Digital health

FDA to form new advisory committee on digital health tech

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The FDA plans to establish a digital health advisory committee to help the regulator keep up with a rapidly evolving technological landscape.

The FDA is seeking expertise from industry experts as it looks to form a new committe that will help the regulator contend with the rapid development of new technologies, including AI, virtual reality and wearables. The agency said it will also seek input on issues such as decentralised trials, patient-generated health data and cybersecurity.

The FDA announced the creation of a new Digital Health Advisory Committee in a statement last week, which it said will help the agency explore the complex scientific and technical issues related to digital health technologies (DHTs).

“Technology moves at an incredible pace, and we’re excited to have a committee of experts throughout the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within parameters of safety and effectiveness standards,” said Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence.

“Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health.”

The committee will advise on artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.

The aim is to help improve the agency’s understanding of the benefits, risks and clinical outcomes. The FDA said the committee should be fully operational in 2024.

“As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness and healthcare to all people where they live – at home, at work, in big cities and rural communities,” said Jeff Shuren, director of the FDA’s Centre for Devices and Radiological Health.

“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. The number of temporary members selected for a particular meeting will depend on the meeting topic.

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