FDA Initiates Formation of a New Advisory Committee for Digital Health Technologies

The FDA has introduced a fresh initiative in the form of the Digital Health Advisory Committee. This committee’s primary objective is to assist the FDA in exploring the intricate scientific and technical aspects of digital health technologies (DHTs), encompassing domains such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software.

Digital health is a swiftly advancing and all-encompassing field that spans a diverse spectrum of technologies. Apart from the aforementioned ones, it also covers topics like decentralized trials, patient-generated health data, and cybersecurity.

Many of these cutting-edge technologies are relatively new and subject to rapid changes. It is the FDA’s responsibility to gather extensive knowledge about them and implement suitable regulations that stimulate innovation while safeguarding public health.

The Digital Health Advisory Committee will serve as a resource for the FDA, offering guidance on DHT-related matters and furnishing pertinent expertise and insights to augment the agency’s comprehension of the advantages, risks, and clinical outcomes associated with the utilization of DHTs. The committee is anticipated to be fully operational by 2024.

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