FDA, EU rules unfit for adaptive AI

- Analysts argue the FDA and EU Medical Device Regulation lack clear pathways for adaptive, continually learning diagnostic AI, leaving liability and physician-accountability gaps. - The critique points to missing rules for post-deployment model updates, unclear oversight responsibilities, and no settled legal framework for model-driven clinical decisions. - The gap could slow hospital adoption of adaptive diagnostic systems until regulators specify update/monitoring requirements and liability rules. (x.com)