The U.S. Food and Drug Administration has established a new committee to advise on the implications of digital health technologies, or DHTs.
Set to be fully operational in 2024, the Digital Health Advisory Committee will focus on complicated scientific and technical considerations surrounding a wide array of DHTs to inform the FDA on the potential benefits, risks and clinical outcomes tied to DHT use, the administration announced on Wednesday.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said DHTs are an important part of the organization’s efforts to improve health equity and expand healthcare to everyone across the U.S.
“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,” Shuren said.
Technologies the committee will look into include artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The committee will also examine the related concepts of decentralized trials, patient-generated health data and cybersecurity.
Committee members will provide the FDA with technical and scientific expertise on relevant topics. These individuals will represent various disciplines and backgrounds to make sure DHTs are created with the needs of diverse populations in mind. The team will comprise nine core voting members, including the chair, and temporary members will be selected for each meeting depending on the topic at hand.
“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 FDA Digital Health Center of Excellence Director Troy Tazbaz.
He added that it is the FDA’s “duty” to seek out as much knowledge as possible on emerging DHTs to ensure that proper regulations are implemented while promoting innovation in healthcare.
The creation of the Digital Health Advisory Committee is just one way the FDA is driving healthcare technology development forward. At the Potomac Officers Club’s 2023 Healthcare Summit, you have the chance to hear from Dr. Ranya Habash, a member of the FDA’s Digital Health Network of Experts, who will participate in a panel discussion on human centered design and rapid prototyping in healthcare applications. You will also hear from numerous officials from other Department of Health and Human Services organizations. To learn more and register to attend, click here.