plainstamp

HHS Section 1557 — Patient Care Decision Support Tools nondiscrimination (2024 final rule)

On May 6, 2024, the U.S. Department of Health and Human Services Office for Civil Rights published a final rule (89 Fed. Reg. 37522) implementing Section 1557 of the Affordable Care Act that imposes nondiscrimination obligations on covered entities' use of 'patient care decision support tools' (PCDSTs) — defined to include automated and non-automated tools, including artificial-intelligence and machine-learning-based clinical decision support. Covered entities (most healthcare providers receiving federal financial assistance, many health insurers, and HHS-administered health programs) must (a) make reasonable efforts to identify uses of PCDSTs in their health programs and activities that employ input variables or factors that measure race, color, national origin, sex, age, or disability; AND (b) make reasonable efforts to mitigate the risk of discrimination resulting from the tool's use. The compliance deadline for the PCDST nondiscrimination obligation was May 1, 2025; the obligation is now in effect and enforceable. Penalties for Section 1557 violations include loss of federal financial assistance, OCR-imposed corrective-action plans, and potential private-right-of-action claims for discrimination.

Mandatory — failure to disclose creates legal exposure.

Quick facts

Field Value
Jurisdiction United States (Federal)
Severity mandatory
Channels ai-generated-content, about-page, privacy-policy
Use cases healthcare
Effective date 2025-05-01
Last verified 2026-05-08

What it requires

Sample disclosure language (plain)

Notice — Use of Decision-Support Tools in Your Care: Some clinical decisions in your care may be informed by automated decision-support tools, including artificial-intelligence and machine-learning systems. These tools assist your healthcare team and do not replace the judgment of a licensed clinician. You have the right to discuss any care decision with your provider. If you believe you have experienced discrimination on the basis of race, color, national origin, sex, age, or disability in connection with these tools or any other aspect of your care, please contact our Civil Rights Coordinator at [contact] or file a complaint with the HHS Office for Civil Rights at https://www.hhs.gov/ocr/.

Sample disclosure language (formal)

Notice under Section 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. § 18116) and the implementing regulations at 45 CFR Part 92 (as amended by the May 6, 2024 final rule, 89 Fed. Reg. 37522): The covered entity uses one or more patient care decision support tools, including artificial-intelligence and machine-learning-based clinical decision support, in its health programs and activities. The covered entity has identified its uses of such tools and is making reasonable efforts to mitigate the risk of discrimination on the bases protected by Section 1557 (race, color, national origin, sex (including sex characteristics, sexual orientation, gender identity, and pregnancy or related conditions), age, and disability) resulting from the tools' use, in accordance with 45 CFR § 92.210. For the entity's Civil Rights Coordinator and Section 1557 grievance procedures, see [contact].

Citation

Notes

Section 1557's PCDST obligation is governance-heavy — most of the compliance work is internal (identifying tools, documenting mitigation, designating coordinators) rather than patient-facing text. The patient-facing element is the Section 1557 notice-of-availability under § 92.11 plus, where the entity exposes AI-informed decisions to patients, a clear acknowledgment that automated tools may inform clinical decisions and a path to discuss with a clinician. Covered entities include most healthcare providers receiving any form of federal financial assistance (Medicare-participating providers, Medicaid-participating providers, federally-qualified health centers, etc.), all health insurers in HHS-administered marketplaces, and HHS itself. The 'reasonable efforts' standard is intentionally flexible — OCR has stated in commentary that what constitutes 'reasonable' will scale with the entity's size and resources, but documentation is essential. PCDSTs explicitly include AI/ML decision-support tools and (per OCR commentary) tools that produce or use clinical scores (e.g., Epic Sepsis Model, Beth Israel Discharge Risk score, etc.). Federal funding loss is the principal sanction; OCR can also impose corrective action plans. State-level overlays may apply (e.g., California SB 1120 — Physicians Make Decisions Act, requiring physician review of AI-driven coverage denials in health plans — effective 2025-01-01). Stack with HIPAA Privacy Rule (45 CFR Part 164) when patient information is processed; stack with state AI hiring/employment-decision laws when the PCDST is used in employment of healthcare workers.

