The EU describes Digital Therapeutics (DTx) as “evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disease.” DTx are increasingly recognised and adopted into national frameworks worldwide to improve patient care: they can now be prescribed, opening new business model for digital health applications. However, they must first be approved for reimbursement, with no specific regulation existing at EU level. Drawing inspiration from the German DiGA Fast Track, France and Belgium have also taken steps to implement reimbursement processes for DTx. Thus, approval rules for DTx are being created by single countries, resulting into a fragmentation in terms of requirements and regulatory standards. How to succeed in this fragmented regulatory landscape? How to facilitate market entry for your DTx? What are the shared requirements among EU members? What are the basics in terms of data protection and security compliance? Where are in the creation of a unique and centralised set of frameworks in Europe?
Moderator: Przemek Czerklewicz, Founder & Partner, milepoint.