Health Canada is very close to publishing a much-anticipated guidance on artificial intelligence/machine learning (AI/ML) medical devices and has incorporated pre-determined change control plans (PCCP) into the document, according to Marc Lamoureux, manager of the Digital Health Division at Health Canada.
Lamoureux spoke on 15 October during a panel on artificial intelligence at the 2024 Medtech Conference, hosted by AdvaMed. During his talk, he updated attendees on how the agency is addressing the emergence of AI/ML and using PCCPs to allow devices on the market.
Health Canada has observed several challenges in the AI/ML space over the past six years, according to Lamoureux, who focused on three specific challenges. First, he noted that algorithmic drift and degradation over time are a major challenge, and said AI/ML models tend to work best when they are continuously updated…
