Since May 5, 2020, health app providers have had the opportunity to have their health app included in the DiGA directory. The DiGA directory is maintained by the BfArM. As soon as the health app has been included in the DiGA directory, the health app has health insurance approval.
Content & topic overview
- Proof of the positive supply effect (pVE)
For this purpose, a positive supply effect (pVE) must be planned, proven and documented. The scientific proof of the pVE is the focus of the event. Depending on the application procedure, one or two clinical trials must be submitted. This includes at least one randomized group-controlled trial. - Doctor's prescription on prescription - without pre-financing by the patient
The principle of benefits in kind applies: Doctors prescribe – the patient receives a code that he/she can use to download the app for free. The manufacturer is reimbursed by the health insurance company. - manufacturer compensation
The manufacturer is reimbursed by the health insurance company: in the first 12 months within the framework of group-related maximum amounts. From the 13th month, the price is freely negotiated with the central health insurance associations. - Doctors reimbursement possible
If a DiGA is listed in the directory, doctors will receive additional remuneration at any time if additional medical services are required due to the use of the DiGA as part of the treatment. - The Schedule
The implementation of the Fast Track provides that manufacturers can submit applications for inclusion of a DiGA in the directory. The following applies: Fast track instead of a joint federal committee/cure/aid directory - 3.5 months instead of years. - application
The application is made via the BfArM portal. Either a trial phase with remuneration from the manufacturer (temporary inclusion in the DiGA directory) or final health insurance approval (inclusion in the DiGA directory) is applied for. The following applies: inclusion in the DiGA directory means: reimbursement by the health insurance companies.
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