Implementing Electronic Health Records in Germany: Lessons (Yet to Be) Learned

Introduction: Ensuring access to the right information at the right time can improve the safety, effectiveness and efficiency of care. A systematic and detailed collection of patient records, commonly known as electronic health records (EHRs), forms the core of the information system architecture in integrated health systems. Description: Since January 2021, seventeen years after the German legislation to implement EHRs (elektronische Patientenakte; ePA) came into force, the sickness funds in Germany have been offering their enrollees a downloadable application with which patients can access their personal EHRs through an electronic device. Looking at the ePA adoption process, it is now safe to argue that the deployment has been anything but successful. After two years of the launch, the number of ePA users amounts to not even 1% of the insured population in Germany, failing to move the needle on integrated care and health data integration. Based on a public policy theory, this article analyses the factors that are influencing the ePA implementation and secondary use of ePA data. Discussion: As the German experience shows, the feasibility of digital health projects depends on several contextual factors: countries with a high degree of self-governance and federal structures have to manage complex coordination processes that often slow down or otherwise impede digitalisation processes. In addition, cultural peculiarities such as concerns about data protection and security can be a hindering factor for digitalisation. Whereas the new German government and European initiatives such as the European Health Data Space (EHDS) create an advantageous situation for the ePA implementation and secondary use of health data, the structural and cultural issues in Germany should be acknowledged and tackled. Conclusion: Concerning the structural factors, a further reorganisation of the board of gematik, the key organisation of digital health solutions in Germany, should be considered. Cultural factors in Germany affect especially the secondary use of data; organising information campaigns, investing in (digital) health literacy of the population and designing a user-friendly ePA application are central in this context. Zusammenfassung Einleitung: Der Zugang zu den richtigen Informationen zur richtigen Zeit kann die Sicherheit, Wirksamkeit und Effizienz der Gesundheitsversorgung verbessern. Eine systematische und detaillierte Sammlung von Patientenakten, bekannt als Electronic Health Records (EHRs), bildet den Kern der Informationssystemarchitektur in integrierten Gesundheitssystemen. Beschreibung: Seit Januar 2021, siebzehn Jahre nach Inkrafttreten der deutschen Gesetzgebung zur Einführung der elektronischen Patientenakte (ePA), bieten die Krankenkassen eine zum Download verfügbare Anwendung an, mit der Patienten über ein elektronisches Gerät auf ihre persönliche elektronische Patientenakte zugreifen können; bisher jedoch mit wenig Erfolg. Zwei Jahre nach der Inbetriebnahme beläuft sich die Zahl der ePA-Nutzer auf weniger als 1 % der gesetzlich versicherten Bevölkerung in Deutschland; es ist also nicht gelungen, die integrierte Versorgung und Datenintegration voranzutreiben. Basierend auf einer politikwissenschaftlichen Theorie, werden in dieser Studie Faktoren analysiert, welche die ePA-Einführung und die sekundäre Nutzung von ePA-Daten beeinflussen. Diskussion: Wie die Erfahrungen mit der ePA in Deutschland zeigen, hängt die Umsetzbarkeit digitaler Gesundheitsprojekte von einer Vielzahl von kontextuellen Faktoren ab: Länder mit einem hohen Maß an Selbstverwaltung und föderalen Strukturen müssen komplexe Koordinationsprozesse bewältigen, die den Digitalisierungsprozess oft verlangsamen oder anderweitig behindern. Darüber hinaus können kulturelle Eigenheiten wie Datenschutz- und Sicherheitsbedenken die Digitalisierung behindern. Obwohl die neue Bundesregierung und europäische Initiativen, wie der Europäische Gesundheitsdatenraum (European Health Data Space; EHDS), die ePA-Implementierung und die Sekundärnutzung von Gesundheitsdaten begünstigen, sollten strukturelle und kulturelle Probleme in Deutschland berücksichtigt und angegangen werden. Schlussfolgerung: Im Hinblick auf die strukturellen Faktoren sollte eine weitere Umstrukturierung der gematik, des wichtigsten Entscheidungsorgans für digitale Gesundheitslösungen in Deutschland, in Betracht gezogen werden. Kulturelle Faktoren in Deutschland beeinflussen vor allem die Sekundärnutzung von Daten; in diesem Zusammenhang sind das Organisieren von Informationskampagnen, die Förderung der (digitalen) Gesundheitskompetenz der Bevölkerung und die Gestaltung einer nutzerfreundlichen ePA-Anwendung von zentraler Bedeutung. Schlüsselwörter: Elektronische Patientenakte; Akzeptanz von Innovationen; Verwaltung von Gesundheitsdaten; Integrierte Versorgung; Datenintegration; Nationales Gesundheitssystem; Deutschlan

What does it take to create a European Health Data Space? International commitments and national realities

