U.S. patent application number 16/162663 was filed with the patent office on 2019-02-14 for systems and methods for independent assessment of image data.
The applicant listed for this patent is Merge Healthcare Incorporated. Invention is credited to Jon T. DeVries.
Application Number | 20190051402 16/162663 |
Document ID | / |
Family ID | 48086023 |
Filed Date | 2019-02-14 |
United States Patent
Application |
20190051402 |
Kind Code |
A1 |
DeVries; Jon T. |
February 14, 2019 |
SYSTEMS AND METHODS FOR INDEPENDENT ASSESSMENT OF IMAGE DATA
Abstract
Systems and methods for managing at least one medical image that
includes image data and metadata. One method includes generating,
at a processor, a number of copies of the at least one medical
image, wherein the number of copies is equal to a number of
independent reviewers associated with the at least one medical
image. Each of the copies includes the image data and the metadata.
The method also includes modifying the metadata of each of the
copies to include a unique identifier, and storing the copies to at
least one image storage device.
Inventors: |
DeVries; Jon T.; (Cary,
NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Merge Healthcare Incorporated |
Chicago |
IL |
US |
|
|
Family ID: |
48086023 |
Appl. No.: |
16/162663 |
Filed: |
October 17, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13650370 |
Oct 12, 2012 |
10140420 |
|
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16162663 |
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61546373 |
Oct 12, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G16Z 99/00 20190201;
G16H 30/40 20180101; G06F 19/321 20130101; G06F 19/00 20130101;
G16H 30/20 20180101; G16H 10/20 20180101 |
International
Class: |
G16H 30/20 20180101
G16H030/20; G06F 19/00 20180101 G06F019/00 |
Claims
1. A method for managing at least one medical image, the at least
one medical image including image data and metadata, the method
comprising: generating, at a processor, a number of copies of the
at least one medical image, the number of copies equal to a number
of independent reviewers associated with the at least one medical
image, each of the copies including the image data and the
metadata; modifying the metadata of each of the copies to include a
unique identifier; and storing the copies to at least one image
storage device.
2. The method of claim 1, wherein modifying the metadata of each of
the copies includes modifying at least one field included in the
metadata of each copy to include a value different from a value of
the field in the other copies.
3. The method of claim 2, wherein modifying the at least one field
includes modifying a study universal identification field.
4. The method of claim 2, wherein modifying the at least one field
includes modifying at least one of patient identification field, a
medical record number field, and an accession number field.
5. The method of claim 1, further comprising assigning the unique
identifier of each of the copies to a different reviewer, each
unique identifier allowing the reviewer to access and review one of
the copies independently of the remaining copies.
6. The method of claim 1, further comprising accessing an image
assessment associated with each of the copies and comparing the
image assessments to determine when additional image assessments
are needed.
7. The method of claim 1, wherein generating the copies includes
instructing a second processor to generate the copies.
8. The method of claim 1, wherein modifying the metadata of each of
the copies includes generating the unique identifier for each of
the copies and instructing a second processor to modify the
metadata of each of the copies based on the generated unique
identifiers.
9. The method of claim 1, wherein storing the copies includes
instructing a second processor to store the copies to at least one
image storage device.
Description
RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 13/650,370 filed Oct. 12, 2012, which claims
priority to U.S. Provisional Patent Application 61/546,373, filed
Oct. 12, 2011. The entire content of both applications is hereby
incorporated by reference.
BACKGROUND
[0002] The present invention relates to digital image processing
systems and methods. In particular, the invention relates to
digital image processing systems and methods for managing medical
images.
SUMMARY
[0003] Medical images can be acquired for various reasons and uses.
Medical images can be acquired for diagnostic and treatment
purposes within a hospital setting. In particular, a physician may
request that a patient undergo a radiological examination so that
the physician can diagnose the patient or track the progress or
treatment of a previously-diagnosed issue. In this context, after
the images are initially acquired, the images are reviewed by the
physician or other healthcare professionals (e.g., a radiologist).
The reviewer uses an image viewer to assess the images and make
measurements and annotations associated with the images. The
reviewer also provides a report summarizing his or her findings,
which often includes a dictated narrative. The measurements,
annotations, and report are stored and associated with the acquired
images. Therefore, if the acquired images are later accessed (e.g.,
as part of a "second" review or as a standard part of reviewing a
patient's health record), the original reviewer's measurements,
annotations, and report are available. Making this information
available to subsequent reviewers aids informed treatment of a
patient based on all available information.
