Foley Special Counsel Kyle Faget, member of the firm’s Health Care, Digital Health, and Telemedicine Industry Team, will be presenting during the Food Drug Law Institute’s “Digital Health Technology and Regulation During COVID-19 and Beyond” virtual event on September 10th. Her panel is titled “Regulation of Digital Health During and After COVID-19,” and will take place at 12:05 p.m. ET. She will be joined by Michele Buenafe (Partner, Morgan, Lewis & Bockius LLP), Megan Coder (Executive Director, Digital Therapeutics Alliance), and Kellie Combs (Partner, Ropes & Gray LLP).
The session will discuss and compare the traditional approval pathways available for software-as-medical device products, as well as significant enforcement discretion policies and exemptions, both pre-and post-COVID-19. The panel will examine how FDA’s enforcement trends during COVID-19 have expanded beyond previously delineated requirements for products such as digital health therapeutic devices for psychiatric conditions, and whether those trends are likely to continue beyond the COVID-19 pandemic. The impact of increased funding for telehealth and remote patient monitoring tools under the CARES Act will also be discussed.
To find out more, or register for the webinar, click here.