AI Compliance for Healthcare AI
Healthcare AI is addressed by 46 regulatory updates across 3 jurisdictions and 2 frameworks. This page tracks how regulators worldwide are approaching healthcare ai in the context of artificial intelligence.
Framework Requirements for Healthcare AI
Regulations Covering Healthcare AI
US Federal(38)
FDA AI-enabled medical device guidance and lifecycle expectations
FDA’s AI/ML medical device guidance set and device list continue to expand, so AI health-tech teams need to align premarket, transparency, and change-control evidence before new or modified systems are submitted or marketed.
FDA draft guidance on artificial intelligence-enabled medical devices
The FDA’s January 2025 draft guidance on AI-enabled medical devices remains the key current benchmark for lifecycle, transparency, bias, and documentation expectations for AI device submissions and post-market controls.
FDA guidance on AI-enabled medical devices remains active
FDA continues to emphasize lifecycle-wide expectations for AI-enabled medical devices, including transparency and predetermined change control, so developers need submission-ready documentation for model changes and postmarket monitoring.
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information
FDA issued a request for information on April 29, 2026 to shape a pilot program for AI-enabled early-phase clinical trials, creating an immediate comment-driven opportunity to influence future expectations for AI use in clinical decision-making.
FDA requests information on AI-enabled early-phase clinical trial pilot
FDA issued a request for information on 2026-04-29 for a pilot program evaluating AI-enabled technologies in early-phase clinical trials, so sponsors and vendors should respond now if they want their operating models reflected in the pilot design.
California(6)
California AB2575 health care services artificial intelligence
California AB2575 was introduced to regulate AI in health care services, adding to the state’s growing AI governance patchwork and requiring ongoing monitoring by health-sector operators.
California AB 2575 – Health care services: artificial intelligence
California AB 2575 was last acted on 2026-05-18 and is still moving as an introduced bill, so healthcare AI teams should track it for emerging state-level obligations rather than treat it as operative law.
California AB1979 advances on health care AI
California AB1979 passed committee on 2026-05-14, keeping health-care AI regulation active in California and requiring providers and vendors to continue preparing for disclosure and oversight duties.
California AB2575: Health care services artificial intelligence
California AB2575 was re-referred to Assembly Appropriations on 2026-04-27, keeping healthcare AI regulation active and signaling that providers and vendors should continue preparing for potential state-level obligations.
California AB 2575: Health care services: artificial intelligence
California AB 2575 was read a second time and amended on April 23, 2026, so healthcare organizations should monitor the bill closely for new AI obligations that could affect clinical workflows and patient-facing tools.
Colorado(2)
Colorado HB1139 advances on use of AI in health care
Colorado HB1139 advanced to Senate third reading on 2026-05-11, increasing the likelihood of new AI-specific obligations for health-care use cases that could require near-term policy and vendor review.
CO HB1139: Use of Artificial Intelligence in Health Care
Colorado HB1139 advanced to Senate Second Reading Special Order on May 8, 2026, signaling continued movement toward state-level AI governance for health-care use cases that may require operational and disclosure planning.
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