Why Attend?

Preliminary Agenda

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 by October 29 and SAVE!


Industry & Firms

  • +$100 for non-members
  • +$100 after 10/29/2021


  • +$100 for non-members
  • +$100 after 10/29/2021


  • +$100 for non-members
  • +$100 after 10/29/2021


  • +$100 for non-members
  • +$100 after 10/29/2021



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Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

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.


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