Digital health, including mobile health apps, health information technology, wearables, telemedicine, and other related medical software functions, already essential innovations prior to the COVID-19 pandemic, have become even more so in the current era. This conference will focus on developments in digital health regulation pre-and post-COVID-19, including significant enforcement discretion policies and exemptions FDA has implemented over the past six months. We will discuss the implications of these policies on industry, and speakers will utilize examples to explore strategies for obtaining permanent clearance or approval for digital health products holding emergency use authorizations (EUAs) during COVID-19. Speakers will also discuss the current regulatory status of clinical decision support (CDS) software and its use during and after the COVID-19 pandemic, FDA’s regulation of artificial intelligence/machine learning (AI/ML) and an update on its use in health care, and lessons learned from digital health cybersecurity and privacy breaches.

Conference Highlights:

• Hear from FDA officials about the latest policy, enforcement, and initiatives;
• Learn how to use data collected under EUAs or other emergency pathways to gain permanent FDA clearance/approval;
• Examine how FDA’s enforcement trends for some products during COVID-19 have expanded beyond previously delineated requirements, and whether those trends are likely to continue beyond the pandemic;
• Learn the regulatory status of clinical decision support software for monitoring of COVID-19 and related conditions;
• Gain updates on the agency’s current thinking regarding its AI/ML Discussion Paper;
• Learn how to avoid cybersecurity and privacy pitfalls that can be associated with health-oriented technological innovations.

Peer Interaction: Virtually network with and learn from legal and regulatory experts.

Planning Committee

Committee Members 

Afia Asamoah, Head of Legal, Google Health, Google
Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
Shelby Buettner, Associate Chief Counsel, FDA – OC
Kellie B. Combs, Partner, Ropes & Gray LLP
Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP
Colleen M. Heisey, Partner, Jones Day
Carmine Jabri, President, E.M.M.A. International Consulting Group, Inc.
Melanie Katrice Gross, Associate Director & Assistant General Counsel Healthcare Law Group,
Genentech, Inc.
Veleka Peeples-Dyer, Partner, Baker McKenzie