AI is part of it, but not the only factor as physicians and patients interact with computers.
The U.S. Food and Drug Administration (FDA) is forming an advisory committee to guide use of new digital technologies in medicine.
FDA is seeking nominations for a nine-member group to weigh in on artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. FDA announced the formation on Oct. 11 and will collect applications through Dec. 11.
The new Digital Health Advisory Committee will advise the commissioner of food and drugs about the technologies. Issues will include benefits, risks and clinical outcomes involved with use of digital health technologies (DHTs), along with risks, barriers or unintended consequences from proposed policies or regulations, according to FDA.
The committee may advise about using DHTs in clinical trials or post-market studies subject to FDA regulations, according to plans.
“As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness and healthcare to all people where they live – at home, at work, in big cities and rural communities,” FDA Center for Devices and Radiological Health Director Jeff Shuren, MD, JD, said in a statement.
“Digital health technologies are critical for achieving this transformation in care delivery,” Shuren said. “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.”
In spring, FDA Commissioner of Food and Drugs Robert M. Califf, MD, FACC, said new technologies, including large language models of AI, could lead to a revolution in medicine, improving doctors’ abilities and patients’ health. But there are risks, he said.
“If we’re not nimble in the use and regulation of large language models, we’ll be swept up quickly by something that we hardly understand,” Califf said at the time. “The great things are really great: Imagine a world in which your questions were answered immediately in language appropriate for your literacy and numeracy; also your clinician can actually talk with you rather than spending all their time cutting, pasting and writing clinic notes; I could go on and on, but I see the regulation of large language models as critical to our future.”
This summer, the U.S. Agency for Healthcare Research and Quality, a sister agency to FDA under the U.S. Department of Health and Human Services, published a report predicting AI will become not just a too, but a new member of the medical team of physicians and other clinicians working with patients.