An enhanced digital mental health assessment framework integrating clinical safety, cultural safety, privacy, and equity, built on the ORCHA Baseline Review (OBR).

Canada
Assure safe, equitable, and culturally appropriate digital mental health tools
Built on OBR+ with Canadian data sovereignty and equity criteria
The MHCC Assured Framework is a Canadian digital mental health assurance model developed in partnership with the Mental Health Commission of Canada.
It builds on the enhanced ORCHA Baseline Review and introduces additional criteria specific to mental health, cultural safety, and Canadian regulatory expectations; ensuring tools are not only safe and effective, but equitable and contextually appropriate.
The framework is designed to provide trusted, independent validation for digital mental health technologies intended for use across Canadian health systems and populations.
Secure, lawful data handling aligned to Canadian privacy expectations.
Proportionate evidence standards and structured risk management.
Robust infrastructure and protection against cyber risk.
Mental health technologies carry unique risk beyond general digital health:
The MHCC Framework addresses these dimensions directly; embedding Canadian priorities such as social responsibility, equity, and data sovereignty into assurance design.
No. It is a voluntary, independent assurance framework designed to support informed digital mental health adoption.
No. Regulatory obligations (including Health Canada medical device requirements where applicable) remain separate.
It builds on OBR+ but introduces Canadian-specific domains for cultural safety, social responsibility, and enhanced data sovereignty.
Strengthen your product’s credibility, align with Canada’s national expectations and demonstrate independent, equity-informed assurance.
Showcase your product’s quality, safety, and global readiness through ISO 82304-2 and ORCHA Assured.