory medium 502
with an exemplary memory arrangement 504. The exemplary memory
arrangement 504 includes databases such as a product database 506,
a biological variables database 508, an interaction database 510,
an alert database 512, a personal information database 514, and the
user's product usage database 516, as well as conventional modules
518. The modules 518 may include database management modules 520,
search modules 522, encryption/decryption modules 524, time/date
modules 526, transmission modules 528, and e-mail modules 530 along
with secure server-based electronic mail application. The exemplary
central server 10 also includes a clock 532, operating systems 536,
RAM, ROM and other typical server 10 applications and hardware well
known in the art. Although the GPI central server 10 preferably
searches using ASCII character and numerical matching and
comparison, it is understood that graphics, multimedia, sound, and
the like can be used according to the style of database and
computer applications utilized.
[0200] Still in reference to FIG. 6, the CPU 500 interfaces with
the operating system 536 which may include single or multiple
high-speed processors operating in parallel or otherwise executing
applications stored in the memory devices, RAM and ROM, to carry
out the necessary functions illustrated below according to the
principles of the invention. The CPU 500 receives UPIs and
biological variables from the user 90 and information on UPIs from
the RIS 60, preferably via the Internet 100 through a
communications interface 540, and stores the data from the user 90
in the product database 506, user's product usage database 516,
biological variables database 508, and personal information
database 514. The CPU 500 stores the information from the RIS 60 on
UPIs and/or biological variables in the alert database 512, and
stores information on interactions in the interaction database
510.
[0201] FIG. 6 also depicts an exemplary memory arrangement in which
the product database 506 includes a drug database in memory area
6A, a cosmetics database in memory area 6B, a baby/toy products
database in memory area 6C, a food products database in memory area
6D, a medical device products database in memory area 6E, and a
miscellaneous products database in memory area 6F. The product
database 506 includes the UPI, preferably the bar code numbers,
associated with the usernames according to a preferred embodiment
of the invention. The product database 506 maintains a list of all
products stored according to the product category, and contains
records of each individual product with all of its users according
to the product category. Thus, each UPI may be associated with a
plurality of users. More specifically, the product database 506
maintains data on products according to the categories including
the drug database which contains the UPI for the drug identity
transferred by the user and all corresponding usernames of people
using that drug. The cosmetic database contains the UPI for all
cosmetics and associated users of each individual cosmetic UPI. To
further illustrate, the food database contains the UPI for food
products and corresponding usernames associated with each food
product, the medical devices database contains the UPI for the
medical devices with corresponding usernames, the baby/toy database
contains the UPI for the infant products and toys with
corresponding usernames, and the miscellaneous products database
contains the UPI for miscellaneous products and corresponding
usernames.
[0202] The user's product usage database 516 includes the name of
the user 90 and associated UPIs for the user 90, and maintains a
list of all usernames stored with all of the UPIs associated with
each individual user 90.
[0203] The biological variables database 508 includes the values
acquired by the various HMDs 50, which values are located in memory
area 6G. The standard normal values for biological variables are
located in area 6H which allows values transmitted by the user to
be correlated with normal standard values. Memory area 6I has the
pathological diagnosis associated with abnormal biological
variables and is called the disease association area. The disease
association area 6I contains an expert system concerning the
diagnosis associated with the abnormal biological variable, for
instance, increased eye pressure indicating glaucoma, elevated
blood sugar indicating diabetes, and so on.
[0204] The product interaction database 510 has updateable fields
including the most commonly known interaction between products
(UPI) and biological variables. The data on interaction of drugs
with biological variables and other products (UPI for the product)
is stored in memory area 6J, the interaction of drugs with food is
stored in memory area 6K, the interaction of drugs with cosmetics
is stored in area 6L, and the interaction of drugs with medical
devices is stored in memory area 6M.
[0205] An example of the interdependence of these databases is as
follows. If, for example, a user 90 performs an eye pressure
measurement (to acquire a biological variable) at home with an HMD
50, as described by Abreu in the aforementioned patent, and the eye
pressure levels are transmitted to the central server 10 (or GPI),
then the CPU 500 in the central server 10 receives the biological
variables (eye pressure) and stores the value in the biological
variables database area 6G which is then evaluated against the
normal values area 6H. Since the values, for example, are high,
which is indicative of glaucoma, the CPU 500 searches the disease
association database 6I for the criteria of eye pressure increase,
in order to identify the disease associated with the transferred
biological variable. In a more descriptive form, if the eye
pressure is above normal limits (e.g., if it is above 30 in the
right eye, indicating that the patient is at risk for glaucoma and
blindness), then the system naturally informs the user about the
risk of blindness due to glaucoma. In addition, the system then
matches that information "increased eye pressure or glaucoma"
against the various products (UPI) stored by the user at risk of
glaucoma and checks whether any of the products in his/her database
is contraindicated for someone with glaucoma. If any record
representative of any UPI is associated with the criteria glaucoma,
a match is found and the information transmitted back to the users
informing him/her that the product for which information was
transferred is contraindicated for patients with increased eye
pressure (or glaucoma).
[0206] As a second example, the user has stored under COSMETICS 6B
a code for a steroid based-shampoo, then the system identifies the
matching steroid product with a "contraindication glaucoma" as
harmful and automatically sends the appropriate alert to the user
according to the principles of the invention. If, for instance, the
user buys a moisturizer skin lotion (UPI .TM.2111211314) and later
on, for instance, the FDA 130 sends a warning about a moisturizer
skin lotion (UPI #2111211314) which contains unlabeled amounts of
steroids, the data for "steroids" is checked against the biological
variables database 508 which contains the usernames associated with
the disease, in this case increased eye pressure data which is
labeled as glaucoma. The system then identifies the match "steroid
lotion-glaucoma" as harmful and automatically alerts all the users
of UPI #2111211314 and who also have increased eye pressure
indicating that they are at high risk of blindness should they use
the skin lotion. Since the information was received from the FDA
130 and there is risk of injury/illness, all of the users 90 of the
product identified by the subject UPI will be informed about the
newly found information on steroids present in the skin lotion,
thereby allowing all of the buyers of the skin lotion to know the
risks related to continued use of the skin lotion. The user with
increased eye pressure is informed about the dangerous situation
even though he may not be aware of the fact that steroids can lead
to blindness when the user exhibits abnormal eye pressure. The
invention thus gives the information to the user even without the
user knowing the name or consequences of the ingredients or
warnings on the label. Furthermore, even if the user knew that
steroids could lead to blindness in someone with glaucoma, without
the invention, the user would have to search through thousands of
daily warnings and then by chance identify the skin lotion he/she
bought as containing unlabeled amounts of steroids.
[0207] Another example will further clarify and demonstrate the
urgent need for the invention. If the user for instance is
prescribed a common drug for high blood pressure such as verapamil
(a calcium channel blocker), then information identifying the drug
is stored under the username of that user 90. If the same user 90
then buys and transfers to the GPI central server 10 under his
username the code for grapefruit juice, the identifier for
grapefruit is entered and the system 1 identifies the harmful match
verapamil-grapefruit juice and alerts the user about the dangerous
interaction. "A bioflavinoid present in grapefruit juice interacts
and inhibits the P-450 enzymatic pathway in the liver. The
decreased first-pass P-450 metabolism increases the concentration
of verapamil with the consequent significant increased
pharmacological effect of the drug." The increased effect of
verapamil caused by grapefruit juice can lead to severe hypotension
and even a fatal event depending on the dose and patient
susceptibility, in addition to a risk of car accidents due to
impaired reflexes or fainting at the wheel, as a result of
decreased blood pressure caused by the harmful combination
verapamil-grapefruit juice. As soon as the harmful interaction is
identified, a warning message is sent to inform the user to avoid
grapefruit juice when taking verapamil. If the user had transferred
information on orange juice, the system would not identify any
harmful interaction between the orange juice and verapamil, and no
warning would be sent. The invention thus optimizes electronic
transmission creating a cost- and time-efficient system in which
only relevant information is sent to the user. The user does not
need to know the meaning of the abnormal biological variable, nor
does he/she need to be aware of the interaction between products
for which identifying information has been stored. Furthermore, the
user does not need to know that a product being used can fatally or
harmfully interact with another product being used. The system of
the invention provides all of this life-saving and cost-saving
information automatically, regardless of the knowledge of the user
in regard to the products being used. If the user then purchases
and transfers information on a certain product, even if the user
does not know the ingredients of the product, the system of the
invention will alert the user about potential interactions between
such products and other products for which there is identifying
information stored in the product database. In addition the system
1 informs about interaction between that product and biological
variables stored in the biological variables database and/or the
product and individual sensitivity, such as allergy with any
product interactions newly received from RIS 60 and stored in the
interaction database according to product category and the
principles of the invention.
[0208] FIG. 6 also shows the alert database 512 which includes data
on harmful effects of products and harmful interactions stored in
memory area 6N, data on beneficial effects of products and
beneficial interactions stored in memory area 6Q, and recall data
stored in memory area 6P. Whenever any of the RIS 60 transfer a
product alert, the CPU 500 of the GPI central server 10 receives
the UPI information and stores the UPI information in the alert
database 512 according to the type of effect (B=beneficial,
H=harmful, or R=recall). The alert database 512 tracks and includes
all of the data warning, product information and recall information
on products (UPI) received/acquired from the various RIS 60 ranked
according to the level of importance/severity (e.g., 1 to 5) and
according to the type of event (B, H or R).
[0209] The data on products (UPI) preferably is checked against the
product database 506. If the search process identifies codes (UPI)
or names stored in the products database that match the code (UPI)
or name of the products received from the RIS 60, then the
usernames under which the product codes (UPI) are identified are
used to effect a subsequent electronic transfer of the
information/message on the products to the username or IP
address.
[0210] The CPU 500 preferably is programmed to automatically search
the product database 506 and use the UPI number as the search
criteria. The CPU 500 thus searches the product database to
identify the same UPI number and the users associated with that UPI
number. The users are then identified and the alert information on
such a UPI is transmitted back to all of the users of the product
(UPI).
[0211] The data on products transferred from the RIS 60 also is
checked against the biological variables database 508 and
interaction database 510 of the users. If the search process
identifies biological variables that match the UPI information
transmitted, then the usernames under which the biological
variables are stored are used to effect a transfer of the
information/message to that username. For instance, if user
Mr.ABC@IBM.com has transferred liver enzyme values using a HMD 50
for non-invasive blood analysis and those values are elevated and
consistent with liver disease, then the disease association
database 61 for the user indicates "liver disease". When the RIS 60
transfers information about the drug Rezulin associated with a
"contraindication liver disease" record, then the CPU 500 stores
the data in the harmful alert database 6N, and then searches the
biological variables database 508 and in this case finds a match
for the criteria. A warning therefore is sent by the CPU 500 to
Mr.ABC@IBM.com about the drug Rezulin being contraindicated to
patients with liver disease. In this case, the user Mr.ABC was not
using the drug Rezulin, and further search did not identify the UPI
for Rezulin associated with his username. In this manner, the GPI
system 1 acts in a preventive manner by informing the user on what
to avoid, and thus helping to preserve the user's health and
simultaneously saving money for the user, who did not waste his
money buying an expensive drug which ultimately could harm him.
[0212] The personal information database 514 includes fields such
as all the data submitted by the user to the GPI server 10 during
the registration process including a unique username with its
Internet address and code and/or password. The user may send
his/her name, but it is more desirable to have the user remain
anonymous and, for example, just use an e-mail address with a
pseudonym. Each new registered user can also be assigned a unique
user identification number. While the invention can be carried out
with any address and preferably is carried out with only the
electronic e-mail address, optimal use of the features of the
invention may require some additional information such as age,
biometric elements, demographic information, address, medical
information, personal information, family history, insurance
information, primary care doctor, preferred and/or nearest
pharmacy, preferred laboratory, and the like. If the user includes
allergies to a certain product in his database, the product name
and/or other identifier are then used during searching. If the
patient is allergic to peanuts, for example, but does not have UPI
information related to a product with an undisclosed amount of
peanuts, then any time a new UPI is sent by the user to the GPI
central server 10, that transferred UPI is checked against the
identifier stored in the allergy field (peanuts), and if there is a
match, (any peanut protein present) then a warning is sent to the
user who transferred the UPI. If the user, on the other hand, has
already stored in the product database a certain UPI (e.g.,
1212131), then if the GPI central server 10 receives information
from the RIS 60 that a certain product UPI 1212131 was found to
have undisclosed amounts of peanuts, then the search criteria "UPI
1212131 peanuts" is checked against the allergy field which
identifies the user as allergic to peanuts. The CPU 500 searches
the product database 506 and finds in the food memory area 6D a
match for the criteria. This indicates that the user is both
allergic to contents of the UPI transmitted by the RIS 60 and also
has stored information indicating that the user is potentially
consuming food contaminated with peanuts. The CPU 500 then can
transmit the information back to all users of the UPI 1212131 as a
warning for products containing undisclosed amounts of peanuts
using the regular electronic information conventionally done for
the non-peanut allergic users. However, for the users identified as
allergic to peanuts and also using the product with a UPI
indicating that it contains peanuts, then an urgent alert is
transmitted by autodialing, paging, etc, in addition to the
electronic messages, since consumption of peanuts by such an
allergic user can lead to a fatal event.
