Please find the session links next to their corresponding agenda item.
Tuesday, November 9
FDLI Welcome, Introductions, and Keynote Address
Amy Comstock Rick, President & CEO, FDLI
Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs, FDA
Watch this session: https://fdli.vids.io/videos/449dd6b91a1be6cbcd/digital-health-day-1-session-1-fdli-welcome-introductions-and-keynote-address-mp4
Sponsor
Congressional Perspectives in Digital Health
Santiago Gonzalez, Senior Policy Advisor, Office of U.S. Senator Michael Bennet
Aliza Fishbein Silver, Senior Health and Oversight Counsel, Senate Committee on HELP
Grace Stuntz Graham, Chief Health Counsel, House Energy & Commerce Health Subcommittee, U.S. House of Representatives
Moderated by Stacy Cline Amin, Partner, Morrison & Foerster LLP
Watch this session: https://fdli.vids.io/videos/4d9dd7be191ce4c6c4/digital-health-day-1-session-2-congressional-perspectives-in-digital-health
Wednesday, November 10
FDLI Welcome
Laura Brown, Director of Educational Programs, FDLI
FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health
Zac Henderson, Head of Legal, Levels Health
Diane Johnson, Senior Director, Strategic Regulatory, Medical Devices & Diagnostics, Johnson & Johnson
Bakul Patel, Director, Digital Health Center of Excellence, CDRH, FDA
Moderated by Shelby Buettner, Principal Legal Counsel, Medtronic
Watch this session: https://fdli.vids.io/videos/799dd7be1814eec1f0/digital-health-day-2-session-1-welcome-and-fdas-digital-health-center-of-excellence-working-with-the-fda-on-digital-health
Artificial Intelligence and Machine Learning: Product Development, Regulation and FDA’s Action Plan
Matthew Diamond, Chief Medical Officer, Digital Health Center of Excellence, CDRH, FDA
Sally Howard, Vice President, Regulatory, External Affairs, & Quality, Adaptive Biotechnologies Corp.
Cassie Scherer, Director or Regulatory Policy, U.S., Medtronic
Moderated by Nathan A. Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
Watch this session: https://fdli.vids.io/videos/709dd6b91a1ae2c2f9/digital-health-day-2-session-2-artificial-intelligence-and-machine-learning-product-development-regulation-and-fdas-action-plan-mp4
Clinical Investigations: Utilizing Software and Digital Health Tools
Nicholas Benetatos, Senior Managing Consultant, Exponent, Inc.
Rasika Kalamegham, Head, US Regulatory Policy, Genentech, Inc.
Anindita (Annie) Saha, Assistant Director, Digital Health Center of Excellence, CDRH, FDA
Watch this session: https://fdli.zoom.us/j/81106901605
Telehealth 2021: Regulatory and Reimbursement Developments
Bethany Hills, Partner, Co-lead FDA Regulatory and Compliance Practice Morrison and Foerster, LLP
Lidia Niecko-Najjum, Counsel, Crowell & Moring LLP
Moderated by Kyle Thomson, Senior Legislative Counsel, American Medical Association
Watch this session: https://fdli.vids.io/videos/4d9dd6b91a1ae4c5c4/digital-health-day-2-session-4-telehealth-2021-regulatory-and-reimbursement-developments-mp4
Cybersecurity vs. Interoperability: Understanding How They Interrelate and Managing Risk
Jodi G. Daniel, Partner, Crowell & Moring LLP
Aftin Ross, Senior Special Advisor for Emerging Initiatives, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
Moderated by Charlene Cho, Senior Counsel, Medical Devices, Global Regulatory Legal Team, Johnson & Johnson
Watch this session: https://fdli.vids.io/videos/a79dd7be1a1fe1c12e/digital-health-day-2-session-5-cybersecurity-vs-interoperability-managing-risk-and-understanding-eachs-unique-considerations
Enforcement Trends and Risks for Digital Health Products
Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
John Claud, Assistant Director, Consumer Protection Branch, DOJ
Fred Medick, Senior Corporate Counsel, Healthcare Law Group, Genentech, Inc.
Moderated by Wade Ackerman, Partner, Covington & Burling LLP
Enter this session: https://fdli.vids.io/videos/709dd6b91a1ae7c7f9/digital-health-day-2-session-6-enforcement-trends-and-post-market-considerations-mp4