The federal model-card requirement for clinical AI is proposed for removal

What changed

On December 29, 2025, ASTP/ONC published the proposed rule "Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity", known as HTI-5, at 90 FR 60970. RIN 0955-AA09, amending 45 CFR Parts 170 and 171. Comments closed on February 27, 2026.

Of the 60 certification criteria currently in effect, the rule proposes to remove 34 and revise seven. In its own words, "one of the proposed revisions would reduce the scope of the 'decision support interventions' certification criterion to fully remove the artificial intelligence (AI) 'model card' requirements."

Specifically, it proposes to remove 45 CFR 170.315(b)(11)(iv) and (v), on source attribute support, access and modification, and (vi), on intervention risk management for predictive decision support interventions. It also proposes to remove 45 CFR 170.402(b)(4), the maintenance-of-certification duty to review and update source attribute information and intervention risk management practices.

The Unified Agenda edition published in 2026 projected a final rule for August 2026. At the time of writing, none has been published against that RIN.

What it actually requires

Nothing has changed yet. Section 170.315(b)(11) stands as adopted in the HTI-1 Final Rule. A developer of certified health IT supplying a predictive decision support intervention still has to supply its source attributes and still has to maintain intervention risk management practices.

If the rule is finalized as proposed, what ends is the certification requirement. Not the capability, and not the artifact: the obligation to have one in order to certify.

The stated rationale is worth reading whole, because it is an evidence claim rather than a policy preference. ASTP/ONC writes that despite source attribute information having been available since the beginning of 2025, "we have no publicly available evidence indicating that a single doctor, nurse, or administrator has accessed, recorded, or modified a single source attribute", and "no publicly available evidence that transparency requirements in Sec. 170.315(b)(11) have led to positive impacts on patient care, such as removing deficient or untested algorithms, or testing a deployed algorithm on local data." It concludes that the assumption behind the HTI-1 Final Rule "was incorrect". The rule also cites Executive Order 14179 as a basis for the removal.

What it means for an engineering team

Do not delete the pipeline. If source attributes are produced as a build artifact, keep producing them. The cost of a model card is in building the generator, and that cost is already sunk.

The removal changes who asks, not whether. Certification was one demand path. Procurement is another, and the health systems that learned to ask for a model card during HTI-1 will keep asking. The EU AI Act's information duties are a third.

Notice the asymmetry, and pay for it once. The EU is bringing transparency obligations into force on roughly the same timeline on which the US proposes removing them. A vendor selling into both markets does the work either way. The only real question is whether it happens once, as a design decision, or twice, as two compliance projects.

If certification was your transparency requirement, you have just learned it was never load-bearing. A control that exists because a certification body asks for it disappears when the body stops asking. A control that exists because you cannot debug a model without it does not.

What is still unsettled

Whether the decision support change is finalized as proposed. The comment period closed in February 2026, the agenda projected a final rule for August 2026, and none has issued.

Whether anything replaces it. The rationale is that no evidence of benefit exists. That is a claim answerable with evidence, and nobody was ever asked to collect any. A requirement removed for want of measurement leaves the measurement question exactly where it was.

What the removal does to the model card as a de facto standard. Source attributes were converging on a shared shape because a rule described one. Without that rule, every buyer defines their own shape, and every vendor answers each buyer separately.

Sources

• ASTP/ONC. Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity. Proposed rule (HTI-5), 90 FR 60970, December 29, 2025. RIN 0955-AA09. Comments closed February 27, 2026.
• Office of Information and Regulatory Affairs. Unified Agenda entry, RIN 0955-AA09. Fall 2025 edition. Retrieved September 11, 2026.
• ONC. Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing. Final rule (HTI-1), 89 FR 1192, January 9, 2024.
• Executive Office of the President. Executive Order 14179, Removing Barriers to American Leadership in Artificial Intelligence. 90 FR 8741, January 31, 2025.