Services
DiGA (Digital Health Applications)
The focus is on the goal of listing your DiGA (Digital Health Application) and the resulting eligibility for reimbursement. The DiGA process begins in the post-market phase of your CE-marked medical device. We are also happy to support and advise you on the path to CE marking! (see Regulatory Affairs & QM)
You must provide evidence of positive healthcare effects (pVE) for your product: "DiGA manufacturers submitting an application for trial approval must plausibly demonstrate that the DiGA can achieve one or more pVE for a specific patient group. This requires the submission of a systematic evaluation of data on the use of the DiGA." (Source: current BfArM guidelines) You can generate the data for this evidence in various ways; we support you in choosing the optimal design.
We design the DiGA studies to meet the requirements of the German Health Applications Act (DGV), the German Digital Healthcare Applications Ordinance (DiGAV), and the guidelines, while also ensuring that the clinical data can be used for clinical evaluation in accordance with the MDR requirements.
The preliminary listing
- Support for the concept of systematic data collection as input for the evaluation concept
- Advice and support regarding possible BfArM meetings
- Systematic data analysis
- Development of the evaluation concept (including targeted literature research and evaluation according to BfArM guidelines)
The final listing
- Planning the DiGA study
- Preparation of all required documents in accordance with ISO 14155
- Conducting the DiGA study including data management and monitoring
- (Statistical) evaluation of the study data and preparation of the clinical trial report
-> You can find our services in the context of clinical trials here