Apply for inclusion of a digital health application (DiGA) in the DiGA directory

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 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 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 that the documents and evidence submitted are formally complete.
• If the documents and evidence are complete, the BfArM will confirm receipt of the application documents within 14 days, stating the corresponding date of receipt as the start of the processing period.
  Otherwise, you will receive a letter with a list of the information and documents that still need to be corrected or submitted.
• At the heart of the procedure are the
  • checking the manufacturer's information 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.
• Upon receipt of a positive decision on the inclusion of a DiGA in the list, it will be published there.

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.

• Authorization of an authorized person to submit the application, if applicable
• Declaration of conformity
• CE certificate, if applicable
• Certificate on the implementation of an information security management system (ISMS) in accordance with ISO 27001 or in accordance with ISO 27001 on the basis of IT-Grundschutz (BSI Standard 200-2: IT-Grundschutz methodology)
• Proof that a penetration test has been carried out and that the vulnerabilities found have been remedied
• Instructions for use
• Study(ies) to prove positive supply effects or results of a systematic data evaluation to justify the improvement in supply (study protocol, study report)
• Scientific evaluation concept, if applicable
• If applicable, study to determine the test accuracy of the diagnostic instruments contained in the DiGA (if applicable)
• Results protocol of the consultation with the BfArM (if applicable)
• Indication of data for which legal requirements for the protection of trade and business secrets or the protection of personal data or intellectual property preclude publication
• Further documents, if further evidence is requested by the BfArM as part of the review.

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

• § Section 33a of the German Social Code (SGB) Fifth Book (V)
• §139e Social Security Code (SGB) Fifth Book (V)
• Ordinance on the procedure and requirements for assessing the eligibility for reimbursement of digital health applications in statutory health insurance (Digital Health Applications Ordinance - DiGAV)
• Act to accelerate the digitalization of the healthcare system (Digital Act - DigiG)

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

31.07.2024