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Accelerating Care: A Roadmap to Interoperable Ophthalmic Imaging Standards in the United States

2023; Elsevier BV; Volume: 131; Issue: 1 Linguagem: Inglês

10.1016/j.ophtha.2023.10.001

1549-4713

Kerry Goetz, Amberlynn A. Reed, Michael F. Chiang, Thomas E. Keane, Micky Tripathi, Elvin Ng, Tieuvi Nguyen, Malvina Eydelman,

Glaucoma and retinal disorders

The vision field plays a leading role in data science and artificial intelligence diagnostics using ocular imaging, creating novel opportunities to improve the quality, accessibility, and equitability of medical care.1Ipp E. Liljenquist D. Bode B. et al.Pivotal evaluation of an artificial intelligence system for autonomous detection of referable and vision-threatening diabetic retinopathy.JAMA Netw Open. 2021; 4e2134254Crossref PubMed Scopus (66) Google Scholar Today's research and clinical communities have access to a wide spectrum of biologic, imaging, clinical, and public health data, creating the potential for unprecedented breakthroughs leveraging computational advancements. This opportunity requires data standardization (i.e., converting data into a standard format that computers can use and share) and interoperability (i.e., the ability to integrate 2 or more datasets), including access to raw data (voxel, pixel, and other metadata) captured by devices. Data standardization is essential because it allows different systems to use and share data efficiently. Ocular imaging has advanced from photographic documentation to investigation of ocular structures, including objective measurements and assessments that can be used to track progression or clinical subtypes at a level of detail unavailable through clinical evaluation alone.2Ilginis T. Clarke J. Patel P.J. Ophthalmic imaging.Br Med Bull. 2014; 111: 77-88Crossref PubMed Scopus (29) Google Scholar Despite advances in imaging technology, clinicians and researchers continue to struggle with efficiently sharing images with others, including their patients. Digital Imaging and Communications in Medicine (DICOM) is the international standard that defines the formats and accompanying data (e.g., patient, image, and device information) for all medical imaging exchanged in a variety of settings. Therefore, DICOM, which includes a wide variety of data elements to capture data such as patient demographics, device details, and discrete measurements of imaging findings, is the gold standard for ocular imaging devices. Widespread adoption of standards will greatly enhance the field by enabling digital workflow, allowing the sharing of large datasets, and creating large training sets for machine learning. However, the adoption of standards in medical imaging is currently optional, and broad DICOM compliance is low for ophthalmic imaging.3Lee A.Y. Campbell J.P. Hwang T.S. et al.Recommendations for standardization of images in ophthalmology.Ophthalmology. 2021; 128: 969-970Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar Many devices marketed as being DICOM compliant fail to meet the full functionality measures of conformance, and different medical devices support the standard to different extents. For example, an ocular imaging device from one vendor may support a certain subset of DICOM's features, whereas an image file storage system (such as a Picture Archiving and Communications System [PACS]) may support another subset. In this scenario, both are technically DICOM compliant, but unless they support complementary features, they will not work together seamlessly to share files and data. Despite decades of effort to support the development and improvement of ocular imaging standards, including publications and policy statements, little progress has been made toward complete adoption in which full implementation of DICOM standards is used natively to store and exchange data on imaging devices, electronic health record (EHR) systems, and image management systems (e.g., PACS).3Lee A.Y. Campbell J.P. Hwang T.S. et al.Recommendations for standardization of images in ophthalmology.Ophthalmology. 2021; 128: 969-970Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar, 4Ma J. Fekrat S. Grewal D. Standardization in ophthalmic imaging. Explore DICOM, devices, and beyond.Retin Physician. January 2022; (Available at:)https://www.retinalphysician.com/issues/2022/jan-feb-2022/standardization-in-ophthalmic-imaging#reference-3Date accessed: September 4, 2023Google Scholar, 5Mills R.P. DICOM? What's that? Why you should care.Eyenet Mag. April 2013; (Available at:)https://www.aao.org/eyenet/article/opinion-20Date accessed: September 4, 2023Google Scholar As part of the United States National Institutes of Health, the National Eye Institute (NEI) issued a Request for Information in 2022 seeking input from the community to help assess opportunities in the adoption of imaging standards.6Goetz K, Reed A, Haqqani S. NEI ocular imaging standards RFI: executive summary. May 6, 2022. Available at: https://zenodo.org/records/6525735. Accessed September 4, 2023.Google Scholar Based on public input, the NEI, the United States Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) jointly supported a workshop in May 2022 to hear from key opinion leaders on the adoption of imaging standards. Participants were tasked with identifying barriers and detailing approaches to encourage widespread adoption of standards for reaching an ideal state of interoperability, as depicted in Figure 1.7J. Weixelbaum, S. Haqqani, A. Reed and K. Goetz, NEI-FDA-ONC Joint Workshop on Promoting Adoption of Ocular Imaging Standards summary, Published August 25, 2022. Available at: https://zenodo.org/records/7023439. Accessed September 4, 2023.Google Scholar,8Lee A.Y. Sadda S. Lum F. Joint American Academy of Ophthalmology and Association for Research in Vision and Ophthalmology policy statement: the time for digital imaging standards implementation is now.Ophthalmology. 2022; 129: 1229-1231Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar Herein, we describe actions that have taken place or have been planned since the workshop. The NEI plans to use policies to encourage strongly increased use of standardized ocular imaging in supported biomedical research, such as adding language to future funding announcements recognizing the advantage of file format standardization and the role of DICOM compliance as the preferred standard. Studies containing ocular imaging (clinical and nonclinical) will be strongly encouraged to include details about standards and conformance statements of the device they intend to use. Investigators will be required to describe the storage and sharing of imaging according to the National Institutes of Health Data Management and Sharing Policy. Additionally, the NEI plans to include an open-access GitHub repository to share coding scripts built on standards. The shared scripts will motivate research groups to use images in nonproprietary formats so they can use shared tools, improve reproducibility, and become a contributor to the research community. The FDA recognizes that significant barriers exist to the adoption of the DICOM standard and supports efforts to expand the use of consensus standards supporting interoperability. As a result, in April 2022, the FDA formally recognized the DICOM standard for ocular imaging devices. This means that as part of the FDA premarket submission process, manufacturers can now declare conformance with part or all of the DICOM standard to meet certain premarket requirements. This can potentially reduce the amount of supporting data and information submitted to the FDA. As medical devices become increasingly connected to each other and to other technologies, the ability of connected systems to use and exchange information safely, securely, and effectively becomes critical. Interoperability is essential for many ocular imaging devices the FDA regulates, including PACS, Medical Image Management and Processing Systems, artificial intelligence diagnostic software, and imaging devices.9United States National Archives, Electronic Code of Federal Regulations Title 21 Section 892.2050. Medical image management and processing system. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-892/subpart-B/section-892.2050. Accessed September 4, 2023.Google Scholar As part of the 21st Century Cures Act, Medical Image Management and Processing Systems device classification regulation recently superseded the former PACS classification regulation to better align with device software functions that fit within the FDA's definition of a medical device.10United States Federal Register, Federal Register notice (86 FR 20284): medical device classification regulations to conform to medical software provisions in the 21st Century Cures Act, Published April 19, 2021. Available at: https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions. Accessed September 4, 2023.Google Scholar The FDA sees standards conformance as an efficient means to advancing technology within the field of ophthalmic imaging to the benefit of patients and manufacturers. The ONC aims to make systemic improvements in health care by supporting the access, exchange, and use of electronic health information. One of the ONC's current initiatives is centered on limiting information blocking through the promotion of secure sharing of health information by providers and EHR vendors when such sharing is desired by the patient. This data sharing requires interoperable health information technology systems, meaning health information technology systems that store data according to an accepted standard and exchange data using standardized protocols.Widespread adoption of standards will greatly enhance the field by enabling digital workflow, allowing the sharing of large datasets, and creating large training sets for machine learning. Widespread adoption of standards will greatly enhance the field by enabling digital workflow, allowing the sharing of large datasets, and creating large training sets for machine learning. Although medical device approval is overseen by the FDA, the development and promulgation of the DICOM standard implemented for medical devices falls within the ONC's authority. The ONC administers 4 programs to facilitate this needed interoperability, each of which will be leveraged to drive the interoperability of ophthalmic imaging devices. First, ONC administers the Interoperability Standards Advisory, a catalog of recognized health interoperability standards and implementation specifications that will be updated to include DICOM standards. Second, the ONC defines and publishes the United States Core Data Set for Interoperability, a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange that includes diagnostic imaging as a data class. Third, in 2022, the ONC released the Trust Exchange Framework and Common Agreement, a specification of principles, terms, and conditions to support the development of a common agreement enabling the nationwide exchange of health information across disparate health information networks. As part of its certification program, the ONC could consider adopting criteria requiring EHRs to provide access to medical images. Such criteria could drive conformance of ocular imaging data files to the current DICOM standard or could result in the production of interfaces allowing for access to ocular imaging data files. The ONC, through its coordination authority, can convene vendors and facilitate their entry into an agreement to exchange ocular imaging data. Finally, the ONC specifies the exchange standard support that health information technology systems must apply to be certified by the federal government. Although the Cures Act legislation requires providers to share imaging data with patients and those directed by patients, it does not specify the format in which this information much be shared, which is why physical image sharing predominates. The ONC is committed to using its regulatory, policy-making, and convening and coordination authorities to drive interoperability of imaging devices and the data they produce, allowing for instantaneous, low-cost, high-quality access. Building on the momentum in the community and the mission critical need for integrated health data exchange, the United States Department of Veterans Affairs and the Department of Defense will begin requiring full DICOM standardization for the PACS, imaging devices, and EHRs they use. This means that the country's two largest integrated health care systems will see improved sharing, efficiency, and safety. Several clinical trial sponsors have suggested they will follow similar actions. Additionally, although the authors of this editorial do not have authority over payments to providers, engaging the Centers for Medicare and Medicaid Services could be a potential future lever given the opportunity for improved quality of care. The NEI, FDA, and ONC acknowledge that moving toward full interoperability will take time and that costs, if any, are likely to be spaced out over time. Additionally, many devices currently on the market already use standards, but not necessarily in compliance with the recommendations listed in a joint policy statement by the American Academy of Ophthalmology and the Association for Research and Vision in Ophthalmology.8Lee A.Y. Sadda S. Lum F. Joint American Academy of Ophthalmology and Association for Research in Vision and Ophthalmology policy statement: the time for digital imaging standards implementation is now.Ophthalmology. 2022; 129: 1229-1231Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar We believe significant value is added when manufacturers build full DICOM conformance into their base products and do not pass the costs of functionality that already exists on to their customers. Finally, we encourage the community to ask the device manufacturers about DICOM conformance in an effort to future-proof their practices, provide improved care, and ensure the intergration of new technologies on the horizon. Overall, the needs and interests of clinicians and patients will be enhanced greatly by adopting and adhering to ocular imaging standards. United States federal agencies are committed partners in the promotion of interoperability for digital imaging in the eye. It will improve patient access to their records, spur research, and advance new products to market. Although we do not have all of the answers at this time, the NEI, FDA, and ONC are beginning to take intentional steps to address the long overdue adoption of DICOM for the capture, storage, and exchange of ocular images.