The German Act to Accelerate the Digitalisation of the Healthcare System (Digital Act, DigiG) has been in force since 26 March 2024. It is the basis for a number of changes in the area of digital health applications (DiGAs).
Inclusion of risk class IIb products
Prior to the Digital Act, DiGAs had been limited to the lower risk classes (I and IIa). This has now also been extended to the higher risk class IIb within the meaning of Art. 51 in conjunction with Annex VIII of Regulation (EU) 2017/745, so that the possibility of inclusion into the catalogue of reimbursable DiGAs now applies to a significantly wider range of products. However, for DiGAs in risk class IIb stricter requirements apply for inclusion into the list of reimbursable products maintained by the BfArM (Federal Institute for Drugs and Medical Devices). Digital health applications in risk class IIb must provide evidence of a medical benefit in addition to the relevant evidence of a positive healthcare effect (Section 139e (2) sentence 4 SGB V). This requires the submission of a prospective comparative study (Section 11a (1) DiGAV). A mere improvement of a patient-relevant structure or procedure is not sufficient for the inclusion of risk class llb DiGAs into the catalogue of reimbursable products.
New § 33 (5a) SGB V: No agreements between manufacturers
The newly inserted subsection (5a) in Section 33 SGB V prohibits manufacturers of digital health applications from entering into legal transactions or agreements with manufacturers of medicinal products or medical aids that are likely to restrict the insured person’s freedom of choice or the freedom of doctors to select medicinal products or medical aids. It is inadmissible to design a DiGA in such a way that it only works with a specific suitable medicinal product or medical aid and does not take other suitable products into account. This is intended to prevent so-called lock-in effects. However, the extent to which cooperation between manufacturers is permitted in connection with DiGAs is not clearly described.
It also remains to be seen what consequences this will have for the manufacturer’s design process for a DiGA. There is still controversy among legal experts as to whether it is sufficient to consider a respectable number of medicinal or auxiliary products or whether an interpretation of the facts based on the corresponding elements of the GWB (Competition Act) and the UWG (Act against Unfair Competition) is more appropriate. This is not yet foreseeable or even bindingly decided. Manufacturers are therefore well advised to check on a case-by-case basis whether the prohibition in Section 33 (5a) SGB V is or has been observed.
Performance measurement and adjustment of remuneration
The DigiG introduces an application-accompanying performance measurement. Manufacturers are obliged to provide the BfArM with data, such as the duration and frequency of use of the DiGA, in anonymised and aggregated form. The newly introduced Section 139e (13) SGB V specifies the data relevant for measuring the success of a DiGA:
- the duration and frequency of use of the digital health application,
- patient satisfaction with regard to the quality of the digital health application and
- the patient-reported health status during the use of the digital health application.
According to the DigiG, the performance-based price components based on this data will be included in the remuneration amounts by at least 20% as of 1 January 2026. Manufacturers of DiGAs must take this increase in the proportion of performance-based components within the remuneration into account in their calculations.
Conclusion
Manufacturers of digital health applications should check whether they can benefit from the extended scope of use for medical devices in risk class IIb. The reuschlaw quick check offers the possibility of a free and non-binding check as to whether a DiGA is suitable for the fast-track procedure and can therefore be included in the SHI reimbursement catalogue.
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