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Presentation Join us for a conversation on the regulation and product safety of medical devices using AI with Michael Da Silva, Marc Lamoureux, Dr. Devin Singh and Colleen Flood. Artificial Intelligence (AI) will potentially transform the Canadian healthcare system. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet the use of health-related AI also presents risks, including the possibility of unsafe AI harming patients, algorithmic bias, and threats to privacy. These considerations jointly present challenges for existing regulatory frameworks. For instance, it can be difficult to assess the safety of a medical device with AI if the AI will ‘adapt’ over time in response to real-world data and change its operations in ways that even developers cannot predict. Health Canada is accordingly in the process of revising its rules on the regulation of medical devices with ‘adaptive’ machine learning AI. Building on a collaborative paper authored with Colleen M. Flood (University of Ottawa) and Matthew Herder (Dalhousie University), Michael Da Silva will discuss the extent to which Health Canada’s regulation of medical devices is up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. He will then present principles that should inform ongoing regulatory reforms for devices with adaptive machine learning AI. The presentation will be followed by a conversation led by Dr. Colleen Flood and featuring comments from the regulator's perspective with Marc Lamoureux and an innovator's one with Dr. Devin Singh.