AMIA calls on FDA to refine its AI regulatory framework

The American Medical Informatics Association wants the Food and Drug Administration to improve its conceptual approach to regulating medical devices that leverage self-updating artificial intelligence algorithms. The FDA sees tremendous potential in healthcare for AI algorithms that continually evolve--called "adaptive" or "continuously learning" algorithms--that don't need manual modification to incorporate learning or updates. While AMIA supports an FDA discussion paper on the topic released in early April, the group is calling on the agency to make further refinements to the Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). "Properly regulating AI and machine learning-based SaMD will require ongoing dialogue between FDA and stakeholders," said AMIA President and CEO Douglas Fridsma, MD, in a written statement. "This draft framework is only the beginning of a vital conversation to improve both patient safety and innovation. We certainly look forward to continuing it."