AI Governance for
Healthcare & Life Sciences
When AI touches patient care, accountability isn't optional.
The Healthcare AI Challenge
AI is assisting with diagnosis, treatment recommendations, and administrative decisions. FDA and CMS require complete audit trails. Patient safety demands it.
Requires electronic signatures, audit trails, and system validation for software affecting patient safety.
Mandates access controls, audit controls, and integrity controls for PHI.
FDA guidance on AI/ML-based clinical decision support software.
Strengthens HIPAA enforcement with breach notification requirements.
Clinical Decision Support
Document the reasoning behind AI-assisted diagnosis and treatment recommendations.
→ Defend clinical decisions with complete evidence chains
Claims Processing
Capture why claims were approved, denied, or flagged for review.
→ Reduce appeals and demonstrate fair claims handling
Prior Authorization
Seal the policies and precedents that informed authorization decisions.
→ Meet CMS interoperability requirements with full transparency
"Case study coming soon"
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