Canada is falling behind in the global race to deploy safe, effective AI in healthcare. Fragmented provincial regulations, lack of post-market oversight, and clinician mistrust are stalling innovation and delaying life-saving tools.

One of the key priorities requiring federal funding is the implementation of HAIVN (Health AI Validation Network), the CAR’s framework for an oversight body responsible for post-market validation of AI applications in healthcare. HAIVN serves as an independent entity dedicated to, monitoring, and optimizing AI technologies in Canadian healthcare, ensuring their safety, efficacy, and ethical compliance across the ecosystem. By fostering collaboration among vendors, providers, policymakers, and patients, HAIVN builds trust and drives innovation while safeguarding equitable and high-quality care. Moreover, HAIVN ensures that health professionals have a central role in shaping how AI technologies are integrated into clinical practice, creating a trusted framework that balances technological advancement with professional insights and public confidence.

HAIVN offers a solution to the impeding regulatory and oversight issues with:

• Clinician-led validation in real-world settings

• Continuous monitoring to prevent performance drift and bias

• National standards that reduce duplication and accelerate adoption

• Independent governance free from vendor influence

The HAIVN framework has four key pillars:

• Phase 1: Initial Post-Approval Monitoring

• Deployment Audit: Ensuring AI solutions follow approved protocols

• Baseline Challenge: Establishing performance benchmarks

• Performance Metrics: Defining key indicators for long-term evaluation

• Phase 2: Continuous Monitoring

• Drift Testing: Regular evaluation against challenge datasets

• Data Collection: Ongoing analysis of performance metrics

• User Feedback: Gathering insights from healthcare providers

• Ethical Audits: Verifying compliance with privacy and ethical standards

• Adverse Event Reporting: Independent mechanisms for safety reporting

• Phase 3: Performance and Safety Re-Evaluation

• Recurrent Review: Annual verification of performance standards

• Longitudinal Assessment: Collaboration with health technology assessors for value-based evaluation

• Re-assessment Triggers: Defined thresholds for immediate review

• Phase 4: Ongoing Improvement and Re-Certification

• Technology Updates: Review of substantial changes to AI models

• Re-Certification: Ongoing assessment of safety, efficacy, and compliance

HAIVN’s certification process ensures that AI solutions surpass safety, efficacy, and ethics standards before and after being deployed in the Canadian healthcare system. Types of AI that can be certified include diagnostic tools, predictive analytics, Clinical Decision Support (CDS) systems, and administrative AI solutions.

Members of the CAR convened in Ottawa in October to meet with government officials from different political affiliations to present this and several other key priorities ahead of the 2026 federal budget. One such meeting took place between President Dr. Alison Harris and her local MP Taleeb Noormohamed, Parliamentary Secretary to the Minister of AI and Digital Innovation Evan Soloman, where they discussed the critical need for government and clinician-led oversight.

“We discussed the Health AI Validation Network (HAIVN) and the importance of having a national entity that provides oversight for AI, that it has an advisory group with representation from multiple specialties, and that is adequately funded as outlined in our 2026 Pre-Budget Submission.” 

HAIVN is a topic the CAR has brought to the federal government consistently for the past several years. In 2023, a session on the need for national oversight of AI was held on Parliament Hill, led by Dr. Jaron Chong, AI Standing Committee President. This year, the CAR has formally lobbied the federal government for $50 million over five years to help establish HAIVN’s administrative framework and ongoing support from various healthcare associations including the Canadian Medical Association, the Canadian Association of Medical Radiation Technologists, and Sonography Canada. Find out more about this important initiative.