Sponsorships and Speaking Engagements | 30 November - 1 December 2022
Current Developments in Digital Health Technology and Regulation Conference Agenda – Food and Drug Law Institute (FDLI)
Digital health, including software, mobile health applications, machine learning and artificial intelligence (AI), wearables, and personalized medicine, have created great opportunities to improve patient health and provider efficiency. This course will explore the essentials of FDA regulation of innovative medical device technologies.
After a brief foray into whether and how these categories of products are regulated as medical devices, the course will cover the various regulatory pathway options for getting a technologically-focused product on the market, current FDA premarket review initiatives, AI/machine learning regulations, and cybersecurity considerations. The course will then explore post-marketing and advertising considerations. Throughout the course, there will be ample time for Q&A and discussion.
This course provides a foundation for understanding the topics that will be discussed at a more advanced level during the conference. Washington, D.C. partner Cybil Roehrenbeck will be participating in the session "Artificial Intelligence and Machine Learning: Regulatory Considerations" where she will be joined by fellow panelists Scott Danzis, Partner, Covington & Burling LLP; Matthew Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA; Cassie Scherer, Director of Regulatory Policy, U.S., Medtronic; and moderated by Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP.
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