[Structural benefits on prescription? Exploring potentials and challenges of the pSVV concept in the approval process of digital health applications in Germany].

Background: With the introduction of the Digital Healthcare Act (DVG) at the end of 2019, digital health applications (DiGA) were included in the statutory health insurance in Germany. DiGA are digital medical products whose primary function is based on digital technologies. In the definition of the approval process, the term "therapeutic benefit", which is crucial to the evaluation of pharmaceuticals, was expanded to include the broader concept of "positive healthcare effect" ("pVE"). In particular, the concept of "patient-relevant structural and procedural improvements" (pSVV) has been introduced alongside the well-known "medical benefit" to facilitate market access for applications that specifically aim to strengthen the role of the patient in healthcare. Three and a half years after the implementation of DiGA, it has become evident that the concept of pSVV has not yet been adopted in the healthcare system to the extent intended by the legislation. As of July 1^st 2024, only one of the 56 listed DiGA uses pSVV as a primary endpoint, with ten others using pSVV as a secondary endpoint.

Method: A qualitative approach was chosen to explore the new and under-researched topic of DiGA and, in particular, pSVV. The Grounded Theory method was applied in combination with the Gioia method, which is particularly suitable for analyzing innovative subject areas. The inductive approach allows for new concepts to be developed from the data of the study participants, thus supporting flexible and dynamic theory building. Decision-makers from groups including DiGA manufacturers with and without pSVV, manufacturers of digital medical products without DiGA approval, consultancies, and institutions involved in the DiGA approval process were included in the study by conducting semi-structured interviews. The evaluation was conducted through a multi-step analysis leading to the identification of first-order concepts, second-order themes, and aggregated dimensions. The developed data structure was supported by the presentation of relevant quotes as part of the Anhang A.

Results: The analysis indicates that refining the benefit definition for the pSVV categories defined in the DiGA guidelines is critical to the successful establishment of the pSVV concept. Additionally, further analysis of potential methods for demonstrating pSVV, suitable measurement tools, and the general inclusion of economic considerations in the benefit analysis appear sensible.

Discussion: The qualitative analysis demonstrates that refining the pSVV concept and defining appropriate measurement methods are essential for a successful implementation in the German healthcare system. An economic evaluation could bring objectivity to the debate on DiGA costs and contribute to transparency in the approval process. Further research and the involvement of key stakeholders are necessary to clarify the intended benefits within the pSVV categories, thereby promoting the introduction of digital health applications with a particular focus on empowering patients in healthcare.