The BfArM assesses medical apps and digital health treatments (DiGA) in terms of patient benefit, positive effects on care, data protection and information security, and quality. After an application is received, the BfArM has three months to check whether the product meets the requirements and has a positive effect on patient care. If the assessment is successful, the product can then be included in the DiGA list. The products on this list can then be prescribed and are covered by SHI funds.
By October 2021, the BfArM had checked 97 DiGAs.
Positive assessment
They accepted 22 of these, e.g. for treating anxiety disorders, migraines, or trouble sleeping. These DiGAs were subsequently included in the DiGA list.
Negative assessment
Less than 5% were assessed negatively.
Remaining assessments
About half of all applications were withdrawn by the manufacturers themselves, as they realized during the assessment that fundamental requirements could not be fulfilled.
In order to avoid these withdrawals after submission, the BfArM offers extensive advice and support opportunities. The BfArM can give precise advice in a kick-off meeting. This can cover, e.g., how to compile meaningful documents and which data are required for inclusion in the DiGA list, in terms of the quality of studies or data security.
Manufacturers who consulted the BfArM before submission often had successful assessments.
The BfArM’s top five tips for manufacturers of DiGAs are:
- Consult with the BfArM before the application
- Keep an eye on deadlines
- Evidence is of highest importance
- RCTs are usually best suited to demonstrate medical benefits
- Think holistically, and also focus on interoperability, accessibility and usability