Proposed rule adds imaging requirements for EHR certification

A proposed rule set to be published August 5 promotes more consistent access to medical images for providers and patients, according to a preview on the U.S. Federal Register.

The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) document seeks to update regulations on certification criteria for electronic health record (EHR) systems and information blocking.

Specifically, the ONC proposes to modify three existing certification criteria to support functions for electronic image exchange. They are transitions of care, application access -- all data request, and standardized API for patient and population services. This is a reintroduction of certification, the American College of Radiology (ACR) said in an update. Related requirements were previously included in Meaningful Use Stage II due to advocacy from the ACR and other radiology stakeholders but were removed in 2015.

The goal of the changes is to include imaging links in certified EHRs by January 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 ACR noted.

Images and other imaging data are already part of the electronic health information that providers, networks/exchanges, and certain vendors are required to share if able in response to legally permissible requests for access, exchange, or use. 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, according to the ACR.

Among the drivers of this proposed rule appears to be the widespread use of CD-ROMs and other physical media. Sharing diagnostic images through physical media persists, despite the adoption of PACS and vendor-neutral archive (VNA) systems, the implementation of web-based viewers for diagnostic imaging, and the emergence of electronic standards and profiles meant to facilitate medical image access and exchange, according to information in the proposed rule.

"While certain standards and others currently exist, there is not yet a clear consensus or full adoption of these pathways in health IT," the proposed rule stated. "ONC believes that promoting access to and the exchange of images via program requirements may encourage more widespread adoption and integration of these already existing pathways and reduce burdens caused by physical media exchange."

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