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.
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.
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.
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.
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.
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.
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.
Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings.
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.
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.
As illustrated in
As illustrated in
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.
As illustrated in
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.
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
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.
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).
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This application is a continuation application of U.S. patent application Ser. No. 16/162,663 filed Oct. 17, 2018, which 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 No. 61/546,373, filed Oct. 12, 2011. The entire content of all prior-filed applications is hereby incorporated by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 5040142 | Mori et al. | Aug 1991 | A |
| 5583758 | McIlroy et al. | Dec 1996 | A |
| 5606609 | Houser et al. | Feb 1997 | A |
| 5740428 | Mortimore et al. | Apr 1998 | A |
| 5835601 | Shimbo et al. | Nov 1998 | A |
| 5890177 | Moody et al. | Mar 1999 | A |
| 5982956 | Lahmi | Nov 1999 | A |
| 6067551 | Brown et al. | May 2000 | A |
| 6175426 | Hirooka | Jan 2001 | B1 |
| 6417870 | Brackett et al. | Jul 2002 | B1 |
| 6519632 | Brackett et al. | Feb 2003 | B1 |
| 6618060 | Brackett | Sep 2003 | B1 |
| 7089247 | Kloos et al. | Aug 2006 | B2 |
| 7102773 | Oosterhout et al. | Sep 2006 | B1 |
| 7283857 | Fallon et al. | Oct 2007 | B1 |
| 7383462 | Osaki et al. | Jun 2008 | B2 |
| 7593918 | Gentles et al. | Sep 2009 | B2 |
| 7707043 | Kuth et al. | Apr 2010 | B2 |
| 7783072 | Work et al. | Aug 2010 | B2 |
| 7854383 | Suzuki | Dec 2010 | B2 |
| 7860287 | Zahlmann et al. | Dec 2010 | B2 |
| 7885825 | Climax et al. | Feb 2011 | B2 |
| 8005921 | Ho et al. | Aug 2011 | B2 |
| 8086077 | Eichhorn | Dec 2011 | B2 |
| 8099307 | Maresh et al. | Jan 2012 | B2 |
| 8140350 | Rothpearl et al. | Mar 2012 | B2 |
| 8200505 | Walker et al. | Jun 2012 | B2 |
| 8417666 | Bailor et al. | Apr 2013 | B2 |
| 8626524 | Koehl | Jan 2014 | B1 |
| 8825594 | Skaria et al. | Sep 2014 | B2 |
| 9354769 | Kudva | May 2016 | B1 |
| 10140420 | DeVries | Nov 2018 | B2 |
| 20010051881 | Filler | Dec 2001 | A1 |
| 20020016718 | Rothschild et al. | Feb 2002 | A1 |
| 20020023172 | Gendron et al. | Feb 2002 | A1 |
| 20020191205 | Stringham | Dec 2002 | A1 |
| 20030208378 | Thangaraj et al. | Nov 2003 | A1 |
| 20040001606 | Levy | Jan 2004 | A1 |
| 20040068516 | Lee | Apr 2004 | A1 |
| 20040071038 | Sterritt | Apr 2004 | A1 |
| 20040085354 | Massand | May 2004 | A1 |
| 20040143171 | Kalies | Jul 2004 | A1 |
| 20040143594 | Kalies | Jul 2004 | A1 |
| 20040176986 | Kuth et al. | Sep 2004 | A1 |
| 20050044492 | Ramaley et al. | Feb 2005 | A1 |
| 20050165623 | Landi et al. | Jul 2005 | A1 |
| 20050185204 | Shelton et al. | Aug 2005 | A1 |
