|12:05 PM - 01:05 PM ET|
|09:05 AM - 10:05 AM PT|
Morgan Lewis FDA partner Michele Buenafe will speak on "Regulation of Digital Health During and After COVID-19" at FDLI's Digital Health Technology and Regulation During COVID-19 and Beyond.
This 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.