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BfArM presents fast track for approval of digital health applications (DiGAs)

The final version of the Digital Health Application enactment (DiGAV) as well as the corresponding fast track guideline have been published.

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The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the admission of requesting manufacturers’ medical apps as so-called “DiGAs”. With this admission, they can be reimbursed by the statutory health insurances.

The BfArM just published a guideline for the fast track of DiGAs according to para 139e SGB V.

The guideline (in German language only) can be downloaded here.

The basic requirements for the approval of a medical device as a DiGA are, among others:

- Medical device of risk class I or IIa

- A digital technology is the basis and the medical purpose of the product.

- The product supports the detection, monitoring and treatment of diseases.

Mainly, the BfArM can evaluate the manufacturer’s data for a period of three months after receiving the complete application. In case all requirements are met and the positive treatment effects are proven, the product will be included into the DiGA catalogue. If the positive treatment effects cannot be proven, an additional and belated trial period of 12 months is necessary.

The guideline as well as the evaluation phase will be discussed during the DiGA Summit on April, 22nd. The federal ministry of health (BMG) and the BfArM will present the these topics in the event (please find the program and the livestream link here) and will answer questions. The summit will be a virtual meeting and free for all participants. Of course, Healthcare Heads will participate at the summit and keep you posted on the latest developments and information.

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