There is a significant gap in the evaluation of “health-adjacent” AI (e.g., triage, scheduling, billing). These tools often fall outside traditional medical device regulations, leading to inconsistent evaluation.
Organizations must navigate a complex web of provincial laws (such as PHIPA) and federal regulations (PIPEDA). Many current AI tools lack clear documentation on how they meet these dual requirements.
Current guidance focuses primarily on pre-implementation review. There is a lack of frameworks for the continuous monitoring of AI performance, “drift,” and bias in live clinical environm
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