Implementation, Use, and Quality of the National Electronic Health Record in Germany: Protocol for an Observational Cohort Study of Healthcare Providers and Patients (Preprint)
Year: 2026
Type: preprint
Study design: Study Protocol
Abstract: BACKGROUND The nationwide rollout of the opt-out electronic health record (abbreviation: eHR; German: Elektronische Patientenakte, abbreviation: ePA) in Germany represents a major digital transformation of the healthcare system. Despite being mandatory for healthcare providers (HCPs) since October 2025 and available by default to nearly 90% of the German population insured under statutory health insurance (SHI), the implementation of the eHR is accompanied by substantial uncertainties. Successful adoption depends on SHI funds as well as HCP and patient engagement, and requires overcoming technical, organizational, and workflow-related barriers. OBJECTIVE The ePA.IMPULS research project aims to systematically identify key facilitators and barriers to the successful implementation, use, and perceived benefits of the eHR. The study evaluates how structured technical and organizational support influences implementation processes, system use, and care-related benefits from the perspectives of HCPs and patients during the national rollout. METHODS The project employs a longitudinal mixed-methods design in terms of a cohort study structured across 4 analytical perspectives (launch, implementation, use & acceptance, and benefit), 2 stakeholder perspectives (HCPs and patients), and 4 time points (t0 – t3). The study builds on a pilot phase (t-1) conducted in a pilot region to test the launch of the German eHR. Practices and hospitals that were part of this pilot phase represent an intervention group receiving intensive support. The control group comprises practices and hospitals that were not part of the pilot phase. Quantitative surveys, qualitative analyses of free-text entries from support or feedback systems, focus groups, and linked administrative claims data will be used to assess implementation challenges, use patterns, and perceived benefits. Data will be analyzed using descriptive and inferential statistics as well as qualitative content analysis. RESULTS The pilot phase (t-1) enabled the establishment of intervention and control groups and generated comprehensive baseline data on technical, organizational, and workflow-related implementation barriers. Retrospective analyses of the pilot-phase (t-1) data have been completed. Subsequent follow-up assessments will compare supported and unsupported HCPs across multiple functional expansions of the eHR (t1 – t3) and integrate patients’ perspectives (t1). CONCLUSIONS ePA.IMPULS prospectively accompanies the nationwide implementation of the eHR in Germany and provides an empirically grounded assessment of real-world implementation processes. By combining quantitative and qualitative evidence across multiple rollout phases and stakeholder perspectives, the project is expected to generate actionable, policy-relevant insights into effective implementation strategies. The findings will inform iterative improvements of the eHR and offer transferable methodological and practical guidance for future large-scale digital health initiatives.
Authors: Pascal Raszke, Timo Neunaber, Isabel Richter, Vera Weirauch, Sophie Peter, Achim Mortsiefer, Margarete Gasch, Liv Jansen, Berit Schoppen, Claudia Gertzobe, Kerstin Hermes-Moll, Silke Hochheim, Daniela Vakalopoulos, Fatima Amjahad, Matthias Brittner, Vanessa Kalka-Prein, Marco Luzius, Lea Nehm, Burkhard Fischer, Klaus Kalkreuter, Sven Meister
Language: English
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7168282982