Federal: AI health law and policy
35 entries on the map: 25 in force or in effect, 3 final or enacted and not yet in force (main duties begin Dec. 28, 2026, and Jan. 1, 2027), 1 proposed rule, 2 draft guidance documents and 4 bills in Congress.
Most federal AI health measures bind device makers, health plans or agencies, not physicians, and no federal law requires telling patients about AI use.
Full overview and dates aheadHide full overview
Since May 1, 2025, practices and hospitals covered by the Affordable Care Act's Section 1557 must make reasonable efforts under 45 CFR 92.210 to identify and mitigate risk from AI and other decision support tools that use race, sex, age or similar inputs. Federal privacy guidance treats a vendor whose AI chatbot handles portal health information as a business associate, as an online tracking bulletin does for tracking vendors. From Dec. 28, 2026, a final rule ends the duty, under a 2024 rule, for certified EHRs to carry decision support source attributes.
From Jan. 1, 2027, the final physician fee schedule and outpatient rule pay for software analyses, including AI. Since Jan. 1, 2026, a Medicare model using AI-assisted review requires clinicians in six states to seek prior authorization or prepayment review for selected services. Under a 2023 rule, Medicare Advantage plans must base medical necessity decisions on individual circumstances, and a February 2024 memo says AI alone cannot justify denying an inpatient admission. Committees approved bills on AI chatbots (S. 3062), Medicare Advantage prior authorization (H.R. 3514) and health privacy (S. 3097), and a House committee approved a spending bill barring funds for that model.
Dates ahead
- Dec. 28, 2026
- Jan. 1, 2027
- Jan. 1, 2027
Devices and FDA oversight
FDA, Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, notice, 90 FR 56768 (Dec. 8, 2025)
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21st Century Cures Act, Pub. L. 114-255, div. A, title III, sec. 3060(a), adding section 520(o) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(o)), software functions excluded from the device definition
Food and Drug Omnibus Reform Act of 2022 (Consolidated Appropriations Act, 2023, Pub. L. 117-328, div. FF, title III, sec. 3308(a)), adding section 515C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-4), Predetermined change control plans for devices
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (docket FDA-2022-D-2628)
General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff (docket FDA-2014-N-1039), issued Jan. 6, 2026
Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff (docket FDA-2017-D-6569), issued Jan. 29, 2026
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff (docket FDA-2024-D-4488), notice of availability, 90 FR 1154 (Jan. 7, 2025)
Clinical decision and chatbot limits
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1), final rule, 89 FR 1192 (Jan. 9, 2024), RIN 0955-AA03; 45 CFR 170.315(b)(11), Decision support interventions
HHS Office for Civil Rights, Dear Colleague letter: Ensuring Nondiscrimination Through the Use of Artificial Intelligence and Other Emerging Technologies (Jan. 10, 2025)
Nondiscrimination in Health Programs and Activities, final rule, 89 FR 37522 (May 6, 2024); 45 CFR 92.210, Nondiscrimination in the use of patient care decision support tools
Health Data, Technology, and Interoperability: ONC "Deregulatory Actions to Unleash Prosperity" (HTI-5), final rule, 91 FR 67916 (Oct. 28, 2026), Federal Register document 2026-21943, RIN 0955-AA09
S. 3062, Guidelines for User Age-verification and Responsible Dialogue Act of 2026 (GUARD Act), 119th Congress, reported by the Senate Judiciary Committee with an amendment (Calendar No. 406)
Also relevant here: 21st Century Cures Act, Pub. L. 114-255, div. A, title III, sec. 3060(a), adding section 520(o) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(o)), software functions excluded from the device definition (under devices and FDA oversight); Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff (docket FDA-2017-D-6569), issued Jan. 29, 2026 (under devices and FDA oversight).
Payer and utilization review AI
Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly, final rule (CMS-4201-F), 88 FR 22120 (April 12, 2023), RIN 0938-AU96; 42 CFR 422.101(b)(6) and (c)(1) and 422.566(d)
CMS, Frequently Asked Questions related to Coverage Criteria and Utilization Management Requirements in CMS Final Rule (CMS-4201-F), HPMS memo, Feb. 6, 2024
Medicare Program; Implementation of Prior Authorization for Select Services for the Wasteful and Inappropriate Services Reduction (WISeR) Model, notice (CMS-5056-N), 90 FR 28749 (July 1, 2025)
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes, final rule (CMS-0057-F), 89 FR 8758 (Feb. 8, 2024), RIN 0938-AU87
H.R. 3514, Improving Seniors' Timely Access to Care Act of 2025, 119th Congress, ordered reported by the House Ways and Means Committee
H.R. 9260, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027
Payment for AI
Medicare physician fee schedule payment for digital mental health treatment devices, HCPCS G0552, G0553 and G0554: CY 2025 final rule (CMS-1807-F), 89 FR 97710 (Dec. 9, 2024), expanded in the CY 2026 final rule (CMS-1832-F), 90 FR 49266 (Nov. 5, 2025)
CMS Innovation Center, Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model (request for applications issued Dec. 5, 2025; version 1.1, Feb. 12, 2026)
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates, final rule (CMS-1849-F), 91 FR 49570 (Aug. 4, 2026), RIN 0938-AV79; new technology add-on payments under 42 CFR 412.87 and 412.88
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs, CY 2027 final rule with comment period (CMS-1850-FC), 91 FR 70284 (Nov. 6, 2026); proposed rule (CMS-1850-P), 91 FR 41734 (July 7, 2026), RIN 0938-AV83
Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies, final rule (CMS-1848-F), 91 FR 70992 (Nov. 9, 2026); proposed rule (CMS-1848-P), 91 FR 43842 (July 16, 2026), RIN 0938-AV82
Also relevant here: FDA, Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, notice, 90 FR 56768 (Dec. 8, 2025) (under devices and FDA oversight).