| 20050256392 | Matory et al. | Nov 2005 | A1 |
| 20060026034 | Yankelevitz et al. | Feb 2006 | A1 |
| 20060064328 | Datta et al. | Mar 2006 | A1 |
| 20060159325 | Zeineh et al. | Jul 2006 | A1 |
| 20060168338 | Bruegl et al. | Jul 2006 | A1 |
| 20060177114 | Tongdee et al. | Aug 2006 | A1 |
| 20060195339 | Backhaus et al. | Aug 2006 | A1 |
| 20060242144 | Esham et al. | Oct 2006 | A1 |
| 20060253487 | O'Blenis | Nov 2006 | A1 |
| 20060259783 | Work et al. | Nov 2006 | A1 |
| 20060282447 | Hollebeek | Dec 2006 | A1 |
| 20070035759 | Fujimori | Feb 2007 | A1 |
| 20070046649 | Reiner | Mar 2007 | A1 |
| 20070100226 | Yankelevitz et al. | May 2007 | A1 |
| 20070191721 | Parker | Aug 2007 | A1 |
| 20070216913 | Toda | Sep 2007 | A1 |
| 20070239782 | Schneider | Oct 2007 | A1 |
| 20070271316 | Hollebeek | Nov 2007 | A1 |
| 20070283420 | Rantalahti | Dec 2007 | A1 |
| 20070291978 | Kim et al. | Dec 2007 | A1 |
| 20070292012 | Brandon et al. | Dec 2007 | A1 |
| 20080031459 | Voltz | Feb 2008 | A1 |
| 20080052112 | Zahlmann et al. | Feb 2008 | A1 |
| 20080059241 | Zahlmann et al. | Mar 2008 | A1 |
| 20080071575 | Climax et al. | Mar 2008 | A1 |
| 20080117451 | Wang | May 2008 | A1 |
| 20080175484 | Hartmann et al. | Jul 2008 | A1 |
| 20080175515 | Hartmann et al. | Jul 2008 | A1 |
| 20080198423 | Ando et al. | Aug 2008 | A1 |
| 20080201709 | Hodges | Aug 2008 | A1 |
| 20090019360 | Lynggaard et al. | Jan 2009 | A1 |
| 20090106331 | Fridman et al. | Apr 2009 | A1 |
| 20090132285 | Jakobovits | May 2009 | A1 |
| 20090138318 | Hawkins et al. | May 2009 | A1 |
| 20090226056 | Vlachos et al. | Sep 2009 | A1 |
| 20090282006 | Misvaer | Nov 2009 | A1 |
| 20090287504 | Benjamin | Nov 2009 | A1 |
| 20100021027 | Hartkens et al. | Jan 2010 | A1 |
| 20100034376 | Okuizumi et al. | Feb 2010 | A1 |
| 20100131873 | Mejia et al. | May 2010 | A1 |
| 20100228699 | Webber et al. | Sep 2010 | A1 |
| 20100250285 | Shelton | Sep 2010 | A1 |
| 20110022414 | Ge | Jan 2011 | A1 |
| 20110059432 | Ballhause et al. | Mar 2011 | A1 |
| 20110093481 | Hussam | Apr 2011 | A1 |
| 20110110568 | Vesper et al. | May 2011 | A1 |
| 20110153351 | Vesper et al. | Jun 2011 | A1 |
| 20110153361 | Hanina | Jun 2011 | A1 |
| 20120105632 | Renkis | May 2012 | A1 |
| 20120143617 | Connors | Jun 2012 | A1 |
| 20120224742 | Musser, Jr. | Sep 2012 | A1 |
| 20120259710 | Peterson | Oct 2012 | A1 |
| 20120302212 | Ross et al. | Nov 2012 | A1 |
| 20130094728 | DeVries | Apr 2013 | A1 |
| 20130103425 | Julsrud | Apr 2013 | A1 |
| 20130185098 | Mitchel et al. | Jul 2013 | A1 |
| 20130346104 | Pillai | Dec 2013 | A1 |
| 20140112447 | Semba | Apr 2014 | A1 |
| 20140142983 | Backhaus et al. | May 2014 | A1 |
| 20140222444 | Cerello et al. | Aug 2014 | A1 |
| 20140297309 | Kim et al. | Oct 2014 | A1 |
| 20140350962 | Robinson | Nov 2014 | A1 |
| 20140379639 | Gasser et al. | Dec 2014 | A1 |
| 20160092943 | Vigier | Mar 2016 | A1 |
| Number | Date | Country |
|---|---|---|
| 9625719 | Aug 1996 | WO |
| Entry |
|---|
| Erickson BJ, Buckner JC. Imaging in clinical trials. Cancer Inform. 2007;4: 13-8. Epub May 12, 2007. PMID: 19390660; PMCID: PMC2666946. (Year: 2007). |
| Brown MS, Pais R, Qing P, Shah S, McNitt-Gray MF, Goldin JG, Petkovska I, Tran L, Aberle DR. An architecture for computer-aided detection and radiologic measurement of lung nodules in clinical trials. Cancer Inform. 2007;4:25-31. Epub May 12, 2007. PMID: 19390662; PMCID: PMC2666948. (Year: 2007). |
