The application portal for inclusion in the directory of digital health apps (DiGA) at the Federal Office for Drugs and Medical Devices (BfArM) has been online since May 27, 2020. The application, which can be submitted only electronically, is the first step for the respective health app to be reimbursed in the future as part of regular care.
DiGA opens a wide range of possibilities to support the detection and treatment of diseases and a self-determined, health-promoting lifestyle. DiGA is thus "digital helper" in the hands of patients.
A DiGA is considered as a medical device with the following characteristics:
- The medical device of risk class I or IIa (according to Medical Device Regulation or, within the framework of the transitional regulations, according to Medical Devices Directive)
- The main function of DiGA is based on digital technologies
- The medical purpose is essentially achieved by the main digital function
- The DiGA supports the detection, monitoring, treatment or alleviation of diseases or the detection, treatment, alleviation or compensation of injuries or disabilities
- The DiGA is used by the patient or by the service provider and the patient together.
Details of this procedure are regulated by a supplementary legal ordinance of the Federal Ministry of Health (BMG), the Digital Health Applications Ordinance (DiGAV), effective from April 20, 2020.
The procedure is designed as a fast track: The evaluation period for the BfArM is three months after receipt of the complete application. The core of the procedure is the examination of the manufacturer's information on the required product characteristics - from data protection to user-friendliness - as well as the examination of evidence to be provided by the manufacturer for the positive supply effects that can be achieved with DiGA.
On May 5, 2020, the BfArM published guidance to the Fast-Track procedure, which offers a summary of the regulations that can be found at various points in the German SGB V, in the DiGAV and the annexes to the DiGAV. In the guidance document, the BfArM explains how it will regularly interpret the normative specifications of DVG and DiGAV. It offers transparency concerning the particular requirements to be fulfilled in the procedure. The guidance document is thus a reliable basis for applicants. At the same time, however, the guidance is also designed in such a way that all interested parties can gain a comprehensive picture of the assessment bases and, consequently, of the (quality) characteristics of a DiGA. It will be continuously adapted, supplemented, and further developed based on experience gained.
The full details in German can be found here. The DiGA application portal can be reached here.
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