Real Value of Patient-Centred Positive Health Effects of Digital Medical Devices: Lessons From the German DiGA

OBJECTIVES: Under Germany's pioneering Digital Healthcare Act (DVG), digital health applications (DiGAs) are required to demonstrate positive care effects through either medical benefits or Positive Structural and Process Improvements (PSVV). Yet, despite their crucial role in enhancing healthcare delivery and reducing inefficiencies within the healthcare sector, PSVV domains remain starkly underutilized. This study investigates the barriers that limit the effective adoption of PSVV and evaluates their implications for healthcare efficiency and economic outcomes.

METHODS: We conducted a systematic review of all listed DiGAs in the DVG registry, examining the clinical trials focusing on study designs, endpoints, and measurement instruments. Additionally, academic and grey literature was systematically reviewed to determine the cost-effectiveness of established therapies in fields related to PSVV domains.

RESULTS: The review revealed that out of 57 DiGAs listed, only eight incorporate PSVV domains, and of these, merely one is exclusively dedicated to these improvements. This limited integration is primarily attributed to substantial measurement challenges. Specifically, our findings highlight the absence of standardized methodologies for evaluating broad and multifaceted PSVV domains, which complicates the definition and validation of specific endpoints. Furthermore, the study underscores a critical gap in the economic evaluation of PSVVs; despite their potential to address inefficiencies in healthcare spending, there is scant evidence of their direct economic benefits. This lack has hindered their broader recognition and inclusion in reimbursement models.

CONCLUSIONS: The findings reveal a significant underutilization of PSVV domains within DiGAs, driven by methodological inadequacies and economic valuation challenges. To bridge this gap, there is an urgent need for developing new evaluative frameworks that can capture the complex benefits of PSVV domains more effectively. Such frameworks would facilitate the demonstration of economic value and support the expanded development and integration of DiGAs that promote PSVVs.