[0213] In another example, the user Mrs.LK20@hotmail.com transfers
a UPI 0911232425 related to a baby-toy product to the GPI central
server 10, in this case the UPI for a certain portable crib. The
CPU 500 of the GPI central server 10 is programmed to receive and
store that UPI 0911232425 with the respective username
Mrs.LK20@hotmail.com in the baby-toy database 6C. The CPU 500 then
searches the alert database 512 for any information related to that
UPI. In this example, at the time of searching, there was no match
for the UPI in the alert database 512. If a few months later,
recall information for UPI 0911232425 is transferred from the CPSC
132 to the GPI central server 10, then the recall information will
be stored by the CPU 500 in the recall area 6P of the alert
database 512. Any UPI stored in the alert database 512 is
automatically compared against the UPI information stored in the
user's product usage database 506, and if there is a match, the
information associated with the UPI is transmitted back to the
users. In this example, Mrs.LK20, although completely unaware of
using a deadly crib, receives the information immediately upon the
CPSC determination that the crib is unsafe or may have killed a
child, as usually occurs when the product first causes injury and
then is recalled. In addition to Mrs.LK20@hotmail.com, all of the
other users of the deadly crib are informed about the fatal danger
posed by the product. The manufacturer of the crib then can reach
all of the users in the most inexpensive way. The company also
minimizes any consequences or financial disaster that it might have
experienced had it publicly announced the recall. The cost savings
become more readily apparent when one considers the company's
virtual obligation, without the system 1, to continue advertising
the "wrong-doing" until every recalled crib is identified.
[0214] The present invention also saves time and effort that might
otherwise have been wasted on mass advertising on a regular basis.
Additional savings are realized as a result of the consequent
reduction in the risk of product liability suits and settlements,
and the savings that are realized by not having to pay health care
and/or disability expenses related to the harm caused by the
product. This also obviates the related risk of going out of
business under the resulting financial strain, and the commercial
embarrassment of having to publicize the dangers of the product.
More importantly, however, thousands of innocent lives can be
saved. Government spending also is reduced because any related
government-funded health care or disability benefits are averted.
The economy of the nation also benefits by saving the companies
from financial disaster or from going out of business, thus
preserving jobs for its people. As can be seen, the present
invention is extremely useful and vital not only for the user, but
also the manufacturer and the government, and it is quite
inexpensively implemented, creating the reliable wide spread recall
and information coverage system urgently needed.
[0215] Considering the crib as an example, the recalled product is
a level 4 (meaning a fatal event can occur with the use of the
product according to the information from the CPSC).
MrsLK20@hotmail.com is then informed by not only electronic means
but also using conventional communication techniques such as
autodialing, paging, and the like. This is done to maximize the
likelihood that the critical information about the deadly crib will
reach the intended recipient. The system, as will be further
described, may even prevent the death of the first child, by
informing the user about the risk before the government even issues
a recall.
[0216] In another embodiment, the GPI system 1 uses a PCT
arrangement 156, which is a Public Computer Terminal, with bar code
reading capabilities and connected to the GPI central server 10.
The PCTs 156 are located in public places, such as post-offices,
malls, grocery-stores, and the like. Thus, any product user, even
those who do not have a computer and/or are not a registered user,
can send information to the GPI central server 10 concerning the
harmful effects of products being used. The user, for example, may
enter only the name of the product or the establishment delivering
the product, but preferably the UPI, which can be manually entered
or scanned with a bar code reader. The user then fills out a simple
standard form with type of effect B or H, and selects from a menu
of types of injuries/illnesses caused by the product, types of
problems according to product and the frequency of occurrence. The
information then is transmitted to the central server 10 (or GPI).
If a significant number of users report a harmful effect related to
a certain product or establishment, the information is transmitted
to the FDA 130, CPSC 132 or any other appropriate RIS computer 60.
Anyone with access to the Internet could transfer product warning
information by logging onto the GPI web site and by filling out the
product warning form. In the case of the deadly crib, if a certain
number of users send warnings identifying the crib as injuring a
child, even if slightly, or as having unsafe features as observed
by the user, the information could be transferred to all of the
users of the crib as a GPI alert, not an RIS alert, allowing the
user to better evaluate the product and, if applicable, take the
necessary precautions in order to keep the product from causing
injury.
[0217] An alternative exemplary embodiment can include a personal
acquired medical database that includes beneficial, harmful,
recall, and interaction data acquired that relates to the
particular medical status of the user according to medical
information and biological variables stored as well as any relevant
past medical or allergy history. If, for instance, the user
transfers blood glucose levels using appropriate devices which
indicate that this patient has diabetes, then all products stored
in the product database 506 for that user, and the biological
variables stored in the biological variables database 508 for that
user, as well as all beneficial, harmful, recall, and interaction
data for that user that meet the criteria "diabetes" are also
stored in the personal acquired medical database under "diabetes".
Thus, if the user wants to know what product data, biological
variables data, recall data, interaction data, harmful effects
data, and beneficial effects data relates to the user's diabetes,
the user can easily access the information which is stored under
"diabetes" in the personal acquired medical information database.
The user can also store any other personal medical information or
acquired medical information in the personal acquired medical
information database.
[0218] The product database 506 also can maintain for each UPI a
plurality of document records, textual or multimedia, that are
representative of the UPI stored. For example, the UPI for a
certain drug has associated document records concerning the
indications, known side-effects, known drug interactions,
description, chemical formula, and the like, stored in the database
for that drug UPI with the information being continuously updated
by a remote manufacturer computer 148.
[0219] It is understood that the transfer of data/information can
be performed using conventional encrypted transmission in order to
increase the level of confidentiality of the information. The GPI
central server 10 uses the communications interface 540 to
communicate with the user and/or RIS 60 with interfaces that
support standard or high-speed connections with the Internet. The
GPI central server 10 transfers data to/from the user 90 and
to/from the RIS 60 including exchanges of messages with attachments
such as files, video, graphics and audio which are communicated in
a variety of ways, including a network interface electronically
connected with commercial on-line providers, or configured as a web
site, electronic mailing address, World Wide Web interface, direct
link, and the like along with other conventional physically wired
and wireless communications and for the purpose of completeness
conventional means such as facsimile, postal mail, voice means,
pagers, and the like. Preferably, however, the electronic means are
provided via a communications interface that transfers data over
the Internet. It also is intended that conventional authentication
means can be used in order to provide the authorized accessing and
transferring of data. It also is understood that the database above
described is only an illustrative system, and a variety of
modifications, changes in database and field combinations can be
made by those skilled in the art without departing from the scope
or principle of the invention.
[0220] In accordance with an exemplary embodiment of the present
invention, after the user acquires the UPI for a drug the UPI is
electronically transmitted to the GPI server 10 and then to the
product database 506 and drug memory area 6A. For instance drugs
"D1", "D2" and "D3" are stored in the product database in the drug
memory area 6A with their respective indications for the users of
such drugs. For example UPI 4546478 corresponds to D1 and is
associated with Mr.ABC@mailcity.com, Mrs.DEF@whitehouse.gov and
Dr.FGH@navy.mil. When a medical device "M1" is used, the individual
unique product identifier UPI141618486 and respective user 15,976
is stored in the product database in the medical device memory area
6E. In this case, as an example, the username or IP address is
assigned a unique user number. When the user Mrs.Ethel@gpi.co.uk
transfers information regarding two different types of cosmetics
"C5" and "C10", the user Mrs.Ethel@gpi.co.uk appears associated
with both "C5" and "C10" and this relationship is stored in the
product database 506 in the cosmetic memory area 6B. When a baby
product "B1" is used, the UPI code number is stored in the product
database 506 in the baby-toy memory area 6C, and when a food
product "F32" is used its individual identification number is
stored in the product database 506 in the food memory area 6D, and
so forth with its associated usernames and representative
records.
[0221] The GPI system 1 can be used in a variety of environments,
but since drugs, medical devices, cosmetics, toy/baby products, and
food define the main sources of harmful products and recalled
products, those are the ones referred to in this part of the
description. This invention, of course, is not limited to such
products, especially since virtually any product could be recalled
or considered harmful, in which case, there would be a need to
identify the affected users and locate and alert them as well, in
accordance with the principles of the present invention.
[0222] Besides the common products described above, a variety of
biological data or biological states or biological functions such
as temperature, weight, visual acuity, blood pressure, eye
pressure, blood glucose level, chemical analytes in the blood, DNA
fragments, as described in patents by Abreu and the like, can be
used as biological variables. Common products or medical devices
which alter these biological states and biological variables also
can be used according to the invention such as the implantation in
living tissue of chemical substances, devices, artificial
prosthesis, radio active seeds, and the like; the external
placement on living tissue of devices such as hearing aids; the
interaction of chemical compounds with living tissue such as
cleaning and sterilizing substances; the manipulation or
modification of living tissue such as with invasive surgical
procedures and the like. It is also understood that any prosthesis,
chemical substances, devices or the like will have appropriate
identification number and codes which can be optically encoded for
identification with subsequent acquisition by the IECLD 40 or GPI
card 39A and then the data on a particular medical device
transmitted to the GPI server 10 for storage in the database.
[0223] For example, if a certain type of prosthesis is later found
to come from a lot which is contaminated, the patient would be sent
a warning and instructions on how to proceed. The same would apply
to defective material which could be found in intraocular lenses,
defective circuits found in pacemakers, chemical substances
implanted in the body such as altered silicone which was found to
cause cancer, defective collagen implants used in cosmetic surgery
which caused severe inflammation due to the material in that
particular lot, defective sutures or staples used inside the body
or outside the body which caused severe granulomatous reactions,
stents used in vascular surgery that came from a particular lot and
then later were found to easily crack and leak, defective X-rays
and imaging devices which were used by a variety of patients and
later found to have exposed the patients to a harmful amount of
radiation, whitening gel to be placed on teeth while sleeping
coming from a tampered lot which were found to cause severe
allergic reactions and to be caustic, cream for the treatment of
skin disorders which were later found to cause permanent skin
thickening and potential severe skin reactions, cosmetics which
were later found to come from a contaminated lot and caused corneal
ulcer and blindness, color additives which were later found to
cause severe neurotoxic reactions, certain food from a certain lot
which was found to be contaminated with E. coli and caused severe
disease and even death, ineffective vaccines which were later found
to come from a tampered lot, and the like. It is understood that
any products that have a particular identification number could be
optically encoded, tracked, identified and located using the GPI
system 1 with the individual user 90 being appropriately informed
and instructed in regard to potential health hazards related to
such product.
[0224] All of the biological variables and/or products (UPI)
transferred by the user 90 to the GPI server 10 are stored in the
GPI database 504 under the code or username for that user, allowing
the information in regards to that user to be continuously updated
by the user 90. If the user 90 deletes, for instance, drug Y from
the list of drugs being used, that information is sent to the GPI
server 10 which then will delete drug Y from the GPI database for
the user 90, allowing the GPI server 10 to continuously update the
GPI database, keeping track of new information which is added and
old information that is deleted. For example, in another embodiment
when a manufacturer of a pharmaceutical product or the FDA sends a
warning to the GPI server 10 about a product P, all users of
product P stored in the GPI database will receive the warning. When
the user of product P logs into the GPI web site, the user receives
automatically the stored messages in the GPI database on product P,
or alternatively when the user of product P logs in the GPI
website, the user is informed that there is a warning about product
P stored in the GPI database 504 which should be retrieved or there
is an e-mail alert on product P that should be retrieved. In
accordance, a duplex communication channel can be created in which
individuals using product P automatically receive information
related to product P from the GPI server 10 and the individual
using product P can receive automatically or interrogate the GPI
server 10 in regards to any information which directly or
indirectly relates to product P and that could have an effect on
the health status of that individual. In this embodiment, the GPI
System is used as a locator and information source which allows
immediate delivery of information to individuals using product P.
In case that post-market surveillance identifies a new side effect
or new drug interaction, then all patients using drug product P,
for example, automatically receive information related to the
update. The electronic automated location and information system of
the present invention allows millions of users at risk of
life-threatening event related to the unintended harmful effect of
drugs and other products, to simultaneously receive lifesaving
information using a timely, private, individual, confidential,
orderly, precise, continuous, reliable, low-cost and cost-efficient
system.
[0225] In another exemplary embodiment shown in FIGS. 5C-5F, the
IECLD 40 is brought by the user to the point-of-prescription of the
product or point-of-care or point-of-sale or point-of-receipt or
point-of-transaction. For example, the user 90 will bring his/her
IECLD 40 to the pharmacy where the user is purchasing a variety of
products including drugs. The user 90 may decide that he/she only
wants to acquire information on the drugs and cosmetics being
purchased, but not on some consumable items as candy, milk, and
other readily consumable food items. The invention thus allows the
user to decide which products the user would be interested in
receiving information and/or recall and/or alert information
concerning. The user 90 can simply scan only the products of
his/her interest to be stored in the GPI server 10. On the other
hand, if all of the products purchased are being scanned at the
point-of-sale by a clerk or at the point-of-care by a health
provider, then applications can be used to select only relevant
products to be transferred and/or stored in the GPI server 10. This
alternative manual selection or automatic selection of products to
be stored is useful in avoiding the storage of excess or useless
data.
[0226] In an example for acquiring identification about a
prescription drug for appetite control, the user brings his/her
IECLD 40 to the pharmacy. The pharmacy has a table with various UPI
bar codes for each drug, or preferably each package will have the
newly created UPI identifier bar code imprinted or the pharmacist
can manually type in and send the drug identifier code to the
central server 10. The user enters his/her ID and password, and
then the unique barcode for the drug is read and the data is stored
and displayed in the display of the IECLD 40. Alternatively, the
user may access the GPI web site and enter the bar code number
directly to the GPI server 10 and database under the user's name.
Alternatively the user may provide his/her code and enter his/her
password and the data sent directly from the point-of-prescription
(pharmacy) to the GPI server 10 station to be stored under the
username. Alternatively, during a purchasing transaction and
payment of goods, the bar code is scanned and the data is directly
transmitted from the point-of-sale to the GPI server 10 station via
conventional or electronic communication lines. Alternatively, the
pharmacy (point-of-transaction) sends the UPI directly to the GPI
server 10 when the patient fills a prescription regardless of the
patient having a portable unit 40 as the IECLD 40. In this instance
the user has all of the information stored in the server 10 with
information directly transmitted from the pharmacy. In countries
like Japan in which the doctor may act as a pharmacy and provide
the drug directly to the patient, the doctor's assistant can enter
the new data into the portable IECLD 40, and the information is
transferred to the GPI server 10 at the point-of-care, in this case
the doctor's office or alternatively the hospital. The IECLD 40 can
be interfaced with a printer in the doctor's office and an updated
drug regimen printed and given to the patient, and/or a
prescription slip may be printed if needed.
