Section 1557 AI rule: patient care decision support tools (45 CFR 92.210)

45 CFR 92.210 is the HHS Section 1557 regulation that prohibits covered health programs from discriminating on the basis of race, color, national origin, sex, age, or disability through their use of patient care decision support tools, including AI. It requires ongoing efforts to identify tools that use those characteristics and to mitigate discrimination risk.

What the rule says

The regulation has three parts:

• (a) General prohibition. "A covered entity must not discriminate on the basis of race, color, national origin, sex, age, or disability in its health programs or activities through the use of patient care decision support tools."
• (b) Identification of risk. A covered entity "has an ongoing duty to make reasonable efforts to identify uses of patient care decision support tools in its health programs or activities that employ input variables or factors that measure race, color, national origin, sex, age, or disability."
• (c) Mitigation of risk. For each tool identified under (b), the covered entity "must make reasonable efforts to mitigate the risk of discrimination resulting from the tool's use."

The definition in 45 CFR 92.4 is broad. A patient care decision support tool is "any automated or non-automated tool, mechanism, method, technology, or combination thereof used by a covered entity to support clinical decision-making in its health programs or activities." That reaches machine learning models and generative AI, but also scoring systems, flowcharts, and calculators.

Who it covers and when

Covered entities include recipients of federal financial assistance, which in practice includes most hospitals and many clinics and health plans, along with HHS itself and entities established under Title I of the Affordable Care Act.

HHS published the final rule, Nondiscrimination in Health Programs and Activities, on May 6, 2024 (89 FR 37522), effective July 5, 2024. The rule gave covered entities a delayed date for paragraphs (b) and (c): compliance was required within 300 days of the effective date, which is May 1, 2025. The general prohibition in (a) applied from July 5, 2024.

What compliance looks like in practice

The rule sets a "reasonable efforts" standard rather than a checklist. In the preamble, HHS said OCR may consider factors such as the entity's size and resources, whether it used the tool as the developer intended or customized it, and whether the developer told it about discrimination risk. Practical steps include:

1. Inventory. Maintain a list of decision support tools, automated and manual, with owners.
2. Screen inputs. For each tool, record whether inputs include any protected characteristic, directly or through documented proxies. Ask vendors for input variable lists; certified EHRs expose source attributes for predictive tools under ONC's HTI-1 rule.
3. Mitigate. Document the mitigation chosen for each flagged tool, such as local validation across subgroups, adjusted thresholds, clinician review, or discontinuing the tool.
4. Repeat. Because the duty is ongoing, revisit the inventory when tools change or new ones are added.

How Skovos handles this

Skovos supports the identification step for AI agents. Its registry records each agent's owner, purpose, and permitted data, and the audit trail records each permission decision and agent action, which helps a compliance team document its reasonable efforts.

Frequently asked questions

Does 45 CFR 92.210 apply only to AI?

No. It covers both automated and non-automated tools used to support clinical decision-making, including clinical algorithms and scoring rules.

When did hospitals have to comply with 92.210?

The prohibition applied from July 5, 2024. The identification and mitigation duties in paragraphs (b) and (c) applied from May 1, 2025.

Does the rule ban using race or age as an input?

No. It requires reasonable efforts to identify tools that use protected characteristics and to mitigate the risk of discrimination. Some uses may be clinically appropriate.

Who enforces Section 1557?

The HHS Office for Civil Rights.

Related reading

• AI agent registry for hospitals
• What is AI governance in healthcare?
• AI governance frameworks for hospitals

Sources

• 45 CFR 92.210: https://www.law.cornell.edu/cfr/text/45/92.210
• 45 CFR 92.4, definitions: https://www.law.cornell.edu/cfr/text/45/92.4
• HHS, Nondiscrimination in Health Programs and Activities, final rule, 89 FR 37522, May 6, 2024: https://www.federalregister.gov/documents/2024/05/06/2024-08711/nondiscrimination-in-health-programs-and-activities
• ONC/ASTP, HTI-1 Decision Support Interventions fact sheet: https://www.healthit.gov/sites/default/files/page/2023-12/HTI-1_DSI_fact%20sheet_508.pdf