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. Which deadlines were and are important? Here you can read it in detail.

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.
    (8) The deadline for compliance with data protection requirements has been postponed from 01.04.2023 to 01.08.2024.

  • § 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 01.01.2024.
    (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 01.01.2024.

  • § 7 Proof through certificates

    (3) The deadline for proving compliance with data security requirements by means of a certificate has been postponed from 01.01.2023 to 01.01.2024.
    (4) The deadline from which a certificate of compliance with data protection requirements can be requested has been postponed from 01.04.2023 to 01.08.2024.

  • Annex 1 Questionnaire according to § 4 paragraph 6

    15a. Authentication
    The deadline for authentication via the secure digital identity in accordance with Section 291 (8) SGB V has been postponed from 01.01.2023 to 01.01.2024.

  • Annex 1 Questionnaire according to § 4 paragraph 6

    5. the deadline for transferring data to the electronic patient file has been postponed from 01.01.2023 to 01.01.2024

The experts at BAYOOMED and BAYOOCARE will support you in the development of your digital health application – from regulatory advice to post-market surveillance (PMS).

Please contact us for an initial consultation.