Assess HIPAA compliance for AI systems processing Protected Health Information (PHI). Evaluates administrative, physical, and technical safeguards required for AI systems in healthcare settings.

Evaluate FDA regulatory requirements for AI/ML-based Software as a Medical Device (SaMD). Determines device classification, regulatory pathway, and compliance requirements per FDA AI/ML Action Plan.

Comprehensive clinical AI safety assessment covering bias, validation, human oversight, and EU AI Act obligations for healthcare AI systems. Provides CASA tier recommendation.

Assess EU Medical Device Regulation (MDR 2017/745) compliance for AI-based medical devices. Determines MDR classification, conformity assessment route, and regulatory requirements.