ePA4all—Exploring facilitators and barriers to the adoption of the electronic health record in Germany: A study protocol for a mixed-methods analysis

Abstract

Background

This manuscript presents the study protocol for a planned mixed-methods study on the transition to an opt-out approach for the electronic health record (elektronische Patientenakte, ePA) in Germany in 2025. This change represents a paradigm shift in the healthcare system and aims to promote broad adoption. While the ePA has the potential to improve cross-sectoral care and patient empowerment, structural and individual barriers may hinder successful implementation. Understanding these factors is crucial to developing strategies for effective integration and long-term utilization of the ePA.

Objective

This study aims to systematically investigate the barriers and facilitators influencing the adoption and use of the ePA among various user groups, including both patients and healthcare providers, in Germany. It seeks to identify sociodemographic and contextual factors affecting acceptance and usage while also exploring the ePAs potential to optimize healthcare processes, patient satisfaction, and empowerment.

Methods

This mixed-methods exploratory study employs the Consolidated Framework for Implementation Research to examine the structural, organizational, and individual determinants of ePA implementation. Data will be collected in four modules: (1) patient interviews and surveys with ePA users and nonusers, (2) analysis of aggregated usage data from all ePAs in Germany, (3) interviews and surveys with stakeholders in outpatient and emergency care, and (4) focus groups for validation and synthesis of findings. Quantitative analyses include descriptive statistics and regression models, whereas qualitative data will be analyzed using structured content analysis.

Discussion

This study is expected to provide a comprehensive understanding of the factors that affect ePA adoption and use in Germany. Insights from different perspectives will inform targeted strategies to overcome barriers, strengthen health literacy, and enhance system usability. These insights will contribute to recommendations for optimizing the implementation of the ePA in Germany and promoting the digital transformation of the German healthcare system.

Introduction

Scientific background

Society and the healthcare system in Germany are facing a decisive turning point. Demographic change is leading to a rapidly aging population that is increasingly affected by complex, multimorbid conditions.^1–3 As a result, there is an increasing demand for holistic, yet specialized medical care, while the healthcare system faces limitations in personnel and financial resources.^4,5 This discrepancy between demand and capacity represents one of the most pressing challenges of the coming years. Access to reliable and comprehensive information about individual preexisting conditions, risk factors and medication is a prerequisite for medically sound and economically sensible decisions in patient care. ⁶ However, this is precisely where a weakness of the current system becomes apparent: medical information is organized decentrally and is often not available in acute emergencies or for new patients. ⁷ This lack of information makes targeted care considerably more difficult and thus also poses risks for patients, for example, through drug interactions. In this context, electronic health records (EHRs) are widely recognized as a key digital technology to address these challenges by improving information flow, patient safety, and coordination of care across healthcare sectors.

A standardized and comprehensive EHR could prove to be a key technology for overcoming these challenges. Since the introduction of the Patient Data Protection Act in 2021 ⁸ in Germany, patients have had the right to apply to their statutory health insurance company for an electronic patient record. However, so far only about 1% of all insured persons in Germany have taken advantage of this. ⁹ As a result, the EHR has had almost negligible effects on medical care in Germany. In consequence, in 2023 the German Bundestag passed two legislative proposals to accelerate the digitalization of the healthcare system (Digital Act - DigiG) ¹⁰ and to improve the use of health data (Health Data Use Act–GDNG). ¹¹ Accordingly, from 2025, all those with statutory health insurance insured persons in Germany will automatically receive an “elektronische Patientenakte” (ePA), unless they opt out by notifying their health insurance provider (ePA für alle, ePA for all). This step is unique in the German statutory healthcare system and will result in over 70 million insured people receiving an ePA.

