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
4:15–5:30 PM | Moderated Panel Discussion with Q&A
5:30–7:00 PM | Reception

Speakers

Afia Asamoah, Senior Counsel & Trust and Compliance Officer, Verily Life Sciences
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Vice Chair, FDLI Board of Directors
Lesley R. Maloney, Head of US Regulatory Policy, Roche Diagnostics
Chin-Wei Soo, Global Head, PTR Combination Products/Devices, Genentech, Inc.
Moderated by Wade Ackerman, Partner and Co-Lead of Covington Digital Health Initiative, Covington & Burling LLP