Live result from /lookup for this surface

This is the actual response from the hosted plainstamp /lookup endpoint for us × ai-generated-content × healthcare — the same data the npm package and MCP server return:

3 rules apply to this surface (us × ai-generated-content × healthcare):

Full JSON response (click to expand) 
{
  "query": {
    "jurisdiction": "us",
    "channel": "ai-generated-content",
    "use_case": "healthcare"
  },
  "count": 3,
  "results": [
    {
      "rule_id": "us-cms-medicare-advantage-ai-prior-auth-2024",
      "severity": "mandatory",
      "short_title": "CMS Medicare Advantage — algorithms / AI in coverage and prior-authorization decisions (CMS-4201-F + Feb 2024 FAQ)",
      "citation": {
        "statute": "Social Security Act §§ 1852, 1854, 1856, 1857, 1860D-4 (42 U.S.C. §§ 1395w-22 et seq.); 42 CFR Part 422 (Medicare Advantage); CMS-4201-F final rule, 88 Fed. Reg. 22120 (April 5, 2023)",
        "section": "42 CFR § 422.101(c) (basis for coverage decisions); 42 CFR § 422.202(b) (consistent application); 42 CFR § 422.566 (organization determinations); 42 CFR § 422.568 (notice of organization determination); CMS FAQ \"Coverage Criteria and Utilization Management Requirements in CMS Final Rule (CMS-4201-F)\" (February 6, 2024)",
        "source_url": "https://www.cms.gov/files/document/faqs-related-coverage-criteria-and-utilization-management-requirements-cms-final-rule-4201-f.pdf",
        "publisher": "U.S. Centers for Medicare & Medicaid Services"
      },
      "last_verified": "2026-05-09",
      "freshness": {
        "status": "fresh",
        "days_since_verified": 1,
        "last_verified": "2026-05-09"
      },
      "applies_because": [
        "jurisdiction exact match: us",
        "channel match: rule covers 'ai-generated-content'",
        "use case match: rule covers 'healthcare'"
      ],
      "generated_text": {
        "plain": "Notice — Use of Automated Tools in Your Medicare Advantage Coverage Decisions: Some prior-authorization and medical-necessity decisions in this plan are supported by automated decision-support tools, including artificial intelligence. These tools assist a qualified clinician who individually reviews each request against your medical history, your physician's recommendations, and Medicare coverage rules. No coverage decision is made by an algorithm alone. If a request for coverage is denied, you will receive a written explanation and you have the right to appeal — see your Evidence of Coverage for the appeals process or contact Member Services at [contact].",
        "formal": "Notice under 42 CFR § 422.101(c), § 422.202(b), § 422.566, and § 422.568, as amended by the Centers for Medicare & Medicaid Services final rule CMS-4201-F (88 Fed. Reg. 22120, April 5, 2023), and as clarified by the CMS public FAQ released February 6, 2024 regarding the use of algorithms and artificial intelligence in Medicare Advantage coverage and prior-authorization determinations: this Medicare Advantage organization may use algorithmic or artificial-intelligence decision-support tools to assist in its medical-necessity and prior-authorization determinations. Each adverse organization determination is based on an individualized clinical assessment of the enrollee's medical history and the applicable Medicare coverage criteria, conducted by a qualified clinician; no coverage determination is issued solely on the output of an algorithm. Enrollees retain all rights to a written organization-determination notice and to appeal under 42 CFR Part 422 Subpart M, including reconsideration, independent review entity review, ALJ hearing, Medicare Appeals Council review, and federal-court review."
      }
    },
    {
      "rule_id": "us-fda-pccp-aiml-device-software-2024",
      "severity": "mandatory",
      "short_title": "FDA Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions (Final Guidance, December 2024)",
      "citation": {
        "statute": "Federal Food, Drug, and Cosmetic Act § 515C (21 U.S.C. § 360e-4), as added by Section 3308 of the Food and Drug Omnibus Reform Act of 2022 (FDORA, P.L. 117-328, Division FF, Title III)",
        "section": "Predetermined Change Control Plans for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Final, December 4, 2024)",
        "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-artificial-intelligence-enabled-device-software-functions",
        "publisher": "U.S. Food and Drug Administration, Center for Devices and Radiological Health"
      },
      "last_verified": "2026-05-08",
      "freshness": {
        "status": "fresh",
        "days_since_verified": 2,
        "last_verified": "2026-05-08"
      },
      "applies_because": [
        "jurisdiction exact match: us",
        "channel match: rule covers 'ai-generated-content'",
        "use case match: rule covers 'healthcare'"
      ],
      "generated_text": {
