United States (federal) · regulation
HHS §1557: what it requires, and the records to keep
Section 92.210 bars covered entities from discriminating on the basis of race, color, national origin, sex, age or disability through patient care decision support tools, a term that covers any automated or manual tool supporting clinical decisions, including AI. Since May 1, 2025, covered entities must make reasonable efforts to find tools that use those characteristics as inputs and to reduce the discrimination risk.
01 / What it requires
What HHS §1557 requires
Covered entities under Section 1557: recipients of HHS federal financial assistance (most hospitals, clinics and health insurers), HHS's own health programs, and ACA Title I entities such as Exchanges.
- 01Do not discriminate on race, color, national origin, sex, age or disability through patient care decision support tools.
- 02Make ongoing reasonable efforts to identify tools whose input variables measure race, color, national origin, sex, age or disability.
- 03For each identified tool, make reasonable efforts to mitigate the risk of discrimination from its use.
- 04Cover tools used in clinical decision-making, whether automated (including AI) or non-automated.
02 / AI work
Where it touches AI work
HHS defined patient care decision support tools broadly so they include AI and machine-learning models, clinical algorithms and risk calculators. It is the first federal civil rights rule aimed directly at bias in clinical algorithms, and it applies to the provider or plan that uses the tool, not the vendor.
03 / Dates
The dates that matter
Final rule published (89 FR 37522)
Rule effective; §92.210(a) general prohibition applies
§92.210(b) identification and (c) mitigation duties apply
Court vacates gender-identity provisions in Tennessee v. Kennedy
HHS notice: vacated provisions void, other provisions remain in force
04 / Enforcement
Who enforces it
HHS Office for Civil Rights through complaints and compliance reviews; remedies include corrective action, suspension or termination of federal financial assistance, and referral to the Department of Justice.
05 / Records
Records an organisation keeps
What an auditor or an inquiry usually asks to see. Your obligations depend on your role and your facts.
- 01Inventory of clinical decision support tools and their input variables
- 02Bias risk assessment for tools using protected characteristics
- 03Mitigation decisions and actions, with dates and owners
- 04Section 1557 policies, procedures and staff training records
Optional evidence · where Planisphere fits
Keep a record anyone can check
When your team meets a duty, Planisphere can seal the event it reports as a receipt.
A disclosure shown, a review signed, a model change approved: the event your system reports.
The event becomes a sealed receipt, dated and attributed to whoever is signed in.
Paste the receipt into Verify. No account or key.
A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.
QUESTIONS
The questions that come next
Is the HHS §1557 patient-care-decision-support-tools rule still in effect in 2026?+
Yes. 45 CFR 92.210 has been in force since the rule took effect on July 5, 2024, and its duties to identify tools that use race, color, national origin, sex, age or disability as inputs and to mitigate the risk of discrimination have applied since May 1, 2025. On October 22, 2025, a federal court in Tennessee v. Kennedy vacated the rule's gender-identity provisions; HHS's June 2, 2026 notice says the rest of the rule remains in force, and §92.210 was not among the vacated provisions. No proposal to amend it had been published as of October 2026. Read the full answer
How do I audit a clinical algorithm for §1557 nondiscrimination?+
Start with an inventory: §92.210(b) requires ongoing, reasonable efforts to find patient care decision support tools whose input variables measure race, color, national origin, sex, age or disability. For each tool found, §92.210(c) requires reasonable efforts to mitigate the risk of discrimination from its use. In practice, document each tool's inputs, test its performance across those groups, record what you changed, such as thresholds, workflow or added human checks, and repeat the review. The rule sets no specific audit method, and the duty falls on the provider or plan that uses the tool. Read the full answer
What's the difference between §1557's algorithm provision and its gender-identity provisions?+
They are separate parts of the 2024 rule with different legal status. §92.210 bars discrimination on race, color, national origin, sex, age or disability through patient care decision support tools, including AI, and remains in force. The provisions that extended sex discrimination to gender identity, such as §92.101(a)(2)(iv) and §92.206(b), were vacated by a federal court on October 22, 2025, and HHS says it will not enforce them. §92.210 still lists sex, but the regulatory text that defined sex discrimination to include gender identity is void. Read the full answer
SOURCES
Go back to the source
Federal Register (HHS)
CHANGE LOG
What changed, and when
Rebuilt from primary sources; facts checked on this date.
Related: HHS §1557 vs HIPAA · HHS §1557 vs Title VI · HHS §1557 for medicine AI workflows · NIST AI RMF · OMB M-25-21/22 · DoW RAI S&IP · EO 14179 · FIPS 140-3 · SHA-256 / FIPS 180-4