The Department of Health and Human Services finalized a rule Oct. 26 eliminating 14 federal health IT certification criteria and scaling back AI transparency requirements, with the agency projecting more than $1.5 billion in regulatory cost savings.
The final rule, known as Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity, or HTI-5, reduces compliance requirements for developers participating in the Office of the National Coordinator for Health Information Technology’s certification program.
HHS initially proposed eliminating 34 of the program’s 60 certification criteria in December 2025. The final rule takes a narrower approach, removing 14 criteria and revising seven while leaving 39 unchanged.
Among the changes is the elimination of AI model-card requirements within the decision support interventions certification criterion. Those requirements, established under the HTI-1 rule, were intended to give healthcare organizations information about predictive algorithms and other decision-support tools incorporated into certified health IT.
The rule also removes or revises requirements involving care coordination, patient engagement and certain health data exchange capabilities, and formally removes a clinical decision support criterion that expired Jan. 1, 2025.
HHS estimates the changes will generate $1.55 billion in present-value regulatory cost savings, or $108.1 million in annualized net savings beginning in 2027.
“American doctors and patients need better technology, not more Washington paperwork,” HHS Secretary Robert F. Kennedy Jr. said in an Oct. 26 HHS news release. “The Trump Administration is eliminating unnecessary regulations that cost more than $1.5 billion and hold back innovation.”
The agency said reducing administrative requirements will allow health IT developers to redirect resources toward improving technology used by patients and clinicians.
The changes also reflect ONC’s broader effort to shift the certification program toward Fast Healthcare Interoperability Resources-based application programming interfaces, which support the electronic exchange of health information.
ONC said it plans to pursue additional proposals involving interoperability standards, expanded API capabilities and targeted conditions of certification.
“Through HTI-5, we have taken decisive action to significantly lower the administrative compliance burden for developers so that they can spend more of their time developing solutions that improve interoperability, automation, and better healthcare for Americans,” National Coordinator for Health IT Tom Keane, MD, said in the news release.
The final rule does not resolve proposed changes to federal information blocking regulations, which are intended to address practices that interfere with access to electronic health information. HHS said comments on those proposals remain under consideration.
The rule is scheduled for publication in the Federal Register on Oct. 28. Most provisions take effect 60 days after publication, while certain changes take effect Jan. 1, 2027. The removal of certain document-based exchange and Direct messaging requirements from the transitions of care criterion takes effect Jan. 1, 2030.
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