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

Digital Health Beyond Medical Devices: Development and Use of Companion Apps for Pharmaceutical Products
Brendan Carroll, Partner, Alston & Bird LLP
Jessica Greenbaum, Partner, King & Spalding
Bradley Thompson, Partner, Epstein Becker & Green, PC

Watch this session: https://fdli.vids.io/videos/0690d4b11819e2c28f/fdli-digital-health-day-1-session-3-more-than-medical-devices-development-and-use-of-companion-apps-for-pharmaceutical-products-and-beyond

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)

Watch this session: https://fdli.vids.io/videos/7990d4b11b1ce9ccf0/fdli-digital-health-day-2-session-4-evolving-expectations-for-proposed-rules-on-laboratory-developed-tests-ldts-how-ldts-and-software-interaction