Grant: Project Grant

Artificial intelligence (AI) is reshaping health care, driving advances in diagnosis, treatment, and access. Yet AI-especially adaptive forms like Machine Learning and Generative AI-poses safety risks that medical device regulation, the core safeguard against harm, was never designed to address. Canada and other countries are scrambling to modernize these outdated rules for fast-changing technologies. We will create a public, online evidence base tracking safety issues and global regulatory responses, updated throughout and beyond the project. Backed by a global network of experts and stakeholders, we will systematically analyze how Canada and six other countries regulate AI in medical devices, pinpointing gaps and testing how different frameworks respond to high-risk AI. From this, we will develop model law/regulations that (i) shield patients from AI-related harms, (ii) adapt to rapid technological change, and (iii) support the uptake of safe AI innovation. By working with regulators, policymakers, patient organizations, Indigenous communities, and health professionals, we will deliver practical, evidence-based reforms. Canada can lead globally in health-AI governance-ensuring safety, fairness, and innovation. Without action, reliance on outdated regulation will leave patients at risk and Canada dependent on foreign-controlled technologies.