Your DiGA in the DiGA directory of the BfArM
We support manufacturers of digital health applications (DiGA) in demonstrating a positive effect on care and inclusion in the BfArM directory. Here, we use our experience from discussions with the BfArM to their understanding of the evidence requirements.
Literature research and evaluation
With the systematic literature review, we ensure a clean rationale for the chosen study design and all study elements.
Evaluation concept
We help you develop an evaluation concept that meets the requirements of the BfArM and shows why and how the evidence of the medical benefit of your product is demonstrated.
Systematic data evaluation
Our expertise in systematic data evaluation supports you in reviewing the effectiveness of your DiGA.
Randomized controlled trial
With the appropriate randomized controlled trial (RCT), we support you in proving the positive supply effect for inclusion in the DiGA list of the BfArM and reimbursement by health insurance companies.