The ePA is a secure digital repository for health data in Germany. It consolidates medical information, such as test results, physician reports, diagnoses, and medication data, in a single location that can be accessed by patients and authorized healthcare professionals to support clinical care and reduce redundant examinations. Importantly, the ePA is not tied to a single healthcare institution but is designed to enable cross-institutional access, allowing data to follow the patient across different sectors of the healthcare system. In practice, the ePA enables quick and secure retrieval of key health information and can serve as a central basis for digital health management in Germany. Moreover, the ePA can become the central basis for digital health management in Germany. All persons with statutory health insurance in Germany were proactively informed by their health insurance companies by post about the upcoming introduction of the ePA and their right to object. A recent analysis by the Federation of German Consumer Organisations (Verbraucherzentrale Bundesverband – vzbv) examined 14 such letters and found that most of the communications highlighted the advantages of the ePA (e.g., improved emergency care, medication safety, easier access to documents), but sometimes raised overly optimistic expectations, for example with regard to the automatic availability of additional digital services such as the electronic vaccination record. ¹²

Preliminary studies on attitudes to the ePA in Germany show that currently 69% ¹³ to 72% ¹⁴ of the population are in favor of the ePA, with younger people being less positive about the ePA than the older general population. Skepticism appears to be particularly high among 18- to 24-year-olds: 37% of them supported the ePA, while 85% of over 65-year-olds rated the ePA positively. ¹⁵ From the patients’ perspective, key facilitators of EHR and patient-portal use are linked to the ability to participate more actively in their own care. Access to personal health data, including laboratory results, diagnostic reports, and medication lists, improves information awareness and health literacy, enabling more effective self-management and shared decision-making. ¹⁶ Integrated features such as secure messaging, medication refills, and appointment scheduling strengthen engagement and adherence, with modest improvements in preventive behaviors and glycemic control. ¹⁷ Patients also associate EHRs with safer medication management and greater convenience through digital communication and document access.^16,18 However, acceptance varies depending on how individuals balance perceived value and privacy concerns, as shown by Cherif and Mzoughi. ¹⁹ Evidence from Australia also shows that privacy remains a key determinant of EHR acceptance: Hollo and Martin ²⁰ argue for a fair and transparent approach to data governance to strengthen public trust and avoid inequities. Similarly, Holt et al. ²¹ demonstrate in a national Australian survey that awareness and trust are decisive predictors of whether individuals actively opt out of a national EHR system or remain enrolled. The most frequently reported barriers include privacy and data protection concerns, particularly fears of unauthorized access or data breaches.^22,23 Usability challenges such as complex interfaces, unclear navigation, and limited perceived value reduce motivation to use digital records. ¹⁶ Beyond technical and organizational determinants, individual competencies such as digital health literacy play a crucial role in the adoption of EHRs. Digital health literacy refers to the ability to seek, understand, and critically appraise digital health information and apply it to decision-making. ²⁴ It has already been shown that higher digital health literacy is associated with greater awareness, stronger engagement, and more frequent use of national EHR systems. ²⁵ Sham et al. ²⁶ emphasize that digital health literacy is crucial for empowering patients and enabling the effective use of EHRs. Building on this, Papadopoulos et al. ²⁷ highlight that trust is an equally critical factor: individuals need not only the skills to access and interpret digital health information but also the confidence that their data are secure and handled responsibly. Trust is fostered by transparency, clear communication of data usage, and meaningful control options for patients, which together transform literacy into active and confident participation in EHR systems.

From the perspectives of healthcare professionals (HCP), a recent German survey by the Association of Statutory Health Insurance Physicians highlights the administrative challenges associated with the ePA: around 90% of practices anticipate time and administrative burdens related to filling out records, managing rights, and educating patients. ²⁸ Expectations regarding the impact of the ePA on care/ treatment processes are somewhat less pessimistic: Between 38% and 40% of practices consider it (rather) realistic that necessary documents will be available more quickly in the future, that they will be able to get a comprehensive picture of their patients more quickly and that communication with each other and with hospitals will be made easier. ²⁸ Most studies among healthcare professionals confirm this mixed picture. While many acknowledge the potential of EHRs to improve information continuity, coordination, and patient safety through faster access to data,^29,30 they also emphasize persistent usability and workflow challenges that increase documentation time and cognitive load.^31,32

International comparisons show that Germany is not alone in facing low adoption rates and trust issues. Many countries have encountered similar challenges when introducing nationwide EHRs.^33–37 The example of Australia illustrates a successful transition from opt-in to opt-out: within a few years, the national “My Health Record” program achieved over 90% population coverage, supported by comprehensive public communication, clear privacy safeguards, and stakeholder engagement.^20,21

Rationale for the study

As described above, the transition to an opt-out strategy for the ePA from 2025 represents a paradigm shift in the German healthcare system, that is intended to promote widespread use. However, the first release of the opt-out ePA will not yet include all the features, and it is unclear how various structural, cultural and individual factors will influence the acceptance and actual use of the ePA in clinical practice.

