Healthcare AI Law Tracker

Colorado Use of Artificial Intelligence in Health Care (HB26-1139)

Colo. HB 26-1139 (2026 Regular Session)

Colorado Automated Decision-Making Technology Act (SB26-189)

Colo. SB 26-189 (2026 Regular Session)

Utah Health Insurance Preauthorization Amendments (SB 319)

Utah Code § 31A-22-650

HHS Office for Civil Rights — Section 1557 Nondiscrimination Rule and AI

ACA Section 1557; 89 FR 37522; 45 CFR Part 92

CMS HPMS Memorandum — FAQs on Use of Algorithms and AI in Medicare Advantage Utilization Management

CMS HPMS Memo (Feb. 2024); 42 C.F.R. §§ 422.101(b)(6), 422.566(d); CMS-4201-F (88 FR 22120)

FDA Artificial Intelligence/Machine Learning-Based Software as a Medical Device (AI/ML-SaMD) Action Plan

FDA AI/ML-SaMD Action Plan (2021)

Colorado Psychotherapy Artificial Intelligence Restrictions (HB26-1195)

Colo. HB 26-1195 (2026 Regular Session)

Utah Healthcare Providers Scope of Practice Amendments (SB 150)

Utah SB 150 (2026); Utah Code §§ 13-1b-203, 13-1b-304, 13-1b-401 to 13-1b-403

CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)

CMS-0057-F; 42 CFR Parts 422, 431, 435, 438, 440, 457; 45 CFR Part 156

Executive Order 14365 — National AI Policy Framework

Exec. Order No. 14365 (Dec. 11, 2025)

Colorado DOI Regulation 10-1-1 (Amended) — AI Governance for Health Benefit Plan Insurers

Colo. DOI Reg. 10-1-1 (Amended; effective Oct. 15, 2025)

Nevada AB 406 — AI in Mental and Behavioral Healthcare

NV Assembly Bill 406 (83rd Session, 2025)

Utah Artificial Intelligence Amendments — Mental Health Chatbots (HB 452)

HB 452 (2025 General Session)

SB 226 — Artificial Intelligence Consumer Protection Amendments

SB 226 (2025 General Session)

Colorado Protect Privacy of Biological and Neural Data (HB24-1058)

Colo. Rev. Stat. § 6-1-1301 et seq. (as amended by HB24-1058)

NIST AI 600-1 — Generative AI Profile

NIST AI 600-1 (2024)

Utah Artificial Intelligence Policy Act (SB 149)

Utah Code § 13-72-101 et seq.

ONC HTI-1 Rule — Health Data, Technology, and Interoperability: Clinical Decision Support

HTI-1 Final Rule; 89 FR 1192; 45 CFR Part 170

Nevada Insurance Bulletin 24-001 — AI in Insurance

NV DOI Bulletin 24-001

FDA 510(k) Clearances for AI-Enabled Medical Devices

FDA AI/ML Medical Device Database

Colorado Privacy Act (CPA / SB21-190)

Colo. Rev. Stat. §§ 6-1-1301 et seq. (SB 21-190)

FDA Marketing Submission Recommendations for AI/ML-Based Software as a Medical Device

FDA Draft Guidance: AI/ML SaMD Marketing Submissions (2023)

FTC Act Section 5 — Unfair or Deceptive AI Practices in Healthcare

FTC Act Section 5; 15 U.S.C. § 45; FTC AI Guidance (2023)

NIST AI Risk Management Framework (AI RMF 1.0)

NIST AI 100-1 (2023)

HIPAA Security Rule Proposed Update

45 C.F.R. Parts 160, 164 (Proposed 2025)

Idaho Conversational AI Safety Act (SB 1297)

Idaho SB 1297 (2026 Session); Idaho Code §§ 48-2101 et seq.; 2026 Session Law Ch. 249

Utah Office of Artificial Intelligence Policy Amendments (HB 320)

Utah HB 320 (2026); Utah Code §§ 13-72-101, 13-72-201, 13-72-301, 13-72-401 to 13-72-403

Colorado Prior Authorization Requirements Alternatives (HB24-1149)

Colo. Rev. Stat. § 10-16-124.5

HHS AI Strategy & RFI on Clinical AI Adoption

HHS AI Strategy (Dec. 4, 2025); 90 Fed. Reg. 84621

Montana Name, Voice & Likeness Rights Act (HB 513)

Montana HB 513 (2025) / Ch. 685

SB 271 — Unauthorized Artificial Intelligence Impersonation Amendments

SB 271 (2025 General Session)

FTC Health Breach Notification Rule — AI and Health Data

Health Breach Notification Rule; 16 CFR Part 318; 89 FR 33111

HHS Strategic Plan for Responsible AI in Health and Human Services

HHS AI Strategy (2024)

CMS Medicare Physician Fee Schedule — Clinical Decision Support Requirements

CY 2024 PFS Final Rule; 88 FR 78818

ISO/IEC 42001:2023 — AI Management System Standard

ISO/IEC 42001:2023

FDA AI/ML Medical Device Framework

FDA PCCP Guidance; 21 U.S.C. § 360c et seq.

ONC Trusted Exchange Framework and Common Agreement (TEFCA) — AI Interoperability

45 C.F.R. § 170.404; HTI-1 Rule (89 Fed. Reg. 1192)

Montana Neurodata Rights Law

Mont. Code § 30-14-2801 et seq. (2025) (Genetic Information Privacy Act, as amended by SB 163)

Kansas AI Platforms of Concern Act (HB 2313)

2025 Kan. Sess. Laws Ch. 84 (HB 2313)

WHO Guidance on Ethics and AI in Health

WHO: Ethics and Governance of AI for Health (June 2021); Regulatory Considerations (Oct 2023)

Texas AI in Utilization Review (SB 815)

Tex. Ins. Code § 4201.156

California AI Healthcare Utilization Law (SB 1120)

Cal. Health & Safety Code § 1367.016; Cal. Ins. Code § 10110.47

EU Artificial Intelligence Act

Regulation (EU) 2024/1689

Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence (DOL / OFCCP)

EO 14110 / DOL OFCCP AI Guidance

General Data Protection Regulation (GDPR)

Regulation (EU) 2016/679

Nevada SB 128 — AI Prohibition in Prior Authorization Denials

NV Senate Bill 128 (83rd Session, 2025)

HJ 4 / LC 1493 — Resolution Requesting Interim Study on Artificial Intelligence

HJ 4 / LC 1493

Wyoming — No AI-Specific Legislation (Active Monitoring)

HEALTH AI Act (H.R. 5045)

H.R. 5045, 119th Congress