| R. Martinez, Y. Alsafadi and J. Kim, “Design of multimedia global PACS distributed computing environment,” Proceedings of the Twenty-Eighth Annual Hawaii International Conference on System Sciences, Wailea, HI, USA, 1995, pp. 461-469 vol.3, doi: 10.1109/HICSS.1995.375629 (Year: 1995). |
| Oct. 17, 2018, U.S. Appl. No. 16/162,663, 2019-0051402. |
| Oct. 12, 2012, U.S. Appl. No. 13/650,370, U.S. Pat. No. 10,140,420. |
| A. L. Belton et al., “Tumour Size Measurement in an Oncology Clinical Trial: Comparison Between Off-site and On-site Measurements”, 2003, Clinical Radiology 58, p. 311-314. |
| Author Unknown, DICOM PS3.3 2021b—Information Object Definitions, http://dicom.nema.org/medical/dicom/current/output/chtml/part03/sect_C.17.2.2.html (Year: 2001). |
| https://www.inspire.com/groups/talk-psoriasis/discussion/protocol-when-two-specialists-disagree/?ga=freshen, Protocol when two Specialists disagree, author unknown, Sep. 11, 2013, p. 1-18. |
| Kevin O'Donnell, Imaging Object Change Management—Detailed Proposal, https://wiki.ihe.net/index.php/Imaging_Object_Change_Management_-_Detailed_Proposal (Year: 2009). |
| Kinson Ho, Basic Imaging Object Change Management—Detailed Proposal, https://wiki.ihe.net/index.php/Basic_Imaging_ Object_Change_Management_Detailed_Proposal (Year: 2010). |
| Oleg, “Digital Imaging and Communications in Medicine (DICOM) A practical Introduction and Survival Guide,” Springer-Verlag Berlin Heidelberg, p. 1-424 (Year 2012). |
| Wang, Fusheng et al., “Towards Building High Performance Medical Image Management System for Clinical Trials”, May 20, 2011, Proc SPIE 2011, p. 1-14. |
| Restriction Requirement from the U.S. Patent and Trademark Office for U.S. Appl. No. 13/650,370 dated Feb. 18, 2015 (6 pages). |
| Non-Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 13/650,370 dated Jun. 3, 2015 (19 pages). |
| Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 13/650,370 dated Jan. 14, 2016 (26 pages). |
| Applicant-Initiated Interview Summary from the U.S. Patent and Trademark Office for U.S. Appl. No. 13/650,370 dated Apr. 18, 2016 (3 pages). |
| Non-Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 13/650,370 dated Aug. 10, 2016 (27 pages). |
| Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 13/650,370 dated Feb. 23, 2017 (34 pages). |
| Non-Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 13/650,370 dated Jan. 11, 2018 (33 pages). |
| Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Appl. No. 13/650,370 dated Jul. 19, 2018 (9 pages). |
| Non-Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 16/162,663 dated May 20, 2020 (12 pages). |
| Applicant-Initiated Interview Summary from the U.S. Patent and Trademark Office for U.S. Appl. No. 16/162,663 dated Aug. 10, 2020 (3 pages). |
| Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 16/162,663 dated Oct. 21, 2020 (14 pages). |
| Non-Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 16/162,663 dated May 24, 2021 (16 pages). |
| Final Office Action from the U.S. Patent and Trademark Office for U.S. Appl. No. 16/162,663 dated Oct. 28, 2021 (23 pages). |
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