healthcare · HIPAA · FDA SaMD guidance · EU AI Act Annex III
Radiology AI (SaMD)
Radiology AI 510(k) — per-read decision receipt for malpractice
—CMA agent liability guidance (live)
Regulatory exposure — commonly overlooked:
Hospital owns read — AI vendor owns cleared device label only · CMA: you are liable for your AI agent like an employee — applies to every agentic commerce vertical.
TAM / Exposure
$2B AI radiology
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
UK CMA Agent Liability Pack — Radiology AI (SaMD) External Validation Pack
Global leaders
Aidoc · Google Health · FDA · CMA · ICO · FCA · Lloyd's
Missed finding
AI flagged then dismissed — who owns miss? Receipt settles.
FDA PCCP
Model update without receipt = off-label use inference
[United Kingdom] Post-Brexit divergence
UK not bound by EU AI Act but CMA/ICO more aggressive on agents.
[United Kingdom] London market
Lloyd's syndicates need AI decision audit for specialty lines.
[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 →