This session will discuss FDA’s evolving approach to digital health, in both the medical device and pharmaceutical sectors. Speakers will address the Digital Health Innovation Action Plan and steps that haven been taken thus far to further the efforts outlined in the Plan. Topics to be discussed include: the 21st Century Cures Act, FDA’s digital health software precertification pilot program, and guidance on clinical decision support software. The latest legal, regulatory, and policy issues in this area will also be considered.

Agenda

3:30–4:00 PM | Registration
4:00–4:15 PM | FDLI Welcome
4:15–4:45 PM | FDA Presentation
4:45–5:30 PM | Moderated Panel Discussion with Q&A
5:30–7:00 PM | Reception