‘Holes’ in Federal AI Healthcare Regulation Should Be Patched, Penn Med Faculty Say

“Before new medical devices are marketed or distributed, they must be deemed ‘safe and effective’ by the Food and Drug Administration.

Penn Medicine assistant professor of pulmonary and critical care medicine Gary Weissman said that these FDA approval pathways ‘were developed decades ago for traditional medical devices, and don’t apply well to modern AI-type devices.’

The current framework for approving such tools is the 510(k) pathway, which, according to Weissman, grants clearance to approximately 98% of all AI-enabled devices. […]

After an AI device is implemented, he explained that its performance may change over time and vary between locations, leading to what is known as ‘shift’ or ‘drift.’ He added that the current regulatory process lacks ‘good infrastructure’ to ensure an AI system is functioning properly at the location where it is deployed.”

Read more at The Daily Pennsylvanian.