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September 2026 brought several developments highlighting a shared challenge in AI-enabled healthcare: ensuring that products are appropriately assessed before use and monitored throughout their lifecycle. In the United States, FDA actions maintained existing premarket...
Agentic AI is already operating inside U.S. healthcare workflows - selecting tools, querying records, and in some cases recommending or initiating clinical actions - faster than any regulator has finished deciding how to evaluate it. Three developments from 2026 make...
August 2026 was a quieter month for Canadian AI regulatory activity, but the United States and the European Union both produced developments with direct implications for AI in healthcare. In the US, the FDA opened a public comment process on how it might regulate...