Experts Debate Need for Federal Regulation of AI in Healthcare

TL/DR –

Experts from the Leonard Davis Institute (LDI) suggest that generative AI in healthcare should be treated like a human clinician, requiring licensing and supervision. In addition, they propose that Congress establish a national licensing and oversight entity within the U.S. Department of Health and Human Services to manage this. Lastly, they recommend that health systems develop their own AI governance structures to ensure safe and effective use of AI in patient care.

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Regulating Generative AI in Healthcare by Treating it Like a Human Clinician

As per Eric Bressman, LDI Senior Fellow and Co-Chair of the LDI AI in Medicine Working Group, the optimal approach to supervise generative AI in healthcare is to treat it akin to a human clinician, through licensing and monitoring. This opinion was shared by LDI Senior Fellow Alon Bergman and fellow authors Zeke Emanuel and Bob Wachter in a related JAMA article.

Implementation of Agentic AI to Tackle Workforce Shortages

The authors suggest that clinical AI systems, which can set their own goals, devise action plans, and execute tasks independently, can be invaluable in addressing workforce shortages. However, implementing this calls for policies that adequately support the introduction of agentic AI.

Establishment of a National AI Oversight Entity

According to the authors, implementing this licensing model would necessitate the creation of new federal capabilities, including a national licensing and oversight entity – the Office of Clinical AI Oversight. Bergman further suggests that this should be established within the U.S. Department of Health and Human Services.

New Federal Approach to AI Suggested by the White House

In a recent executive order, the
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