Dean Colleen M. Flood has been awarded $355,724 from the Canadian Institutes of Health Research (CIHR) to spearhead a global initiative aimed at enhancing medical device regulation to better support the safe and effective use of artificial intelligence (AI) in healthcare. The four-year project, titled “Optimizing Medical Device Regulation of Artificial Intelligence,” is co-led by esteemed colleagues including Professor Catherine Régis from Université de Montréal, Professor Anna Goldenberg from The Hospital for Sick Children/University of Toronto, Dr. Devin Singh, also from The Hospital for Sick Children, and Professor Teresa Scassa from University of Ottawa.
Flood emphasized the transformative potential of Health-AI in improving healthcare access, enhancing quality, and fostering more efficient and equitable health systems. “Realizing that promise, however, depends on addressing real and evolving risks so that Canadians receive the safe, high-quality care they deserve,” she stated. This initiative seeks to ensure that regulatory practices can keep pace with the rapid advancements in technologies such as machine learning and generative AI.
While Health Canada has implemented significant steps toward modernizing oversight in this domain, the adaptability and responsiveness of regulations will be paramount. The project aims to leverage lessons from various jurisdictions to identify regulatory approaches that can adjust to the dynamic nature of AI systems, which may perform differently across clinical settings and introduce unique forms of risk.
As a leading scholar in health law and policy, Flood also leads the CIHR-funded Machine M.D. research initiative, addressing how AI challenges conventional regulatory frameworks that often assume static technology. “Ensuring patient safety, public trust, and sustained innovation requires regulatory approaches that can adapt alongside technological change,” she remarked.
The project will conduct a comparative analysis of regulatory frameworks in Canada, the United States, the United Kingdom, the European Union, Australia, Brazil, and Nigeria. By collaborating with a global network of researchers, regulators, patient groups, Indigenous communities, and health professional organizations, the team aims to develop model laws and regulatory tools that not only protect patients but also encourage responsible innovation. Additionally, the project will establish a public, online evidence base designed to monitor safety issues and regulatory responses throughout its duration and beyond.
Flood expressed a vision for Canada to emerge as a global leader not only in health-AI innovation but also in the regulatory frameworks that underpin such advancements. “Innovation and regulation are interdependent — and Canada’s success depends on advancing both together,” Flood asserted.
To further engage the public on these critical issues, Dean Flood will present a talk titled “Machine M.D.: The Governance of Health-Related AI” on February 12 from 12–2 pm in Robert Sutherland Hall. This event, hosted by Queen’s School of Policy Studies, will provide further insights into the governance challenges posed by the integration of AI into healthcare.
As AI technologies continue to evolve, the outcomes of this research could significantly influence the interplay between innovation and regulation, potentially setting a benchmark for countries worldwide. This initiative reflects a growing recognition that effective governance of health-related AI is essential for ensuring patient safety and public trust in these transformative technologies.
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