Reference · Healthcare

HHS Section 1557 and Patient Care Decision Support Tools, Explained

45 CFR 92.210, Nondiscrimination in the use of patient care decision support tools

Last reviewed October 11, 2026

At a glance

Rule: 45 CFR 92.210, added by the Section 1557 final rule (89 FR 37522, 6 May 2024), effective 5 July 2024
Applies to: Health programs and activities receiving HHS financial assistance, HHS's own programs, and ACA Exchanges
Duties: No discrimination through the tools; identify tools with protected-class inputs; mitigate the risk
Identify and mitigate: Required within 300 days of 5 July 2024, which was 1 May 2025
Status: In force. The court orders on the 2024 rule leave it untouched; HHS lists a proposal to modify its Section 1557 rules for February 2027.
Official text: 45 CFR 92.210 (eCFR)

Section 1557 of the Affordable Care Act prohibits discrimination on the basis of race, color, national origin, sex, age or disability in federally funded health programs. The 2024 final rule applied that prohibition to the tools clinicians use to make decisions, in 45 CFR 92.210.2024 final rule A covered entity may not discriminate through those tools, must make reasonable efforts to identify the ones whose inputs measure a protected characteristic, and must make reasonable efforts to mitigate the risk of discrimination from each one it identifies.45 CFR 92.210

The identification and mitigation duties have applied since 1 May 2025.45 CFR 92.1 · Table 1 The court orders now in effect against the 2024 rule cover other provisions, and HHS has confirmed that the rest of the rule remains in force.Vacatur notice

Any tool that supports clinical decisions is in scope, automated or not

A patient care decision support tool is any automated or non-automated tool, mechanism, method, technology or combination of them that a covered entity uses to support clinical decision-making in its health programs or activities.45 CFR 92.4 The definition reaches a predictive model in the EHR, a large language model that suggests a diagnosis, a clinical risk score and a paper flowchart alike.

Covered entities are recipients of federal financial assistance from HHS, HHS itself, and entities established under title I of the ACA, such as the Exchanges. The rule applies to every health program or activity any part of which receives HHS financial assistance, directly or indirectly.45 CFR 92.4 45 CFR 92.2 · (a) When any part of a health program receives HHS financial assistance, the whole program is covered.

Three duties: do not discriminate, identify, mitigate

Nondiscrimination: 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.45 CFR 92.210 · (a)
Identification: an ongoing duty to make reasonable efforts to identify uses of tools that employ input variables or factors measuring race, color, national origin, sex, age or disability.45 CFR 92.210 · (b)
Mitigation: for each tool identified, reasonable efforts to mitigate the risk of discrimination resulting from its use.45 CFR 92.210 · (c)

The rule prescribes no test and no outcome. OCR evaluates mitigation case by case, and its example is a covered entity replacing the race-adjusted eGFR equation with the revised equation that does not adjust for race.2024 final rule · 89 FR 37648

What OCR weighs when it asks about reasonable efforts

In assessing whether a covered entity made reasonable efforts to identify tools, OCR may consider, among other factors:2024 final rule · 89 FR 37648

The entity's size and resources: a large hospital with an IT department and a health equity officer is expected to do more than a small practice.
Whether the entity used the tool as the developer intended and regulators approved, or adapted or customized it.
Whether the entity received product information from the developer about the potential for discrimination, or found that the tool's inputs include a protected characteristic.
Whether the entity has a methodology or process for evaluating the tools it adopts, such as asking the developer, reviewing the literature, drawing on professional associations, and analyzing comments or complaints.

For predictive tools in certified EHRs, the developer information already exists. The ONC HTI-1 criterion requires developers to disclose whether each predictive intervention uses race, ethnicity, sex, date of birth and other demographic variables as input features. That disclosure is the developer-side input to the determination, which remains the covered entity's to make and record.

