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September 19, 2017

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FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

January 24, 2018

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain.

The Result: Both the 21st Century Cures Act and recent FDA activities provide important, but incomplete, insight regarding regulation of health products utilizing artificial intelligence.

Looking Ahead: Digital health product manufacturers should recognize how recent regulatory changes may affect them, and that FDA is engaging industry to further refine its oversight approach.

 

 

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