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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 · Netherlands transposes Platform Work first — Deliveroo/Uber NL = first algorithmic management test case.
Missed finding
AI flagged then dismissed — who owns miss? Receipt settles.
FDA PCCP
Model update without receipt = off-label use inference
[Netherlands] Platform work first
NL historically aggressive on gig economy — deactivation receipt critical.
[Netherlands] DNB banking
Dutch bank AI — DNB expects model documentation in English and Dutch.
[Text / Chat] Modality hook
Baseline — all frameworks apply to text decisions.
7 mandate layers (live)
Regulatory Clock
Countdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition.
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Domain Classifier
Industry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping.
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Exhibit / Filing Pack
Regulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11.
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Mandate Registry
Enroll deployers/insureds under vertical-specific governance mandate.
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Bind / Action Gate
ALLOW/BLOCK before consequential action — bind policy, sell loan, deactivate worker.
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Compliance Certificate
Deployer-facing downloadable cert — forward to counsel, auditor, regulator.
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Actuarial / Risk Feed
Anonymized asymmetry signals for pricing, reserving, reinsurance correlation.
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