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Regulatory Calendar
healthcare · FDA 21 CFR Part 11 · GCP ICH E6 · EU AI Act Annex III
Pharmacy Dispensing AI
Pharmacy Dispensing AI — AI decision audit trail required for liability defense
—EU AI Act + sector regulator
Regulatory exposure — commonly overlooked:
Niche Pharmacy Dispensing AI deployer owns AI harm — vertical SaaS vendor owns liability cap.
Niche litigation
Pharmacy Dispensing AI plaintiffs challenge AI decision without independent verify.
Insurance bind
Sector insurers asking AI governance questions on Pharmacy Dispensing AI accounts.
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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