How to Regulate Generative AI in Health Care

Harvard Business Review September 4, 2024
David Blumenthal, Bakul Patel

Summary: A challenge confronting the Food and Drug Administration — and other regulators around the world — is how to regulate generative AI. The approach it uses for new drugs and devices isn’t appropriate. Instead, the FDA should be conceiving of LLMs as novel forms of intelligence. It should employ similar approaches to those it applies to clinicians.

Generative AI has arrived in medicine. Normally, when a new device or drug enters the U.S. market, the Food and Drug Administration (FDA) reviews it for safety...

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