The Food and Drug Administration (FDA) announced today the formation of a new committee which aims to advise the head of the agency on digital health technologies (DHTs).
According to an Oct. 12 notice published in the Federal Register, the new Digital Health Advisory Committee will consider the regulation and use of AI and ML, virtual reality, remote patient monitoring, and other emerging technologies within the health ecosystem.
The FDA is now accepting applications until Dec. 11 for the nine-member committee – which is expected to be operational next calendar year – to consist of health IT subject matter experts.
“The Committee advises the Commissioner on issues related to DHTs, including, for example, realworld data, real-world evidence, patient-generated health data, interoperability, personalized medicine/genetics, decentralized clinical trials, use of DHTs in clinical trials for medical products, cybersecurity, DHT user experience, and Agency policies and regulations regarding these technologies,” the Federal Register notice said.
“The Committee provides relevant expertise and perspective to improve Agency understanding of the benefits, risks, and clinical outcomes associated with use of DHTs,” the notice says.
According to the FDA, the committee will also provide recommendations on new approaches to develop and evaluate digital health tech while promoting innovation, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established agency policy or regulation for topics related to DHTs.
The FDA is also calling on the public to provide feedback over the next 60 days on relevant topics the new Digital Health Advisory Committee should discuss, including bias management, AI, cybersecurity, and many others.
