AI and Mental Health – White Paper
AI and Mental Health – Policy and regulatory analysis
Canada | United States
Mental Health AI Deployment
Regulatory Classification
☐ Determine if AI qualifies as SaMD
☐ Confirm FDA clearance status (if applicable)
☐ Review vendor PCCP documentation
☐ Confirm intended use clarity
Privacy
☐ HIPAA compliance review
☐ Business Associate Agreement executed
☐ De-identification standards verified
☐ Audit logging enabled
Telehealth
☐ State licensure compliance verified
☐ Controlled substance prescribing rules reviewed
☐ Telehealth reimbursement alignment
Governance
☐ Clinical oversight established
☐ Human-in-the-loop protocols defined
☐ Adverse event reporting mechanism
☐ Model drift monitoring
Executive Summary
AI in mental health is no longer experimental.
It is entering mainstream clinical infrastructure.
The difference between safe transformation and reputational risk lies in:
• Governance discipline
• Clear classification
• Vendor accountability
• Executive oversight
• Measured, phased deployment