healthcare · HIPAA · FDA SaMD guidance · EU AI Act Annex III
Digital Pathology AI
Digital Pathology AI — AI decision audit trail required for liability defense
—EU AI Act + sector regulator
Regulatory exposure — commonly overlooked:
Niche Digital Pathology 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 Digital Pathology AI market
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
France CNIL AI Pack — Digital Pathology AI External Validation Pack