As of November 3, 2026
Healthcare
Healthcare AI sits at the intersection of medical-device regulation, privacy law, clinical guidelines, and professional liability. This chapter is a factual map, not clinical or legal advice.
In one minute
- In the U.S., some clinical AI products are regulated as medical devices by the FDA; others are clinical-decision support or administrative tools outside device pathways. Classification is fact-specific.
- HIPAA still governs protected health information when covered entities and business associates use AI vendors; BAAs and minimum-necessary rules remain relevant.
- The EU AI Act treats certain medical-device AI and Annex III health uses as high-risk with conformity duties when those provisions apply.
- U.S. FDADevice software functions and AI/ML materials are published by FDA. FDA AI/ML SaMD
- HIPAAHHS materials address third-party tools with ePHI; AI vendors processing PHI typically need BAAs. HHS HIPAA
- EUMedical devices regulation plus AI Act high-risk duties may both apply. See Federal & EU and the law tracker.
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