The illusion of safety: A report to the FDA on AI healthcare product approvals.

Abstract

Artificial intelligence is rapidly transforming healthcare, offering promising advancements in diagnosis, treatment, and patient outcomes. However, concerns regarding the regulatory oversight of artificial intelligence driven medical technologies have emerged, particularly with the U.S. Food and Drug Administration's current approval processes. This paper critically examines the U.S. Food and Drug Administration's regulatory framework for artificial intelligence powered healthcare products, high