[0004] Medical images can also be acquired as part of a clinical
trial. For example, during a clinical trial for a new cancer drug,
trial participants may undergo one or more radiological
examinations to determine how a cancerous tumor reacts to the new
drug. Images acquired during a clinical trial are typically handled
differently than images acquired in a hospital setting. First, as
compared to the non-standard, narrative report generated by a
reviewer in a hospital setting, a reviewer in a clinical trial
provides an objective quantitative analysis that relies on
evidence-based measurements, such as biomarkers. To ensure the
accuracy of these objective observations and measurements, images
acquired as part of a clinical trial are often blindly reviewed
(e.g., in tandem) by at least two reviewers. The results from the
reviewers are compared to determine whether the results match. If
the results match, the independent assessments are saved for
subsequent use and/or review. If the results do not match, one or
more additional reviewers may be used to evaluate the images as a
tie-breaker. In the end, all of the independent assessments are
saved for subsequent use and/or review.
[0005] Because images in a clinical trial need to be reviewed
blindly by multiple reviewers, systems and methods used to analyze
images in a hospital setting are often unusable for clinical trials
or require extensive (and costly) modification. Accordingly, many
clinical trials rely on manual processes to manage images, which
are slow, inefficient, and prone to human errors. Accordingly,
embodiments of the invention provide systems and methods for
managing image assessment within a clinical trial setting.
[0006] In one embodiment, the invention provides a method for
managing at least one medical image. The method includes receiving
information regarding the at least one medical image, and
determining, at a first processor, a number of copies needed of the
at least one medical image based on the information regarding the
at least one medical image. The method also includes generating, at
the first processor, a unique identifier for each copy and
providing, to a second processor, the number of copies needed and
the unique identifiers. The second processor generates the number
of copies of the at least one medical image, modifies each of the
copies based on one of the unique identifiers, and stores the
copies to at least one image storage device.
[0007] In another embodiment, the invention provides a method for
managing at least one medical image, wherein the at least one
medical image includes image data and metadata. The method includes
generating, at a processor, a number of copies of the at least one
medical image, wherein the number of copies is equal to a number of
independent reviewers associated with the at least one medical
image and each of the copies includes the image data and the
metadata. The method also includes modifying the metadata of each
of the copies to include a unique identifier, and storing the
copies to at least one image storage device.
[0008] In yet another embodiment, the invention provides a system
for managing at least one medical image. The system includes a
first processor configured to receive information regarding the at
least one medical image, wherein the at least one medical image
includes image data and metadata, and to determine a number of
copies needed of the at least one medical image based on the
information regarding the at least one medical image. The first
processor is also configured to generate a number of unique
identifiers, the number of unique identifiers equal to the number
of copies needed, and to provide, to a second processor, the number
of copies needed and the unique identifiers. The second processor
generates the number of copies of the at least one medical image,
modifies each of the copies to include one of the unique
identifiers, and stores the copies to at least one image storage
device.
[0009] Other aspects of the invention will become apparent by
consideration of the detailed description and accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 illustrates a digital image processing system
according to one embodiment of the invention.
[0011] FIG. 2 illustrates a controller included in the digital
image processing system of FIG. 1.
[0012] FIGS. 3 and 4 are flow charts illustrating methods performed
by the digital image processing system of FIG. 1.
DETAILED DESCRIPTION
[0013] Before any embodiments of the invention are explained in
detail, it is to be understood that the invention is not limited in
its application to the details of construction and the arrangement
of components set forth in the following description or illustrated
in the accompanying drawings. The invention is capable of other
embodiments and of being practiced or of being carried out in
various ways. It should also be noted that a plurality of hardware
and software based devices, as well as a plurality of different
structural components may be utilized to implement the invention.
Furthermore, and as described in subsequent paragraphs, the
specific configurations illustrated in the drawings are intended to
exemplify embodiments of the invention and that other alternative
configurations are possible.
