What is the difference between provisional and final listing of a digital health application (DiGA) in the DiGA Directory?

The terms "provisional inclusion" and "final listing" refer to the process of inclusion of digital health applications (DiGA) in the DiGA Directory of the Federal Institute for Drugs and Medical Devices (BfArM). Both provisionally and definitively admitted DiGAs can be prescribed by doctors and reimbursed by health insurance companies.

Here is a simplified explanation:

Provisional Inclusion:

• This is a medical device with a low or medium risk class and other characteristics of a DiGA.
• Requirements for safety, functional suitability, quality, data protection and data security as well as interoperability and other quality requirements have been met.
• Initial results from a study (systematic data analysis on the use of the DiGA) are already available, but the study was not large enough, is not forward-looking, has methodological flaws, only shows a trend or has other comparable weaknesses that are not compatible with inclusion. There is therefore not yet sufficient evidence of a so-called positive healthcare effect.
• Provisional inclusion is limited to a maximum of 24 months. After that, final proof of positive healthcare effects must be provided in order to achieve final listing.

Final listing:

• As for provisional inclusion, but in addition there is evidence of the positive healthcare effect.

The exact nature of a clinical study (clinical investigation) for provisional or final listing in the DiGA Directory must always be determined on a case-by-case basis, taking into account a complex decision-making process and in close consultation with the BfArM. In general, important aspects of such a study must be discussed with the BfArM with the involvement of specialists in their fields. As the procedure is currently (12/2023) still in a state of flux with further specifications of requirements for study elements, it always requires up-to-date and very careful preparation with specialists.

Can we support you too? You are welcome to arrange a first non-binding appointment here.