The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring.

The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs.

The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to "help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”.

The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said: "As digital health technologies advance, the FDA must capitalise 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 a rapidly growing field that spans a wide range of technologies, including machine learning, augmented reality, virtual reality and wearables, and also encompasses issues such as decentralised trials and patient-generated health data.

Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, said: “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.”

Earlier this year, the FDA issued new draft guidance on the implementation of decentralised clinical trials, in which some or all trial-related activities occur at locations other than traditional investigation sites.

The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the use of these trials, which the agency expects “will play an important role in addressing public health needs”.

The guidance covers topics such as trial design, the use of DHTs for remote patient monitoring, and the roles and responsibilities of sponsors and investigators.

https://www.pmlive.com/pharma_news/fda_establishes_new_advisory_committee_to_provide_expertise_on_digital_health_1501884