HIT Consultant June 23, 2025
What You Should Know:
– A new report from the Bipartisan Policy Center (BPC) examines the complex and often fragmented regulatory landscape for health AI tools that fall outside the jurisdiction of the U.S. Food and Drug Administration (FDA). As AI becomes increasingly embedded in healthcare—automating administrative tasks, guiding clinical decisions, and powering consumer wellness apps—these tools operate within a patchwork of federal rules, state laws, and voluntary industry standards.
– The issue brief outlines the types of health AI that are not regulated as medical devices, the key federal and state bodies providing oversight, and the challenges and opportunities this creates for responsible innovation.
Which Health AI Tools Fall Outside FDA Jurisdiction?
While AI tools designed to diagnose,...
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