The Digital Health Applications Ordinance ( DiGAV) was passed in April 2020 and supplemented by the DVPMG in June 2021.

The DiGAV determines the requirements for reimbursement of digital health applications (DiGA) by health insurance companies.

Find out what requirements the regulation places on manufacturers. This allows you to decide whether an application is promising and whether the costs are in relation to the expected economic benefit .

In parallel to the DiGAV, the BfArM published a guideline. This also reveals which American tech group you should avoid in order to meet the requirements of the DiGAV. You can find out more about this in section 6 “DiGAV requirements for the products”.

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You can find the Digital Health Applications Ordinance (DiGAV) here and the BfArM DiGA guidelines here.

1. DiGAV: what it's all about

The full name of the DiGAV is: "Regulation on the procedure and requirements for checking the reimbursement of digital health applications in statutory health insurance."

This ordinance specifies how the "Digital Supply Act" (DVG) is to be implemented. The DVG already lists the most important requirements for digital health applications:

  • The product must be a class I or IIa medical device (according to MDR or MDD).
  • It must meet the requirements for data protection and interoperability , among other things.
  • The manufacturer must demonstrate positive supply aspects.
  • The manufacturer must submit a successful application to the BfArM for inclusion in the "Directory of reimbursable digital health applications according to § 33a" .
Additional information

Read more about the Digital Supply Act (DVG) here.

The DiGAV now describes more precisely than the DVG how manufacturers can prove that they or their products meet the legal requirements. For example, the regulation contains specific checklists that manufacturers must use to check whether the IT security requirements are met.

In contrast to the law, the ordinance also regulates the costs, the procedure and the exact contents of the electronic directory.

2. DiGAV at a glance

The DiGAV comprises 43 paragraphs, which are divided into 9 sections (see Fig. 1).

Fig. 1: Chapter structure of the DiGAV (click to enlarge)

Sections 2, 3 and 5 are particularly relevant for manufacturers:

  • Section 2 defines the requirements for the DiGA, e.g. with regard to data security, interoperability and quality.
  • Section 3 describes how manufacturers must prove that their product has a "positive supply aspect".
  • Section 5 determines the content that manufacturers must make public in the "DiGA directory".
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