Although the benefits of the ePA depend significantly on user behavior, there is a lack of detailed knowledge about how the ePA is actually used in different care contexts and what obstacles hinder comprehensive integration. This study addresses this knowledge gap and aims to analyze the implementation of the ePA for all from a multidimensional perspective. The use of the Consolidated Framework for Implementation Research (CFIR) ³⁸ makes it possible to examine both the systemic and individual factors that influence the use of the ePA. By identifying specific barriers and facilitating elements, the study should help to develop strategies for the successful implementation and use of the ePA. The results of this study are highly relevant for advancing the digital transformation of the German healthcare system and creating the prerequisites for sustainable, patient-centered care. By taking into account the perspectives and needs of both patients and HCPs, the study provides valuable insights for the design of a user-friendly and inclusive digital infrastructure in the healthcare system.

Objectives of the study

The objective of the project is to systematically identify both structural and individual factors that hinder or facilitate the sustainable and active use of the ePA across different patient user groups and HCPs. In addition, the study will analyze how the ePA is changing care and which adjustments to the functionality of the ePA should follow in order to achieve greater user satisfaction and an increase in patient empowerment. A particular focus here is on the consideration of sociodemographic and disease-related aspects of users and nonusers.

System details and system in use

The ePA is developed and operated under the responsibility of gematik (Gesellschaft für Telematikanwendungen der Gesundheitskarte mbH) (https://www.gematik.de), the national agency responsible for Germany's digital health infrastructure. Gematik defines the technical specifications, ensures secure networking via the telematics infrastructure, and coordinates the rollout of the ePA across all statutory health insurance funds and healthcare providers. The ePA system ³⁹ is a key component of Germany's digital healthcare strategy, ⁴⁰ enabling structured and secure data exchange among all stakeholders in the healthcare sector. The following explains how access to the ePA can be established (see Figure 1). This process primarily works either through the ePA app provided by the health insurance company or by inserting the electronic health card at the healthcare provider's facility (Step 1). By default, the access period is limited to 90 days for doctors’ offices and hospitals, and 3 days for pharmacies. Custom settings can be configured via the ePA app.

Figure 1.

Depiction of the usage of the ePA in the healthcare context; own illustration of the gematik (the national agency responsible for digital health infrastructure in Germany). This figure depicts the technical and organizational steps for accessing, updating, and using the ePA within routine care. It is intended to provide background information and does not represent the study design or data collection steps described in this protocol. eP: electronic prescription; eD: electronic dispensing data.

Healthcare providers including doctor's offices, hospitals, pharmacies, and care services can then retrieve and update the ePA using their practice or hospital information systems (Step 2). There is a legal obligation to upload specific documents, such as medical reports, laboratory results, and imaging data (Step 3), ensuring comprehensive and standardized patient records. Health insurers automatically transfer billing data into the ePA system. These interactions are managed through the telematics infrastructure. With the ePA, applications of the telematics infrastructure are being interconnected for the first time. Data from electronic prescriptions (prescription and dispensing data) are automatically compiled into a medication list within the ePA (Step 4). Insured individuals retain full control over their data. Using the certified ePA mobile app (Step 5), they can grant or revoke access permissions for healthcare providers, either permanently or for a limited time. The app serves as the central frontend for patients, integrating access to the ePA and the data contained (Step 6). This empowers individuals to view documents, manage settings, and control access rights independently and securely. In addition, the ePA enables the targeted retrieval of medical information by all involved parties: physicians can quickly access diagnostic findings, medication plans, or laboratory results, which is particularly crucial in emergency situations or in cross-sectoral care. Insured individuals have access to their health documents at any time via the ePA app, can download and store them for personal use, or selectively share them.

Methods

Study design

This exploratory mixed-methods study investigates factors associated with the use and nonuse of the ePA.^41,42 The study follows established reporting standards for mixed-methods research and was prepared according to the GRAMMS criteria (Good Reporting of A Mixed Methods Study). ⁴³ A completed GRAMMS checklist is provided in Supplementary Material 1.

