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. · CNIL among most aggressive EU DPAs on AI — French language audit trail required.
TAM / Exposure
Global Pharmacy Dispensing AI market
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
France CNIL AI Pack — Pharmacy Dispensing AI External Validation Pack