[0227] In another embodiment the user may carry a smartcard 39A
which can acquire and store the product identification data for
subsequent transmission of the product information to the main GPI
server 10. In another alternative embodiment the users carries
their smartcard consisting of a GPI smartcard 39A which contains
information on the user which identifies the user, and for instance
when the user purchases a product such as drugs, at the
point-of-sale during check-out at the cashier, the GPI smartcard
39A is entered or scanned, then products are scanned and the data
on the drugs (or any selected products) being purchased is
automatically transmitted from the point-of-sale to the GPI server
10 and stored under the username for the GPI smartcard 39A.
Alternatively the GPI smartcard 39A is placed on a receptacle at
the point-of-transaction for acquisition of the unique product
identifier codes with the user being able then to later select what
products or group of products stored in the smartcard 39A will be
transferred to the GPI server 10 or CCC 80 for storage, thus
allowing the user to later select, and then transfer the data. It
is intended that any physical data memory device besides a card can
be used to acquire the product identifiers such as floppy disks,
hard disks, optical disks, opto-magnetic disks, tapes, CDs,
cartridges, semiconductor medium, and the like for later
transmission to the server 10 or to communicate with the server 10.
Furthermore, any of the input/output devices can be connected to a
printer 39F for printing a list of the selected product identifiers
transmitted with or without an associated bar code printed. If the
bar code is printed, the user can then take the printed bar code
39H and later scan the printed bar code at the user's domicile.
[0228] When the IECLD 40 interfaces with the home-monitoring
devices (HMD) 50 and a connection is established between the user
90 and the GPI server 10, the user 90 can transfer the biological
variables to the GPI server 10 with the data acquired being
transmitted to the GPI server 10 and stored under the biological
variables (BV) 508 for that particular username. For instance if
user Mr.XYZ has an eye pressure of 28, a blood pressure of 140/90,
a blood sugar of 210, an average temperature of 98.6 F., and a
weight of 250 lbs., then all of this data which is acquired from
the home-monitoring devices (HMD) 50 is then transmitted to the GPI
server 10 and stored under the BV database 508 for Mr.XYZ with
address Mr.XYZ@TYG.net. The GPI server 10 then checks to see if
there are any messages, warnings, information, recall or Web pages
related to the product's UPI code or if there are any potential
interactions between the biological variables stored and the
products used by a particular username stored in the GPI database,
with such information as what biological variables can interact
with the effects of drugs, food, and the like, and vice-versa.
[0229] In accordance, in an exemplary embodiment, a patient is
prescribed a drug called Dexfenfluramine (Redux.RTM.) as an
appetite suppressor. In this particular embodiment the patient
enters his personal and demographic data in his portable unit 40
or, alternatively, the patient can enter the same data by using any
personal computer system 30, with the initial data including a
username and/or IP address which uniquely identify the user.
Although the patient could enter his own name, it is preferable
that the patient enter a pseudo-name in order for the medical
information to remain confidential and not be associated with the
patient's real name. This is an advantage of the recall system as
disclosed in the present invention which preferably uses the user's
pseudo-name and Internet address to inform the user about a
recalled product that the user is utilizing. Thus, the invention
allows the user to remain anonymous during the entire process of
acquiring, transmitting and storing his medical data and then
receiving the recall information. Thus the patient Mr. Gerald M. M.
Jones enters his name as Mr.XYZ@GPI.org or Mr.XYZ@TLJ.net or
Mr.XYZ@Yale.edu and the like. Subsequently, the user, optionally,
enters his age and other personal information, as well as type of
health plan and medical information related to pre-existing medical
conditions and current medical therapy and/or medical diagnosis. It
is understood that although the patient can input as much
personal/medical data as he/she wants, the system of the invention
can be carried out, in the preferred embodiment, by simply having a
username as defined by the principles of the invention.
[0230] In a preferred embodiment Mr.XYZ also has means to acquire
data related to his biological variables and/or has home-monitoring
devices 50 with IECLD-like features and means to transmit the data
to the main GPI server 10 either directly from the home-monitoring
devices 50 or by using the portable unit 40 which, in a preferred
embodiment, acquires the signals from the various home-monitoring
devices 50. Although the preferred embodiment uses biological
variables acquired by home devices, it is understood that
biological variables acquired in other places, other than the
user's domicile, such as doctor's office, hospital, and the like,
can be used with the data thus acquired and transmitted for storage
in the main GPI server 10. Although the preferred embodiment uses
acquisition, transmission, and storage of biological variables for
the particular user, it is understood that the system of the
invention can be carried out simply with the acquisition,
transmission and storage of the products being utilized by the
user.
[0231] After entering personal/medical data, the user is requested
to choose a PIN or password and login name, preferably the username
for example Mr.XYZ, with all of the above information being stored
in both the portable unit 40 as well as transmitted for storage in
the main GPI server 10, creating a file for Mr.XYZ in the GPI
database stored in the user's personal information database 514.
Subsequently, the GPI central server 10 is ready to acquire,
process, transmit and receive any data or information concerning
products being used and/or biological variables being acquired on
Mr.XYZ according to the principles of the invention. In the
exemplary embodiment, Mr.XYZ was prescribed Dexfenfluramine
(Redux.RTM.), and thus the Dexfenfluramine UPI, which uniquely
identify that particular package and specific contents of that
package, is acquired by reading the bar code symbology with a bar
code reader of the portable unit IECLD 40. The data acquired by the
portable unit 40 is then transferred to Mr.XYZ computer system 30
which in turn is connected to the Internet 100 and the data further
transmitted to the GPI server 10 for storage as, for instance,
under Mr.XYZ@GPI.org in the drug database 6A having file
Dexfenfluramine and/or code 090911919.
[0232] Although the use of optically-encoded symbology provides the
most time-efficient, orderly and virtually error-free system as
used in the preferred embodiment, it is understood that the user
can enter and transmit this data in a variety of ways including
wireless acquisition and transmission, keyboard entry, physically
wired connection, and the like, and alternatively the pharmacy or
any point-of-transaction can transfer the information. In some
cases the user of the product can use the serial number of the
product which is already in the package and manually enter the data
into a conventional computer system for transmission to the GPI
server 10.
[0233] A further example will illustrate the value of the present
invention. Mr.XYZ has moved to another state or country and has
about a year's supply of his Dexfenfluramine (Redux.RTM.) or, in
another scenario Mr.XYZ will be on a trip abroad for the next 4
months. Suddenly, during post-market surveillance, the FDA uncovers
potentially fatal adverse reactions caused by this drug
Dexfenfluramine (Redux.RTM.) and issues a recall. The drugs from
the pharmacies are recalled, but the ones already being used are
still out there being used by millions of patients across the
world. Expensive printed matter to health care providers and
institutions are distributed, but there are no means in the prior
art to address and identify the actual individual unique user of
the product, and thus unfortunately the actual user cannot be
directly addressed and is at risk of injury/illness and death. As
mentioned, public announcement recall through media is used in
order to alert patients to stop using the drug with the dire
financial consequences to the manufacturer and distributor who now
have to go public and basically admit that they have made a product
that may harm or kill people. Furthermore, this system is quite
ineffective and neither identifies the individual user nor
identifies all the users of the product. With the present
invention, as soon as the FDA 130 issues even a warning or a recall
for the drug Dexfenfluramine, the recall information is immediately
and preferably electronically transmitted to or acquired by the GPI
server 10 as Dexfenfluramine code 090911919, and the GPI server 10
automatically stores the recall information acquired in the alert
database 512. Each time the server 10 receives product information,
the server 10 checks its database for users of the product. In the
case described regarding the recall of Dexfenfluramine, the server
10 searches its database to identify all users of Dexfenfluramine
code 090911919 and, after the users are identified, the recall
notice is instantaneously and automatically and electronically and
privately sent to all users of the drug alerting them about the
fatal risk involved with the use of the drug, with electronic
transmission preferably done using conventional e-mail. The system
of the invention can then timely locate and alert all of the users
using immediate electronic transmission of information regardless
of the user's physical address or even if the user has moved and/or
is lost to medical follow-up or is on a trip abroad in Mongolia.
The system thus provide means to locate each user individually by
using an exclusive unique name and address, as the Internet
address. The real name of the user of the drug remain confidential
and the name of the company with the recalled product has minimal
public exposure since it can privately address the users of the
recalled product and thus preserve the company's name.
[0234] Returning to the example of Mr.XYZ, he is travelling abroad
and has basically no means to know about the recall in his country
of origin. However, Mr.XYZ can have continuous access about
recalled products that he is using by either using his portable
IECLD 40 unit with connection to the Internet 100 or has means to
connect to the Internet 100 with conventional computer terminals
30. Then as soon as Mr.XYZ either checks his regular e-mail; or
web-based GPI site e-mail; or logs in the GPI website and enters
his password, the specific information (not random) on the recalled
drugs that Mr.XYZ is using is disclosed and displayed on the
display of his computer device.
[0235] The GPI system 1 thus allows any remote user to access the
information on potentially harmful products being used by the user.
Besides warning about the fatal risk with the drug, the system also
instructs the patient on how to proceed. In this case a particular
formulation of the drug-type Dexfenfluramine was later found out,
after almost two years on the market, to cause severe and
potentially fatal heart disease by affecting the valves of the
heart. In response to that, the GPI system 1 instructs the patient
about alternative products, actions to be taken including how to
stop the drug, and the need to see a heart specialist and to have
an echocardiogram done. The GPI system also automatically contacts
the patient health care provider and schedules an appointment,
contacts the hospital and laboratory and schedules the test
(echocardiogram), and contacts the patient's health plan for
approval if needed for the tests and appointments. The GPI system 1
sends information on the recall to the health care provider
(doctor) with the name of a replacement for the recalled drug and a
list of patients using the drug with the phone number of the
pharmacy for each patient. This GPI function provides an important
service to the doctor. The doctor receives the names of patients,
thus the doctor does not have to review charts to try to find out
if any patient is using a recalled drug. In addition, as mentioned
before, this is impractical. The doctor also receives the phone
number of the pharmacy for each patient, and thus the doctor does
not need to call patients and search to find out what pharmacy to
call for prescription concerning the replacement drug.
Simultaneously the patient using the recalled drug receives a
message that the his/her doctor has been contacted and a
prescription filled at his/her preferred pharmacy, including a
message to "call the pharmacy to find out if the replacement drug
is available for pick up". The GPI Safety Program thus provides a
complete, efficient and low-cost comprehensive prevention and
treatment of illness/injury caused by a harmful product.
Furthermore Mr.XYZ will have an option to fill out an electronic
questionnaire about cardiopulmonary symptoms and other symptoms in
order to better assess the level of urgency for medical therapy
since Mr.XYZ is travelling abroad. The present invention also
provides a complete set of instructions according to official and
medical recommendations such as the need for antibiotic prophylaxis
when Mr.XYZ undergoes a dental or medical procedure in case he has
the heart valve disease caused by the harmful drug.
[0236] The GPI system 1 has the ability to continuously locate a
patient and alert the patient about potential problems with the
products they are using. For instance, patients who have had
permanent implants are often lost to follow-up, with the doctor
being unable to locate the patient and inform about the
complications related to the product being used or implanted. Even
if the patient moves, change addresses, or simply cannot be
reached, an update about the prosthesis permanently implanted could
be sent to the patient as long as they have their IECLD 40 or
access to the Internet 100 and log onto the free GPI web site. If
the patient has access to the Internet 100 and knows the UPI code
number or name of the product, then the data can be entered using a
keyboard and the patient can access its GPI server 10 file or
general recall information at the GPI web site. Patients usually
carry a card identifying the number of the prosthesis which was
implanted and can check the information related to the prosthesis.
The same also would apply for patients receiving living issues such
as kidneys or any other type of transplant. If the subject who
donated the organ was later identified as having a transmissible
disorder such as viral disorders, the recipient of the organ could
be notified and instructed how to proceed.
[0237] If the user is buying or using a product which does not have
a UPI, the user can enter the name of the product and, if a recall
notice has been issued for that product, the GPI system 1 will
match the name against its database and identify the product with
the consequent recall alert sent to all of the users of the
product. If for instance the user is buying products over the
Internet, then the product purchased can be transmitted to the GPI
server 10 using conventional applications. For example, if a
vitamin being sold over the Internet were being recalled, the user
of the GPI system 1 could, before actually purchasing the product,
send the information to the GPI server 10 which would return any
recall or information available on the product. Thus, by alerting
the user before the user purchases the potentially harmful product,
the user saves money and avoid health risks.
[0238] While the system is being described in connection with human
use, it is understood that veterinary and other non-human use is
another alternative application of the current invention in regards
to identification and location of harmful or recalled products.
[0239] One aspect of the invention provides a system composed of
HTML documents and information transfer using Hyper Text Transfer
Protocol (HTTP). Although the exemplary embodiment uses data
communication using HTTP, other protocols such as FTP, Gopher, XML
and other emerging protocols can be used to transfer recall,
harmful or beneficial information on particular products being used
by a particular user and biological variables for the user.
Although the exemplary embodiment uses HTML documents, it is
understood that many other types of documents can be used,
including but not limited to Adobe PDF, motion pictures, still
pictures, voice or any other means related to the provision of
information about potentially harmful or beneficial products,
recall and interaction information.
