Feds Propose to Certify EHRs' Ability to Link to Images

In a proposed rule scheduled for Federal Register publication on Aug. 5, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) proposes to update regulations on certification criteria for electronic health record (EHR) systems and information blocking.

Among the various updates in the “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2)” proposed rule is a reintroduction of certification for the ability of EHR modules to support the access, exchange and use of diagnostic images via links. Related requirements were previously included in “Meaningful Use Stage 2” due to advocacy from the American College of Radiology® (ACR®) and other radiology stakeholders but were removed in 2015.

Specifically, the ONC proposes to modify three existing certification criteria to support functions for electronic image exchange (transitions of care, application access – all data request, and standardized API for patient and population services). The goal of these changes is to include imaging links in certified EHRs by Jan. 1, 2028, that enable the viewing or retrieval of images over a network. The agency will require that modules certified for this functionality enable the viewing and downloading of both diagnostic- and low-quality images. The ONC did not propose specific standards corresponding with these criteria, although noted the DICOMweb standard (e.g., DICOM PS3.18 2023d – Web Services) is likely to be among the most widely used standards for supporting these links.

Revisions to EHR certification criteria should not affect HHS’ information blocking rules, which are generally separate from the ONC’s health IT certification program though updated via the same HTI-2 rulemaking. Importantly, images and other imaging data are already part of the electronic health information (EHI) that providers, networks/exchanges and certain vendors are required to share if able in response to legally permissible requests for access, exchange or use. See ACR’s Information Blocking page for educational resources on radiologist-relevant aspects of the information blocking rules.

ONC proposes in the proposed rule a new information blocking exception for protecting care access that would exempt practices based on the actor’s good faith belief that sharing specific EHI related to lawful reproductive healthcare could result in potential legal exposure for the involved persons.

For more information about the proposed rule or digital health policy in general, contact Michael Peters, ACR Senior Government Affairs Director.