February 1, 2022
National Eye Institute (NEI)
This Request for Information (RFI) seeks public input on barriers to the implementation of standards (such as DICOM) in ocular imaging. We are particularly interested in input from the vision research, ocular healthcare, device manufacturing, patient, regulatory and policymaker communities Individuals and organizations with relevant expertise are invited to submit comments.
The National Eye Institute (NEI) has asked imaging device makers to standardize data formatting (https://www.nei.nih.gov/about/news-and-events/news/nei-joins-call-standardization-ophthalmic-imaging-devices). Standardization is expected to optimize communication between providers, improve care quality, and promote the creation of research datasets. Image standardization is also expected to improve patient access to important eye health information and to enhance patients’ ability to share their healthcare data across care providers and with researchers. This kind of patient access is already routine in other care settings.
Vision care providers use a variety of imaging and testing devices to diagnose, monitor, and treat eye disease. For example, basic photography and optical coherence tomography (OCT) devices are used to evaluate the retina and other structures inside the eye. This type of imaging is critical for detecting subtle anatomic changes that track disease progression and guide treatment. Researchers are interested in using this type of non-invasive imaging to determine if there are signs of diseases, or biomarkers, that can be used to diagnose and treat patients.
For many years, vision researchers, policymakers, and regulators have supported adoption of the Digital Imaging and Communications in Medicine (DICOM) standard. For example: FDA Recognized Consensus Standards and Interoperability Standards Advisory Medical Image Formats for Data Exchange and Distribution. DICOM includes a taxonomy of ocular data element definitions, in addition to data element definitions supporting other medical specialties (such as radiology). When deployed, DICOM has promoted the seamless sharing of medical images, specifying how to electronically store, format, and exchange images. DICOM also standardizes associated non-imaging information, such as patient demographics. Currently, it is voluntary for ocular imaging devices to meet these standards, and DICOM conformance for image storage technology is low. Even devices marketed as “DICOM compliant” may fail to fully implement important features of the DICOM standard, limiting its utility as a data exchange standard. (Customers must build costly interfaces to allow for seamless data exchange between “DICOM Compliant” devices.)
NIH would like to better understand researchers’ experiences using ocular imaging standards and in particular DICOM. Specific information about the extent to which researchers and clinicians plan or do not plan to use DICOM, what tools may be needed to effectively use imaging standards, the need for research regarding standards development, and opportunities and challenges with using these standards.
This RFI requests input regarding:
1) specific benefits of using the DICOM standard for ocular imaging, both for research and clinical care;
2) the elements of DICOM that are most important;
3) specific barriers to adoption of ocular imaging standards, and/or approaches to addressing these barriers;
4) resources, tools, or technologies that could be further developed to evaluate DICOM conformance;
5) emerging scientific developments, techniques, or other approaches to advance seamless ocular imaging exchange such as DICOMwebTM;
6) sustainability of creating, extending, and evolving imaging standards in the future;
7) current workflow in capturing and sharing images in electronic health records technology (EHRs) and the use of DICOM or other standards in EHRs;
8) use of EHRs to capture structured results and reports associated with the images; and the standards used to represent the results
Submitting a Response
All responses can be submitted via (RFI Weblink)
Please indicate by number which prompt(s) is (are) being addressed in your response. Your response is not limited to the questions listed above. Responses are due by March 12, 2022.
The NEI will use the information submitted at its discretion and will not necessarily provide comments to submissions. Responses to the RFI will be considered in future planning activities and potential funding opportunity announcements. Any information submitted in response to this RFI shall not be construed as a solicitation, grant application, cooperative agreement, or obligation on part of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), or the United States Federal Government. Please do not include any proprietary, classified, or sensitive information.
National Eye Institute (NEI), Office of Data Science and Health Informatics