Copenhagen Capacity and Digital Therapeutics Alliance invites you to an exciting webinar about digital health and the winding road to reimbursement of digital solutions in the EU and the Nordics
Digital health is changing the landscape of healthcare in ways we are only beginning to understand.
While traditional products used in healthcare provisions, such as medicines and medical devices, follow a well-defined path from idea to patient it is very different for digital health where technology development in many instances has outpaced regulation. This is also the case for market access and the regulation which in the EU decides of a product is reimbursed or not. Reimbursement, also known as the 4th hurdle, stands between any new health product and the patient.
When: 23rd of February, 2021 | 15:00 - 16:30 CET
Where: Adobe Connect (You will receive a link on email when you sign up for the event)
The event is free of charge.
About the webinar
This webinar explores the regulatory framework for the EU before exploring assessment frameworks in specific countries. The focus is on digital health products with special attention to digital therapeutics, but learnings are applicable for all CE marked digital health solutions that seek reimbursement from healthcare systems deploying the solution.
15.00 - 15.05 Welcome & Opening Remarks by Niels Christian Ganderup, Copenhagen Capacity
15.05 - 15.10 About Digital Therapeutics Alliance by Jessica Shull, Digital Therapeutics Alliance
15.10 - 15.20 European DTx experiences – Germany by Jan Broenneke, Health-tech Innovation Hub of the German Ministry of Health
15.20 - 15.30 The Nordic and EU perspective by Niklas Hedberg, The Swedish Dental and Pharmaceutical Benefits Agency (TLV) & EUnetHTA
15.30 - 15.40 Danish regulatory perspective on DTx by Tomas Weis Møller, Danish Medicines Agency
15.40 - 15.50 Reimbursement ready data for DTx – considerations by Jakob Kjellberg, VIVE - The National Center for Social Science Research Denmark
15.50 - 16.00 Two Case Studies:
1) DVG in Germany - pain or paradise for DTx companies? by Matthias Zencker, Gaia
2) Considerations for obtaining reimbursement for a neurological rehabilitation app by Beth Wolff, Brain+
16.00 - 16.10 Case Studies the regulator's view: Asthmatuner and Enerzair Breezhaler by Ina Schäffner, The Swedish Dental and Pharmaceutical Benefits Agency (TLV)
16.10 - 16.30 Open Q&A
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