Regulation of Health-Related Artificial Intelligence in Medical Devices: The Canadian Story

Forthcoming in the University of British Columbia Law Review

40 Pages Posted: 7 Mar 2022 Last revised: 12 Mar 2022

See all articles by Michael Da Silva

Michael Da Silva

University of Southampton; University of Ottawa

Colleen M. Flood

University of Ottawa - Faculty of Law

Matthew Herder

Dalhousie University - Faculties of Medicine and Law; Dalhousie University - Faculty of Medicine

Date Written: February 4, 2022

Abstract

Artificial Intelligence (AI) may transform Canadian healthcare. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet, despite this tantalizing prospect, there are risks of unsafe AI harming patients, algorithmic bias, and threats to privacy. This work begins analysis of whether applicable Canadian laws are up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. It focuses on Health Canada’s regulation of medical devices, a ‘first line of defence’ that decides which devices are safe, effective, and thus permitted for trade in Canadian markets. After highlighting the regulatory challenge, we provide the first detailed explanation of Canadian medical device regulations and how they apply to AI-enabled devices. We then discuss a still-developing “alternative pathway” for licencing devices with AI and the regulatory gaps left open. We conclude with recommendations that a recent emphasis on post-market surveillance should not be at the expense of robust pre-market review and that safety and efficacy review embrace bias- and privacy-related risks. Further, whilst post-market surveillance holds potential for ensuring the safety of adaptive machine-learning medical devices over time, much will depend on regulatory capacity and competency and investments therein.

Note: This is a draft version of the paper, which has been accepted for publication in the University of British Columbia Law Review. The final text will include several revisions. That version is forthcoming in Volume 55(3) of the aforementioned U.B.C. journal.

Funding Information: This paper is part of the Canadian Institutes of Health Research (CIHR)-funded (grant 155390) project Machine MD: How Should We Regulate AI in Health Care?, co-led by Colleen M. Flood, Anna Goldenberg, Catherine Régis, and Teresa Scassa.

Declaration of Interests: Matthew Herder reported being a member of the Patented Medicine Prices Review Board, Canada’s national drug price regulator, and receiving honoraria for his service. Michael Da Silva was a nonremunerated member of Health Canada’s External Reference Group on Adaptive Machine Learning-Enabled Medical Devices.

Keywords: Law, Health Law, Artificial Intelligence, Medical Devices, Canada

Suggested Citation

Da Silva, Michael and Flood, Colleen M. and Herder, Matthew, Regulation of Health-Related Artificial Intelligence in Medical Devices: The Canadian Story (February 4, 2022). Forthcoming in the University of British Columbia Law Review, Available at SSRN: https://ssrn.com/abstract=4027076 or http://dx.doi.org/10.2139/ssrn.4027076

Michael Da Silva (Contact Author)

University of Southampton ( email )

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

University of Ottawa ( email )

2292 Edwin Crescent
Ottawa, Ontario K2C 1H7
Canada

Colleen M. Flood

University of Ottawa - Faculty of Law ( email )

57 Louis Pasteur Street
Ottawa, K1N 6N5
Canada
416-697-4594 (Phone)

Matthew Herder

Dalhousie University - Faculties of Medicine and Law ( email )

6225 University Avenue
Halifax, Nova Scotia B3H 4H7
Canada

Dalhousie University - Faculty of Medicine ( email )

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