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HHS just removed the AI "model card" rule from certified EHRs. Here is what goes, and what still applies

Since January 2025, an EHR certified by HHS had to tell its users how a predictive AI tool was built, tested and kept current: 31 facts per tool. On 28 December 2026 that requirement ends, over the objections of most commenters.

3 min read11 sourcesYoonbo Cho

Not legal advice. This read summarizes primary legal texts for engineers. Check the source, and talk to a lawyer before acting on it.

44source attributes removed13 evidence-based + 31 predictive
251certified products affectedfrom 206 developers
298unique commentsmost on this part opposed the cut
$7.4–53.3Mestimated savings per yearONC's range, undiscounted

What the rule required

HHS certifies the software hospitals and clinics use to keep health records. In January 2024, its health IT office (ONC) added a criterion for "decision support interventions", the alerts and predictions an EHR shows clinicians, including those built on machine learning 4. From 1 January 2025, a certified EHR had to give its users a set of plain-language facts about each tool: 13 for evidence-based tools and 31 for predictive ones 2. Commentators called these model cards. The developer also had to analyze each predictive tool's risks (validity, fairness, safety, privacy and more), reduce them, and govern the data it used.

What a certified EHR had to disclose about each predictive AI tool

The 31 source attributes in 45 CFR 170.315(b)(11)(iv)(B), by group; all removed on 28 Dec 2026

Quantitative performance5
Details and output4
Purpose4
Development details and input features4
External validation4
Ongoing maintenance4
Cautioned out-of-scope use2
Fairness process2
Update and revalidation schedule2

Source: eCFR, 45 CFR 170.315(b)(11), issue of 29 Oct 2026, counted line by line 2

Show the data
labelvaluedisplay
Quantitative performance55
Details and output44
Purpose44
Development details and input features44
External validation44
Ongoing maintenance44
Cautioned out-of-scope use22
Fairness process22
Update and revalidation schedule22

Download the data (CSV)

What changes on 28 December 2026

The HTI-5 final rule, published 28 October, removes three parts of the criterion 1:

  • The source attributes: all 13 evidence-based and all 31 predictive.
  • Users' ability to see, record and change them.
  • Intervention risk management: the risk analysis, mitigation and governance duty, with the yearly upkeep duty and the certification body's job of linking each developer's risk summary.

It also narrows the data a predictive tool must be able to use. Several parts stay. Users must still be able to select which decision-support tools are active, evidence-based tools still export feedback, and the criterion stays in the definition of a certified "Base EHR". ONC says it may consider restoring transparency for evidence-based tools in a later rule 1.

The rule also renames the technology. It calls the removed provisions the "super intelligence 'model card' requirements" and uses "SI" throughout, following an executive order that tells agencies to say "Super Intelligence" instead of "Artificial Intelligence" 1. The legal definition of AI is unchanged.

ONC's reasons, and the objections

ONC's case is about use and burden. Developers reported that clinicians rarely open the attributes and lack the time to use them. ONC said it found no evidence that the attributes improved care or helped organizations evaluate AI, and that other parts of HHS, such as FDA, are better placed to oversee it. In its words, it was "not persuaded of their value" 1.

The comments ran the other way. ONC itself reports that most commenters on this proposal opposed it, and more than half of those raising transparency concerns wanted the attributes or the whole criterion kept 1. The AMA proposed a risk-tiered alternative instead of removal 5, and said after the final rule that it will keep working to preserve AI transparency 10. The AHA called the criterion one of the few standards that give hospitals AI information for buying decisions 6. Nursing-home groups asked to strengthen the cards, including validation on older and multimorbid patients 7. Even the vendors' association reported that its members were split, and that many would keep providing the information because customers ask for it 9.

From model cards to no model cards in three years

Each date is from the Federal Register or the agency's own page

ONC rulesExecutive ordersOther HHS and FDA
  1. 18 Apr 2023HTI-1 proposedFirst proposes source attributes and risk management for decision support (88 FR 23746)
  2. 9 Jan 2024HTI-1 final ruleCreates the decision support criterion 170.315(b)(11): 13 + 31 source attributes and risk management (89 FR 1192)
  3. 6 May 2024Section 1557 ruleAdds 45 CFR 92.210 on patient care decision support tools (89 FR 37522)
  4. 1 Jan 2025Model cards required(b)(11) replaces the old CDS criterion in the Base EHR definition; upkeep duty begins
  5. 23 Jan 2025Executive Order 14179Later cited by ONC as a reason to drop the model cards
  6. 1 May 202592.210 duties applyIdentify and mitigate discrimination risk in decision support tools
  7. 29 Dec 2025HTI-5 proposedRemove 34 of 60 certification criteria, revise 7, including the model cards (90 FR 60970)
  8. 6 Jan 2026FDA CDS guidanceFinal guidance adds enforcement discretion for single-recommendation tools (re-issued 29 Jan)
  9. 27 Feb 2026Comments close298 unique submissions; most comments on this part opposed the cut
  10. 29 Sep 2026Executive Order 14434Agencies to say \Super Intelligence (SI)\"; HTI-5 uses the new term"
  11. 28 Oct 2026HTI-5 final rule14 criteria removed, 7 revised, 39 kept (91 FR 67916)
  12. 2026-11-02Today
  13. 28 Dec 2026Model cards removedSource attributes, access/modify and risk management deleted from (b)(11)

