The Digital Health Applications Ordinance (DiGAV) forms a central building block for the app on prescription. The last amendment to the current DiGAV was made by the Hospital Nursing Relief Act (KHPflEG) of 20.12.2022. There have also been further changes this year. Which deadlines are important now? You can find the latest details here.

An overview of the innovations
of the DiGAV

The changes relate to deadlines that have been extended:

  • § 4 Data protection and data security requirements

    (7) The deadline for compliance with data security requirements has been postponed from 01.01.2023 to 01.01.2025. From this point onwards, a certificate from the Federal Office for Information Security (BSI) is required for all DiGAs already listed and for all DiGAs in the process of being listed. This will be issued after examination by certified test centers issued after testing by certified test centers.

    (8) The deadline for compliance with data protection requirements has been postponed from 01.04.2023 to 01.08.2024. The certificate is currently still under development. There is currently no final list of criteria. However, it is recommended that you familiarize yourself with the test criteria.

  • § Section 6a Interoperability of digital health applications with the electronic patient record

    (1) The deadline for data transfer to the electronic patient file has been postponed from 01.01.2023 to 30.04.2024.

    (2) The deadline for data export to the electronic patient record with regard to semantic and syntactic interoperability has been postponed from 01.01.2023 to 30.04.2024.

    (3) From this date, all DiGAs must be connected to the telematics infrastructure. Questions?

  • Annex 1 Questionnaire according to § 4 paragraph 6

    15a. Authentication
    The deadline for authentication via the secure digital identity (health ID) in accordance with Section 291 (8) SGB V has been postponed from 01.01.2023 to 30.04.2024.

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