Module 1 focuses on patient perspectives: active users (Module 1a) are surveyed regarding their motivations, facilitating factors, and patterns of use. Individuals who have opted out of the ePA (Module 1b) and those who have an ePA but do not actively use it (Module 1c) are examined with regard to barriers and reasons for nonuse. In Module 2, the current status of ePA utilization (such as usage numbers, access frequency, requests over time, and the types of uploaded documents) is recorded in aggregated form and analyzed. Module 3 involves interviewing HCPs from both outpatient (Modules 3a and 3b), emergency care and inpatients settings (Modules 3c and 3d) regarding their attitudes toward the ePA, structural and individual barriers, specific information needs, and patterns of use. In Module 4, the results from Modules 1–3 will be validated and triangulated through focus groups. Based on these findings, recommendations for necessary steps toward a meaningful evolution of the ePA, as well as further developments required for broad acceptance and successful implementation in routine care, will be compiled in a workshop with experts and patient representatives. These results are then prioritized in a Delphi procedure. Throughout the entire process, a continuous coordination with the expert advisory board takes place. Detailed Study design is illustrated in Figure 2.

Figure 2.

Study design; own illustration.

Conceptual framework

For this analysis, the CFIR ³⁸ is used as a theoretical framework to analyze the implementation of the ePA, identifying the structural and individual factors that influence the adoption and use of the ePA in different contexts. This will help to identify and understand barriers to successful ePA adoption and derive appropriate strategies to promote its use. The CFIR aims to identify factors that promote or hinder patient empowerment in the context of ePA use. These can be structural factors such as the availability and accessibility of the ePA, individual factors such as the patients’ health literacy, and organizational factors such as stakeholder support. By identifying these factors, targeted measures can be developed to strengthen patient empowerment through the ePA. In summary, this project aims to analyze the interaction of individual factors (e.g., user skills) and systemic conditions (e.g., the digital infrastructure) in order to better understand and improve the implementation of the ePA.

Participants

Module 1

Module 1 explores patients’ perspectives on the use of the ePA. In Module 1a, active users are asked about the functions of the ePA, structural conditions, individual attitudes, prerequisites for use, and their treatment pathways. Module 1b includes individuals who possess an ePA but actively refuse to use it (opt-out). Module 1c focuses on “passive users,” who have an ePA but do not actively engage with it (e.g., do not open the app or upload/download documents), leaving their records largely empty. The aim of Modules 1b and 1c is to identify barriers and reasons for nonuse or low use in order to inform strategies to increase engagement. The detailed research questions can be found in the Supplementary Material 2.

Patients in modules 1 are recruited with the help of the Association of Statutory Health Insurance Physicians in Westphalia-Lippe (KVWL), Association of Statutory Health Insurance Physicians in Schleswig-Holstein (KVSH), Association of Statutory Health Insurance Physicians in Lower Saxony (KVN), Association of Statutory Health Insurance Physicians in Berlin (KVB), and Charité Universitätsmedizin via patient admissions. The associations of statutory health insurance physicians are contacting general practitioner practices and asking them to help with recruitment. A total of 40 GP practices (10 per Association of Statutory Health Insurance Physicians area) are to support the recruitment of patients in Module 1.

The required sample size was determined based on the methodology approved in the study protocol. The calculation was based on the HLS-EU-Q16 (1–16 points) ²⁴ as the primary endpoint. For a two-sided t-test at α = 0.05 and 80% power, a sample of n = 157 participants per group allows detection of a small to moderate mean difference (Cohen's d ≈ 0.32). To account for subgroup analyses, a target of approximately 160 participants per submodule was set. Assuming a response rate of approximately 30%, 1048 patients need to be invited.

Module 2

This module uses aggregated usage data from gematik. No individual participants are recruited; instead, existing data are used. The study investigates the extent and patterns of ePA usage. The detailed research questions can be found in Supplementary Material 2.

