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. · Federal agencies disagree on AI approach — but examiners agree internal logs are insufficient.
TAM / Exposure
Global Digital Pathology AI market
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
US Federal Exhibit — Digital Pathology AI External Validation Pack