[0240] FIGS. 7A-7E are exemplary diagrams showing second, third and
fourth windows opened on a user's computer. FIG. 7A shows
electronic information converted to an HTML document depicting an
exemplary home web page for the free web site, GPI Recall, Location
and Information System, as it appears on a computer system 30
display screen or a portable IECLD 40 device with Internet and HTML
capabilities for both registered and non-registered users. FIG. 7B
is an exemplary diagram of the electronic alert and recall
documents with hyperlinks displayed on a computer of a registered
user. A secured page "GPI Products Alert/Recall" (accessed only by
the user of products presented in that page, after appropriate
identification is confirmed) with information on products used,
biological variables, and information on recall and effects
(harmful and beneficial) is shown. The information about the
various products used by the user and associated hyperlinks are
displayed on the document. To illustrate in more detail this
particular document, the "GPI Products Alert/Recall" document shows
a box with the itemized product groups being used by Mr.XYZ which
can be individually accessed by point-and-click. A second box in
the same document shows the current information on recall or
warnings for the products used by Mr.XYZ with the product name and
group in one column and the information about the product in a
second column with its associated hazard degree code, all of which
accessible by point-and-click. FIG. 7C is an exemplary diagram of a
non-restricted document on recall and alert, displayed on a
computer of a non-registered user. FIG. 7D is an exemplary diagram
of biological variables with hyperlinks, displayed on a computer of
a registered user. In FIG. 7D, a portion of the secured document
Biological Variables for the particular user is shown with the
values measured and the links to the various potential interactions
of products being used with the biological variables measured. FIG.
7E is an exemplary diagram of a document displayed on a computer of
a registered user with a variety of hyperlinks to manufacturer and
government computers. A portion of the page, Recall Info, shows
text and HyperText illustrative of recall of a certain drug with
links to documents relevant to the recall such as, to the
manufacturer, to the recall government agency, and links to support
groups, information on the medical condition, how to get a doctor's
appointment (with both doctor's located in brick-and-mortar offices
or Internet offices) and scheduling of laboratory test
(echocardiogram) and insurance information. The portion of the
document, Recall Info, also has links for registered users to
access personal and confidential information such as previously
scheduled appointments and insurance approval.
[0241] The registered user can access the personal and private
information on recalled products used in different ways. One
preferred way includes the user checking his/her GPI web-based
e-mail, and in this case the user receives in his/her e-mail box
all of the secured pages related to warning and recalled products
such as GPI Alert/Recall document (7B), Biological Variables
document (7D), Recall Info document (7E), appointment and insurance
information, and the like. Another way is for the user to log onto
the GPI web site and with his/her password access the same
personal/private information, as described above, on products being
used, biological variables measured and alert/recall information on
these products. A further way to retrieve the personal/private
alert/recall information is by reading his/her conventional text
e-mail messages.
[0242] The information on products used, biological variables and
personal appointment information is in a secured area accessible
only by the user of the products. Alternatively, the page Search
and Recall Info (FIG. 7C) represents non-secured documents and can
be accessed by anyone simply by logging onto the GPI web. Thus, the
GPI system provides a free service to both registered and
non-registered users. However, the registered user does not have to
search for recalled products or warning or information on products
being used, since the GPI system 1 delivers such information on
products being used to registered users automatically. This is in
addition to all of the other numerous additional advantages such as
information on the beneficial effects of products being used.
[0243] This system helps companies reduce their exposure to the
financial disaster that may occur as a result of publicly announced
recalls through the media as previously explained. Moreover, the
companies and government agencies avoid the significant costs
associated with conventional printed, televised and audio recall
and warning about potentially harmful products.
[0244] The system of the invention searches and/or acquires data
from the various RIS 60 not only about the harmful effects of
products, but also the newly found beneficial effects of products.
For instance in FIG. 7 the document Alert/Recall 7B shows in the
product column D1--"Verapamil" and under information "beneficial".
In this particular case, a RIS Research Institution 60 and a RIS
Medical Institution 60 transferred information that verapamil was
found to decrease eye pressure. This patient has hypertension and
is using this drug verapamil to treat his hypertension. This
patient also has abnormal and elevated eye pressure. The
information indicating that verapamil decreases eye pressure is
checked against the users' database, and since this user has
glaucoma with increased eye pressure, the interaction
product-biological variables is considered beneficial and the
information is transmitted back to the user as previously
described.
[0245] The GPI website also offers a unique feature called "Spend
more time with your doctor". Doctors have an enormous amount of
knowledge and information, but in the U.S. patients only spend an
average of 8 minutes with their doctors. Thus, many questions and
concerns about drugs prescribed or other products used go
unanswered. As soon as the product is added to the users' usage
record in server 10, the information on the product is transmitted
to the user 90. The information that could have been acquired by
talking to the doctor is sent to the user, giving virtual extra
time with the doctor. This is done at the user's discretion and the
user may choose not to receive such of product information.
[0246] FIGS. 7A and 7B also show the GPI home page 7A linked to the
GPI AlertRecall page 7B by means of link (i) which in turn is
linked to document Biological variables 7D by link (ii). Document
GPI Alert/Recall 7B is also linked to page Recall Info 7E by means
of link (iii). Home page GPI 7A is linked to Search page 7C by
means of link (iv), which in turn is linked to page Recall Info 7E
by link (v). Although the links shown relate to text document only,
it is understood that images, videos, sound, programs or any binary
data link can be implemented and used. For example, the HyperText
surgical correction can be linked to an actual video of a heart
surgery with valve replacement, which gives more information for
the user of recalled products while allowing the users to seek
immediate therapy and better evaluate all of the potential aspects
related to the delivery of health care for his/her medical
condition caused by the harmful product. It can be easily
appreciated that the principles disclosed in this section can be
applied to any product including but not limited to the main
product groups (drugs, cosmetics, food, medical devices, toys/baby
products, and miscellaneous) and the user informed about the
potential hazards and recalls associated with the products being
used. It is clearly also noted that the figures presented are
simply a way to illustratively describe one of the embodiments of
the present invention, but obviously there are numerous other ways
to display and deliver the information and many variations all of
which can be used in the present invention. Moreover, in accordance
with the principles of the present invention, user applications
such as a web browser can set up a connection to the remote GPI
server 10 in order to retrieve the information on potentially
harmful products that is requested by a user. As an example, a user
browser application displays a hyperlink associated with documents
related to the recall/warning and information system for a unique
user, which can be selected with another document being retrieved
over the Internet from the GPI server 10 in which case the GPI
server 10, acts as a HTTP server 10. It is understood though, that
the present invention can be employed with other types of user and
GPI server 10 applications allowing access to certain sources and
certain data over the Internet 100 with the data and/or sources
relating to harmful/beneficial products and/or recall/warning
information. It is also understood that the user 90 and server 10
computing systems according to the present invention can include a
variety of operating systems and commercial applications to assist
the implementation of the needed acquisition and transfer of
information related to the potentially harmful products with
creation and transmission of messages.
[0247] Besides informing the user about the harmful effects of
products, the GPI system also informs the user about the potential
beneficial effects of the products being used. If Mrs.XYZ has
stored in the GPI database that she is age 50 and using estrogen
replacement, the GPI system 1 identifies that association as
beneficial since during post-market surveillance the GPI system 1
has acquired from RIS 60 information indicating that estrogen use
in post-menopausal women reduces death from cardiovascular
disease.
[0248] In another embodiment the user has stored in his/her
personal information database that he/she has a family history of
Alzheimer's disease. Information about a drug that helps Alzheimer
is transferred from the RIS 60 to the GPI system 1, indicating "low
doses of risperidone, regularly prescribed for schizophrenia was
found to help relieve symptoms in Alzheimer's patients and may
delay hospitalization. Please consult your doctor." In this
instance, although the user does not have Alzheimer, since he/she
has a family history of Alzheimer the information is sent to said
user which allows the user to better care for a family member with
the disease. This information could also be useful to the doctor
who may not be aware of the potential beneficial interaction, and
the information is also passed on to the doctor.
[0249] Another embodiment relates to use of the system not only by
patients, but also doctors, medical institutions, and the like. In
an exemplary embodiment, doctors who prescribe certain drugs and
medical institutions which use certain devices could easily acquire
the unique UPI for the drug or device and send the unique UPIs to
the GPI server 10, allowing the doctors and medical institutions to
have updated information in regards to the products being used by
the practitioners and/or institutions. Furthermore, although the
present invention can be preferably used by an individual user of a
certain product, alternatively the current invention can be used by
the provider prescribing the product or the institution delivering
health care or the establishment selling the product. In this
alternative embodiment the hospital, providers, establishments,
seller, distributor, and the like send the information on the
products to the GPI server 10 and receive feedback specifically
tailored to the products being used or delivered or sold by the
practitioners and establishments. For example, if a doctor
prescribes risperidone on a daily basis, then the doctor transfers
the UPI according to the principles of the invention described, and
the information is stored in his/her database. In this embodiment
the UPI stored relates to drugs being prescribed by the doctor, and
not the UPI for drugs personally used by the doctor. Then when new
information related to risperidone such as beneficial effects,
harmful effects, and recall information is transferred from the RIS
60 to the GPI server 10 according to the principles of the
invention, the information is then automatically electronically
sent to the doctor as an alert message. Naturally, the same
information and updates would apply to all of the commonly used
prescribed drugs by the doctor which are stored in the user
database as products being used. In addition the GPI server 10 can
send Safety Alerts and labeling changes for drugs according to the
doctor prescription pattern. Thus this alternative embodiment is an
incredibly useful tool for any doctor helping to deliver the
specific information that the practitioner needs according to his
practice and prescription patterns. In this case the doctor could
have two registered names: Dr.X20@GPI.org in which the user/doctor
stores in the product and user database the names of drugs commonly
prescribed, and then have another registered name Mr.X20@GPI.org in
which the doctor stores in the user and product database his
personal list of drugs and other products being used. This thus
allows the GPI system to meet both the personal as well as the
professional needs of the user.
[0250] If a product that is uniquely identified with a code or its
name is transferred to the GPI database by a registered user, that
code or name can be stored in the Miscellaneous database 6F. Then
the registered users of the products, according to their
preference, will receive updates tailored to the products stored
under their username, such as but not limited to, software
downloads and updates related to the recalled product stored in the
GPI database, links to Internet resources related to the product
stored in the GPI database, and the like. This same alternative
embodiment could be used by a merchant or medical institution
interested in receiving updates and information about a particular
group of products being sold or delivered. In an exemplary
embodiment, a restaurant serving fish will have in the products
database Food the types of fish being served by the restaurant, and
then if any of the RIS 60 send information for example stating "cod
found to decrease blood pressure", then that information could be
used for the benefit of the customers eating at that restaurant.
The restaurant can disclose in the menu that according to source
FDA 130 cod was found to reduce blood pressure. Then a customer
with high blood pressure can make an educated choice concerning
his/her health and choose cod and thus better control his/her blood
pressure. On the other hand, the customer with low blood pressure
or taking drugs to lower blood pressure can make an educated and
healthy choice of not eating cod since that could aggravate his/her
status, potentially leading to lower pressure, dizziness, and even
a car accident due to the exceedingly low blood pressure caused by
eating cod. In another exemplary embodiment, a farmer using a
certain fertilizer will have in the product database Miscellaneous
a memory area for chemicals, or alternatively the drug area memory
can be used as chemicals and drugs. Then the RIS 60 provides
information concerning the type of fertilizer used by the farmer
stating "fertilizer FZ found to be mostly beneficial in crops, such
as corn, and actually detrimental to wheat." In this case the
farmer then can use the information to optimize production since
the GPI System 1 delivered valuable information for increasing crop
production specifically tailored to that individual user. Since the
GPI system 1 only uses well-founded and proven information and data
from well recognized established government and private
institutions, the information acquired from the RIS 60 can be
considered sound and valid, and thus very useful.
[0251] Although much less frequent, harm by a product can occur in
a very odd manner, and the present invention can prevent even these
unusual harmful events. More specifically, a book purchased in the
USA by a user who went back to China had a printing error that
could cause harm. Without the present invention, the user would
never learn of the harmful printing error. However, with the
present invention the user in China receives the Alert message
stating that "the combination proposed for experiment 12 about
x-ray may pose a serious radiation hazard, please refer to the
enclosed information for the correct sequence for the experiment".
Although, only a few exemplary alternative embodiments are
disclosed herein, it is intended that the current invention can be
used with any product, subjects, articles, and the like, tangible
or non-tangible items, which have an identifier indicia, belonging
to or delivered or acquired by any individual, establishment,
entity, and the like, with data and information preferably
transmitted to the user via the Internet or a public network
according to the principles of the invention.
[0252] The GPI system 1 is also designed to acquire information
from the user 90 which may be significant from a warning or recall
standpoint. The GPI system 1 uses biological variables to determine
if a certain UPI product has been consistently and temporally
associated with an abnormal biological variable. In the case that
hundreds of users using a certain drug PPS transfer biological
variables consistent with abnormal heart rate, then the data meet
the criteria for potential harmful effect of the drug PPS. This
information can then, for example, be transferred to the RIS 60 as
"drug PPS potentially implicated with abnormal heart rate". In this
scenario the GPI system 1 acts as an auxiliary in the detection of
harmful products. The same approach applies to the detection of a
certain plant number or lot numbers causing widespread illness or
injury. The information thus can be used for locating plants for
inspection. The system 1 can also identify contaminated food before
an outbreak occurs. The users can transmit information to the GPI
system 1 about their symptoms and comments on the product such as
labeling, appearance, questionable ingredients, and the like. When
a certain number of users report similar symptoms after ingesting
the same food, the GPI system 1 identifies a potential outbreak.
The system GPI 1 then can transfer this information back to the RIS
60.
[0253] As previously stated, the GPI arrangement is designed to be
a completely free-of-charge system to any user of any product, but
for the sake of completion of the description of the invention, a
few exemplary compensation methods are described. Naturally the
transfer of UPI or biological variables or receipt of keys may only
occur after the occurrence of appropriate transfer of funds to the
GPI server 10 and/or to a third party. Furthermore, appropriate
transfer of funds to the GPI server 10 and/or a third party may be
required at any time and may occur at any of the steps described in
this whole specification. It is also understood that a tracking
arrangement for the number of requests and/or information delivered
or acquired by either the user or/and the RIS 60 can be used as a
means to quantify and charge for the utilization of the system.
