Digital Health Applications (DiGA)
With the Digitale-Versorgungs-Gesetz (DVG; Digital Healthcare Act), digital health applications (DiGA), also known as medical apps, can be reimbursed by German statutory health insurance. Ecker + Ecker provides advice on:
Reimbursement Strategy
- Review of legal requirements
- Analysis of studies required to prove positive healthcare effects
- Early advice with involvement of BfArM
Listing in the DiGA Directory
- Supporting the listing in the DiGA directory of BfArM
- Compilation of all documents needed for the listing application
- Analysis of ongoing assessment procedures
Generation of Evidence
- Evaluation of available studies
- Development of suitable study designs and evaluation concepts
Negotiation of Reimbursement Price
- Development of the negotiation strategy
- Support in the negotiation with GKV-SV
- Price modelling
- Concepts for direct contracts with health insurance funds
Statistical Advice
- Evaluation of SAP and study protocol
- Sample size planning and questionnaire search
- Preparation of statistical documents
- Raw data analysis and written report
DiGA Trainings
Ecker + Ecker offers tailor-made trainings that can optionally be held either locally, in Hamburg, or online.
- Requirements on systematic data analyses and studies
- Special statistical requirements of the Federal Institute for Drugs and Medical Devices (BfArM): primary endpoints, multiple testing, imputation methods, and others
- Concept and planning of DiGA studies
- The BfArM assessment procedure
Please contact
Janine Leismann
Phone +49 (40) 41 33 081-26
Dr. Florentin Köhnemann
Phone +49 (40) 41 33 081-48