Module 3

In this module, HCPs who are directly involved in the use of the ePA are interviewed. The primary aim is to find out how the HCPs feel about the ePA, how the attitude and implementation are related and what experiences have already been made with the ePA. As a result, individual and structural obstacles associated with implementation should be identified. The detailed research questions can be found in the Supplementary Material 2. The sample size is set at n = 200 per group according to an a priori power analysis (G*Power) for the χ² test with the following assumptions: medium effect size (w = 0.2), α = 0.05, power (1–β) = 0.80, and df = 1 (resulting required sample size n = 197). Accordingly, a total target sample size of 800 is defined for Module 3. The required sample size of 197 was rounded up, taking into account a cost–benefit consideration, in order to have a buffer in case some questionnaires need to be excluded. Since the hypotheses are generated and further developed based on the qualitative preliminary study, the factors to be investigated cannot yet be determined conclusively.

Module 4

Main study results from Modules 1–3 are processed, synthesized, and then discussed with various experts, stakeholders, and patient representatives. The selection of experts, stakeholders, and patient representatives for Module 4 will follow an iterative process. As the preceding modules are exploratory in nature, the specific profiles of relevant actors can only be precisely determined once the main themes and determinants have been identified in Modules 1–3. In close collaboration with the project's expert advisory board, suitable representatives from statutory health insurance funds, general practitioners, hospitals, digital health experts, policymakers, and patient advocacy groups will then be identified and invited to participate. This approach ensures that the perspectives included in Module 4 are directly informed by the study's empirical findings and are most relevant for the validation and prioritization of recommendations.

Inclusion and exclusion criteria

The following Table 1 illustrates the detailed inclusion and exclusion criteria for each module.

Table 1.

Inclusion and exclusion criteria of the participants in the modules 1, 3 and 4.

	Inclusion criteria	Exclusion criteria
Module 1a ePA user (who regularly access and use their ePA)	- ePA-user - have statutory health insurance - 18 years or older - Willingness to participate in written surveys and/or interviews	- Existing language barrier that impairs mutual comprehensible oral communication completely or only with the risk of a major loss of information. - Severe cognitive impairment. - Persons under the age of 18 are excluded. - Persons who do not give informed consent or withdraw it during the study.
Module 1b Non-ePA user (who have actively declined participation in the ePA system)	- people who have an ePA but do not actively use it, i.e., have actively spoken out against its use - have statutory health insurance - 18 years or older - Willingness to participate in written surveys and/or interviews
Module 1c Nonactive ePA user (who technically possess an ePA but have not yet completed the authentication process or used the application)	- people who have an ePA but do not actively use it, i.e., do not use it in their daily care - have statutory health insurance - 18 years or older - Willingness to participate in written surveys and/or interviews
Module 3a General practitioners	- working as general practitioner - field of activity where ePA is used	- Stakeholders whose field of activity is not related to the use of the ePA - Existing language barrier that impairs mutual comprehensible oral communication completely or only with the risk of a major loss of information - Persons who do not give informed consent or withdraw it during the study
Module 3b Medical assistants/ nurses	- working as medical assistants/ nurses - field of activity where ePA is used
Module 3c Physician Assistants	- working as Physician Assistant - field of activity where ePA is used
Module 3d Employees emergency departments	- employed in an emergency department - field of activity where ePA is used
Module 4 Stakeholders	- stakeholders in the German healthcare system - field of activity where ePA is used

Study timeline

The study will follow a staged timeline aligned with the nationwide introduction of the opt-out ePA system on January 1, 2025. Qualitative data collection (Modules 1 and 3) will take place in Q3 and Q4 2025. Quantitative data collection (surveys in Modules 1 and 3) is scheduled for Q1 and Q2 2026. Routine data analyses in Module 2 will be conducted on a monthly basis from Q4 2025 until Q1 2027 to capture longitudinal usage patterns over time. In Q3 and Q4 2026, results from all modules will be synthesized and triangulated. Based on these findings, evidence-based recommendations will be developed in Q1 2027 and subsequently validated and prioritized through expert and patient focus groups (Module 4) in Q2 and Q3 2027.