There are herein described only a few embodiments and modifications
concerning environmental as well as compensation issues, but it is
understood that the invention is capable of use in various other
environments in conventional messaging and broadcasting, as well as
in any `cyberspace" environment based on the Internet and using a
variety of payment methods and account databases. Naturally it is
understood that the user can block receipt, or select products and
conditions for which the user wants to receive information,
messages and/or web pages.
[0254] The system is constructed as a pure electronic system with
no inventory, nothing to ship, and no warehouse. The system can
provide personalized advertisement according to product identifiers
and sales of replacement products as substitutes for the recalled
products. Participant companies interested in offering the GPI
Safety Program to their customers can benefit by being able to sell
alternative replacement products to the customers who purchased a
harmful or recalled product. In an exemplary embodiment a company
recalling a harmful product can offer, in the Alert Message or in
any electronic means to report the recall alert, an alternative
product that is proven to be safe or a newer more advanced model.
In case the company recalling the product does not have an
alternative product, the GPI system 1 will offer replacement
products from other participating companies or non-participating
companies.
[0255] The above financial benefit offering a new source of
revenues should further encourage companies to offer the
free-of-charge GPI protection program to customers. The GPI system
1 can be maintained by charging a fee according to replacement
products sold by the participant companies or by receiving a fee
according to the number of recalled products identified, located,
or removed from the market or alternatively according to the number
of users identified. Yet every company which offers replacement
products can be charged a fee. The companies can have their product
information directly reach consumers who need the replacement
product. The embodiment involves partnering with GPI member
companies for sales of their replacement products and direct to
customer activities with personalized sales. Offer of an
alternative product is triggered by the product recalled. For each
product recalled an alternative replacement product is offered,
preferably at a discount rate by the manufacturer of the defective
or harmful product. In addition, the GPI server 10 can provide via
the IECLD 40, besides alternative products and drugs, reminders
about taking medication and reminders for filling or refilling a
prescription.
[0256] FIGS. 8A to 8C present a schematic view of an exemplary
memory, fields and record arrangement for carrying out the
principles of the invention. FIG. 8A shows the user's personal
information database 700 which is keyed on the username 701, 702
and contains: field A (demographic information such as name,
address, occupation, date of birth) 710, field B (password and
other security data) 711, field C (doctor's information) 712, field
D (laboratory information) 713, field E (pharmacy information) 714,
field F (insurance information) 715, field G (current illnesses)
716, field H (range of normal biological variables) 717, field I
(timely monitoring period) 718, field J (hazard with untimely
monitoring) 719, and field K (inform doctor of abnormal value) 720.
The product database 730 is keyed on the product identifier (UPI)
731, 732 and contains field username (UN) 733. The user's product
usage database 740 is keyed on UN 741 preferably described as a
full Internet address 742, 743, 744, 745. For each UN record there
are associated one or various UPIs 746, 747, 748, 749. The
databases 700, 730, 740 are primarily updated by the user. The
disease association database 750 includes an expert system with
fields biological variables (BV) 751 and indicated diseases (ID)
752. The BV field 751 contains the status of the biological
variable such as the abnormal values for each biological variable
753, 754, 755, 756, 757, with the disease indicated by the abnormal
values contained in the ID field 752.
[0257] FIG. 8B shows the product information database 760 which is
keyed on the product identifier (UPI) 761 (as example 762, 769) and
contains fields (GI) general information 763 (description of the
product, precautions, how to use, warnings, and in case of drugs,
also includes the indications and usage, effects, side-effects,
adverse reactions, and in some cases dosage and administration,
chemical and clinical information), contraindication (CI) field 764
with its associated hazard degree (HD) field (Recall, Harmful 1 to
5, Beneficial) 765, doctor appointment required field (DARq) 766,
and laboratory appointment required field (LARq) 767. The product
information database 760 also contains the product interaction (PI)
field 768 with its associated product identifier field 830 with,
for example, interaction of product identifier 762 with drug M
(product identifier 831) and interaction with food F (product
identifier 832). The PI field 768 also contains its associated
warning message (WM) field 833, HD field 834, DARq field 835 and
LARq field 836.
[0258] As an example, product identifier 762 is aspirin with the
aspirin UPI 0031 also stored under numerous UN 741 in user's
product usage database 740, and product (drug M) 831 is warfarin.
Drug M 831 warfarin interacts with aspirin 762. The WM 833 is then
"aspirin-warfarin increases risk of bleeding", the HD 834 is H4,
DARq 835 is "yes", and LARq is "yes" with coagulation profile
required.
[0259] The product information database 760 is primarily updated by
the manufacturer of the product. The biological variables database
770 is keyed on the UN 771 as example addresses 772,773 and
contains parameter field (PAR) 774 (biological status evaluated),
value (VA) field 775 (values for each biological function), and
time/date (DA) field (time and date at which biological function
was transferred going from most recent to least recent). Sample
parameters within PAR 774 include eye pressure 777, glucose 778,
liver enzymes 779, triglycerides 780, and weight 781. The
biological variables database 770 is updated primarily by the
user.
[0260] FIG. 8C shows the alert database 790 which is keyed on the
product identifier (UPI) 791, as example 792, 793, and contains the
alert information (AI) field 794 and its associated HD 795 as well
as alert level (AL) field 796. The alert information field 794
contains the information acquired from the RIS 60 such as FDA 130.
For example, the UPI for Redux.RTM. contains in the AI field 794
"patients taking this drug are at risk of damaging the valves of
the heart which may cause heart failure and infection of the heart
valves which can be fatal", and its associated HD 795 is H4. The AL
796 is R for recall.
[0261] The alert database also contains the CI field 797, HD field
798, DARq field 799 and LARq field 800 in a similar structure as
the product information database 760 but with the information being
related to recall and harmful/beneficial effects and derived
primarily from government and regulatory RIS 60. The same UPI 0031
is present in the product information database 760 and alert
database 790, but for instance CI 764 relates to established
contraindications and CI 797 relates to contraindications newly
identified by regulatory agencies. Alert database 790 also contains
PI field 801, with its associated product identifier field 805
with, for example, interaction of product identifier 792 with drug
A (product identifier 810), interaction with drug B (product
identifier 811), interaction with food E (product identifier 812),
and interaction with cosmetic X (product identifier 813). The PI
field 801 also contains its associated warning message (WM) field
806, HD field 807, DARq field 808 and LARq field 809. The same UPI
0031 in the product information database 760 is known to interact
with drug M 831 and food F 832 which are established interactions.
On the other hand the same UPI 0031 in the alert database 790
interacts with new products such as drug A 810, drug B 811, food E
812 and cosmetic X 813. These are new interactions found during
post-market surveillance which were acquired over time during years
of use of the product. As new information from the RIS 60 is
acquired, the alert database 790 adds the new interactions found
and transfers information to the user of the product, but only to
the specific user of the product, thereby optimizing the transfer
and use of information. The alert database 790 also contains the
fields name of medications (name M) 802, is prescription required
(Is Rx Rq) 803, and instructions and directions, including
alternative drugs or products (Message Dir) 804 which contains the
information needed by the user in regard to drugs and instructions
necessary to treat or prevent the harmful effect of the
product.
[0262] FIG. 9 is an illustration of an exemplary embodiment of the
central server 10 in accordance with FIGS. 8A through 8C and the
associated algorithmic logic flow diagrams in accordance with the
principles of the current invention. The depicted central server 10
includes data storage device 699 with a product database 730,
product information database 760, user's product usage database
740, alert database 790, biological variables database 770, disease
association database 750 and user's personal information database
700. The central server 10 also includes a CPU 856, operating
system 860, RAM 858, ROM 857, clock 859, and modules to carry out
and configure the applications such as general administration
module and database management module 850, search module 851,
encryption/decryption module 852, e-mail module 853, time/date
module 854, transmission module 855, as well as communications
interface 861.
[0263] The product information database 760 is primarily the result
of information derived from a certain type of RIS 60, namely the
manufacturer of the product 148. The alert database 790 is
primarily the result of information derived from another RIS 60,
namely government agencies such as the FDA 130 and the like.
[0264] An exemplary GPI server 10 infrastructure includes: (1) High
availability server (HA), Rad 5, disk clustering, disk mirroring,
and disk shadowing, (2) Redundant gigabit network (OC3), (3) SAN
(storage area network) with a Tivoli system, (4) web server (5)
Demilitarized zone (DMZ) with double firewall (6) Server hardware
such as Compaq ES 40, or alternatively the IBM RISK 2000, with
multiple processors and UNIX operating system, (7) Database
Management Product such as Oracle 8 or higher, (8) UPS
(uninterruptable power supply), (9) multiple modem lines with
autodialers, (10) fax modem, (11) IVRs.
[0265] FIGS. 10 through 20 show algorithmic logic flow diagrams to
carry out the operation in the most efficient way while optimizing
time spent online, according to the principles of the invention. It
is to be understood that changing the amount of time online and/or
continuous coupling between local computer (e.g., IECLD 40,
computer system 30, or the like) and the server 10 and other
connections/processing variations are considered alternative
embodiments, but do not optimize the use of communications
medium.
[0266] In reference to FIG. 10 there is shown a flow chart of an
exemplary data acquisition procedure in the current invention by
the portable IECLD 40, and with options for subsequent transmission
of data. The illustrative steps depicted refer to a preferred
embodiment where the user acquires optically encoded unique product
identifiers using a bar code reader mounted in a portable hand-held
programmable microprocessor such as for instance the IECLD 40. It
is intended that other manual or automatic means of acquiring the
unique product identifier can be used, such as manual keyboard
entry, verbal entry, RF, optical, satellite, cable, telephone lines
as well as any other wired or wireless means. Telephone lines, for
instance, can be used for acquisition of UPIs at the point-of-sale.
It is easily appreciated by one skilled in the art that the user
can enter and transfer unique product identifiers using standard
computer systems 30 previously described and thus bypass the IECLD
40. The GPI system 1 can also work using different links such as
on-line connection, off-line connection, direct link, and the like,
and the few following examples will better demonstrate the options.
For instance, the user can transfer the UPI and remain connected
with the GPI server 10, receiving immediate product
recall/information feedback, or the user can send the UPI and
biological variables, and then disconnect from the GPI server 10.
As another example, the user can remain online but if there is no
information in the GPI server 10 for the UPI transmitted by the
user, then the user disconnects and in this later case as soon as
the information on the UPI is transferred to the GPI server 10 by
the RIS 60, the recall/product information is transmitted to the
user who may be connected or disconnected to/from the GPI server
10. Alternatively, the user may only receive information by
conventional e-mail from the GPI server 10 after transmitting
biological variables and/or UPIs, and so on. The e-mail Alert
Message can connect the user with the GPI website for further
information on the recalled product.
[0267] In the exemplary embodiment of FIG. 10, the user activates
the IECLD 40 and the first step during the process is to prompt the
username at step 900 and password at step 910. The user then enters
his username and password in the standard manner. The password is
stored in the portable unit 40 and compared with a corresponding
stored password 920, preferably stored within another memory unit
in the portable unit microprocessor. If there is a positive match
between the entered password and the stored password at step 930,
then step 952 proceeds to the next operation. If there is no
positive match an alarm will sound, step 940, informing the user
that the password is invalid, step 950. It is understood that a
variety of other means to ensure security and password systems are
described in the prior art and can be used in the invention.
[0268] Once the password is validated, a Select Function screen is
displayed, step 952, allowing the user to select the desired
function. These functions include enter biometric data 954, acquire
key 956, enter product identifier 958, remove product identifier
960, and enter biological variable 962.
[0269] When the enter product identifier function is selected, step
958, the user can select a product type at step 1000, shown in FIG.
11A. Upon selection of a product type, the scanner is enabled at
step 1010 and the user is prompted to scan the bar code at step
1020. Step 1030 determines if the product identifier is the last
one to be scanned. If it is not the last product identifier, the
bar code for the product identifier is scanned at step 1040. The
next operation, step 1050, determines if the bar code is valid. If
it is valid, processing continues to step 1070 and the scanned
unique bar code for the product is stored in the portable unit
memory. If the bar code is not valid, the user is prompted to
rescan at step 1060. Next, the user is prompted to scan another bar
code related to a new product identifier and the process repeats
until the last product identifier is scanned. After the last
product identifier is scanned, step 1030, the next operation
connects the portable unit 40 with the central server 10 at step
1080 and username and password are transferred at step 1090.
Although the above description refers to the acquisition of UPIs
using the portable unit 40, it is understood that similar
processing can be used at the point-of-sale when using the GPI
cards 39A for acquisition and transfer of UPIs to CCC 80.
[0270] Referring now to FIG. 11B, upon valid verification and
authentication, the encrypted product identifier is transferred to
the central server 10 at step 1100. Then step 1110 searches product
information database 760 for product identifiers transferred. Next,
step 1120 checks the product information database 760 to determine
whether there is any data on product identifier transferred. If
not, then a list of product identifiers without data is created,
step 1130, and a message "No data. Rescan in 24 hours" is
transferred to the portable unit 40, step 1150. The list is then
used to search for the data related to the product identifiers
transferred by users. If there is product identifier data, step
1120, such data in any of the fields 763, 764, 765, 766, 767, 768
is retrieved, step 1140. Next the product information data about
product identifier is transferred to portable unit 40, step 1160.
The data about product identifier is then stored in the portable
unit memory and displayed, step 1170.
