HHS Finalizes HTI-5, Cutting EHR Certification Criteria and AI Transparency Rules

The US Department of Health and Human Services has finalized a rule that removes 14 of the 60 certification criteria for electronic health record software and drops transparency requirements for AI and predictive tools built into those systems, the Office of the National Coordinator for Health IT (ONC) announced on Monday, October 26.

The rule, titled "Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity" and known as HTI-5, also revises seven criteria in the ONC Health IT Certification Program. HHS projects it will save more than $1.5 billion in regulatory costs. The text was filed for public inspection at the Federal Register as document 2026-21943.

What was removed

According to ONC's list of changes, the criteria removed include clinical decision support, family health history, security tags for sending and receiving summary-of-care documents, care plan, patient health information capture, two application access criteria, and the Direct Project messaging criteria. Some removals take effect on the rule's effective date and others on January 1, 2027. The revised criteria include decision support interventions, transitions of care and safety-enhanced design.

The change to decision support interventions affects AI. Healthcare Dive reported that developers no longer must provide AI "model cards," which had required source information on training, performance and validation data for AI, machine learning and other predictive tools under the earlier HTI-1 rule. Holland & Knight wrote that the final rule removes the HTI-1 transparency, documentation and annual review requirements, that hospital and clinician commenters had objected that this shifts the burden of vetting AI onto providers, and that ONC said it may revisit AI oversight in a later rule.

Healthcare Dive also reported that developers no longer need to submit annual real-world testing plans.

What stayed

The final rule is narrower than the HTI-5 proposed rule, which would have removed 34 criteria. ONC did not finalize proposals to remove privacy and security criteria, Healthcare Dive reported, including the requirement that certified health IT include at least one capability that helps users comply with HIPAA. Holland & Knight said public health reporting requirements and the criteria adopted in HTI-4 also remain.

ONC did not finalize the information blocking proposals in the HTI-5 proposed rule, which Holland & Knight said included clarifications on automated processes and access to electronic health information by autonomous AI. ONC said comments on those proposals remain under consideration.

Officials' statements

"American doctors and patients need better technology, not more Washington paperwork," HHS Secretary Robert F. Kennedy Jr. said in the announcement. "The Trump Administration is eliminating unnecessary regulations that cost more than $1.5 billion and hold back innovation."

National Coordinator for Health IT Tom Keane, MD, said "we have taken decisive action to significantly lower the administrative compliance burden for developers," according to Healthcare Dive.

ONC said it plans future proposals on standards adoption, expanded uses of application programming interfaces in the certification program and targeted conditions of certification.