Lexology October 16, 2023
Axinn Veltrop & Harkrider LLP

FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies (“DHTs”), including artificial intelligence, wearables, virtual reality, and remote patient monitoring. DHTs play an increasingly important role in our healthcare system, from wearables that monitor daily physical activity to remote monitoring devices that provide continuing information to healthcare professionals regarding heart function throughout the day. And, we are increasingly witnessing the potential for AI to be used in our healthcare system, including performing complicated analyses of data and even potentially assisting in the decision-making process.

Given the growing importance of DHTs and the rapidly changing nature of the technology, FDA has been...

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