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
—NYDFS AI guidance + Local Law 144 enforcement
Regulatory exposure — commonly overlooked:
Insurers underwriting health AI exclusions while using AI in claims — same governance gap NAIC flags for carriers. · Local Law 144 requires annual bias audit — Velaru receipts are continuous audit, not annual snapshot.
TAM / Exposure
$4B+ US med mal · coverage-denial AI in active litigation
Insurance lines
Med mal · Hospital liability · Health cyber
Exhibit authority
New York AI Governance Pack — Clinical AI SaMD + Med Mal Evidence Pack
Global leaders
FDA · Joint Commission · Gallagher Re · Epic · UnitedHealth · NYDFS · NYC DCWP · Goldman Sachs
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.
[New York] Financial capital
NYDFS regulates insurers AND banks — same receipt primitive for both books.
[New York] Hiring audit law
NYC AEDT law is template for other cities — receipt architecture scales municipally.
[Text / Chat] Modality hook
Baseline — all frameworks apply to text decisions.
7 mandate layers (live)
Regulatory ClockCountdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition.Open →
Domain ClassifierIndustry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping.Open →
Exhibit / Filing PackRegulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11.Open →
Mandate RegistryEnroll deployers/insureds under vertical-specific governance mandate.Open →