HHS Issues Health IT Interoperability Rule

The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), has finalized a rule that would advance health IT interoperability and algorithm transparency.

The rule, titled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1),” looks to advance patient access and standards.

“The public feedback and participation in the HTI-1 process was tremendous,” Micky Tripathi, Ph.D., the national coordinator for health information technology, said in a press release.

“Through the HTI-1 final rule, our upcoming HTI-2 proposed rule, and our broader efforts, ONC continues its important work to build health care’s digital foundation, make interoperability easier, and ensure that digital information and tools are being appropriately used to support patient access and to improve the health and well-being of all Americans,” Tripathi added.

Specifically, the rule establishes transparency requirements for artificial intelligence and other predictive algorithms that are part of certified health IT. HHS said this approach will promote the use of responsible AI and provide clinical users will a baseline set of information on the algorithms they use.

Additionally, the rule adopts the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program (Certification Program) as of Jan. 1, 2026. According to the release, developers of certified health IT will also be able to move to USCDI v3 sooner.

The rule also enhances information blocking definitions and exceptions to support information sharing, as well as adds a new exception to encourage a secure, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common AgreementSM (TEFCASM).

Finally, the rule meets a requirement of the 21st Century Cures Act to adopt a Condition of Certification for developers of certified health IT to report metrics as part of their participation in the Certification Program. HHS said these metrics “will give more insight into how certified health IT is used in support of care delivery.”

HHS said the final rule is posted at HealthIT.gov/HTI-1. Due to the technical nature of the rule, ONC will host five separate information sessions in January and February to explain the final rule.