• slide
  • slide

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


More about DiGA

Publications on DiGA


Please contact

Dr. Claudia Pütz

Dr. Claudia Pütz
Phone +49 (40) 41 33 081-12