The AI + Society Initiative at the University of Ottawa is delighted to announce the release of AI & Health Care: A Fusion of Law & Science. Regulation of Medical Devices with AI, a second finding report supported by CIFAR AI and Society Program and led by Dr. Colleen M. Flood.
AI is poised to radically change the Canadian healthcare system. It would lead to radical improvements, but also raises a number of issues, including those relating to safety and efficacy, bias and discrimination, and privacy. With the support of the CIFAR AI + Society program, the “AI & Health Care: A Fusion of Law & Science” workshop team organized events where experts in AI, law, ethics, policy, and medicine examined the range of regulatory challenges and different legal tools that could be used to leverage AI’s benefits while minimizing its risks. In March, the team released AI & Health Care: A Fusion of Law & Science - An Introduction to the Issues, an initial finding report that highlighted the need for a full audit of the range of laws that apply to the use of AI in healthcare. It also provided an examination of regulatory gaps, and explored law reform options.
The new report AI & Health Care: A Fusion of Law & Science. Regulation of Medical Devices with AI presents findings from a February 2021 workshop that focused on a particular set of laws, namely those applying to the regulation of ‘medical devices’ with AI. Researchers and innovators with expertise in law, ethics, policy, medicine, and computer science met to address a central question: How should Health Canada regulate medical devices with AI? Many AI tools in healthcare are likely to interface with, or constitute medical devices. Health Canada’s review and licensing of medical devices is a ‘first line of defense’ in ensuring medical device safety and efficacy. Yet, AI may challenge traditional approaches to pre- and post-market review of medical devices. Questions remain as to whether existing evidentiary standards for product safety are appropriate when dealing with AI, and which forms of post-market review are appropriate to address the challenges of ‘machine learning’ AI which changes over time by definition and may present unexpected challenges. Health Canada is accordingly re-examining its approach to medical device regulation.
The CIFAR workshop team collaborated to help guide Health Canada in its efforts to regulate in ways that can leverage AI’s benefits. Having representatives from Health Canada in attendance helped to further ensure that the insights and recommendations made were timely and well-informed .
This new report summarizes these discussions and presentations on how medical devices are regulated in Canada, the U.S.A., and New Zealand; innovator reflections on the comparative legal data; and three breakout sessions focused on the regulatory challenge.
The report is also available in French.
Led by Dr. Colleen M. Flood, the AI + Health lead and the University of Ottawa Research Chair in Health Law and Policy, the workshop was co-organized with Dr. Joelle Pineau, Associate Professor and William Dawson Scholar at McGill University and a core member of Mila.
The report was prepared by Dr. Michael Da Silva, the Alex Trebek Postdoctoral Fellow in AI and Health at the AI + Society Initiative. Dr. Florian Martin-Bariteau, University of Ottawa Research Chair in Technology and Society, and Dr. Teresa Scassa, Canada Research Chair in Information Law and Policy, and Dr. Céline Castets-Renard, a CLTS Faculty member and the University of Ottawa Research Chair in Accountable AI in Global World, also contributed to the report findings
More details about our AI + Health research program can be found at aisociety.ca/health.