The Regulation of Medical Devices with Artificial Intelligence

Posted on Monday, November 8, 2021

The Alex Trebek Forum for Dialogue Project on AI for Healthy Humans and Environments at the AI + Society Initiative presents,
in collaboration with the Centre for Law, Technology and Society, the Institute for Science, Society and Policy and the Centre for Health Law, Policy and Ethics:


The Regulation of Medical Devices with Artificial Intelligence


Michael Da Silva

in conversation with Marc Lamoureux and Dr Devin Singh

moderated by Colleen Flood

Monday, November 8, 2021
at 11:30 ET


Watch The Video Now


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.

About the speakers

Dr. Michael Da Silva is the Alex Trebek Postdoctoral Fellow in AI and Health Care and a Research Associate of the Canadian Institutes of Health Research-funded Machine M.D. research team in the University of Ottawa Faculty of Law and AI + Society Initiative. Michael Da Silva possesses a doctorate from the University of Toronto and previously served as a Banting Postdoctoral Fellow in the McGill University Faculty of Law and Institute for Health and Social Policy. He is affiliated with the Centre for Law, Technology, and Society and the Centre for Health Law, Policy, and Ethics.

Marc Lamoureux is the manager of the Digital Health Division at Health Canada. Since 2011, Marc Lamoureux has worked at Health Canada specializing in the technical assessment of medical software, diagnostic imaging devices, and radiotherapy equipment. He is vice-chair of Canada’s IEC Subcommittees for Diagnostic Imaging and Radiotherapy and he co-chairs the International Medical Device Regulators Forum’s (IMDRF) Cybersecurity Working Group with the US FDA. He is heavily involved in innovative policies to adapt Canada’s regulatory framework for emerging technologies, and is currently Health Canada’s lead for the G7’s Digital Health AI Governance Working Group. He obtained his B.Sc. in Biophysics from the University of Guelph and his M.Sc. in Medical Physics from Carleton University. After graduate work at the University of Ottawa Heart Institute, he spent two years as a Medical Health Physicist with The Ottawa Hospital where he worked closely with federal and provincial regulatory bodies to improve the quality and safety of diagnostic and therapeutic radiation programs.

Dr. Devin Singh is a practicing Paediatric Emergency Medicine Physician from the Hospital for Sick Children (SickKids) in Toronto. He completed his undergraduate studies at the University of Western in medical sciences and went to work for the Ontario Provincial Government as a business analyst. Afterwards, he attended medical school at the University of Sydney, Australia with his paediatric residency and emergency medicine subspecialty training at SickKids Hospital. He also completed an additional fellowship in Clinical AI. His research focuses on the use of machine learning to solve some of healthcare’s largest problems. He is the Physician Lead for Clinical Artificial Intelligence and Machine Learning at SickKids for the Division of Emergency Medicine and has a Masters of Computer Science from the University of Toronto. Most recently he founded Hero AI, an innovative start-up lab dedicated to empowering patients and healthcare providers with AI. 


Dr. Colleen M. Flood is the University Research Chair in Health Law & Policy at the University of Ottawa and a Full Professor in the Faculty of Law, Common Law Section. Dr. Colleen Flood is the inaugural Director of the University of Ottawa Centre for Health Law, Policy and Ethics, a Faculty member at the Centre for Law, Technology and Society, and the Research Lead on AI and Health at the AI + Society Initiative. From 2000–2015 she was a Professor and Canada Research Chair at the Faculty of Law, University of Toronto, with cross-appointments to the School of Public Policy and the Institute of Health Policy, Management and Evaluation. From 2006–2011 she served as Scientific Director at the Canadian Institute for Health Services and Policy Research (CIHR). Her primary areas of scholarship are comparative health care law and policy, public/private financing of health care systems, health care reform, constitutional law, administrative law, and accountability and governance issues more broadly.


This event will be in English only.
This event will be recorded.

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