Regulating the Safety of Health‑Related Artificial Intelligence

Abstract

This article analyzes whether Canada’s present approach to regulating health-related artificial intelligence (AI) can address relevant safety-related challenges. Focusing primarily on Health Canada’s regulation of medical devices with AI, it examines whether the existing regulatory approach can adequately address general safety concerns, as well as those related to algorithmic bias and challenges posed by the intersections of these concerns with privacy and security interests. It identifies several issues and proposes reforms that aim to ensure that Canadians can access beneficial AI while keeping unsafe products off Canadian markets and motivating safe, effective use of AI products for appropriate purposes and populations.