[0014] As described above in the summary section, medical images
are used and assessed differently in hospital settings than in
clinical trial settings. Within the hospital setting, numerous
systems and methods have been developed that match the way images
are used and processed. For example, hospitals and other image
acquisition sites and networks typically use (1) a Radiology
Information System ("RIS") that stores and manages billing, image
reports, scheduling, etc. associated with radiological examinations
and (2) a Picture Archiving and Communication System ("PACS") that
stores and manages the images associated with the radiological
examinations. The RIS runs in parallel with the PACS in a
streamlined, linear process that automates the standard process of
assessing images in a hospital setting. As noted above, the PACS
allows individuals to access stored images and any associated
annotations, measurements, or reports for a particular radiological
examination or a particular patient. Accordingly, as previously
noted, although clinical trials also assess medical images,
clinical trials often cannot use the standard products and systems
used in a hospital setting.
[0015] FIG. 1 illustrates a digital image processing system 10. The
system 10 can be used to manage images acquired for a clinical
trial. The system 10 includes one or more acquisition devices 12,
an editor 14 (e.g., a digital imaging and communications in
medicine ("DICOM") editor), a controller 16, and an image storage
device 18. As described in more detail below, the acquisition
devices 12 acquire digital images of a patient and transmit the
images to the editor 14. The editor 14 communicates with the
controller 16 to manage the processing of acquired images, which
includes storing the images in the image storage device 18. After
the images are stored, a reviewer (e.g., an individual reviewing
the acquired images for the clinical trial) can use a computing
device executing a viewer application (hereinafter referred to as a
"viewing device 26") to access stored images. Viewer applications
are well-known in the medical image industry and are provided by
numerous vendors. The available viewer applications provide
different functionality and different compatibility with particular
image storage devices 18. In some embodiments, the image storage
device 18 includes a PACS, a RIS, and/or a clinical image
management system ("CIMS"), which are well-known in the medical
industry. Although illustrated as a single device, the image
storage device 18 can include multiple devices (e.g., multiple
servers or databases).
[0016] As illustrated in FIG. 1, a plurality of networks 20, 22,
and 24 connect the acquisition devices 12, the editor 14, the
controller 16, the image storage device 18, and the viewing device
26. The networks 20, 22, and 24 can include the Internet, a wide
area-network ("WAN"), a local-area network ("LAN"), or combinations
thereof. The networks 20, 22, and 24 can include wired connections,
wireless connections, or combinations thereof. It should be
understood that in some embodiments, two or more of the components
can be combined into a single system and connected by internal
connections as opposed to networks. For example, the controller 16,
editor 14, image storage device 18, and viewing device 26 can be
connected by internal connections to form a consolidated system for
managing images without the need for networks 22 and 24.
[0017] As illustrated in FIG. 2, the controller 16 includes at
least one processing unit 36 (e.g., a microprocessor, a
microcontroller, or another suitable programmable device), one or
more non-transitory memory modules 38, one or more input units 40,
and one or more output units 42. In some embodiments, the
controller 16 includes a combined input/output module in addition
to or in place of the separate modules 40 and 42. In addition,
alternative configurations of the controller 16 are possible that
include more, less, or different components.
[0018] The memory module 38 can include one or more types of
memory, such as read-only memory ("ROM"), random access memory
("RAM"), flash memory, a hard disk, a removable drive, or other
suitable magnetic, optical, physical, or electronic memory devices.
As described in more detail below, the controller 16 is configured
to retrieve instructions from memory 38 and execute the
instructions to manage images. The instructions can include
firmware, one or more applications, program data, filters, rules,
one or more program modules, and other executable instructions. In
some embodiments, the editor 14 is similarly implemented as a
software-based device.
[0019] As illustrated in FIG. 2, the controller 16 communicates
with a user interface 28. The user interface 28 can include a
display and input devices such as a touch-screen, a keyboard, a
mouse, a plurality of knobs, dials, switches, buttons, etc. As
described in more detail below, a user can use the user interface
28 to configure the controller 16 and set parameters for how
acquired images are managed and stored for a particular clinical
trial.
