The Pulse
HHS Drops AI Model-Card Rules From Health IT Certification
HHS finalized changes removing federal certification requirements for disclosures about certain clinical decision-support tools, despite commenters’ concerns about transparency and provider oversight. The rule removes specific disclosure an
AI.info Team · Written with AI · fact-checked ·
HHS has finalized the removal of federal health IT certification requirements that made developers disclose information about certain clinical decision-support tools, despite commenters’ warnings that the change could leave providers with less help assessing those tools. The department says the transparency rules had not shown a positive effect on patient care and imposed costs on developers. The opposing views now sit in the final rule: ONC removes the requirements while urging health care organizations to ask vendors about the tools they buy.
The Office of the National Coordinator for Health Information Technology announced the Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity rule, known as HTI-5, on October 26. The final rule was scheduled for publication in the Federal Register on October 28, 2026. Its general effective date is 60 days after publication; three specified amendatory instructions instead take effect January 1, 2027.
Model cards and risk-management duties go
HTI-5 revises the certification criterion for decision-support interventions, § 170.315(b)(11). The revision removes requirements for developers to support disclosures about source attributes—including information about a predictive tool’s training, intended use, limitations and performance across patient groups—and to support users’ access to and modification of those attributes. It also removes the criterion’s predictive-intervention risk-management requirements and the related duty for developers to review and update that information.
Those disclosures functioned as “model cards” for predictive decision-support interventions. HHS also removes the separate clinical decision-support criterion at § 170.315(a)(9). Across the rule, ONC finalizes the removal of 14 certification criteria and revisions to seven, a narrower set of removals than the 34 the agency proposed.
ONC says it found no patient-care benefit
The department’s rationale rests on its assessment of how clinicians use the disclosures. In the final rule, ONC says it found no evidence in peer-reviewed publications or trade press that users relied on the source-attribute requirements to access, record or modify information, or that the requirements improved patient care. It says developers described the requirements as burdensome and detrimental to innovation.
“American doctors and patients need better technology, not more Washington paperwork,” said HHS Secretary Robert F. Kennedy, Jr.
The department projects that HTI-5 will save more than $1.5 billion in regulatory costs across the rule; that estimate is not limited to the AI transparency changes.
Commenters warned of a governance gap
A large majority of commenters opposed the proposed changes to decision-support transparency and risk management, according to the final rule. They warned that removing standardized disclosures could shift evaluation, governance and liability work to providers, while making it harder to examine bias, performance and whether a tool fits a particular patient population. Some also argued that the requirements had been in force for less than two years and had not been fully evaluated.
ONC rejected the view that the change would significantly hinder evaluation, pointing to remaining certification provisions and arguing that providers could seek information directly from developers. The agency encourages health care organizations to discuss a tool’s quality and performance with its developer before deployment. Requirements for feedback tools for evidence-based decision support remain in the revised criterion, according to the rule.
Vendors become a more direct source of information
The practical change is not a ban on model documentation: HHS says information about intended use, provenance, training data, limitations, performance and known risks may still be communicated to certified health IT users. But the federal certification program will no longer require the specific disclosures and risk-management steps removed by HTI-5.
That leaves health systems with a more direct task: ask developers for evidence about a tool before putting it into clinical workflows. HHS says it plans future proposals on interoperability standards, expanded API use and targeted certification conditions; comments on HTI-5’s separate information-blocking proposals remain under consideration.