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Digital health application; application for inclusion in the DiGA directory

If you are a manufacturer of a digital application that is to be included in the DiGA directory as a digital health application (DiGA), you must submit an application to the Federal Institute for Drugs and Medical Devices (BfArM).

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  • Fast-Track-Verfahren für DiGA-Antragsportal
    The aim of the portal is to enable you to easily manage your corresponding applications and notifications to the BfArM and to provide you with the best possible support when submitting them.

Responsible for you

Bundesinstitut für Arzneimittel und Medizinprodukte

Street address

Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Postal address

Kurt-Georg-Kiesinger-Allee 3

53175 Bonn

Website

www.bfarm.de

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Procedure details

Since the Digital Healthcare Act (DVG) came into force, people insured under the statutory health insurance scheme (GKV) have been entitled to be provided with digital health applications (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 medical devices in risk classes I, IIa or IIb.

The prerequisite for this is that

  • the DiGA must have successfully passed a test procedure at the Federal Institute for Drugs and Medical Devices (BfArM) and
  • are listed in the "Directory of reimbursable digital health applications" (DiGA directory).

Only you as the manufacturer of the medical device or a person authorized by you can submit an application for inclusion in the directory. Inclusion in the BfArM directory is a prerequisite for reimbursement as part of the standard care provided by statutory health insurance (SHI).

The procedure is designed as a fast-track process: The BfArM usually evaluates the complete application within 3 months. Only in justified individual cases can the deadline be extended by up to a further 3 months. If there is sufficient evidence of positive treatment effects, the product is permanently included in the DiGA directory. If there is not yet sufficient evidence of the positive effects on care, an application for provisional inclusion can be submitted. The trial period is a maximum of 12 months. During this period, data can be collected, for example as part of clinical trials. In exceptional cases, this period can also be extended by a further 12 months.

However, when planning the extended trial period, the three-month evaluation period of the submitted evidence by the BfArM must be taken into account. Accordingly, proof of the positive supply effect must be submitted at least 3 months before the end of the extended trial period. This ensures that the duration of the trial period is limited to a maximum of 24 months in the event of an extension.

If you require support from the BfArM, you can arrange a consultation appointment with the Institute. The BfArM will advise you on the requirements for inclusion in the DiGA directory in order to support you at an early stage in generating meaningful documents and data for inclusion.

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

  • Security and functionality,
  • data protection and information security,
  • quality, in particular interoperability, and
  • proof of positive supply effects, depending on the type of application.

  • Required Documents
    • gegebenenfalls Vollmacht einer bevollmächtigten Person zur Antragstellung
    • Konformitätserklärung
    • gegebenenfalls CE-Zertifikat
    • Zertifikat über die Umsetzung eines Informationssicherheitsmanagementsystem (ISMS) gemäß ISO 27001 oder gemäß ISO 27001 auf der Basis von IT-Grundschutz (BSI-Standard 200-2: IT-Grundschutz-Methodik)
    • Nachweise für die Durchführung eines Penetrationstests und die Behebung der dabei gefundenen Schwachstellen
    • 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
    • Weitere Unterlagen, soweit weitere Nachweise im Rahmen der Prüfung durch das BfArM angefordert werden.

The entire application procedure takes place exclusively electronically via the BfArM application portal. The link can be found 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:
    • 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 the e-mail address via a link in the mailbox and
    • Set a password.
  • For the submission of applications and notifications: Extended Validation (EV) certificate must be available and the public part of the certificate must be uploaded to the portal.

After successful registration, you can create one or more DiGAs in the application portal and complete and submit the following online forms for applications and notifications for each DiGA, depending on the issue:

  • Application for inclusion in the DiGA directory
  • Application for extension of the trial
  • Submission of evidence for final inclusion in the DiGA directory after testing
  • Notification of significant changes
  • Application for removal from the directory

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 goods inspection to check the formal completeness of the documents and evidence submitted.
  • If the documents and evidence are complete, the BfArM will confirm receipt of the application documents within 14 days and notify you of the corresponding date of receipt as the start of the processing period.
    Otherwise, you will receive a letter listing the information and documents that still need to be corrected or submitted.
  • The core of the procedure is
    • checking the manufacturer's information on the required product properties
    • as well as the examination of proof to be provided by the manufacturer of the positive supply effects that can be realized with the DiGA.
  • Upon receipt of a positive decision on the inclusion of a DiGA in the list, it is published there.

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

Decision on inclusion in the directory
Fee: EUR 1,500 - EUR 9,000

Notification of variations
Fee: EUR 300 - EUR 4,900

Application for extension of the trial
Fee: EUR 1,500 - EUR 4,900

Submission of evidence for final inclusion in the DiGA directory
Fee: EUR 1,500 - EUR 6,600

Removal from the directory
Fee: EUR 200

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.

After receipt of the complete application. In justified individual cases, the deadline can be extended by up to a further three months. (3 months)

- Appeal
- Detailed information on how to lodge an appeal can be found in the notification of your application.

Status: 20.08.2024
Editorially responsible for prodecure description: Bundesministerium für Gesundheit
Source: Federal Portal
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