[0020] It should be understood that the components of the system 10
can be combined and distributed in various configurations. For
example, in some embodiments, the controller 16 can be combined
with the editor 14. Furthermore, the controller 16 can be combined
with other systems and devices commonly used in the medical
industry, such as an electronic data capture system, a PACS, a RIS,
a CIMS or a similar system used to store and manage patient
information and subsequent access and processing. For example, in
some embodiments, the controller 16 is combined with the image
storage device 18, which includes a PACS, RIS, and/or CIMS.
[0021] FIG. 3 illustrates a workflow performed by the system 10 for
acquiring and managing images. As illustrated in FIG. 3, an
acquisition device 12 acquires images and transmits an image object
44 to the editor 14. The image object 44 includes image data (i.e.,
the digital images captured during a radiological exam by the
acquisition device 12) and metadata, which provides information
regarding the image data (e.g., patient name, exam date, clinical
trial identifier, etc.). In some embodiments, the metadata is
contained in a header of the image data.
[0022] In some embodiments, the metadata is de-identified and
standardized before it is transmitted to the editor 14 to comply
with industry standards such as the Health Insurance Portability
and Accountability Act ("HIPAA"). For example, if the editor 14 is
located at a different location than the acquisition device 12,
which requires that the image object 44 be transmitted over one or
more public or non-secure networks, the acquisition device 12 can
de-identify the metadata before transmitting the image object 44 to
the editor 14 (e.g., using software installed at the acquisition
device 12). In other embodiments, as illustrated in FIG. 4, the
system 10 uses a gateway 55 to collect and coordinate the image
object 44 to ensure that the image object 44 is compliant with
industry standards and regulations (e.g., HIPAA) before the gateway
55 passes the object 44 to the editor 14 for additional processing.
Gateways 55 are generally known in the art by various names such as
an image gateway or image appliance, and are provided by a number
of vendors including, for example, AG Mednet. A gateway can be
implemented as an integrated hardware and software device or as a
software-based device. For example, as illustrated in FIG. 4, a
software-based gateway 55a ("a sending gateway") can be implemented
at the acquisition site (e.g., as part of the acquisition device
12) to de-identify the image object 44 and send the image object
44, and a hardware and software gateway 55b ("a receiving gateway")
can be implemented at the editor 14 (or as an intermediary device
between the sending gateway 55a and the editor 14) to handle
receipt of the image object 44. In addition to de-identifying the
image object 44, a gateway 55 can provide data security, encrypt
and de-crypt the image object 44, and/or compress and de-compress
the image object 44. In some embodiments, if the editor 14 is
located at or near the acquisition device 12 or the gateway 55, the
editor 14 can be configured to perform the de-identification of the
image object 44.
[0023] The editor 14 is a temporary repository of the image object
44. Once the image object 44 is received by the editor 14, the
editor 14 communicates with the controller 16. For example, the
editor 14 transmits one or more signals 108 to the controller 16
that notify the controller 16 that the editor 14 has received the
image object 44. The signals 108 can include information regarding
the received image object 44. For example, in some embodiments, the
signals 108 include a clinical trial or subject identifier and
other information included in the object's metadata.
[0024] Based on the signals 108, the controller 16 determines the
clinical trial associated with the image object 44 and determines a
number of copies of the image object 44 that is needed. The number
of copies can correspond to the minimum number of independent
reviewers (e.g., two) used in the determined clinical trial. In
other embodiments, the number of copies corresponds to a maximum
number of independent reviewers used (e.g., assuming that a
tie-breaker may be needed).
[0025] To determine the number of copies needed, the controller 16
can access information (stored locally or on an external server or
device) that specifies parameters for clinical trials. In some
embodiments, a user inputs or sets the parameters for a particular
clinical trial using the user interface 28 coupled to the
controller 16. The parameters can include a number of independent
reviewers (e.g., minimum or maximum) for a particular clinical
trial. Upon receiving the parameters from the user through the user
interface 28, the controller 16 stores the parameters (e.g., to one
or more of the memory modules 38). Therefore, the controller 16 can
use the clinical trial identifier included in the signals 108 to
determine the clinical trial associated with the received images.
The controller 16 can then access the parameters associated with
the identified clinical trial to determine the number of copies of
the image object 44 needed for the trial.
[0026] After determining the number of copies needed for the
received image object 44, the controller 16 transmits one or more
signals (e.g., processing instructions) 110 to the editor 14. The
processing instructions 110 instruct the editor 14 to create a
particular number of copies of the received image object 44. For
example, the processing instructions 110 can include a number ("N")
representing the number of copies needed for the image object 44.