Source: Federal Register, healthit.gov and fda.gov 1438

Show the data
datehumanlabeldetailtone
2023-04-1818 Apr 2023HTI-1 proposedFirst proposes source attributes and risk management for decision support (88 FR 23746)0
2024-01-099 Jan 2024HTI-1 final ruleCreates the decision support criterion 170.315(b)(11): 13 + 31 source attributes and risk management (89 FR 1192)0
2024-05-066 May 2024Section 1557 ruleAdds 45 CFR 92.210 on patient care decision support tools (89 FR 37522)2
2025-01-011 Jan 2025Model cards required(b)(11) replaces the old CDS criterion in the Base EHR definition; upkeep duty begins0
2025-01-2323 Jan 2025Executive Order 14179Later cited by ONC as a reason to drop the model cards1
2025-05-011 May 202592.210 duties applyIdentify and mitigate discrimination risk in decision support tools2
2025-12-2929 Dec 2025HTI-5 proposedRemove 34 of 60 certification criteria, revise 7, including the model cards (90 FR 60970)0
2026-01-066 Jan 2026FDA CDS guidanceFinal guidance adds enforcement discretion for single-recommendation tools (re-issued 29 Jan)2
2026-02-2727 Feb 2026Comments close298 unique submissions; most comments on this part opposed the cut0
2026-09-2929 Sep 2026Executive Order 14434Agencies to say \Super Intelligence (SI)\"; HTI-5 uses the new term"1
2026-10-2828 Oct 2026HTI-5 final rule14 criteria removed, 7 revised, 39 kept (91 FR 67916)0
2026-12-2828 Dec 2026Model cards removedSource attributes, access/modify and risk management deleted from (b)(11)0

Download the data (CSV)

What still applies

  • Section 1557 (45 CFR 92.210). Hospitals and other covered entities must make reasonable efforts to identify decision-support tools that use race, color, national origin, sex, age or disability as inputs, and to reduce the risk of discrimination from them 3. HTI-5 itself points readers to it. Arbiter's agent keeps this inventory and will not start without it (S1557-INVENTORY).
  • State laws. California's AB 3030 still requires a disclosure on AI-written patient messages about clinical information, unless a clinician reviewed them (rule CA-AB3030-DISCLOSURE). More state laws start on 1 January 2027.
  • FDA, for software that is a medical device. Its January 2026 guidance on clinical decision support widened the room for tools that make a single recommendation 8.
  • Contracts. With no federal requirement, a hospital that wants a tool's training data, validation and fairness testing now has to ask for them in procurement. The 31 attributes are still a useful checklist 2.

Show your work

How this was done

Everything here is from primary text read on 2 November 2026: the full HTI-5 final rule (FR Doc 2026-21943) and proposed rule, the HTI-1 final rule, the 2024 Section 1557 rule, the current eCFR text of 45 CFR 170.315 and 92.210, ONC's own pages, and each organization's comment letter. The 31 and 13 attribute counts were made by counting the regulatory text line by line. The comment count is ONC's own (298 unique submissions). The docket shows 305 posted comments, and regulations.gov reports 6,459 received, which probably includes duplicates. Page numbers for each fact are in the research notes kept with the site.

What this does not tell you

We did not find a statement on HTI-5 from the Coalition for Health AI (CHAI). Epic's and Oracle's own comments were not read, and HHS's press release returned an error, so its wording is not quoted. The rule's text is inconsistent in one place: one passage says 5 criteria were revised where the rest of the rule and ONC's fact sheet say 7. We use 7. The Section 1557 compliance date (1 May 2025) is calculated from the rule's 300-day window. This read does not cover FDA's draft guidance on AI-enabled devices.

Data

Every number in the charts, as CSV:

Agent policy

This read is evidence for these rules in the agent's policy:

Sources

  1. ONC, "Health Data, Technology, and Interoperability: ONC Deregulatory Actions To Unleash Prosperity" (HTI-5 final rule), 91 FR 67916, 28 Oct 2026 primary source; read 2026-11-02
  2. eCFR, 45 CFR 170.315(b)(11), decision support interventions primary source; read 2026-11-02
  3. eCFR, 45 CFR 92.210, nondiscrimination in the use of patient care decision support tools primary source; read 2026-11-02
  4. ONC, HTI-1 final rule, 89 FR 1192, 9 Jan 2024 primary source; read 2026-11-02
  5. American Medical Association, letter on the HTI-5 proposed rule, 27 Feb 2026 primary source; read 2026-11-02
  6. American Hospital Association, comments on the HTI-5 proposed rule, 27 Feb 2026 primary source; read 2026-11-02
  7. AHCA/NCAL, comments on the HTI-5 proposed rule, 24 Feb 2026 primary source; read 2026-11-02
  8. FDA, Clinical Decision Support Software final guidance (January 2026) primary source; read 2026-11-02
  9. EHR Association, comments on the HTI-5 proposed rule, 27 Feb 2026 primary source; read 2026-11-02
  10. AMA, National Advocacy Update, 30 Oct 2026 primary source; read 2026-11-02
  11. ONC, HTI-5 final rule overview primary source; read 2026-11-02

Corrections

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