HHS § 1557 Rule (AI clinical tools)
HHS Office for Civil Rights — Section 1557 Final Rule (nondiscrimination in patient care decision-support tools, including AI)
United States · 45 C.F.R. § 92.210; 89 Fed. Reg. 37522
- Status
- In effect
- Took effect
- July 5, 2024
- Applies to
- Health programs and activities receiving federal financial assistance from HHS; HHS-administered programs; health insurance marketplaces
- Enforced by
- HHS Office for Civil Rights
HHS's Section 1557 rule bans discrimination in 'patient care decision-support tools,' which includes AI and algorithmic clinical tools. Covered health programs and providers must identify when a tool relies on patient race, age, disability, or other protected traits and take steps to mitigate the risk of discrimination.
Who is protected: Patients in covered health programs — protected categories include race, color, national origin, sex (including pregnancy, sexual orientation, gender identity), age, and disability
Legal detail
45 C.F.R. § 92.210 (HHS Final Rule, 89 Fed. Reg. 37522, May 6, 2024) requires covered entities receiving HHS funding to make reasonable efforts to identify uses of patient care decision-support tools (defined to include AI/clinical algorithms) that employ protected characteristics as inputs and to mitigate the risk of discrimination resulting from their use. Compliance for § 92.210 began May 1, 2025.
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Strength | Moderate |
| Enacted | May 6, 2024 |
| Citation | 45 C.F.R. § 92.210; 89 Fed. Reg. 37522 |
| Private right of action | Yes, individuals can sue |
| Penalties | Loss of federal financial assistance; corrective action plans; referral to DOJ for litigation; private right of action under § 1557 |
| Topics | healthcare AI · automated decision-making · consumer protection |
| Agency page | Nondiscrimination in Health Programs and Activities — Final Rule (89 FR 37522) |
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