With the coming into force of the Digital Health Care Act (DVG), insured persons in the statutory health insurance (GKV) have a right to be provided with DiGA. These are, for example, medical health apps that can be prescribed by doctors and psychotherapists and are reimbursed by the health insurance fund. These are exclusively low-risk medical devices (Class I or IIa).
The prerequisite for this is that
- the DiGA has successfully passed a test procedure at the BfArM, and
- are listed in the "Directory of reimbursable digital health applications" (DiGA directory).
Only the manufacturer of the medical device or an authorized representative can submit an application for inclusion in the directory. Inclusion in the list of the BfArM is the decisive step towards reimbursability (standard care) within the statutory health insurance (GKV).
The procedure is designed as a fast track: The BfArM evaluates the complete application within 3 months. If the evidence of positive health care effects is sufficient, inclusion in the DiGA directory takes place. If there is not yet sufficient evidence of positive supply effects, an application for provisional inclusion can be submitted. The trial period is a maximum of 12 months. During this time, data may be collected, for example, as part of clinical trials. In exceptional cases, this period can also be extended by a further 12 months upon early application.
If manufacturers specifically require support from the BfArM, they can arrange a consultation appointment with the institute. The BfArM advises on the requirements for inclusion in the DiGA list in order to support manufacturers at an early stage in generating meaningful documents and data for inclusion.
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