Early Implementation of a Nationwide Opt-Out Electronic Health Record for Outpatient Care in Germany: Qualitative Semistructured Interview Study.

BACKGROUND: Electronic health records are a central component of digital health strategies worldwide. Early implementation phases are particularly critical for shaping long-term adoption patterns but remain insufficiently studied, especially in large-scale, policy-driven rollouts. In January 2025, Germany introduced the electronic patient record (elektronische Patientenakte, ePA) as a nationwide opt-out system, creating a unique opportunity to examine early implementation in routine outpatient care. OBJECTIVE: This study aimed to explore facilitators and barriers influencing the early implementation of the ePA in German outpatient practices from the perspective of health care professionals. METHODS: A qualitative study based on semistructured interviews with general practitioners, medical assistants, and physician assistants was conducted between August and December 2025. Participants were recruited nationwide through regional physician associations and a professional organization using a criterion-based purposive recruitment strategy with maximum variation elements. Interviews were analyzed using qualitative content analysis guided by the Consolidated Framework for Implementation Research. Coding combined deductive framework-based and inductive thematic approaches. RESULTS: A total of 49 interviews were conducted. Facilitators and barriers were identified across all 5 Consolidated Framework for Implementation Research domains, with the largest number of categories in the inner setting. Organizational factors such as leadership engagement, internal communication structures, and learning climate were central facilitators of implementation. In contrast, barriers were primarily related to technical instability, heterogeneous functionality of practice management systems, limited interoperability across care sectors, and insufficient patient awareness. Although the ePA was generally perceived as intuitive and potentially beneficial, particularly for improving information availability and reducing redundant diagnostics, its routine use remained strongly dependent on organizational capacity, infrastructure stability, and cross-sectoral integration. CONCLUSIONS: Early implementation of the nationwide opt-out ePA in Germany is shaped less by professional resistance than by organizational, technical, and systemic conditions. These findings highlight that successful large-scale digital health implementation requires coordinated strategies addressing technical infrastructure, organizational readiness, governance, and patient engagement beyond the mere deployment of digital systems.