Effective regulations can ensure a minimum level of performance from artificial intelligence (AI) systems. Canadian regulators face two major categories of challenges. First, the AI-specific challenges stem from the unpredictable developments, use, evidence, and acceptable ethical trade-offs around AI systems. These uncertainties can drive the need for flexible definitions of risk, evidentiary threshold, change plan, and post hoc determination of ethical trade-off. These regulatory flexibilities could neglect impactful AI systems, allow regulatory capture, and undermine public oversight. Second, the jurisdictional challenges obfuscate the scope of products, regulatory boundaries, and division of power across regulations. Clarifying regulatory definitions, the responsibilities of professional bodies, and the need for provincial and territorial legislations may help. However, the lack of reason to believe that regulators have clear motivation and capacity to meaningfully protect patient health is worrisome.

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