FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence, wearables, virtual reality, and remote patient monitoring. DHTs play an increasingly important role in our healthcare system, from wearables that monitor daily physical activity to remote monitoring devices that provide continuing information to healthcare professionals regarding heart function throughout the day. And, we are increasingly witnessing the potential for AI to be used in our healthcare system, including performing complicated analyses of data and even potentially assisting in the decision-making process.

Given the growing importance of DHTs and the rapidly changing nature of the technology, FDA has been wrestling with its regulatory role in the space to protect patients while at the same time support innovative developments that will improve health and expand access to healthcare. The creation of this advisory committee is one more step in FDA's evolution. Companies developing DHTs should continue to monitor for further developments as the advisory committee gets off the ground in 2024 and should be ready to engage with the committee and FDA generally as it continues to find its way in this important area.

“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. “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.”