        "plain": "Notice — AI/ML-Enabled Medical Device: This device incorporates an artificial intelligence or machine-learning algorithm. The device has been authorized for marketing by the U.S. Food and Drug Administration under [510(k) / De Novo / PMA number]. The manufacturer's authorized marketing submission includes a Predetermined Change Control Plan (PCCP) describing the modifications that may be implemented to the device's algorithm without a new FDA submission. For the current PCCP scope, the device's intended use, validated performance, and the latest model version, see the manufacturer's device summary at [URL]. Discuss any clinical decisions informed by this device with your healthcare provider.",
        "formal": "Notice under FD&C Act § 515C (21 U.S.C. § 360e-4) and FDA's Predetermined Change Control Plans for Artificial Intelligence-Enabled Device Software Functions (Final Guidance, December 4, 2024): The device identified herein is an artificial intelligence-enabled device software function (AI-DSF) authorized by FDA under [submission type and reference number]. The manufacturer's authorized marketing submission includes a Predetermined Change Control Plan (PCCP) comprising a Description of Modifications, a Modification Protocol, and an Impact Assessment. PCCP-conforming modifications may be implemented without a new marketing submission; modifications outside the authorized PCCP require a new submission per applicable FDA regulations. The device's labeling reflects the PCCP; the manufacturer's public device summary at [URL] reflects the current model version, validation data, and the cumulative record of PCCP-conforming modifications implemented to date."
      }
    },
    {
      "rule_id": "us-hhs-section-1557-pcdst-2024",
      "severity": "mandatory",
      "short_title": "HHS Section 1557 — Patient Care Decision Support Tools nondiscrimination (2024 final rule)",
      "citation": {
        "statute": "Section 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. § 18116); 45 CFR Part 92, as amended by the May 6, 2024 final rule, 89 Fed. Reg. 37522",
        "section": "45 CFR § 92.210 (Discrimination through the use of patient care decision support tools)",
        "source_url": "https://www.federalregister.gov/documents/2024/05/06/2024-08711/nondiscrimination-in-health-programs-and-activities",
        "publisher": "U.S. Department of Health and Human Services, Office for Civil Rights"
      },
      "last_verified": "2026-05-08",
      "freshness": {
        "status": "fresh",
        "days_since_verified": 2,
        "last_verified": "2026-05-08"
      },
      "applies_because": [
        "jurisdiction exact match: us",
        "channel match: rule covers 'ai-generated-content'",
        "use case match: rule covers 'healthcare'"
      ],
      "generated_text": {
        "plain": "Notice — Use of Decision-Support Tools in Your Care: Some clinical decisions in your care may be informed by automated decision-support tools, including artificial-intelligence and machine-learning systems. These tools assist your healthcare team and do not replace the judgment of a licensed clinician. You have the right to discuss any care decision with your provider. If you believe you have experienced discrimination on the basis of race, color, national origin, sex, age, or disability in connection with these tools or any other aspect of your care, please contact our Civil Rights Coordinator at [contact] or file a complaint with the HHS Office for Civil Rights at https://www.hhs.gov/ocr/.",
        "formal": "Notice under Section 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. § 18116) and the implementing regulations at 45 CFR Part 92 (as amended by the May 6, 2024 final rule, 89 Fed. Reg. 37522): The covered entity uses one or more patient care decision support tools, including artificial-intelligence and machine-learning-based clinical decision support, in its health programs and activities. The covered entity has identified its uses of such tools and is making reasonable efforts to mitigate the risk of discrimination on the bases protected by Section 1557 (race, color, national origin, sex (including sex characteristics, sexual orientation, gender identity, and pregnancy or related conditions), age, and disability) resulting from the tools' use, in accordance with 45 CFR § 92.210. For the entity's Civil Rights Coordinator and Section 1557 grievance procedures, see [contact]."
      }
    }
  ],
  "ai_notice": "This API is operated by an autonomous AI agent under KS Elevated Solutions LLC. plainstamp is open-source under MIT (see https://www.npmjs.com/package/plainstamp)."
}

Open this in the interactive demo → (auto-runs on load; you can change channels and use-cases inline)

Use it from code

Same lookup, no install:

curl 'https://plainstamp.helpfulbutton140.workers.dev/lookup?jurisdiction=us&channel=ai-generated-content&use_case=healthcare'

Via npm:

npx plainstamp lookup --jurisdiction us --channel ai-generated-content --use-case healthcare

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Related rules

Other AI-disclosure rules in the corpus that may apply to the same surfaces:

Or browse the full rules index.

US-based customers. Operated by an autonomous AI agent under KS Elevated Solutions LLC. Not legal advice — for binding interpretation, consult counsel.