FDA Forms New Advisory Committee On Digital Health Technologies

The U.S. Food and Drug Administration has formed a new Digital Health Advisory Committee to help it explore the complex, scientific and technical issues related to digital health technologies or DHTs.

The new Digital Health Advisory Committee, which will be fully operational in 2024, will advise the health regulator on issues related to artificial intelligence/machine learning or AI/ML, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.

According to the agency, digital health is a rapidly evolving, cross-cutting space that spans a wide range of technologies, as well as issues such as decentralized trials, patient-generated health data and cybersecurity.

The Committee of experts will advise the FDA on issues related to DHTs to help improve its understanding of the benefits, risks, and clinical outcomes associated with use of DHTs.

The Commissioner of Food and Drugs will be advised on issues related to DHTs, and FDA policies and regulations about these technologies. The Committee will help to identify risks, barriers, or unintended consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. It may also advice on the use of DHTs in clinical trials or post-market studies subject to the FDA’s regulation.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “Digital health technologies are critical for achieving this transformation in care delivery. As digital health technologies advance, the FDA must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation.”

The committee will consist of a core of nine voting members including the chair. It will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds.

The FDA is now accepting applications for the Digital Health Advisory Committee until December 11, 2023.

Source: Read Full Article