healthcare · HIPAA · FDA SaMD guidance · EU AI Act Annex III
Radiology AI (SaMD)
Radiology AI 510(k) — per-read decision receipt for malpractice
—HB 3773 AI in employment (live)
Regulatory exposure — commonly overlooked:
Hospital owns read — AI vendor owns cleared device label only · Chicago = AmTrust HQ = hiring AI civil rights law live NOW. Notice + audit trail or per se violation.
TAM / Exposure
$2B AI radiology
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
Illinois IHRA AI Pack — Radiology AI (SaMD) External Validation Pack
Global leaders
Aidoc · Google Health · FDA · IL Dept Human Rights · AmTrust · Equifax Workforce
Missed finding
AI flagged then dismissed — who owns miss? Receipt settles.
FDA PCCP
Model update without receipt = off-label use inference
[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 →