[0271] In FIG. 11C, step 1180 determines whether there is any data
on the product identifier transferred which is present in the alert
database 790. If yes, the alert level 796 on product identifier is
retrieved, step 1190; otherwise the process proceeds to step 1280
and disconnect from central server 10. Following retrieval of the
alert level, step 1200 determines if the alert level 796 is a
recall code. If yes, then an alarm sounds and an alert light is
activated in portable unit 40 at step 1230. If the alert level is
not a recall code, step 1210 determines if the alert level is a
hazard degree 5 (life-threatening). If yes, the process proceeds to
step 1230; if no, processing continues to step 1220 to determine
whether the alert level is a harmful code. If yes, appropriate
audio and visible signs are activated in the portable unit 40 at
step 1230. If the alert level is not a harmful code, alert
information 794 on product identifier is transferred, step 1240, to
portable unit 40. Then alert level 796 and alert information 794
with hazard degree 795 about product identifier are stored in the
portable unit memory and displayed, step 1260. At step 1280 the
central server 10 is disconnected from portable unit 40. Although
in the above description the product information is displayed on
the portable unit 40, it is understood that the information can be
displayed on other devices such as the point-of-sale terminals,
screen of telephones, watches, and the like.
[0272] FIG. 11D shows operation continuing to step 1300 to create
an alert message and highest hazard degree=0. Next, "doctor's
appointment required" and "lab appointment required" flags are
created and initialized to NO, step 1310. Then step 1320 determines
whether for each product identifier in step 1110 there is product
identifier in the user's product usage record in the user's product
usage database 740. If not, then the product identifier transferred
is added to user's product usage record at step 1330 and the
username is added to product record in product database, step 1340.
If there is product identifier in user's product usage record,
operation proceeds to determine, step 1350, whether there is
product identifier in product information database 760. If there
is, then step 1360 retrieves product general information 763 from
product information database 760 and step 1370 attaches product
general information 763 to alert message, as shown in FIG. 11E. If
there is no product identifier, or following attachment of the
product general information to the alert message, the process
proceeds to the step 1380 to determine if for each product
identifier in step 1110 there are contraindications 764 listed in
its product information record in product information database 760.
If yes, contraindications 764 are retrieved, step 1390, from
product information record in product information database 760;
otherwise the process proceeds to step 1550.
[0273] Once contraindications have been retrieved, step 1400
determines for the username in the user's personal information
record whether there are current illnesses 716 listed. If yes, then
current illnesses 716 are retrieved, step 1420. If not, the process
proceeds to step 1480. Once current illnesses have been retrieved,
step 1420 then determines whether any of the current illnesses 716
match contraindications 764. If yes, step 1430 attaches to alert
message that product is contra-indicated for user's current
illnesses 716, as shown in FIG 11F. Processing then continues to
step 1440, in which if "doctor's appointment required" 766 of
contraindication 764 is "Yes" then "doctor's appointment required"
equals Yes. Next, step 1450, if "laboratory appointment required"
767 equals "Yes" then "lab appointment required" equals Yes. At
step 1460, if hazard degree 765 of contraindication 764 in product
information database 760 is greater than highest hazard degree,
then highest hazard degree equals hazard degree of
contraindication.
[0274] Referring now to FIG. 11G, step 1480 determines whether for
the username 771 in the biological variables database 770 there are
biological variables parameters 774 listed. If yes, step 1490
retrieves biological variables parameters 774, values 775 and
time/date 776 from biological variables database 770. If no, the
process proceeds to step 1550.
[0275] Once the biological data has been retrieved, identified
diseases are determined, step 1500, based on user's biological
variables parameters 774 and values 775 using disease association
database 750. Step 1510 then determines if any of the identified
diseases 752 match contraindication 764. If no, the process
proceeds to step 1550. If yes, step 1520 attaches to alert message
that product is contraindicated for identified diseases 752
indicated according to the user's biological variable values. Next,
step 1530, steps 1440 and 1450 are repeated to determine if
doctor's appointment or lab appointment is required according to
contraindication 764 information in product information database
760. Then at step 1540, if hazard degree of contraindication in
product information database is greater than highest hazard degree
then highest hazard degree, equals highest hazard degree of
contraindication.
[0276] Referring now to FIG. 11H, step 1550 repeats the steps of
1380 to 1540 using alert database 790 instead of product
information database 760. The routine allows the identification of
the hazard degree, need for doctor or lab appointment according to
the contraindication in both databases, product information
database 760 and alert database 790. For instance, in case the user
is utilizing a product and then later changes occur in the user's
health status according to the user's biological variables, the GPI
system 1 identifies the contraindication with its hazard degree and
the need for doctor or laboratory evaluation according to the
information in the product information database 760. In case the
use of the product is contraindicated according to the health
status of the user, the GPI system 1 informs the user about the
hazard and the action that the user should take.
[0277] The method continues with step 1560 which, determines
whether, for each product identifier in step 1110, there are
product interactions listed in product interaction field 768 in
product information database 760. If yes, step 1570 retrieves
product identifiers in product interaction field 768 in product
information database 760 based on product identifiers at step 1560,
identifying thus known product interactions concerning the products
which were transferred. If not, processing continues with step
1660.
[0278] After product identifiers in product interaction filed have
been retrieved, step 1580 retrieves product identifiers for the
user from the user's product usage database 740 thus identifying
the products currently being used. Step 1590 then determines
whether any product identifier from step 1570 matches product
identifier from step 1580 in order to determine product-product
interaction or, more precisely, interaction between products
transferred and products being used. If there is no match, now
referring to FIGS. 11I and 11J, processing proceeds to step 1660.
For example as described above, the heart rate and rhythm of a
patient who has an implanted pacemaker is being monitored and the
data is sent to the GPI server 10 via the Internet. In this case
the HMD 50 consists of a heart monitoring device used at home with
continuous 24 hour monitoring. If momentarily the heart rate slows
down, the information is identified as bradicardia and if the user
also has in his/her database a product identifier for verapamil and
furthermore a product identifier for grapefruit juice, then the
system identifies the product as interacting with verapamil as
previously described, in which grapefruit juice could be
potentially increasing the effect of verapamil which in consequence
increases its heart blocking properties which ultimately is
responsible for the slow heart rate transferred. In this case a
simple change in the diet and/or other drug can fix the problem.
Using the prior art, most likely the doctor may have a tendency to
consider a malfunctioning pacemaker or interaction of the pacemaker
with verapamil and then great effort, time and expense is used in
checking and fixing the pacemaker and/or changing the drug regimen,
not knowing that potentially a small change in diet could have
fixed the problem.
[0279] Referring again to FIG 11I, the next step 1600 retrieves
product interaction warning message 833 from product interaction
field 768 in product information database 760 based on product
identifier from step 1560 and product identifier from match at step
1590, thus precisely informing the user about the potential injury
or illness caused by the concomitant use of products acquired or
stored for the user. Then, step 1610, the interaction warning
message 833 is attached to alert message. Next, at step 1620 if
"doctor's appointment required" 835 of interaction warning message
833 equals "yes" then "doctor's appointment required" equals "yes".
At step 1630 if "laboratory appointment required" 836 of
interaction warning message 833 equals "yes" then "laboratory
appointment required" equals "yes". Next, at step 1640 if hazard
degree 834 of interaction warning message 833 is greater than
highest hazard degree, then highest hazard degree equals hazard
degree of interaction warning message.
[0280] Referring now to FIG. 11J, step 1660 then repeats the steps
of 1560 to 1640 using alert database 790 instead of product
information database 760. According to the exemplary embodiment,
the product information database 760 provided information derived
from the manufacturer indicating that product UPI 0031, for
instance a pain killer (aspirin), interacts with drug M 831 and
food F 832 while the alert database 790 provided information
derived from post-market surveillance by the FDA 130 indicating new
interactions that were later discovered after the drug had been on
the market; the newly discovered interactions include drug A 810,
drug B 811, food E 812 and cosmetic X 813. The user is then
informed about potential interactions involving established
information as well as new information acquired during post-market
surveillance, for example. The processing then continues to address
another important area of recalled products and harmful products
according to information provided by the RIS 60.
[0281] Step 1670 determines whether, for each product identifier in
step 1110, there is a record in alert database 790. If not,
processing proceeds to step 1710. Otherwise, the highest hazard
degree value is determined, step 1680, based on product identifiers
at step 1670 using hazard degree 795 in alert information field 794
in alert database 790. Then if the highest value is greater than
the highest hazard degree, then highest hazard degree equals hazard
degree, step 1690, thus informing of the user the highest hazard
degree related to a recall and the information related to the
recall. Step 1700 then retrieves product alert information for
product identifier from alert information field 794 in alert
database 790.
[0282] Upon that, and referring now to FIG. 11K, processing at step
1710 determines if highest hazard degree equals code 4. If yes,
then step 1735 determines if the user is online and, if so, an
instant message is sent to the user, step 1740. If the highest
hazard degree is not equal to code 4, step 1720 determines if
highest hazard degree equals code 5. If not, the process proceeds
to step 1780; otherwise at step 1725 EMS or ambulance service 72 is
called and step 1730 determines if the call is completed. If yes,
processing continues with step 1735 to determine if the user is
online and, if the user is online, an instant message is sent, step
1740. If the call is not completed, then step 1770 connects with a
24-hour nurse or auto dial 911 if in the USA. After an instant
message is sent, product alert information 794 is attached to alert
message, step 1780.
[0283] If the user is not online, in order for critical and
life-saving information to reach the user, step 1745 autodials the
user. Step 1750 then determines if the call is completed. If yes,
step 1755 instructs the user; otherwise an alternate number is
dialed, step 1760, according to information from the user's
personal information database 700. Next, step 1765 determines if
the call is completed for alternate number. If yes, processing
proceeds with step 1755 and the user is instructed; otherwise step
1770 connects with a 24-hour nurse and then proceeds to step 1780.
After instructing the user, processing continues, step 1780, with
the product alert information 794 being attached to alert
message.
[0284] Referring now to FIG. 11L, step 1790 determines whether
there is doctor information, 712 or laboratory information 713 or
pharmacy information 714 in the user's personal information
database 700. If yes, step 1800 retrieves user's personal
information; otherwise the operation proceeds to step 1960. Once
the user's personal information has been retrieved, "doctor's
appointment required" flag is tested at step 1810. If the flag is
set, step 1820 connects with doctor and an appointment is
scheduled, step 1830. If the flag is not set, the process
determines, step 1840, whether the "laboratory appointment
required" flag is set. If yes, step 1850 connects with laboratory
and an appointment is scheduled, step 1860. If the laboratory flag
is not set, step 1870 determines if medications are required 802
according to alert database 790. If not, processing proceeds to
step 1920. If medications are required, step 1880 determines if a
prescription is required 803. If yes, doctor is contacted and
prescription is requested, step 1900, and the pharmacy is
contacted, step 1890. If prescription is not required, then
pharmacy is contacted at step 1890 with medication requested at
step 1910.
[0285] Step 1920 determines if insurance approval 715 is needed
based on the user's personal information record. If not, processing
continues with step 1950. If approval is required, step 1930 sends
information to the insurance company and requests approval
according to insurance information 715 in the user's personal
information database 700. Then if for example a drug as
Dexfenfluramine (Redux.RTM.) as previously described was used and
since the recommendations by the FDA include heart evaluation by a
doctor, then the user of the UPI Dexfenfluramine (Redux.RTM.) is
automatically scheduled for an appointment with a suitable doctor
in the user's domicile area. Then if for example a drug as
Dexfenfluramine (Redux.RTM.) was used and since the recommendations
by the FDA include laboratory evaluation with an echocardiogram,
then the user of the UPI Dexfenfluramine (Redux.RTM.) is
automatically scheduled for an echocardiogram in a suitable
laboratory or medical institution in the user's domicile area
according to the user's record in the user's personal information
database 700. After the laboratory tests are performed, the results
of the laboratory tests are electronically sent to the GPI server
10 and the data is stored in the biological variables database 770
for the user who underwent the laboratory evaluation. If a
prescription is needed, as recommended by, for instance, an RIS 60
such as FDA 130, then the doctor is contacted and a prescription
sent to a pharmacy in the user's domicile area. If there is need
for insurance approval according to the user's record, then the
approval code is acquired, step 1940, and transferred to the
various health care providers. Next, step 1950 generates a message
with doctor appointment and laboratory appointment, approval code
from insurance, name of medications 802 and directions, alternative
medications, and instructions 804 and attaches this information to
alert message. Next, step 1960 sends alert message to user and
doctor, and processing ends.
[0286] Returning to FIG. 10, the transfer of user's biological
variable to central server 10 occurs once the password is
validated. Upon that, a Select Function screen is displayed at step
952, allowing the user to select the desired function.
[0287] After selecting enter biological variable 962, processing
continues with step 965. Biological variables can be acquired in
various ways as previously described. After acquisition of the
biological variable, step 970 determines if it is the last
biological variable. If yes, then connection with central server 10
is established at step 985. If it is not the last variable,
processing continues with selection of a biological variable, step
975, and entry of biological variable at step 980. Next, step 965
acquires biological variable and, if it is the last biological
variable, connects with central server 10 at step 985.
[0288] Upon that, and now referring to FIG. 12A, step 2000
transfers parameters 774 (for example: eye pressure, blood
pressure, heart rhythm, blood analytes such as glucose and
cholesterol, and the like) and values 775 of biological variables
to central server 10. If continuous heart rhythm or continuous eye
pressure is being transferred, in an alternative embodiment, the
central server 10 for continuous mode receives the information and
is set up to send an alert message according to specific criteria
such as peak in eye pressure above 30 or heart rate faster than 100
or slower than 50 and the like. In the current embodiment, after
parameters 774 and values 775 are transferred, the portable unit 40
disconnects from the central server 10 at step 2010. Next, step
2020 creates an alert message. Step 2030 then retrieves parameters
774 and values 775 for the biological variables for username 771
from biological variables database 770. Next, step 2040 determines
if the transferred biological variable parameter 774 is in
biological variable record for user in biological variables
database 770. If not, step 2050 adds the biological variable
parameter for user. If the variable is in the record, processing
proceeds to step 2060 and adds time/date stamp to field 776. Next
biological variables database is updated to reflect the new data
transferred, step 2070, and the new values 775 transferred are
attached to alert message, step 2080.