The processing instructions 110 can also include a unique
identifier for each copy. In particular, to prevent the copies 118
from being exactly identical (which would causes access problems
and errors if multiple image objects 44 were stored to the image
storage device 18 with identical metadata), each copy 118 needs to
be uniquely identifiable. For example, the metadata associated with
each copy 118 needs to include at least one piece of information
that is different from the metadata of the other copies 118.
Therefore, the controller 16 can generate and provide the editor 14
(through the processing instructions 110) a unique identifier for
each copy 118. As described below, the editor 14 can modify the
metadata for each copy based on one of the unique identifiers
provided by the controller 16. In some embodiments, the unique
identifier is a value for at least one field included in the image
object's header, such as a patient identification field, a medical
record number field, a study universal identification number
("SUID") field, and/or an accession number field. It should be
understood that the unique identifier can be the value of a single
field or the combination of values of multiple fields. For example,
the unique identifier can be a combination of the value of a trial
identification field (similar to a patient identification field in
a hospital setting) and the value of the medical record number
field, SUID field, or accession number field.
[0027] Therefore, the editor 14 receives the processing
instructions 110 and creates N copies 118 of the image object 44.
The editor 14 also modifies the metadata associated with each copy
118 based on of the unique identifiers provided by the controller
16. For example, the metadata of each copy 118 includes at least
one field 116, such as the SUID field illustrated in FIGS. 3 and 4,
and the editor 14 sets the field 116 of each copy 118 to one of the
unique identifiers provided by the controller 16. Accordingly,
although each copy 118 includes most of the same data as included
in the original image object 44 (e.g., the image data and metadata
associated with administrative data, such as patient demographics,
acquisition site information, etc.), each copy 118 is identifiable
as a unique image object based on the information included in the
field 116.
[0028] After creating the copies 118 and modifying the copies 118
based on the unique identifiers, the editor 14 transmits the copies
118 to the image storage device 18 for storage (e.g., as image
objects 44). In some embodiments, the editor 14 discards the
original image object 44 and does not transmit the original image
object 44 to the image storage device 18. In other embodiments, the
editor transmits the original image object 44 to the image storage
device 18 with the copies 118 or transmits the original image
object 44 to a second storage location separate from the image
storage device 18. It should be understood that the functionality
of the controller 16 and the editor 14 described above can be
combined and distributed in various ways. For example, in some
embodiments, the editor 14 generates the unique identifier for each
copy 118 rather than the controller 16. In other embodiments, the
controller 16 generates the copies 118 and supplies the copies 118
to the editor 14, and the editor 14 assigns the unique identifiers
and stores the copies 118 to the image storage device 18.
Furthermore, in some embodiments, the controller 16 is combined
with the editor 14 and the functionality of each component as
described above is provided by a single system or device.
[0029] Because the copies 118 have unique identifiers (e.g., field
116), the image storage device 18 stores and treats each copy 118
as a unique image object 44 (i.e., a unique study or exam) that can
be independently accessed, and measurements, observations, and
other annotations made to one copy 118 do not affect the other
copies 118. Accordingly, the image storage device 18 can include
standard, unmodified devices or products, such as a PACS, RIS,
and/or CIMS, while still providing blind review for a clinical
trial.
[0030] Although the image storage device 18 treats the copies 118
independently, the controller 16 can store information that
associates the copies 118 with the original image object 44 (e.g.,
metadata from the original image object 44 and the unique
identifiers assigned to the copies 118), such that the controller
16 can track the copies 118 made from the original image object 44.
Accordingly, the controller 16 can provide information to
individuals or other computing devices or systems regarding what
image objects stored to the image storage device 18 are copies of
the same original image object. This information can be used by the
controller 16 or other computing devices or systems to reconcile
assessments (e.g., compare independent assessments of images and
request tie-breakers as needed). This information can also be used
to alert particular reviewers when images are available for review.
