About

HTI-5 final rule strips 14 of 60 health IT certification criteria, far fewer than proposed

Published
Score
19

Why it matters

On October 26, 2026, the Office of the National Coordinator for Health Information Technology (ONC) at HHS released the HTI-5 final rule, formally titled Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity. The Federal Register published it on October 28. The rule retires 14 of the 60 certification criteria, revises seven, and leaves 39 untouched. Retired criteria include family health history and care plan. The rule also drops the requirement to submit real-world testing plans and removes AI model-card transparency and risk-management mandates from the decision support intervention criterion. National Coordinator Tom Keane framed the rule as a cut to administrative burden for vendors.

The HHS Office of Inspector General is still conducting investigations. ONC says it is issuing notices of nonconformity to certified developers, and the scope of those notices is not yet public. The College of American Pathologists and other groups opposed removing the AI transparency requirements. ONC did not address information blocking in the final rule, so existing information blocking regulations remain in force. The final rule also scaled back considerably from the December 2025 proposal, which would have removed 34 criteria. ONC declined to finalize the proposed removal of privacy and security criteria and kept the electronic prior authorization and real-time prescription benefit criteria added under HTI-4. HHS projects more than $1.5 billion in regulatory cost savings.

Vendors should map their certification obligations now. Many changes take effect 60 days after Federal Register publication, and others start January 1, 2027. Proposals ONC did not finalize, including the information blocking changes, remain under consideration and could return in later rulemaking, so attorneys should track the docket.

Sources

mail Subscribe to Health Care email updates

Primary sources. No fluff. Straight to your inbox.

Also on LawSnap