The HHS office responsible for certifying health IT (ASTP/ONC) published its final rule “ONC Deregulatory Actions To Unleash Prosperity” in today’s Federal Register (91 FR 67916, FR Doc. 2026-21943). It takes effect on 28 December 2026.

What changes

  • Of 60 certification criteria in force, ONC had proposed removing 34 and revising seven. The final rule removes 14 and revises seven; 39 are unchanged.
  • The most significant revision narrows the “decision support interventions” (DSI) criterion, 45 CFR 170.315(b)(11). It removes the source-attribute requirements, which the rule itself describes as “model cards” working like “nutrition labels” for predictive tools: how the algorithm was trained, its intended use and limits, and how it performs across patient groups. It also removes the intervention risk management requirements for predictive DSIs.
  • Kept: the requirement that certified systems let users select evidence-based and predictive DSIs, and feedback tools that let providers export and report on how evidence-based DSIs perform.

HHS’s reasons, and the objections

ONC says developers reported that “most clinical users lack the time or technical background” to use the source-attribute information, and that it found no peer-reviewed or trade-press evidence that the requirements were used or improved patient care. It calls the requirements “burdensome and detrimental to innovation.” It encourages users to ask developers for the information and reminds them of the existing anti-discrimination duty in 45 CFR 92.210.

The rule records that “a large majority of commenters were not supportive.” Their concerns, as ONC summarises them: liability and evaluation would shift to providers and hospitals; it is too early to judge rules in effect for under two years; there would be a “regulatory gap” as adoption speeds up; and drift monitoring and auditability would weaken. Some warned of a patchwork of state rules.

“A large majority of commenters were not supportive of our proposal, primarily due to concerns about removing DSI transparency and risk-management requirements.” — ONC final rule, 91 FR 67941
Citizen impact: Predictive decision-support tools in certified record systems are used to estimate patient risk. After 28 December, federal certification will no longer require vendors to show clinicians training-data, performance and limitation details for those tools, so hospitals will have to ask for them. Vendors save compliance costs. Patients will not see a direct change, but less of the paperwork on how such tools perform will be public by default.

A note on wording

The rule refers to artificial intelligence as “SI” and “super intelligence,” the term the administration now uses in its documents. We use “AI” for clarity.

Bottom line

Federal health-IT certification will stop requiring AI model cards and risk-management checks for predictive tools from 28 December. HHS says nobody used them; most commenters disagreed.