Digital Therapeutics Seminar Series - Part I
The marriage of healthcare and software has led to the emergence of digital therapeutics (Dtx), a nascent area of digital health that has the potential to improve patient care and deliver better clinical outcomes. And, with an increased focus on telehealth and disruptive methods of delivering care accelerated by the COVID-19 pandemic, the Dtx market is estimated to soar to more than $5 billion by 2027.
Life sciences and technology companies are looking at Dtx as a way to deliver value, but unlocking this potential will require they navigate a number of regulatory and market challenges. Join Foley Hoag for a two-part webinar series exploring the current legal and regulatory landscape, the future of the Dtx market, and the key considerations for new and existing manufacturers.
Part I – Reimbursement & Regulatory Landscape
How can companies seeking to introduce new Dtx solutions navigate the rapidly evolving policy and regulatory environment? Our panelists will discuss:
- The FDA approval and clearance pathways
- The current outlook for coverage and reimbursement in the government payer market, including Medicare and Medicaid
- Commercial reimbursement considerations
- The unique challenges related to privacy and data protection
- Areta Kupchyk, Partner, Co-Chair, Administrative Law Department and FDA Practice, Foley Hoag LLP
- Ross Margulies, Partner, Foley Hoag LLP
- Haider Andazola, Associate, Foley Hoag LLP
- Jeremy Meisinger, Associate, Foley Hoag LLP
- Tina Papagiannopoulos, Associate, Foley Hoag LLP