CIHR Funds Law Dean for Global Project on Safe Health-AI Regulation
Dean Colleen M. Flood has received $355,724 from the Canadian Institutes of Health Research (CIHR) for a global project aimed at examining how medical device regulation can better support the safe and effective use of artificial intelligence (AI) in health care.
The project is co-led by:
- Professor Catherine Régis (Université de Montréal)
- Professor Anna Goldenberg (The Hospital for Sick Children/University of Toronto)
- Dr. Devin Singh (The Hospital for Sick Children)
- Professor Teresa Scassa (University of Ottawa)
Project Overview
Flood emphasizes that Health-AI has the potential to radically improve access to care, enhance quality, and support more efficient and equitable health systems. However, realizing that promise depends on addressing real and evolving risks to ensure Canadians receive safe, high-quality care.
The project, titled “Optimizing Medical Device Regulation of Artificial Intelligence,” is a four-year study focusing on how Canada’s medical device framework can evolve to respond to rapidly advancing technologies, particularly machine learning and generative AI.
Regulatory Challenges
While Health Canada has taken important steps to modernize oversight, the pace and adaptability of regulation are critical. The project will emphasize learning from other jurisdictions to identify agile regulatory approaches that can respond to evolving AI systems, which perform differently across clinical settings and introduce new forms of risk.
Flood, a leading scholar in health law and policy, notes that AI challenges traditional regulatory assumptions about static technologies. “Ensuring patient safety, public trust, and sustained innovation requires regulatory approaches that can adapt alongside technological change,” she states.
Comparative Analysis
The project will analyze and compare regulatory frameworks in:
- Canada
- The United States
- The United Kingdom
- The European Union
- Australia
- Brazil
- Nigeria
Working 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 protect patients while supporting responsible innovation. A public, online evidence base will track safety issues and regulatory responses throughout and beyond the project.
Vision for Canada
The ultimate goal is to position Canada as a global leader not only in health-AI innovation but also in the regulatory approaches that make such innovation safe, trustworthy, and scalable. Flood explains, “Innovation and regulation are interdependent — and Canada’s success depends on advancing both together.”
Upcoming Public Talk
Dean Flood will give a public talk titled “Machine M.D.: The Governance of Health-Related AI” on February 12 from 12–2 pm in Robert Sutherland Hall. This event is hosted by Queen’s School of Policy Studies.
