Why Attend?

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.



Industry & Firms

  • +$100 for non-members


  • +$100 for non-members


  • +$100 for non-members


  • +$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.


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