Part Two: Regulation of Medical Devices with AI (Full report)
This report is the outcome of the second part of a two-part workshop about the fusion of law and science.
« The second event, Regulation of Medical Devices with AI, continued the research team’s work by focusing on a narrower issue: medical device regulation.
Researchers and innovators with expertise in law, ethics, policy, medicine, and computer science met to address a central question: How should Health Canada regulate medical devices with AI?
Health Canada possesses clear regulatory authority over medical devices and conducts safety analyses to determine which medical devices will be authorized for use in Canada. It is in the process of changing its approach to the regulation of medical devices, partly due to a concern with how to regulate AI. This is, accordingly, an important and timely case study in the regulation of AI in healthcare.
The interdisciplinary scholars who were convened for this workshop collaborated to help guide Health Canada in its efforts to regulate in ways that can leverage AI’s benefits. Having representatives from Health Canada in attendance helped to further ensure that the insights and recommendations made were timely and well-informed.
Leadership Team: Colleen Flood, University of Ottawa, Canada; Ian Kerr (until 2019), University of Ottawa, Canada; Joelle Pineau, McGill University, Canada; Céline Castets-Renard, Université Toulouse Capitole, France.«