Regulating the safety of health–related artificial intelligence.
Open accessAbstract
This article analyzes whether Canada's present approach to regulating health-related artificial intelligence (AI) can address relevant safety-related challenges. Focusing primarily on Health Canada's regulation of medical devices with AI, it examines whether the existing regulatory approach can adequately address general safety concerns, as well as those related to algorithmic bias and challenges posed by the intersections of these concerns with privacy and security interests. It identifies several issues and proposes reforms that aim to ensure that Canadians can access beneficial AI while keeping unsafe products off Canadian markets and motivating safe, effective use of AI products for appropriate purposes and populations.
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Artificial intelligence-linked medical devices are considered software as a medical device and are regulated under federal departments such as Health Canada and the US Food and Drug Administration.
“Artificial intelligence–linked medical devices are considered software as a medical device and are regulated under federal departments such as Health Canada and the US Food and Drug Administration.170”
From Large Language Models for Chatbot Health Advice Studies: A Systematic Review (2025) · cites this paper as [170]
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References 30 · Cited by 23
Research works printed but not linked: 4
- Flood C.M. Régis C.. 2021. AI & Health Law in Canada. In Bariteau-Martin F. Scassa T., eds., Artificial Intelligence and the Law in Canada (pp. 203– 28). LexisNexis.
- Gerriets V. Anderson J. Nappe T.M.. 2021. Acetaminophen. StatPearls Publishing. 29493991
- Krishnamurthy K. 2021. AI and Human Rights Law. In Bariteau-Martin F. Scassa T., eds., Artificial Intelligence and the Law in Canada (pp. 229– 41). LexisNexis.
- Pasquale F. 2020. New Laws of Robotics: Defending Human Expertise in the Age of AI. Harvard University Press.
- Authors
- Silva, M., Flood, C., Goldenberg, A., & Singh, D.
- Affiliations
- University of Ottawa (CA)
- Canadian Institute for Advanced Research (CA)
- University of Toronto (CA)
- Corresponding author
- Flood, Colleen
- Venue
- Healthcare Policy | Politiques de Santé
- Publisher
- Longwoods Publishing
- Published
- 2022-05-23
- Volume
- 17
- Issue
- 4
- Pages
- 63-77
- ISSN
- 1715-6572 (ISSN-L)
- 1715-6580
- PMC
- PMC9170055
- OpenAlex
- W4281726525
- Cited by
- 23
- References
- 30
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 8 · 2023: 1 · 2022: 2
- FWCI
- 3.56
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Healthcare policy (publishedVersion)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- Funders
- Canadian Institutes of Health Research (155390)
- Topics
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Social Sciences › Law › Digitalization, Law, and Regulation
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Keywords
- Health Canada, algorithmic bias, privacy, cybersecurity, regulatory reform, Canada
- MeSH terms
- Artificial Intelligence, Canada, Humans
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