HHS proposes rule aimed at improving patients’ electronic access to medical images

The Department of Health and Human Services has proposed a rule aimed at improving patients’ access to medical images and curbing the use of physical media in radiology.

X-rays, CT scans and MRIs are often stored in platforms external to electronic health records, such as picture archiving and communication systems. But this has made the electronic exchange of images more difficult, forcing patients to obtain their results via flash drives or CDs.

HHS, however, is proposing to update regulations related to certification of EHR systems and info blocking, the American College of Radiology reported Thursday. Its goal is to start having certified EHRs include links to medical images beginning Jan. 1, 2028.

“We believe the prevalence of CD-ROMs and other physical media to share diagnostic quality images across healthcare settings indicates a lack of interoperability and access to imaging results that represents a continued burden for patients and clinicians,” the HHS Office of the National Coordinator for Health IT said in the rule, which is slated to be published in the Federal Register Aug. 5. “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,” the agency added later.

HHS first introduced the “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2)” rule on July 10. Requirements related to EHR links to access medical images were previously included in “Meaningful Use Stage 2,” following advocacy from the ACR and other radiology stakeholders, the college reported. However, the feds removed them in 2015.

Under the HTI-2 rule, the administration is proposing to modify three existing certification criteria to support functions for electronic image exchange. These would include transitions of care, application access (all data request), and standardized application programming interfaces for patient and population services. ACR noted that the feds will require that modules certified for this functionality enable the viewing and downloading of small and large file sizes.  

“We believe it is important to support the ability to view and download both diagnostic and lower quality images,” the ONC noted. “While it is critical for patients to have access to diagnostic imaging, lower quality images are also important and, for example, a patient may decide that it is useful to have the lower quality images for quick reference. This revised certification criterion requires that both types of imaging be supported for viewing and for direct downloading by patients.”

Revisions to EHR certification criteria should not impact HHS’ information blocking rules, the college noted. These are generally separate from ONC’s health IT certification program, though they are updated through the same HTI-2 rulemaking. HHS also previously released an HTI-1 rule in January, with this latest version building upon the previous proposal.

HHS said this latest iteration reflects focused efforts to “advance interoperability and improve information sharing among patients, providers, payers, and public health authorities.”

“The HTI-2 proposed rule is a tour de force. We have harnessed all the tools at ONC’s disposal to advance HHS-wide interoperability priorities,” Micky Tripathi, PhD, national coordinator for health IT, said in a statement. “As always, we look forward to reviewing public comments and engaging with the health IT community in the weeks and months ahead.”

Radiology stakeholders have 60 days to submit comments once the rule is published on Monday.