Digital health application; application for inclusion in DiGA directory.

If you manufacture digital health applications (DiGA) and you want your products to be included in the DiGA directory, you must submit an application to the Federal Institute for Drugs and Medical Devices (BfArM).

Description

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.

Prerequisites

To be listed in the directory, a DiGA must meet the following requirements:

  • Security and fitness for purpose,
  • Data protection and information security,
  • quality, especially interoperability, and
  • Demonstration of positive supply effects, depending on the application type.

Procedure

The entire application process takes place exclusively electronically via the BfArM application portal. You will find the reference to this on the BfArM website.

  • In order to submit an application for inclusion of a DiGA in the directory, you must register.
  • To do this, you must create a user account (for initial registration). The following steps are necessary for this:
    • Registration in the portal with a valid e-mail address, the use of a functional e-mail address is recommended for data protection reasons.
    • Confirm e-mail address via link in mailbox and
    • Set password.

After successful registration, you can create one or more DiGAs in the application portal and fill out and submit the following online forms for applications and advertisements per DiGA - depending on the issue:

  • Application for admission
  • Request for extension of the trial
  • Notification of significant changes
  • Request for removal from the list

The application procedure begins when you have submitted the complete application for inclusion of a DiGA in the DiGA directory to the BfArM.

  • Once the application procedure has begun, the BfArM first carries out an incoming inspection in which the formal completeness of the submitted documents and evidence is checked:
  • If the documents and evidence are complete, the BfArM will confirm receipt of the application documents within 14 days, informing you of the corresponding date of receipt as the start of the processing period.
  • Core of the procedure are the
    • Examination of the manufacturer's data on the required product properties
    • as well as the examination of a proof to be provided by the manufacturer for the positive supply effects that can be realized with the DiGA.
  • With the delivery of a positive decision on the inclusion of a DiGA in the directory, it will be published there.

Deadlines

If the BfArM determines during the review that the application documents are incomplete, it will ask you to complete the application within a period of up to 3 months and submit the changes or additions via the application portal.

Processing time

The processing time is 3 months after receipt of the complete application.

Required documents

  • Required Documents

    • gegebenenfalls Vollmacht eines Bevollmächtigten zur Antragstellung
    • Konformitätserklärung
    • gegebenenfalls CE-Zertifikat
    • Gebrauchsanweisung
    • Studie(n) zum Nachweis positiver Versorgungseffekte oder Ergebnisse einer systematischen Datenauswertung zur Begründung der Versorgungsverbesserung (Studienprotokoll, Studienbericht)
    • gegebenenfalls wissenschaftliches Evaluationskonzept
    • gegebenenfalls Studie zur Ermittlung der Testgenauigkeit der in der DiGA enthaltenen diagnostischen Instrumente (sofern zutreffend)
    • Ergebnisprotokoll des Beratungsgesprächs mit dem BfArM (sofern zutreffend)
    • Angabe von Daten, bei denen rechtliche Anforderungen an den Schutz der Betriebs- und Geschäftsgeheimnisse oder an den Schutz personenbezogener Daten oder des geistigen Eigentums einer Veröffentlichung entgegenstehen
       

Online procedures

  • Fast-Track-Verfahren für DiGA

    The Digital Health Application (DiGA) Fast Track Application Portal allows you to manage, process and submit electronic applications and notifications. After one-time registration, you can log in to your user account and start processing applications.

Fees

  • The BfArM charges fees for processing applications and notifications (inclusion of DiGA in the DiGA list, notification of significant changes).

    • The fees for decisions on the inclusion of your application in the DiGA directory are between EUR 1,500 and EUR 9,000.
    • The fees for notifications of changes are between EUR 300 and EUR 4,900.
    • Removal from the directory costs EUR 200.


    The details are regulated by the DiGAV.

Remedy

- Appeal
- Detailed information on how to appeal can be found in the decision on your application.

Status: 23.06.2022

Responsible for editing: Bundesministerium für Gesundheit

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