The legislature relied on three different types of standards to structure the legal framework for DiGA. At the highest level, there is the parliamentary law, the Digital Health Care Act (DVG), which defines the regulatory framework, the essential key points and criteria. A second elaboration of the DVG framework is provided by a legal ordinance of the Federal Ministry of Health (BMG), the so-called Digital Health Applications Ordinance (DiGAV).
According to Section 139 e (9) of the German Social Health Code (SGB V), the DiGAV is intended to regulate relevant detailed questions regarding the material requirements of DiGA, the inclusion procedure in the directory for digital health applications pursuant to Section 139 e of the German Social Health Code (SGB V) (“DiGA directory”), and the arbitration procedure regarding the payment amount.
The third type of standard is an administrative regulation of the BfArM, the so-called DiGA Guideline, which was published at the end of April 2020.