healthcare · HIPAA · FDA SaMD guidance · EU AI Act Annex III
Healthcare AI / Medical Malpractice
Deployer owns AI failure — vendor caps liability; hospital pays claim then subrogates nothing
—EU AI Act high-risk + global AI governance wave
Regulatory exposure — commonly overlooked:
Insurers underwriting health AI exclusions while using AI in claims — same governance gap NAIC flags for carriers. · Multinationals built for one jurisdiction fail exams in another — one receipt architecture, many filing packs.
TAM / Exposure
$4B+ US med mal · coverage-denial AI in active litigation
Insurance lines
Med mal · Hospital liability · Health cyber
Exhibit authority
Global External Validation — Clinical AI SaMD + Med Mal Evidence Pack
Global leaders
FDA · Joint Commission · Gallagher Re · Epic · UnitedHealth · ISO · NIST · OECD
Coverage denial litigation
Algorithms denying care are in discovery now — reconstructability beats internal EHR logs.
PCCP gap
FDA change control plans don't cover vendor foundation model updates — undocumented drift = liability.
Board accountability
Public health systems: AI governance is SEC-disclosable material risk in 2026.