The committee will help the FDA address issues related to digital health technologies, including artificial intelligence, virtual reality, cyber security, and patient-generated health data.
The FDA has announced that it will be creating a new Digital Health Advisory Committee that will be fully operational in 2024.
The committee will help the agency explore issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. The committee will advise the FDA on the complex, scientific, and technical issues related to DHTs, providing perspective to help improve the agency’s understanding of potential benefits, risks, and clinical outcomes associated with DHTs.
The FDA will receive guidance from the committee to support the development of safe and effective DHTs. The committee will be comprised of individuals with technical and scientific expertise from a variety of disciplines and backgrounds who will help ensure that DHTs are designed and targeted to meet the needs of a variety of populations. Including the chair, the committee will consist of a core 9 voting members, with temporary members selected for certain meetings depending on the topic.
“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,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “[DHTs] are critical for achieving this transformation in care delivery. As DHTs 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.”
Digital health is evolving rapidly and reaching across a wide range of technologies. In addition, DHTs can help address issues such as decentralized trials, patient-generated health data, and cybersecurity.
“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, in the press release. “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.”
U.S. Food and Drug Administration. FDA Establishes New Advisory Committee on Digital Health Technologies. News release. October 11, 2023. Accessed October 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-establishes-new-advisory-committee-digital-health-technologies?utm_medium=email&utm_source=govdelivery