Methods for data analysis

Qualitative data analysis

Structured interview guides, developed based on the CFIR model, are used to gain deeper insights into individual experiences and attitudes regarding the ePA. Focus groups are conducted to validate and expand upon the findings from the interviews and questionnaires. All interviews and focus groups are recorded and transcribed in a pseudonymized manner. The qualitative data from the interviews and open-ended responses in the questionnaire are analyzed using Kuckartz's qualitative content analysis method. ⁴⁴ This approach enables a systematic and rule-based reduction of data to develop a comprehensive category system. The analysis involves creating a structured framework of categories and subcategories, with the main and subthemes directly derived from the research questions. In the initial coding process, the texts are reviewed sequentially, line by line, from start to finish, assigning text segments to the relevant categories. The coding begins with a collaborative approach within the research team, using the method of consensual coding. In this process, one interview is independently coded by two team members. Their codes are then jointly reviewed and discussed. Any discrepancies are resolved by reaching a consensus, which is then clearly defined. In the subsequent phase, after the initial coding, all codes within a main category are collated. Inductive subcategories are then developed for each main category based on the grouped coded text segments. In a further coding cycle, the entire dataset is reviewed again to assign text segments to the subcategories. The final application of the category system is validated using a member check to ensure accuracy and reliability of the findings. Data collection will continue until no new findings emerge and both code saturation and meaning saturation are achieved. ⁴⁵ Code saturation is defined as the point at which no additional issues are identified, whereas meaning saturation indicates that no further dimensions, nuances, or insights emerge from the data. The final number of interviews will therefore be guided by this principle of saturation.

Quantitative data analysis

The quantitative analysis of data collected through standardized questionnaires will follow a structured approach, beginning with descriptive statistics and advancing to inferential methods to examine relationships and predictors. Initially, descriptive statistics such as absolute and relative frequencies, medians, and standard deviations will be used to summarize and characterize the dataset. Subsequently, association analyses will be conducted to explore relationships between variables. Chi-square (χ²) tests will be employed to assess associations between variables, such as ePA usage (e.g., users vs. nonusers) and demographic characteristics (e.g., age, gender). For continuous outcome variables and binary independent factors, t-tests will be used to compare mean values between groups, such as ePA users and nonusers, with 95% confidence intervals providing precision for the estimated means. To further investigate potential predictors of ePA usage, regression analyses will be conducted. Logistic regression will be applied for binary outcomes, and linear regression will analyze continuous outcomes. These models will help identify associations between patient characteristics, such as sociodemographic factors (e.g., age, education level) and digital health competencies, and outcomes of interest, including ePA user group (e.g., active users, nonactive users, opt-out). Finally, multivariate analyses, such as analysis of variance (ANOVA) and multivariate ANOVA, will be used to explore more complex interactions among multiple independent variables. These methods will allow for a deeper understanding of the interplay between different factors and their combined impact on ePA usage.

Results (planned outcomes and outcome measures)

A detailed overview of the collection instruments in the individual modules can be found in Supplementary Material 3.

Interviews (Module 1a–c and Module 3a–d)

A qualitative framework analysis will be used to synthesize the information gathered across participant groups, facilitating the integration of findings into the updated CFIR. ³⁸ Outcomes will be reported following the COREQ criteria and checklist. ⁴⁶ Additionally, basic demographic information will be collected online before the interviews take place.

Surveys (Module 1a–c and Module 3a–d)

On the one hand, validated scales are used, for example, the HLS-EU-Q16 ²⁴ to obtain health literacy. This questionnaire comprises 16 items, which are rated on a Likert scale from 1 to 4 and provide a reliable measure of health literacy. In addition, further items and individual items were constructed for the present study, using the CFIR. ³⁸ Specific items from the individual domains of the CFIR and based on the interviews are developed for the questionnaires. Sociodemographic data (age, gender, education level, marital status, occupational status) will be collected. Outcomes will be reported following the Checklist for Reporting Of Survey Studies. ⁴⁷

Routine data (Module 2)

Module 2 focuses on the analysis of anonymized routine data to investigate usage patterns of the ePA. The analysis utilizes data routinely collected and aggregated by the gematik. The primary objective is to quantitatively assess ePA utilization at both patient and provider levels under real-world conditions. Key analyses will examine the frequency and patterns of ePA usage, including the proportion of patients actively engaging with the ePA, those registered but not actively using it, and individuals who have opted out. Additionally, the study will assess which healthcare institutions (e.g., hospitals, general practitioners, emergency departments) access the ePA and the timing of these accesses, including activities outside regular working hours. The nature and extent of user interactions such as reading, viewing, or editing data will also be evaluated. A secondary focus involves analyzing document upload behaviors to the ePA. This includes identifying the sectors from which documents originate (e.g., outpatient care, inpatient facilities, pharmacies) and determining who uploads these documents (patients, healthcare providers, or health insurance entities). The study will compare the proportion of documents uploaded by patients versus HCPs and explore variations across different sectors, regions, and insurance providers.

