Healthcare · Industry Guide
AI Risk for Healthcare
PHI plus AI plus regulator scrutiny. Get the controls right before HHS, OCR, or your provincial commissioner asks.
Regulatory drivers
- HIPAA (US)
- PHIPA (Ontario)
- Quebec Law 25 + Loi 95
- FDA AI/ML SaMD guidance
- EU AI Act high-risk for medical devices
Top AI risks for healthcare
- Clinical-decision-support AI requiring FDA clearance or equivalent regulatory pathway
- PHI flowing into LLM prompts without proper BAAs
- Vendor BAAs not covering AI-specific data handling
- Hallucinated clinical content in patient-facing channels
- AI-generated documentation accuracy under physician sign-off requirements
Common engagement use cases
- AI Posture Check for hospital-network-wide AI use
- Vendor BAA review specifically for AI providers
- Pre-deployment safety review for clinical-decision-support tools
- PHIPA and HIPAA evidence production for AI deployments
Engagement shape
Same three-tier structure.
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