Advancements underway in AI and machine learning (ML) have been portended to transform our world on a scale that surpasses previous Industrial Revolutions. AI will not only assist and become an integral part of the medical decision-making team, but will also act as a potential substitute for human caregivers, medical service providers, diagnosticians, and expert decision-makers. Current legal and regulatory regimes—protecting patient safety, privacy, and other values—were developed for an era of medicine that will be eclipsed. For AI health technologies to deliver optimal and equitable health care benefit to all Canadians, we should proactively identify and address how to ensure our regulatory governance is equal to the benefits and challenges emerging with new technologies. We will survey the salient legal issues that emerge as we consider the appropriate adoption of AI and machine learning into healthcare systems.
The research primarily focuses on the regulation of medical devices to ensure the safety and quality of AI as it is implemented within our healthcare system. Our goal will be to support Canadian regulators to enable the rapid infusion of beneficial AI and ML into the healthcare systems that empower patients and their health care providers whilst ensuring appropriate regulation for quality, safety, and privacy.
Launched as part of the Alex Trebek Forum for Dialogue’s Project on AI for Healthy Humans and Environments, this research stream is co-stewarded by the Centre for Law, Technology and Society, the Centre for Health Law, Policy and Ethics, and the Institute for Science, Society and Policy. The research program is integrated with the “Machine M.D.” project funded by the Canadian Institutes of Health Research.