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Healthcare AI / Medical Malpractice

Deployer owns AI failure — vendor caps liability; hospital pays claim then subrogates nothing

—EU Product Liability Directive transposition

Regulatory exposure — commonly overlooked:
Insurers underwriting health AI exclusions while using AI in claims — same governance gap NAIC flags for carriers.

TAM / Exposure

$4B+ US med mal · coverage-denial AI in active litigation

Insurance lines

Med mal · Hospital liability · Health cyber

Exhibit authority

Clinical AI SaMD + Med Mal Evidence Pack

Global leaders

FDA · Joint Commission · Gallagher Re · Epic · UnitedHealth

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.

7 mandate layers (live)

Regulatory Clock Countdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition. Open →

Domain Classifier Industry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping. Open →

Exhibit / Filing Pack Regulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11. Open →

Mandate Registry Enroll deployers/insureds under vertical-specific governance mandate. Open →

Bind / Action Gate ALLOW/BLOCK before consequential action — bind policy, sell loan, deactivate worker. Open →

Compliance Certificate Deployer-facing downloadable cert — forward to counsel, auditor, regulator. Open →

Actuarial / Risk Feed Anonymized asymmetry signals for pricing, reserving, reinsurance correlation. Open →

Run healthcare demo Regulatory calendar Download exhibit pack Verify independently