Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Mar 4, 2026
Date Accepted: Jul 23, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Early implementation of a nationwide opt-out electronic health record in Germany: a qualitative study in outpatient care
ABSTRACT
Background:
Electronic health records (EHRs) 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 healthcare professionals (HCPs).
Methods:
A qualitative study based on semi-structured interviews with general practitioners, medical assistants, and physician assistants was conducted between August and December 2025. Participants were recruited nationwide using purposive sampling. Interviews were analyzed using qualitative content analysis guided by the Consolidated Framework for Implementation Research (CFIR). Coding combined deductive framework-based and inductive thematic approaches.
Results:
A total of 49 interviews were conducted. Facilitators and barriers were identified across all five CFIR 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. Clinical Trial: https://www.drks.de/search/de/trial/DRKS00037053 identifier DRKS00037053, Registration Date: 05.06.2025
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