healthcare · HIPAA · FDA SaMD guidance · EU AI Act Annex III
Radiology AI (SaMD)
Radiology AI 510(k) — per-read decision receipt for malpractice
—FDA SaMD + EU MDR
Regulatory exposure — commonly overlooked:
Hospital owns read — AI vendor owns cleared device label only · Ireland DPC leads EU enforcement against US tech — AI decisions in Ireland = DPC jurisdiction.
TAM / Exposure
$2B AI radiology
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
Ireland DPC AI Pack — Radiology AI (SaMD) External Validation Pack
Global leaders
Aidoc · Google Health · FDA · DPC · Central Bank of Ireland · Stripe EU
Missed finding
AI flagged then dismissed — who owns miss? Receipt settles.
FDA PCCP
Model update without receipt = off-label use inference
[Ireland] Tech HQ density
Meta, Google, Apple EU HQ — AI governance tested in Irish courts first.
[Ireland] CBI insurance
Irish insurance undertakings — Solvency II + AI governance overlap.
[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 →