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

The terms "provisional inclusion" and "permanent inclusion" 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). Here is a simplified explanation:

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Preliminary recording:

- It is a medical device with a low risk class and other characteristics of a DiGA.

- Requirements for security, functionality, quality, data protection and data security as well as interoperability and other quality requirements were met.

- There is insufficient evidence of a so-called positive care effect. Initial results from a study (systematic data analysis on the use of 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.

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Permanent recording: 

- As with provisional admission, but with additional proof of the positive supply effect.

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The exact nature of a clinical study (clinical trial) for provisional or permanent inclusion 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, up-to-date and very careful preparation with specialists is always required.