In particular, the controller 16 can provide a reviewer with a
unique identifier associated with a particular image object stored
in the image storage device 18 (e.g., a value for the field 116),
and the reviewer can access the image from the image storage device
18 using the provided identifier and the viewing device 26. In some
embodiments, the controller 16 can be configured to provide the
unique identifier automatically to a particular reviewer. In other
embodiments, the controller 16 can provide this information to
individuals who manually inform the reviewers. In still other
embodiments, the controller 16 can provide this information to
other computing devices or systems that use the information to
alert reviewers of available images.
[0031] Upon receiving a unique identifier for a stored image
object, a reviewer can access the image object stored in the image
storage device 18 using the viewing device 26. As noted above,
because the image storage device 18 can include standard image
management systems and devices, such as a RIS, PACS, and/or CIMS,
the viewing device 26 can execute any standard viewer application
compatible with the image storage device 18. Accordingly, the
system 10 can be used to access images without requiring customized
viewer applications.
[0032] Upon accessing an image object, the reviewer can provide
measurements and annotations of the image data (hereinafter
referred to as an "image assessment"). The image assessment can be
saved with the image object in the image storage device 18. For
example, in some embodiments, the image assessment is stored as
part of the object's metadata. In other embodiments, the assessment
is stored in a separate file, database, or server. However, even
when the image assessment is stored separately from the image
storage device 18, the assessment is linked to the associated
object (e.g., based on the unique identifier included in the field
116 of the object). Therefore, the image assessment can be
subsequently retrieved with the object.
[0033] Because each copy 118 is associated with a different unique
identifier, even if one reviewer completes his or her review of
their copy 118 in tandem with another reviewer, each reviewer is
assessing a different copy 118. Furthermore, without having the
unique identifiers of the other copies 118, each reviewer cannot
access the assessments generated by the other reviewers of the
other copies 118. Therefore, the reviewers remain blind to the
assessments performed by other reviewers. The controller 16,
however, retains the information necessary to link the copies 118
created for a particular original image object 44. The controller
16 can use this information to reconcile the independent
assessments (e.g., compare the assessments to determine if a
tie-breaker assessment is necessary) and manage review of each copy
118. It should be understood that the controller 16 can store the
information necessary to link the copies 118 in the memory 38 or in
a separate memory accessible by the controller 16 (e.g., over a
direct connection or a network). Furthermore, in some embodiments,
a component different from the controller 16 accesses the
information linking the copies 118 and uses the information to
reconcile the independent assessments or otherwise manage review of
each copy 118.
[0034] In some embodiments, the system 10 also provides quality
control to check for and correct various errors that can occur
during a clinical trial. For example, in some cases an image object
is received that uses various names for the same pathology or
anatomy or an acquisition site sends too many series. In these
cases, a quality control technologist would edit the exam or image
object so that it complies with the clinical trial parameters.
These changes need to be included in all of the copies created for
the image object. If the quality control function takes place
before the image object 44 reaches the editor 14, the editor 14
copies the image object 44 that already includes the quality
control changes. Alternatively, if the quality control function
takes place after the editor 14 copies the object, the editor 14
(based on information supplied from the controller 16) can update
each of the previously-generated copes to include the quality
control changes.
[0035] It should be understood that the components of the system 10
can be arranged in various configurations. For example, the editor
14 and the controller 16 can be included in the same location or
alternatively, the controller 16 can be at a remote location with
respect to the editor 14. Additionally, the editor 14 and the image
storage device 18 can be included in the same location or
alternatively, the image storage device 18 can be at a remote
location with respect to the editor 14. Furthermore, as noted
above, the system 10 may include a database or server other than
the image storage device 18 to store image assessments. In
addition, one or more of the above-described components can be
hosted, such as in a "cloud" environment. For example, in some
embodiments, the controller 16 is hosted but is configured to
receive and provide information regarding acquired images and
corresponding copies as described above. However, it should be
understood that any combination of the components described herein
may be hosted.
[0036] It should also be understood that, although systems and
methods described herein are used in the context of managing
medical images associated with a clinical trial, these systems and
methods may be used for other applications. For example, the
systems and methods described herein can be used in any application
that requires independent blind or tandem review of images, such as
for teaching or student evaluation purposes or for providing second
opinions.
[0037] Thus, the invention provides, among other things, a system
and method for creating and managing data objects that are
independently retrievable for independent assessment. Various
features and advantages of the invention are set forth in the
following claims.
* * * * *