Data and privacy
HHS Office for Civil Rights, Business Associates guidance (web page, content last reviewed July 30, 2026): AI chatbot example
HHS Office for Civil Rights, Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates (bulletin issued December 2022, revised March 18, 2024)
Health Breach Notification Rule, final rule, 89 FR 47028 (May 30, 2024), RIN 3084-AB56, 16 CFR part 318
HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information, proposed rule, 90 FR 898 (Jan. 6, 2025), RIN 0945-AA22
S. 3097, Health Information Privacy Reform Act, 119th Congress, reported by the Senate Health, Education, Labor, and Pensions Committee with an amendment (Calendar No. 538)
Also relevant here: Executive Order 14355, Unlocking Cures for Pediatric Cancer With Artificial Intelligence, 90 FR 48153 (Oct. 7, 2025) (under government-wide AI policy).
Mental health AI
No federal statute, rule or final guidance is specific to AI in mental health care. FDA's Digital Health Advisory Committee met on generative AI-enabled digital mental health devices on Nov. 6, 2025, and FDA has issued no guidance on them since; Medicare's payment for digital mental health treatment devices is listed under payment.
Also relevant here: Medicare physician fee schedule payment for digital mental health treatment devices, HCPCS G0552, G0553 and G0554: CY 2025 final rule (CMS-1807-F), 89 FR 97710 (Dec. 9, 2024), expanded in the CY 2026 final rule (CMS-1832-F), 90 FR 49266 (Nov. 5, 2025) (under payment for AI); CMS Innovation Center, Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model (request for applications issued Dec. 5, 2025; version 1.1, Feb. 12, 2026) (under payment for AI); S. 3062, Guidelines for User Age-verification and Responsible Dialogue Act of 2026 (GUARD Act), 119th Congress, reported by the Senate Judiciary Committee with an amendment (Calendar No. 406) (under clinical decision and chatbot limits).
Patient disclosure of AI use
No federal statute or rule requires telling patients that AI is used in their care. Federal transparency duties run to device labeling and certified health IT, and those entries are listed under devices and clinical.
Also relevant here: 6 entries listed under other categories
Also relevant here: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (docket FDA-2022-D-2628) (under devices and FDA oversight); Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1), final rule, 89 FR 1192 (Jan. 9, 2024), RIN 0955-AA03; 45 CFR 170.315(b)(11), Decision support interventions (under clinical decision and chatbot limits); HHS Office for Civil Rights, Dear Colleague letter: Ensuring Nondiscrimination Through the Use of Artificial Intelligence and Other Emerging Technologies (Jan. 10, 2025) (under clinical decision and chatbot limits); Health Data, Technology, and Interoperability: ONC "Deregulatory Actions to Unleash Prosperity" (HTI-5), final rule, 91 FR 67916 (Oct. 28, 2026), Federal Register document 2026-21943, RIN 0955-AA09 (under clinical decision and chatbot limits); Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff (docket FDA-2024-D-4488), notice of availability, 90 FR 1154 (Jan. 7, 2025) (under devices and FDA oversight); S. 3062, Guidelines for User Age-verification and Responsible Dialogue Act of 2026 (GUARD Act), 119th Congress, reported by the Senate Judiciary Committee with an amendment (Calendar No. 406) (under clinical decision and chatbot limits).
Government-wide AI policy
Executive Order 14179, Removing Barriers to American Leadership in Artificial Intelligence, 90 FR 8741 (Jan. 31, 2025)
Winning the Race: America's AI Action Plan (White House, July 2025)
Executive Order 14355, Unlocking Cures for Pediatric Cancer With Artificial Intelligence, 90 FR 48153 (Oct. 7, 2025)
HHS Artificial Intelligence (AI) Strategy, version 1.0 (issued Sept. 30, 2025)
Executive Order 14365, Ensuring a National Policy Framework for Artificial Intelligence, 90 FR 58499 (Dec. 16, 2025)
OMB Memorandum M-25-21, Accelerating Federal Use of AI through Innovation, Governance, and Public Trust (April 3, 2025)
FTC, Policy Statement Concerning the Suppression of Accuracy in Artificial Intelligence Systems (proposed), 91 FR 41638 (July 7, 2026)
Which federal rules apply to me: physician, practice owner, hospital.
Calendar of dates laws take effect (federal entries): subscribe or download the .ics file.
General information, not legal advice. The whole map is available as data at /law-map/laws.json.