Focus groups (Module 4)

First, key study findings from Modules 1 to 3 will be prepared and subsequently discussed and communicatively validated in focus groups with various experts, stakeholders, and patient representatives. This will be followed by the compilation of recommendations and practical implications. Outcomes will be reported following the COREQ criteria and checklist. ⁴⁶

Discussion

This study addresses one of the central challenges of the German healthcare system in the context of digital transformation: the implementation and acceptance of the ePA. By exploring structural and individual factors and incorporating perspectives of both users and nonusers, the study enables a comprehensive analysis of the conditions necessary for the successful implementation and effective evolution of the ePA. The paradigm shift in legislation toward an opt-out ePA not only offers the opportunity for widespread introduction of the ePA but also raises questions regarding acceptance, effective use, and appropriate further evolution. Insights into barriers and facilitating factors are critical for developing strategies that address technological, cultural, and social challenges. A key focus lies in understanding differences in health literacy and sociodemographic characteristics among users. The results can provide valuable information for targeting nonusers and developing measures to improve the accessibility and usability of the ePA. From the perspective of HCPs, the findings highlight existing administrative hurdles and informational needs, alongside potential benefits for improving care quality and communication. Analysis of usage patterns and uploaded documents offers crucial insights into how the ePA can be optimized to better align with the needs of HCPs. Finally, the use of the CFIR as a theoretical framework underscores the study's robust methodological foundation. By systematically examining contextual factors and their impact on ePA implementation, the study provides evidence-based recommendations for advancing a patient-centered and sustainable digital infrastructure within the German healthcare system.

Strengths and weaknesses of the study

The study is the first publicly funded accompanying research after the introduction of the ePA for all and is conducted with the participation of gematik as a member of the study consortium and is responsible for the construction, operation, and further development of the German telematics infrastructure (TI), the national platform enabling secure networking and communication in the healthcare system. In this role, it also defines the technical specifications of the ePA.

The use of a mixed-methods design, combining qualitative and quantitative data collection across multiple modules, allows for a holistic analysis of factors influencing ePA adoption and use, including user characteristics, attitudes, barriers, and facilitators, from the perspectives of patients, HCPs, and other system stakeholders. The application of the CFIR as a theoretical framework provides a solid methodological basis that allows the identification of influencing systemic, organizational, and individual factors. Analyzing sociodemographic characteristics and health literacy of participants further enriches the results and provides important insights for targeted further development. This enables the development of practical recommendations to increase acceptance and optimize further implementation processes. Despite these strengths, certain limitations must be recognized.

This study will analyze the frequency of use and the perspectives of users and nonusers of the ePA. However, based on the data, no clinically or health-economically robust conclusions can be drawn about the effectiveness of the ePA. The generalizability of the results could be limited as the study focuses on a few regions in Germany. In addition, the recruitment of participants via regional statutory health insurance funds and GP practices harbors the risk of selection bias, which means that certain demographic groups may be underrepresented. Another potential limitation is the reliance on participant recall and self-report, particularly among nonusers, which could lead to incomplete or biased responses. In addition, the study focuses on the early stages of the ePA implementation, which may not fully capture long-term usage patterns or potential barriers and benefits as the system evolves. While the use of aggregated usage data from the gematik in Module 2 provides valuable insights into general usage trends, the lack of detailed individual-level data limits the ability to conduct a deeper analysis of interactions with the ePA.

Conclusion

This study aims to provide important insights into the multifaceted factors influencing the implementation and use of the ePA within the German healthcare system. By employing a multidimensional approach and leveraging the CFIR, it is expected to highlight both structural and individual barriers, as well as facilitators, to ePA implementation. The anticipated findings will emphasize the importance of addressing health literacy, sociodemographic disparities, and stakeholder engagement to optimize the adoption process. Furthermore, the study is projected to underscore the potential of the ePA to improve care quality, and empower patients, while identifying the challenges that need to be overcome for its successful integration. It is expected that these findings will provide a valuable basis for supporting the digital transformation of the healthcare system in Germany and contribute to sustainable, patient-centered care.