FDA will add digital health advisory committee to its roster

The FDA is setting up a new advisory committee to provide independent expertise on the emerging category of technologies like digital therapeutics, virtual and augmented reality, wearable devices, and artificial intelligence (AI).

The regulator said it is currently seeking nominations of individuals with “technical and scientific expertise from diverse disciplines and backgrounds” who can advise it on the benefits, risks, and clinical outcomes associated with the use of digital health technologies (DHTs).

The committee will consist of nine voting members, including the chair, and could include representatives from industry, consumer organisations, and the medical profession. It is due to be fully operational in 2024, said the FDA, which will accept nominations through to 11th December.

“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,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

Other areas that the agency would like its advisors to cover include remote patient monitoring, technology to support decentralised trials, the role of patient-generated health data, and cybersecurity.

In a speech earlier this week, FDA Commissioner Robert Califf acknowledged that DHTs are developing faster than the agency can adapt its regulatory processes.

He said these technologies can have many benefits – helping to generate data and evidence to better inform our knowledge about the benefits and risks of therapies and fostering more efficient conduct of and access to clinical investigations, for example – but come with risks like any other intervention.

To give one example, AI algorithms, including large language models (LLMs), evolve after they are put into practice and it is unlikely that an accurate algorithm will stay accurate when deployed in real life over time.

“Across industry, digitisation and insertion of machine learning and other types of mathematical algorithms into everyday life is making a profound difference, but government agencies lag behind private industry,” said Califf.

“Quite simply, we need to assemble the resources to put in place these policies and tools and adaptively align our digital health efforts to support public health and regulatory innovation in a world that is changing rapidly.”