ARTICLE SUMMARY:
A growing chorus of proposals seeks to subject autonomous generative AI tools to board exams, residency programs, scope of practice determinations, and continuing medical education requirements like those of doctors as an alternative to medical device regulatory oversight.
There is deep, ongoing policy work focusing on how governments should oversee generative artificial intelligence tools in healthcare. And then there is real-world practice.
The policy debate is centered around a few fundamental questions, including what types of tools and indications qualify as regulated medical devices, and what role regulatory frameworks focused on specific sectors, like medical devices, should play versus cross-cutting rules targeting AI such as the EU AI Act.
However, in practice while some companies are attempting to fashion their work on large language models, agentic AI, or other generative systems within the frame of established regulatory models, others are taking a more freewheeling approach.
