On 19 Dec 2019, the DVG came into force in Germany. This meant that since 2020, clinicians can prescribe and SHI funds will reimburse medical apps and digital health treatments (DiGAs). To make such treatments available to patients as quickly as possible, the regulatory agency, BfArM, has developed a new process to speed up reimbursement: the DiGA fast track.
DiGA fast track process
The BfArM assesses these DiGA treatments in terms of patient benefit, data protection and information security, and quality. After an application is received, the BfArM checks within 3 months whether the products meet the requirements set out in the Digital Health Applications Ordinance. However, the manufacturers must also prove that the app has a positive effect on patient care. If the assessment was 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. The legal basis is §139e SGB V.
If the requirements are not fulfilled, and/or no positive effects on care were demonstrated, the BfArM will reject the application.
If the evidence to demonstrate a positive effect on care is not available yet but the other requirements are fulfilled, a manufacturer can apply for the provisional inclusion of the DiGA in the DiGA list, and can complete the necessary study within 12 months in a trial phase.