Unpacking Performance Factors of Innovation Systems and Studying Germany's Attempt to Foster the Role of the Patient Through a Market Access Pathway for Digital Health Applications (DiGAs): Exploratory Mixed Methods Study.

Background: Health care innovation faces significant challenges, including system inertia and diverse stakeholders, making regulated market access pathways essential for facilitating the adoption of new technologies. The German Digital Healthcare Act, introduced in 2019, offers a model by enabling digital health applications (DiGAs) to be reimbursed by statutory health insurance, improving market access and patient empowerment. However, the factors influencing the success of these pathways in driving innovation remain unclear.

Objective: This study aims to identify the key performance factors of the innovation system shaped by the patient-relevant structural and procedural improvement (pSVV) pathway within the DiGA model. By examining how this pathway supports the entry of innovative digital health technologies, we seek to uncover the systemic dynamics that influence its effectiveness in fostering patient-centered digital health solutions.

Methods: This study, conducted from May 2023 to November 2024, used a mixed methods approach. A descriptive analysis assessed how DiGA manufacturers use positive health care effects, giving a market overview of the pSVV technology. A qualitative analysis using grounded theory and Gioia methodology provided insights into stakeholder perspectives, focusing on manufacturers and regulatory bodies. A functional-structural analysis examined how components of the innovation system, such as actors, institutions, interactions, and infrastructure, interact and impact the effectiveness of the pathway.

Results: The descriptive analysis showed that only 11 (20%) of the 56 DiGAs available in Germany used the pSVV pathway, with only 1 (2%) provisionally listed DiGA using pSVV as a primary end point; 6 of 9 (67%) pSVV key areas were used. The qualitative analysis revealed that manufacturers prioritize demonstrating medical benefits over pSVV due to evidence requirements and uncertainties around pSVV acceptance. Operational barriers hindered the adoption of pSVV, despite a positive reception among stakeholders. The systemic analysis identified key issues, including a lack of entrepreneurial focus on pSVV, limited regulatory experience, inadequate measurement methods, and entrenched practices prioritizing medical benefits, that hinder market formation and legitimacy.

Conclusions: This study identifies key factors for effectively implementing innovation systems through regulated market access pathways, including content and format security, clearer framework specification, active innovation process management, and market formation stimulation. Addressing these factors can reduce uncertainties and promote wider adoption of digital health technologies. The findings highlight the need for future research on patient empowerment and the development of methodologies beyond traditional therapeutic outcomes.