The Food and Drug Administration has announced the technical experts and industry representatives that will take part in its new Digital Health Advisory Committee (DHAC). The committee will address the use of generative AI in medical devices at its first meeting in November.
FDA announced in October 2023 that it would create a digital health advisory committee to inform FDA on considerations for digital health technologies such as AI/ML, virtual reality, wearables, digital therapeutics and remote patient monitoring. DHAC will also weigh in on issues like decentralized clinical trials, patient-generated health data, real-world data, real-world evidence and cybersecurity, the FDA’s website says.
The FDA put out an open call for technical experts on digital health technologies to apply to sit on the committee. The FDA also sought applications for a consumer representative to sit on the committee and for industry representatives who would be temporary nonvoting members.
The committee will inform FDA on new approaches to evaluate digital health technologies and complex scientific and technical issues with digital health. They will also discuss the benefits, risks and clinical outcomes associated with the use of these technologies.
The committee will identify risks, barriers and unintended consequences of proposed or established FDA policy on digital health tech and advise the FDA on the use of the digital health for clinical trials and postmarket studies.
The DHAC’s nine voting members will serve overlapping terms of four years.
The DHAC will hold its first meeting Nov. 20-21 in Gaithersburg, Maryland, and online. It will discuss the use of generative AI in medical devices and impacts to safety and effectiveness of devices.
The list of voting members is as follows:
Chairperson:
Ami Bhatt, M.D.: Chief innovation officer of the American College of Cardiology
Designated federal officer:
James Swink, FDA’s Center for Devices and Radiological Health
Voting members:
Ray Dorsey, M.D.: Professor of neurology at the University of Rochester. Expertise: telemedicine and digital measures
Yaniv Kerem, M.D.: Physician in the Department of Emergency Medicine at Kaiser Permanente Redwood City Medical Center. Expertise: emergency medicine and clinical informatics
Joyce Ho, Ph.D.: Associate professor of computer science at Emory University. Expertise: machine learning and chronic diseases
Jessica Jackson, Ph.D.: Founder and CEO of Therapy is for Everyone. Expertise: psychology and digital mental health
Thomas Maddox, M.D.: Professor of cardiology at Washington University School of Medicine. Expertise: healthcare innovation
Chevon Rariy, M.D.: Chief health officer and senior vice president of digital health at Oncology Care Partners. Expertise: digital health
Laura Stanley, Ph.D.: Associate professor in the School of Computing at Montana State University. Expertise: Digital health and human system integration
Melissa Denise Clarkson, Ph.D.: Professor of the Department of Internal Medicine at the University of Kentucky College of Medicine. Expertise: biomedical informatics and patient advocacy. Clarkson is the consumer representative of the council.
FDA also selected industry representatives that will participate in select DHAC meetings.
This article was originally published on fiercehealthcare