JMIR Publications

ABSTRACT

Background:

Healthcare 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 (DVG), 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 regulated market access 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:

Conducted from May 2023 to August 2024, this study used a mixed methods approach. A descriptive analysis was performed to assess the use of positive healthcare effects by DiGA manufacturers, providing a market status of the pSVV technology. A qualitative analysis, using Grounded Theory and Gioia methodology, was employed to gain insights into stakeholder perspectives, focusing on manufacturers and regulatory bodies. A functional-structural analysis was also conducted to examine how various components of the innovation system—actors, institutions, interactions, and infrastructure—interact and influence the pathway's effectiveness.

Results:

The descriptive analysis showed that only 11 DiGAs use the pSVV pathway, with just one as a primary endpoint. Six out of nine pSVV key areas were utilized. 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 positive reception among stakeholders. The systemic analysis identified five key issues, including a lack of entrepreneurial focus on pSVV, limited regulatory experience, inadequate measurement methods, and entrenched practices prioritizing medical benefits, which hinder market formation and legitimacy.

Conclusions:

This study identifies key factors for successfully implementing innovation systems through regulatory market access pathways. These include content and format security, clearer framework specification, active innovation process management, and market formation stimulation. Addressing these factors can reduce uncertainties and foster the broader 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.