[0289] Referring now to FIG. 12B, step 2090 retrieves from user's
personal information database 700 the normal range of biological
variables 717 for the user, such that the information is precisely
crafted according to the individual health status and needs of each
individual user. Step 2100 then determines if transferred
biological variables are within the normal range. If yes, step 2110
attaches a message indicating that biological variable values are
normal to the alert message and proceeds to step 2370.
[0290] If the values are not in the normal range, the timely
monitoring period 718 is retrieved, step 2120, from user's personal
information database 700. Next, step 2130 retrieves from biological
variable database 770 the time/date 776 the biological variable was
last transferred. Then, step 2140 determines if today's date minus
date of last transferred biological variable is less than timely
monitoring period. If yes, step 2150 attaches a message indicating
the value abnormal but timely monitored to the alert message, and
then continues to step 2260. If the difference is greater than the
timely period, step 2160 attaches a user instruction on timely
monitoring to the alert message.
[0291] Now referring to FIG. 12C, step 2170 retrieves from user's
personal information database 700 hazard associated with untimely
transmission 719 and attaches, step 2180, hazard to alert message.
Step 2190 then retrieves from user personal information database
700 the message indicating "inform doctor of abnormal value
untimely transmitted" 720. Then processing proceeds to test "inform
doctor of abnormal value untimely transmitted", step 2200. If
doctor is not to be informed, then operation proceeds to step 2260.
If doctor is to be informed, the doctor is contacted, step 2210,
and priority appointment scheduled, step 2220. This previous
embodiment relates to the timely intervention and appointments
scheduling according to the transmission of biological variables
and products being used. Patients sometimes come to their doctor at
a critical stage of their medical condition in which sometimes
irreversible damage or life-threatening complications have already
occurred. It is very difficult to evaluate with certainty when an
appointment is needed for a certain patient or certain condition.
Sometimes if the patient had come just a few days earlier, a life
could have been saved or irreversible and costly complications
avoided. For instance patients with history of renal failure or
heart failure need a very strict control of their body weight to
avoid potentially fatal complications such as acute heart failure
and/or pulmonary edema. Patients may call the doctor's office for
an appointment, but most of the time if they do not have any
clearly warning symptoms, the appointment is scheduled according to
the openings in the doctor's schedule or according to a pre-set
time period for instance every 4 months. Unfortunately in either
case as the appointment is scheduled randomly, when the patient
comes to the doctor's office complications could already have
occurred. According to an exemplary embodiment an electronic scale
or any other medical monitoring device transfers the information
about the patient's weight which is evaluated against values which
are considered safe for the patient. If the monitored weight is not
within normal limits for the patient and timely transferred, a
priority appointment can be scheduled before serious complications
occur.
[0292] Next, processing continues to evaluate the need for
insurance approval. Referring now to FIG. 12D, step 2230 determines
if insurance approval is needed according to record 715. If yes,
step 2235 sends information to insurance company and requests
approval. Next the approval code is sent to health care provider
for the user, step 2240. If approval is not needed, step 2250
attaches priority appointment and approval code to alert message.
Next, step 2260 determines if transferred biological variable
values are associated with disease 752 in the disease association
database 750. If not, step 2280 attaches to alert message "abnormal
value for biological variable transferred but no disease indicated"
and then proceeds to step 2370. If transferred values are
associated with a disease, then step 2270 retrieves disease 752
associated with transferred biological variable values 751. Then,
step 2290 attaches disease message 751, 752 to alert message.
[0293] Now referring to FIG. 12E, step 2300 retrieves the user's
product identifiers 749 from the user's product usage record in the
user's product usage database 740. At step 2310, contraindications
764 from product information database 760 are retrieved for product
identifiers at step 2300. Next, step 2320 determines whether any
disease 752 associated with biological variables transferred
matches contraindication 764 in product information database 760
associated with product identifiers 749 for the user in the user's
product usage record. If yes, then step 2330 attaches to alert
message "contraindication associated with product identifier in the
user's product usage record", and "consult your doctor". Processing
thus precisely determines interaction between unique products used
by each individual user and health status of each individual user.
Next, step 2350 contacts doctor and informs about contraindication.
This message to the doctor allows the practitioner to evaluate the
interaction between a drug prescribed and a change in the health
status of the patient who is now at risk of harm by using the drug.
If there are no diseases associated with the transferred variable,
then step 2340 attaches to alert message "no contraindication found
between product identifiers and biological variables". Next,
processing addresses information related to contraindication
received from RIS 60 such as government agencies, with the
information stored in alert database 790. In accordance, step 2360
repeats the steps of 2300 to 2350 for the alert database 790
instead of product information database 760. Next, an alert message
is sent, step 2370, with the information acquired, to the user and
operation ends.
[0294] FIGS. 13A and 13B depict the flow diagram concerning
acquisition of data from the RIS 60. In this exemplary embodiment,
a government remote computer transfers information to alert
database 790. At step 2400 the remote computer sends message to
central server 10 that updated information is available. Next,
after appropriate identification and authentication, central server
10 establishes connection with remote computer, step 2410. At step
2420, the remote computer 60 transfers product identifiers with
associated "new warning information," which can be a recall
warning, harmful warning levels 1 to 5, or a beneficial notice
according to the new data acquired by the government agency. Step
2430 then stores product identifiers and "new warning information"
in alert database 790. Next step 2440 disconnects remote computer
from central server 10. Step 2450 then creates alert message. Step
2460 then determines if product identifiers transferred are in the
product database 730. If not, the operation ends. If product
identifier is in product database, step 2470 retrieves usernames
associated with product identifiers. Next step 2480 attaches "new
warning information" to alert message. Step 2490 then sends alert
message to all usernames identified at step 2470, and operation
ends.
[0295] Referring now to FIGS. 14A and 14B, a similar processing as
above is used, but now using the manufacturer 148 as remote
computer updating product information in the product information
database 760. In accordance, at step 2500 remote manufacturer
computer 148 sends message to central server 10 that updated
information is available. Next, at step 2510 central server 10
establishes connection with remote manufacturer computer 148. At
step 2520 remote manufacturer computer 148 then sends product
identifiers with associated "new product information". Next, step
2530 stores product identifiers and "new product information" in
product information database 760. Next, step 2540 disconnects
central server 10 from remote computer 148 and step 2550 creates
alert message. Next, step 2560 determines if product identifier is
in the product database 730. If not, the operation ends. If the
product identifier is in the database 730, step 2570 retrieves
usernames associated with product identifiers. Then step 2580
attaches "new product information" to alert message and step 2590
sends alert message to all usernames identified at step 2570, and
operation ends.
[0296] For every product identifier transferred by a user, the
central server 10 provides the information related to the product.
When the central server 10 receives for the first time a certain
product identifier from a user, the central server 10 may not have
data on the product identifier transferred and will ask the user to
rescan the product in 24 hours. The central server 10 then, in the
next 24 hours, searches the RIS 60 for the information related to
the product identifier. In accordance, and now referring to FIGS.
15A and 15B, at step 2600 central server 10 initiates connection
with a remote computer 60, which can be a government agency, the
manufacturer, a medical institution, a research facility, and the
like. Next, step 2610 connects the central server 10 to the remote
computer 60. At step 2620 the central server 10 accesses the remote
computer database. Step 2630 then determines whether there is a
primary key in the remote computer database. If not, the process
proceeds with step 2670 and disconnection from the remote computer
60. If there is a primary key, the information associated with the
primary key is retrieved, step 2640. Step 2650 then stores the
retrieved information in the database of central server 10. Next,
step 2660 generates a list of updated information on the primary
keys and disconnects from remote computer at step 2670. Step 2680
then determines if the primary key is product identifier. If not,
the process proceeds with step 2720 to determine if the primary key
is a username and, if not, the operation ends. If the primary key
is a username, for that username step 2730 performs step 2000
through 2370, and the operation ends.
[0297] If primary key is a product identifier, then step 2690
determines if product identifier is in product database 730. If
not, the operation ends. If the product identifier is in the
product database, step 2700 retrieves usernames associated with
product identifiers. Next, step 2710, for usernames retrieved in
step 2700, steps 1300 through 1960 are performed for product
identifier, and processing ends.
[0298] FIG. 16 depicts an exemplary function related to the use of
biometric data and the visual or audio identification of products
primarily for visual and hearing impaired users. In accordance
therewith, entry of biometric data is the function selected (step
954 of FIG. 10). The first processing step, step 2800, is to input
biometric data (for instance: iris scanning or finger print. At
step 2810 the biometric data entered is then compared with the
stored biometric data 2805. If there is a positive match between
the entered biometric data and the stored biometric data, then step
2830 enables key pad. If there is no positive match, an alarm will
sound (2815) and the display will inform the user that the
biometric data is invalid, step 2820.
[0299] Once the biometric data is validated and the keypad enabled,
step 2830, the user selects product type, step 2840. Step 2850
enables scanner and step 2860 prompts user to scan. Next, the user
scans barcode, step 2870, and stores bar code in the memory of the
portable unit 40, step 2880. Next, step 2890 determines if name is
available for bar code scanned. If not, operation proceeds to step
2910 and the bar code number is displayed. If the name is
available, the name of the product is presented using visual and
audio means, step 2900, and the process continues with step 2900 to
display bar code number, and the operation ends.
[0300] FIG. 17A shows an exemplary function related to the
acquisition of a key or password by the user in order to access the
database or chat room related to the product being used or illness
indicated by the user's biological variables and/or injury/illness
caused by a product, including chat rooms related to support groups
for a certain type of illness/injury. The user can acquire a key
for any condition or product of interest. In accordance, acquire
key 956 (FIG. 10) is the function selected.
[0301] According to the function, in step 3000 the user transfers
product identifier to central server 10 according to the principles
of the invention. Then central server 10 generates a product key at
step 3010. Step 3020 then transfers the key to the user and step
3030 stores the key in user's computer. At step. 3040, if user is
online then user's computer accesses product chat room or database,
and the operation ends. Alternatively, the user can acquire the key
and later access chat room. Accordingly, and now referring to FIG.
17B, at step 3050 user's computer enters the key and then accesses
chat room or database at step 3055 and the operation ends.
[0302] When user deletes a product identifier (see, for example,
step 4120 of FIG. 19B), then the central server 10 voids the key
related to the product identifier. In accordance, and referring to
FIG. 17C, anytime the user removes or deletes a product identifier,
step 3060, the central server 10 voids that key for the product
identifier, step 3065, and the operation ends. Alternatively, the
GPI server 10 can automatically transmit a key to all of the users
of the product. The key is necessary to enter a room, for example,
an electronic room, board or window found on commercial on-line
providers. Moreover, the users of the same recalled product who
sustained harm caused by the product can communicate with each
other, thus creating a support system for the victims and allowing
the victims to share experiences, tips on treatment, how to
personally control certain symptoms, and the like.
[0303] FIG. 18A shows an exemplary embodiment related to the
acquisition of a key by a medical provider or authorized provider.
The doctor, for example, can then access the biological variables
transferred to a central database. In this embodiment the user, who
may be a patient with glaucoma or diabetes, transfers his/her
biological variables to a central database. The doctor then at
his/her discretion can access the database and check the biological
variables parameters and values for any of the doctor's patients.
In accordance, operation starts and at step 3070 the doctor
transfers the username and password. The password is needed so that
only the doctor treating the patient or authorized provider can
access the biological variable database for the patient. After
proper authentication and identification according to conventional
means is secured, at step 3080 the central server 10 generates the
key for biological variables database for the username transferred.
Next, at step 3090 central server 10 transfers key to doctors
computer for biological variable record for username. At step 3100
the doctor's computer stores the key and accesses biological
variables record for the user in biological variables database,
step 3110, and the operation ends.
[0304] Although biological variables can be electronically
transferred to a remote computer such as the doctor's computer,
this can be considered as an alternative embodiment since it can
flood the doctor's remote computer with vast amounts of data.
According to the preferred embodiment, data remains stored in a
central database that can be easily accessed by any person at any
place in the world as long as the person is an authorized user. The
doctor can also acquire the key and later access the patient's
biological variable record or chat room. Accordingly, and referring
to FIG. 18B, at step 3115 the doctor's computer enters the key and
then accesses biological variables record or chat room, step 3120,
and the operation ends. FIG 18C shows a summary of processing
related to voiding a key. When the doctor deletes username or
preferably the user removes doctor's name 712 from personal
information database at step 3125, then the central server 10 voids
the doctor's key related to the username biological variable
record, step 3130, and the operation ends. Alternatively, the GPI
server 10 can transmit a key to the doctor who is responsible for
the medical care of a certain user.
[0305] FIGS. 19A and 19B depicts an exemplary embodiment related to
removal of product identifier from the database by the user. In
accordance, when remove product identifier function is selected,
step 960 of FIG. 10, the user can select a product type at step
4000. Upon selection of product, the scanner is enabled at step
4010 and prompts the user to scan the bar code at step 4020. The
next step 4030 then determines if the product identifier is the
last one to be scanned. If it is not the last product identifier,
then the bar code for the product identifier is scanned at step
4040. The next operation, step 4050, determines if the bar code is
valid. If it is valid, processing continues with step 4070 and the
scanned unique bar code for the product is stored in the portable
unit memory. If the bar code is not valid, the user is prompted to
rescan, step 4060. Next, the user is prompted to scan another bar
code related to a new product identifier and the process repeats
until the last product identifier is scanned.
[0306] After the last product identifier is scanned, processing
connects the portable unit 40 with the central server 10 at step
4080 and username and password are transferred at step 4090. Upon
valid verification and authentication, the encrypted product
identifier is transferred to the central server 10 at step 4100.
Next, step 4110 determines if product identifier transferred is in
user's product usage record for user in user's product usage
database 740. If not, step 4130 sends a message to portable unit
40, "product identifier not in user's record" and then proceeds to
step 4160. If the product identifier is in the user's record, step
4120 removes product identifier for user in user's product usage
record. Next, step 4140 removes username for product identifier
from product database. Then step 4150 sends message to portable
unit 40 "product identifier successfully deleted". Step 4160 then
disconnects from central server 10 and operation ends.
