Updates for 2021
FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind, we are excited to announce that the Digital Health Technology and Regulation Conference will be a completely virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience. Be sure to check the course website regularly for additional announcements and updates.
Digital health, including mobile health apps, health information technology, wearables, telemedicine, and other related medical software functions, continue to enter the market and be essential in the current era. This conference will focus on developments in digital health regulation, including updates on FDA’s Digital Health Center of Excellence and Artificial Intelligence/Machine Learning (AI/ML) Action Plan, released earlier this year. Speakers will also discuss the current regulatory status of clinical decision support (CDS) software, FDA’s Software Precertification Pilot Program, how to ensure racial, ethnic, gender, and population diversity in data used to develop digital health products, and lessons learned from digital health cybersecurity and privacy breaches.
Register
Industry & Firms
- +$100 for non-members
Non-Profit
- +$100 for non-members
Government
- +$100 for non-members
Academic
- +$100 for non-members
Are You New to Digital Health?
Add the training course, Fundamentals of Digital Health Regulation, to your conference registration to gain a comprehensive overview of FDA regulation of digital health technologies.
Sponsors
Sponsorship opportunities are available. Please let us know if you would like more information.
Silver Sponsor
Planning Committee
Stacy Amin, Partner, Morrison & Foerster, LLP
Afia Asamoah, Head of Legal, Google Health, Google
Nicolas M. Benetatos, Senior Manager, Exponent, Inc.
Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
Shelby Buettner, Principal Legal Counsel, Medtronic
Mahnu Davar, Partner, Arnold & Porter LLP
Rasika Kalamegham, Head, US Regulatory Policy, Genentech, Inc.
Lidia Niecko-Najjum, Counsel, Crowell & Moring LLP
Michelle Tarver, Deputy Director, Office of Strategic Partnerships and Technology Innovation, Program Director for Patient Science, Digital Health Center of Excellence, CDRH, FDA
