AI Compliance for Healthcare AI
Healthcare AI is addressed by 50 regulatory updates across 3 jurisdictions and 3 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(37)
FDA AI-enabled medical device public list and transparency resource
The FDA’s AI-enabled medical device list is a periodically updated transparency resource that identifies authorized devices and encourages sponsors to include enough information in public summaries to support future tagging of foundation-model-based functionality.
FDA AI-enabled medical devices overview and resource list
The FDA describes its risk-based oversight of AI-enabled medical devices and provides a periodically updated public list for transparency and regulatory expectations.
FDA draft guidance on lifecycle management and marketing submissions for AI-enabled devices
The FDA’s draft guidance recommends documentation and lifecycle-management practices for marketing submissions covering AI-enabled device software functions.
FDA final PCCP webinar for AI-enabled device software functions
On January 14, 2025, the FDA held a webinar on the final guidance for Predetermined Change Control Plans for AI-enabled device software functions, explaining how sponsors should plan iterative modifications and their validation impacts.
FDA regulatory evaluation of new AI uses in medical practices
FDA says novel AI clinical uses may require new assessment paradigms, especially for rule-out, triage, prognosis, treatment response, risk assessment, and large language model applications.
California(9)
California AI bills on healthcare, employment, and transparency
California state AI bills AB2575, SB947, SB503, AB1979, and SB1159 advanced in late August 2026, signaling continued movement on healthcare AI, automated decision systems, and AI transparency/governance.
California AI bills advance on employment, health care, and governance
Multiple California AI bills moved forward on August 12-13, 2026, including measures on automated decision systems, agentic AI, transparency, and health-care AI, so companies operating in California should treat state legislative tracking as an active near-term compliance task.
California 2026 AI bills on employment, health care, and agentic AI
California has introduced multiple AI bills affecting employment, health care, labor impacts, and agentic AI, and several were already set for hearing or suspense-file consideration as of early August 2026, so employers and AI vendors should review them immediately.
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.
Colorado(4)
California AI bills advancing on healthcare and employment automation
California’s 2026 AI bills on healthcare services and automated decision systems advanced late in session, so employers and health providers should continue tracking whether they become enacted obligations.
California AI health-care bills and transparency bill advance in the 2026 session
Several California AI bills were active in late August 2026, including health-care AI and transparency measures moving through amendments and enrollment, meaning California-facing AI teams should monitor final text closely for new obligations.
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.
Weekly digest
Leave your email to get each issue in your inbox. Free, no account required.
We use your email only for the digest. Privacy policy