[0307] FIG. 20A and 20B shows an exemplary embodiment related to
automatically removal of biological variable values by the central
server in order to avoid retention of a large amount of old data in
the database. Biological variables relate to dynamic changes
occurring in the human body, thus data that it is more than a year
old may not be relevant to the user's present health status and
thus will be automatically deleted. Biological variables acquired
either at the doctor's office or at the user's domicile are
automatically deleted if the data is more than a year old. However,
the system will preserve at least one value since healthy
individuals may go to their doctor only once every two or three
years while older patients may go the doctor on a routine basis
every three months. The system will preserve at least one value for
each biological variable parameter transferred which can be used as
a reference for the medical status of the user.
[0308] Accordingly operation starts and at step 5000 the central
server 10 accesses the biological variables database 770. Then at
step 5010 username equals the name of the first user in biological
variables database. Next, step 5020 gets first parameter record 774
for username. Then, from parameter record 774, step 5030 gets first
value 775 and time/date 776. Next step 5040 determines if today's
time/date minus time/date is greater than one year. If not,
operation proceeds to step 5080; otherwise, step 5050 determines if
value is the last value in parameter record. If yes, step 5055
sends message to user that "most recent biological variable value
is more than 1 year old" and proceeds to step 5080. If the value is
not the last value, then step 5060 removes value and time/date from
parameter record. Next, from parameter record, step 5070 gets next
value and time/date and repeats processing, step 5040, to determine
if today's time/date minus time/date is greater than 1 year. If
not, processing proceeds to evaluate another biological variable
parameter and step 5080 determines if parameter record is the last
parameter record for the user. If the difference is greater than 1
year, the process proceeds to step 5050.
[0309] If the record is not the last parameter record, step 5090
gets next parameter record for username, and processing repeats
until all values and parameters are evaluated for the username. If
the record is the last, step 5100 determines if username is the
last user in biological variables database. If yes, the operation
ends; otherwise, at step 5110 username equals name of the next user
in biological variables database, and at step 5120 go to step 5020
for further processing until biological variables for all users are
evaluated.
[0310] The system can work on information locally stored, but if
the information on the unique potentially harmful product
transferred by the user is not located over the GPI server 10, the
GPI server 10 can then connect the user to the remote site over the
Internet 100 which contains the warning information on the harmful
product. It is thus understood that alternative embodiments can be
implemented with the information sent to the user concerning a
warning or recall related to a product being used and/or
interaction product-product and product-biological variable
comprising also a web URL (Uniform Resource Locators), bulletin
board address, direct connection with a web site, and the like as
well as a voice mail address, phone number, mail address and the
like, with all of these sources containing relevant information
related to the product warning and/or recall and other
interactions. Alternatively, the GPI server 10 can electronically
connect the user of the product with the site on the Internet which
contains the warning information, such as the research institution
154, or the manufacturer 148, or the FDA 130, or the CPSC 132, and
the like. Information relevant only to the products associated with
a unique user is transferred back to the user and the user receives
selected information on only the products being utilized by the
user and only on interaction product-biological variables
corresponding to the health status of the single user. It is
understood that advances in processing and communication mediums
will allow the unique product identifiers and biological variables
to be automatically, continuously, and instantaneously transferred
to the GPI server 10 as the unique product identifiers and
biological variables are acquired and/or selected by the user with
the subsequent automated processing and transfer of alert
information related to the product identifiers and biological
variables back to the user related to the product identifiers and
biological variables.
[0311] The user's personal information 700 can be expanded to
include other information about said user. The user can include
credit card information and other commonly used data linked to the
user including a train schedule. For example, the user, Mr. Martin,
is on a three month trip in Switzerland. The user checks his eye
pressure, blood cholesterol and blood sugar using the
aforementioned Abreu self-monitoring devices using a cell phone as
the receiver for the signal from the monitoring devices. The data
is sent to the GPI server 10 which identifies increased eye
pressure and, considering that the user is using amiodarone, a
harmful interaction causing eye damage is identified. The GPI
server 10 also identifies a newly recalled product (Redux.RTM.)
which is stored in the user's product usage database 740. A newly
recalled chocolate found to have undisclosed amounts of peanuts is
also identified. Since the user is allergic to peanuts an alert is
generated. While the GPI server 10 had also identified a recalled
crib as being used, the system notes that a successful phone alert
was sent. The user has a doctor's name in Switzerland stored in his
personal information database 700 and an appointment is scheduled.
Since the user had his credit card information and train schedule
stored in the user's personal database 700, the message delivered
identifies which train to take to get to the doctor and includes a
reserved ticket for the trip.
[0312] Although sequencing processing is primarily described, it is
understood that other processing design known by one skilled in the
art can be used. For instance, an object oriented design with
parallel processing can be used. For example step 1710 to 1780 can
be an-alert object class applied to any product identifier or any
biological variable.
[0313] Alternatively, hand-held IECLD 40 may also be used in an
on-line manner using conventional communication lines such as
telephone lines or electronic communications medium in which there
is a link and transmission of data to and/or from the IECLD 40 to
the GPI server 10 computer station. The IECLD 40 has data storage,
processing and transmission capabilities and the on-line
communication between the IECLD 40 and the central GPI server 10
can be done digitally using, for instance, an acoustic coupler. In
this alternative embodiment, the coupling station is located at the
doctor's office or at a pharmacy where the user receives or fills a
prescription for the drug, or alternatively can be done by the
patient at home. The patient enters a Personal Identification
Number or password manually, which is then compared with a number
stored in the IECLD 40 memory unit. If there is a match, the new
drug can be scanned in using the bar code reader system and the
data sent to the GPI server 10 using conventional communication
lines. If at the time of entering, there is a warning about the
drug stored in the IECLD 40, an alarm will sound and stored
information will appear on the display. Although it is technically
possible for the hand-held device to be updated with information
from the GPI database at the time of the on-line coupling with GPI
server 10 computer station, this is not the preferred way since the
hand-held device would have to have very large memory capabilities
to be able to store the data on the thousands of drugs and/or
products stored in the GPI database. When, however, the IECLD 40 is
used in this manner, any time a drug is entered, such as for
instance scanning a bar code for that drug, the entered drug would
automatically be evaluated against the data stored in the memory of
the portable device. If the drug prescribed is found to have
potentially detrimental effects, an alarm would be activated and
the information on the drug displayed in the display and a flashing
light activated allowing immediate recognition of the potential
harmful effect before the drug was even used or even purchased. At
any time of coupling the new data is transferred from the GPI
server 10 station to the portable IECLD 40 and vice-versa.
[0314] FIG. 21 illustrates another exemplary embodiment in which
the IECLD 40 can interface with standard telephone lines using
binary data, with the binary data generated by the IECLD 40 being
processed via standard encryption applications using conventional
encryption algorithms available from the National Bureau of
Standards. The encrypted binary data is then transmitted and
demodulated and decrypted at the receiving unit with the unit being
the GPI server 10 computer station, but preferably in this
embodiment the receiving/transferring unit is another IECLD 40
device. The GPI system 1 thus allows secured communication not only
between the GPI server 10 computer station, but also between one
IECLD 40 and another suitable IECLD 40. The communication between
two IECLD's 40 would be useful if a patient with one IECLD 200
wants to communicate and transmit the data on the drugs being used
to a doctor who also has a IECLD 202, or to an insurance company
which has a IECLD 204, or to a hospital which also has a IECLD 206,
or to a pharmacy which has a IECLD 212, or to an ambulance which
carries a suitable corresponding IECLD 208 and need to know
precisely what drugs and devices a patient is using, or to another
institution which may not have an IECLD 40 but has some device 210
able to access and decode the data being transmitted by the
patient's IECLD 200, and the like. This allows the transmission of
data in an accurate, time- and cost-efficient manner from one IECLD
200 to a receiving point in need of that data. For the transmission
of data between two IECLD 40, the IECLD 40 #1 is used in a barter
way and IECLD 40 #2 is programmed to accept data from another
corresponding IECLD 40, such as IECLD 40 #1, and the data is then
electronically transferred directly between the two IECLD 40s. The
responding unit such as the ambulance which carries a IECLD #2 208,
may then automatically and electronically receive the data from the
patient's IECLD #1 200 including the biological variables measured
at home by the patient such as blood pressure, eye pressure, blood
glucose, temperature etc, as well as the information on the
products used and drugs and medical devices used. The ambulance
IECLD 208 can then send the information on the condition of the
patient and treatment being administered back to the patient's
IECLD 200 for storage, and also to a receiving unit at a hospital
206 and at the doctor's office 202 which then will have all of the
information on previous drugs and devices previously being used by
the patient as well as biological variables measured at home plus
the new information on treatment that was administered on the way
to the hospital in the ambulance. For a complete and reliable
information system to be implemented, in this embodiment it is
preferred that the patient carry with him some type of
identification informing that he/she has a IECLD 200 and how to
contact or access the patient's IECLD 200 because sometimes a
patient will suffer a heart attack or other acute medical event and
become unconscious, with paramedics and physicians not being able
to learn what medications or devices are used by the patient. The
knowledge of that information is sometimes the difference between
life and death for that particular patient and the IECLD 200 will
provide the life-saving information in a timely, inexpensive, and
efficient manner.
[0315] When for instance, the communication between the IECLD 200
is established with the GPI server 10, the microprocessor is
programmed to access the GPI database in the GPI server 10 after a
conventional data stream is exchanged and connection established
between the IECLD 200 and the GPI central server 10 computer
station. The IECLD 200 then obtains any data on the drugs and
products from the GPI server 10 computer related to the drugs and
products which are then stored in the IECLD 200 memory unit for the
user. The data is then displayed on the display of the IECLD 40
with updating of the data and new data being stored in the IECLD
200 memory unit. If the new input data relates to drug "D" for
instance, which is given by the paramedics in the ambulance, the
IECLD 200 will send data informing the GPI server 10 station that a
particular patient Mr.XYZ was given the drug "D", and the IECLD 200
is programmed to obtain from the GPI server 10 any information
available on drug "D" or any information on interactions of drug
"D" with biological variables of patient Mr.XYZ. So if there is new
data, the new data on drug "D" will be displayed in the display of
the IECLD 200. If there is new data encoded with harmful
interaction code, then a special alarm will sound to inform the
user of the harmful condition caused by the harmful product being
bought or prescribed or given. If a potentially harmful product is
identified and coded as harmful, the user is informed and if there
is a recall or potentially harmful effect, then the various
points-of-sale carrying or selling the harmful product and doctors
prescribing the harmful product, which can be identified by the GPI
server 10, are contacted and an alert notice and information sent
are to the numerous places and professionals.
[0316] In the aforementioned Abreu patent, there is described a
system in which no numerical values are displayed in the display in
relation to providing output related to measured biological
variables. Abreu utilizes a system of lights which corresponds to
the range of values for the biological variables. The portable unit
IECLD 40 provides an improvement over Abreu's invention by
providing an interactive display in which the user can receive
information and information on how to proceed according to the
level of the biological variable measured. For instance when
measuring eye pressure if the pressure is within acceptable levels,
the green light by Abreu would appear. In the present invention a
message would appear stating that "You are fine" and "You should
keep the appointment with Dr. Jones at 6 p.m. on January 1st.
Please bring your glasses and medications with you". Since there
was a record entered by the doctor that the patient did not bring
his glasses with him in the previous appointment, the IECLD 40 will
remind the patient of that. A list of the medications with its
schedule would subsequently appear on the screen indicating which
should be the next medications to be taken and what is the dosage
to be taken according to the prescription by the doctor. The
patient could then interrogate the IECLD 40 in regards to the
meaning of the level of the pressure measured and then receive
information stored in the IECLD 40's memory in regards to what that
level of pressure means for that particular patient according to
the patient's specific health status. If the pressure measured was
within borderline values, the yellow light by Abreu would appear.
In the present invention, a message would appear stating "Your eye
pressure is borderline and you should check your eye pressure again
in three hours. If you experience any eye pain please press the
contact office button on your screen." If the eye pressure measured
is above acceptable levels, the red light by Abreu would appear. In
the present invention, a message would appear stating "Your eye
pressure is above acceptable limits. Please check your eye pressure
again in 15 minutes. If you experience any eye pain or redness
please press the contact office button on your screen." If the
pressure measured is very high, which could potentially cause
irreversible damage in a short period of time, the present
invention would display a message stating "Please come immediately
to the office for evaluation. Your pressure is well above
acceptable safe limits." A warning message about the patient's
condition would also be transmitted to the medical provider's
office over the public network. Each IECLD 40 is calibrated
according to the range of pressure which is considered safe for
that particular patient and according to the overall health status
of that patient. It is also understood that the above disclosed
technology could be applied to any other home monitoring device
such as blood sugar monitoring as described by Abreu, blood
pressure measuring devices, heart monitors, pregnancy tests, and
the like.
[0317] Another embodiment of the present invention relates to the
transmission of biological data acquired using diagnostic or
monitoring tests as described in the patents by Abreu or any
diagnostic or monitoring device. The IECLD 40 interface with the
various monitoring and diagnostic devices via a low power RF or IR
interfaces. The IECLD 40 could be activated at prescribed intervals
to store the biological data which was received from the other
monitoring devices and to subsequently deliver the biological data
over a public network such as the Internet and to a server 10 and
then to a database. It is also understood that the IECLD 40 could
be placed next to the monitoring device in order to receive the
biological data at the time of measuring the biological data. The
data could then be stored for later transmission or the data could
be immediately transmitted over the public network to the
corresponding database in the server 10.
[0318] The foregoing description of the preferred embodiments of
the present invention have been provided for the purposes of
illustration and description. Many modifications and variations
will be apparent to those skilled in the art. The embodiments were
chosen in order not to limit the scope of the invention but to best
explain the principles of the invention and its practical
applications.
* * * * *