AI and Mental Health – White Paper
AI and Mental Health – Policy and regulatory analysis
12-Month AI Implementation Roadmap
Canada | United States
Mental Health AI Deployment
Regulatory Classification
☐ Determine if AI qualifies as ML-enabled medical device
☐ Confirm Health Canada classification
☐ Confirm need for device licence
☐ Validate PCCP (Predetermined Change Control Plan)
Privacy
☐ Conduct Privacy Impact Assessment
☐ Confirm PHIPA compliance
☐ Address cross-provincial data transfer
☐ Review Quebec-specific health data law (if applicable)
☐ Confirm vendor cannot reuse data
Governance
☐ AI Oversight Committee established
☐ Bias testing documented
☐ Model monitoring in place
☐ Escalation protocol documented
Contracts
☐ Data ownership defined
☐ Indemnification clauses included
☐ Model update notice requirement
☐ Breach notification timeline
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