When Medical Devices Have a Mind of Their Own: The Challenges of Regulating Artificial Intelligence.

Abstract

How can an agency like the U.S. Food & Drug Administration ("FDA") effectively regulate software that is constantly learning and adapting to real-world data? Continuously learning algorithms pose significant public health risks if a medical device can change overtime to fundamentally alter the nature of a device post-market. This Article evaluates the FDA's proposed regulatory framework for artificially intelligent medical devices against the backdrop of the current technology, as well as indust