Section 92.210 is outside the court rulings, and a rewrite is on the agenda

The court orders in effect against the 2024 rule do not reach section 92.210. A Texas federal court's nationwide stay, as narrowed in August 2024, covers specific provisions outside it.Texas v. Becerra On 22 October 2025 a Mississippi federal court vacated provisions to the extent they extend sex discrimination to gender identity, again outside 92.210.Tennessee v. Kennedy HHS published notice of that vacatur on 2 June 2026 and stated that the rule's other provisions remain in force.Vacatur notice

OCR has said it will continue to enforce the rule's protections against discrimination based on race, color, national origin, age, disability, and the aspects of sex discrimination the court's order does not affect.HHS The 2026 Unified Agenda lists a deregulatory proposal to modify HHS's Section 1557 regulations, to conform them more closely with the statutory text, recent executive orders and court decisions and to reduce burden, with a proposed rule expected in February 2027.Unified Agenda The entry does not name 92.210, and no proposal has been published.

Until a final rule changes it, 92.210 binds every covered entity as written.

Notices, coordinators and grievance procedures reach AI-assisted care

Every covered entity must provide a notice of nondiscrimination to participants, beneficiaries, enrollees and applicants.45 CFR 92.10 A covered entity with fifteen or more employees must also designate a Section 1557 Coordinator and implement written grievance procedures.45 CFR 92.7 45 CFR 92.8 · (c) A patient who believes an algorithm treated them differently will use those channels, so they should be able to route a complaint about a decision support tool to the people who hold the inventory.

Control mapping

What a reviewer expects to be able to see.

Obligation	What the system must do	Evidence a reviewer expects
Identification (92.210(b))	Know which decision support tools are in use and which employ protected-class inputs	A tool inventory with a dated, per-tool determination and the developer information it relied on
Ongoing identification	Revisit the determination when a tool, its model or its configuration changes	Configuration change history and re-determination records
Mitigation (92.210(c))	Make reasonable efforts to mitigate the risk of discrimination for each identified tool	The mitigation chosen per tool, its owner, testing results and review cadence
Evaluation methodology	Have a process for evaluating tools before and after adoption	The written process, developer questionnaires, and the complaints reviewed
Notice, coordinator, grievances (92.7, 92.8, 92.10)	Route complaints about AI-assisted care through the Section 1557 channels	The notice, the coordinator's designation, and grievance records that name the tool

Key dates

Timeline, drawn to scale

Section 92.210 from the final rule to the court rulings

In effect as of October 11, 2026Decision support duties apply

Dates from 45 CFR 92.1, the 2024 final rule and the June 2026 notice of vacatur. Status as of October 11, 2026.

6 May 2024Section 1557 final rule published (89 FR 37522), adding 45 CFR 92.210.
5 July 2024Final rule takes effect, including 92.210(a).
30 August 2024Texas federal court stays specific provisions of the rule nationwide, none of them in 92.210.
1 May 202592.210(b) and (c) apply: identify tools with protected-class inputs and mitigate the risk.
22 October 2025Mississippi federal court vacates the rule's gender identity provisions; 92.210 untouched.
2 June 2026HHS notice of the vacatur: the rule's other provisions remain in force.
February 2027Proposed rule to modify the Section 1557 regulations expected, per the 2026 Unified Agenda.

Sources cited

Common gaps

Where covered entities most often fall short of 92.210.

No inventory of decision support tools. The identification duty presumes a list. An entity that cannot say which tools run cannot say which use protected-class inputs.
Only the AI counted. The definition covers non-automated tools as well. Risk calculators, scoring sheets and clinical pathways belong in the same inventory as the predictive models.
The determination made once. The identification duty is ongoing. A tool whose model, prompt or configuration changed since the determination has to be looked at again.
Mitigation with no record. Clinician override exists in practice and nowhere on paper. OCR asks what the entity did; the answer needs a date and an owner.
Waiting for the rewrite. A listed proposal is not a rule. Section 92.210 applies as written until a final rule changes it.

In practice

How Meilynx maps to 92.210 →

Last reviewed October 11, 2026. This reference summarises publicly available regulatory guidance and is provided for general information. It is not legal advice. Obligations depend on an institution's charter, registration status, size, and activities. Verify against the primary sources cited above and consult counsel before relying on any summary here.