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
—HB 3773 AI in employment (live)
Regulatory exposure — commonly overlooked:
Insurers underwriting health AI exclusions while using AI in claims — same governance gap NAIC flags for carriers. · Chicago = AmTrust HQ = hiring AI civil rights law live NOW. Notice + audit trail or per se violation.
TAM / Exposure
$4B+ US med mal · coverage-denial AI in active litigation
Insurance lines
Med mal · Hospital liability · Health cyber
Exhibit authority
Illinois IHRA AI Pack — Clinical AI SaMD + Med Mal Evidence Pack
Global leaders
FDA · Joint Commission · Gallagher Re · Epic · UnitedHealth · IL Dept Human Rights · AmTrust · Equifax Workforce
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.
[Illinois] BIPA + HB 3773 stack
Biometric hiring + AI employment decisions — double exposure for same tool.
[Illinois] Home court
Illinois employers and insurers underwriting them need Illinois-specific receipt metadata.
[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 →