Current Developments in Digital Health Technology and Regulation Conference
Recorded January 31–February 1, 2024 | On-Demand Materials
Wednesday, January 31, 2024
FDLI Welcome, Introductions, and Keynote Address
Christine Simmon, President & CEO, Food and Drug Law Institute
Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, FDA
Watch this session: https://fdli.vids.io/videos/ea90d4b11819e5c163/fdli-digital-health-day-1-session-1-welcome-and-keynote-address
Navigating Laws and Regulations Globally in the Artificial Intelligence and Machine Learning Era
Madison Green, Director, Technical Operations, Emma International
Anindita (Annie) Saha, Assistant Director, Digital Health Center of Excellence, FDA
Keo Shaw, Of Counsel, DLA Piper (US)
Moderated by Charlotte Walker-Osborne, Partner, Morrison & Foerster LLP
Watch this session: https://fdli.vids.io/videos/7990d4b1181ae0c0f0/fdli-digital-health-day-1-session-2-navigating-laws-and-regulations-globally-in-the-artificial-intelligence-and-machine-learning-era
Brendan Carroll, Partner, Alston & Bird LLP
Jessica Greenbaum, Partner, King & Spalding
Bradley Thompson, Partner, Epstein Becker & Green, PC
Securing the Future: Cybersecurity in Medical Devices
Teal Bjoraker, Sr. Manager Regulatory Affairs, Intelligent Data Solutions, Cranial & Spinal Technologies, Medtronic
Nidhi Gani, Archimedes Medical Device Security Fellow, Archimedes Center for Medical Device Security, Northeastern University
Monroe Molesky, Cybersecurity Specialist, FDA
Moderated by William Garvin, Shareholder, Buchanan Ingersoll & Rooney PC
Watch this session: https://fdli.vids.io/videos/d390d4b1181ae2c05a/fdli-digital-health-day-1-session-4-securing-the-future-cybersecurity-in-medical-devices
Safeguarding Data and Privacy in Digital Health
Heather Deixler, Partner, Latham & Watkins
Sara Shanti, Partner, Sheppard Mullin Richter & Hampton LLP
Moderated by Nancy Perkins, Counsel, Arnold & Porter LLP
Watch this session: https://fdli.vids.io/videos/4d90d4b1181ae2c6c4/fdli-digital-health-day-1-session-5-safeguarding-data-and-privacy-in-digital-health
Thursday, February 1, 2024
FDLI Welcome, Panel Discussion: The New Era of Clinical Decision Support Software (CDS): Risks and Unknowns
FDLI Welcome
Bianca Cardona Melendez, Assistant Director, Educational Programs, FDLI
Panel Discussion: The New Era of Clinical Decision Support Software: Risks and Unknowns
Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, FDA
Greg Levine, Partner, Ropes & Gray LLP
Sonia W. Nath, Partner, Cooley LLP
Moderated by M. Jason Brooke, Attorney & Managing Member, Brooke & Associates
Watch this session: https://fdli.vids.io/videos/a790d4b11b1ce7c42e/fdli-digital-health-day-2-session-1-welcome-and-panel-discussion
Exploring the Regulatory Terrain of Decentralized Clinical Trials
Kalah Auchincloss, Executive Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health, Inc.
Elizabeth Richards, Partner, Latham & Watkins
Blake E. Wilson, Partner, Hogan Lovells US LLP
Moderated by Shelby Buettner, Assistant General Counsel, Regulatory Law and Compliance Officer, Becton Dickinson (BD)
Watch this session: https://fdli.vids.io/videos/0690d4b11b1ce6c08f/fdli-digital-health-day-2-session-2-exploring-the-regulatory-terrain-of-decentralized-clinical-trials
Enforcement and Litigation Trends in Digital Health
Mahnu V. Davar, Partner, Arnold & Porter LLP
Gabriel Scannapieco, Assistant Director, Consumer Protection Branch, US Department of Justice
Moderated by Christina Kuhn, Special Counsel, Covington & Burling LLP
Enter this session: https://fdli.vids.io/videos/4490d4b11b1ce6cacd/fdli-digital-health-day-2-session-3-enforcement-and-litigation-trends-hot-topics
Expectations for the Final Rule on Laboratory Developed Tests: Focus on Software Interaction
Lisa M. Dwyer, Partner, King & Spalding LLP
Jeremiah J. Kelly, Partner, Venable LLP
Joshua M. Oyster, Partner, Ropes & Gray LLP
Moderated by Bethany Hills, Vice Chair, FDA Regulatory Practice, DLA Piper (US)