Artificial intelligence (AI) is transforming health care, improving diagnosis, treatment, and access to services. However, AI systems—especially machine learning and generative AI—pose significant safety challenges. Thesetools can evolve after regulatory approval, experience performance degradation, and behave unpredictably across different clinical settings.
In the face of these challenges, the Canadian Institutes of Health Research (CIHR) has announced the funding of “Optimizing Medical Device Regulation of Artificial Intelligence,” a four-year study that will examine how Canada’s medical device framework can continue to evolve in response to rapidly advancing technologies, particularly machine learning and generative AI. The project will xplores how Canada’s medical device regulations can be reformed to better address the evolving safety risks posed by AI in health care. Its goal will be to develop model laws and regulatory approaches that protect patients from AI-related safety risks, adapt to rapid technological change, and support the timely adoption of safe and effective health AI.
The project will be led by Dr. Collen M. Flood, Associate member at the Centre for Law, Technology and Society and Dean of Law and Full Professor at Queen’s University. The project leadership includes Dr. Teresa Scassa,Faculty member at the Centre for Law, Technology and Society and Canada Research Chair in Information Law and Policy at the University of Ottawa, as well as co-investigators Dr. Devin Singh, Dr. Anna Goldberg, and Dr. Catherine Régis.
The project will analyze and compare regulatory frameworks in Canada, the United States, the United Kingdom, the European Union, Australia, Brazil, and Nigeria. Working with a global network of researchers, regulators, patient groups, Indigenous communities, and health professional organizations, the team will develop model laws and regulatory tools that protect patients while supporting responsible innovation.
Congratulations to Drs. Flood and Scassa.