• IGES Medtech - the medical technology experts for Europe
Webinar:

Webinar: "Fast Track" for Digital Health Applications

Expert: Michael Weisser, CEO of AiM

Strategic questions and proof of positive healthcare effects - what does a DiGA manufacturer need for successful implementation?

After the publication of the Digital Health Applications Ordinance (DiGAV) and the guide to the "fast-track procedure" for digital health applications (DiGA), manufacturers can now submit their application for inclusion of their product in the positive list managed by the Federal Institute for Drugs and Medical Devices (BfArM). As an alternative to the application for a final inclusion, manufacturers also have the possibility of being provisionally included in the list and to provide proof of positive healthcare effects within the framework of a study. An integral part of the application procedure is a scientific evaluation concept, on the basis of which proof of positive healthcare effects can be provided. The results of the evaluation are then expected to be part of the price negotiations with the GKV-Spitzenverband happening later.

  • Which strategic questions need to be answered with regard to the decision for or against the fast-track procedure?
  • Which experiences from previous evaluation and testing procedures can be transferred to the new process?
  • What considerations must be incorporated into a scientific evaluation concept and what are the options for implementation?

Organizer: BVMed - The German Medical Technology Association

Date: June 23, 2020

For more information, please contact AiM’s team: info@aim.iges.com

https://www.bvmed.de/de/bvmed/veranstaltungen/2020-06-23-medinform