Public health concerns in Europe demonstrate the necessity of building a health policy that could contribute to the long-term sustainable development of the European Union (EU), as stated in the European Health Union (EHU) manifesto. The main desire to create an EHU is embodied in the launch of the European Health Data Space (EHDS). The EHDS seeks to foster a genuine single market for digital health services and products by, among other things, accelerating the uptake and implementation of harmonised and interoperable electronic health record (EHR) systems across the EU. In the context of primary and secondary use of EHR data, developments in Europe have thus far resulted in patchy and, in some places, non-interoperable solutions. Taking the gap between international ambitions and national realities as a starting point, this paper contends that both EU level and Member State level circumstances should be considered to make the EHDS a reality

a review of methodological design choices

Publisher Copyright: © 2023 Cambridge University Press. All rights reserved.This systematic literature review aimed to provide an overview of the characteristics and methods used in studies applying the Disability-Adjusted Life Years (DALY) concept for infectious diseases within European Union (EU)/European Economic Area (EEA)/European Free Trade Association (EFTA) countries and the United Kingdom. Electronic databases and grey literature were searched for articles reporting the assessment of DALY and its components. We considered studies in which researchers performed DALY calculations using primary epidemiological data input sources. We screened 3,053 studies of which 2,948 were excluded and 105 studies met our inclusion criteria. Of these studies, 22 were multi-country and 83 were single-country studies, of which 46 were from the Netherlands. Food- and water-borne diseases were the most frequently studied infectious diseases. Between 2015 and 2022, the number of burden of infectious disease studies was 1.6 times higher compared to that published between 2000 and 2014. Almost all studies (97%) estimated DALYs based on the incidence- and pathogen-based approach and without social weighting functions; however, there was less methodological consensus with regards to the disability weights and life tables that were applied. The number of burden of infectious disease studies undertaken across Europe has increased over time. Development and use of guidelines will promote performing burden of infectious disease studies and facilitate comparability of the results.publishersversionepub_ahead_of_prin

Burden of disease attributable to risk factors in European countries: a scoping literature review

Objectives: Within the framework of the burden of disease (BoD) approach, disease, and injury burden estimates attributable to risk factors are a useful guide for policy formulation and priority setting in disease prevention. Considering the important differences in methods, and their impact on burden estimates, we conducted a scoping literature review to: (1) map the BoD assessments including risk factors performed across Europe, and (2) identify the methodological choices in comparative risk assessment (CRA) and risk assessment methods. Methods: We searched multiple literature databases, including grey literature websites, and targeted public health agencies' websites. Results: A total of 113 studies were included in the synthesis and further divided into independent BoD assessments (54 studies) and studies linked to the Global Burden of Disease (59 papers). Our results showed that the methods used to perform CRA varied substantially across independent European BoD studies. While there were some methodological choices that were more common than others, we did not observe patterns in terms of country, year, or risk factor. Each methodological choice can affect the comparability of estimates between and within countries and/or risk factors since they might significantly influence the quantification of the attributable burden. From our analysis, we observed that the use of CRA was less common for some types of risk factors and outcomes. These included environmental and occupational risk factors, which are more likely to use bottom-up approaches for health outcomes where disease envelopes may not be available. Conclusions: Our review also highlighted misreporting, the lack of uncertainty analysis, and the under-investigation of causal relationships in BoD studies. Development and use of guidelines for performing and reporting BoD studies will help understand differences, and avoid misinterpretations thus improving comparability among estimates.info:eu-repo/semantics/publishedVersio

Burden of infectious disease studies in Europe and the United Kingdom: a review of methodological design choices.

This systematic literature review aimed to provide an overview of the characteristics and methods used in studies applying the disability-adjusted life years (DALY) concept for infectious diseases within European Union (EU)/European Economic Area (EEA)/European Free Trade Association (EFTA) countries and the United Kingdom. Electronic databases and grey literature were searched for articles reporting the assessment of DALY and its components. We considered studies in which researchers performed DALY calculations using primary epidemiological data input sources. We screened 3053 studies of which 2948 were excluded and 105 studies met our inclusion criteria. Of these studies, 22 were multi-country and 83 were single-country studies, of which 46 were from the Netherlands. Food- and water-borne diseases were the most frequently studied infectious diseases. Between 2015 and 2022, the number of burden of infectious disease studies was 1.6 times higher compared to that published between 2000 and 2014. Almost all studies (97%) estimated DALYs based on the incidence- and pathogen-based approach and without social weighting functions; however, there was less methodological consensus with regards to the disability weights and life tables that were applied. The number of burden of infectious disease studies undertaken across Europe has increased over time. Development and use of guidelines will promote performing burden of infectious disease studies and facilitate comparability of the results

The Effects of Federalism, Corporatism and Legislative Power on Health System Transformation in Germany

International comparisons show that although health services are becoming increasingly digital, interconnected, and person-centred in industrialised countries, Germany lags behind in utilising and linking health data to provide better healthcare. A detailed analysis focusing on structural factors is crucial for policy studies involving international comparisons and country rankings. In Germany, factors such as the constraints of federalism, a well-established bureaucracy and a fragmented political decision-making system contribute to a deeply rooted resistance to change across various public service sectors. In the same vein, this article outlines the current landscape of data-driven innovations in the German health system. It identifies federalism, corporatism, and legislative power as three structural reasons why the country has been lagging behind in this field, while also discussing potential future developments

New governance of the digital health agency:a way out of the joint decision trap to implement electronic health records in Germany?

Fragmentation in health systems leads to discontinuities in the provision of health services, reduces the effectiveness of interventions, and increases costs. In international comparisons, Germany is notably lagging in the context of healthcare (data) integration. Despite various political efforts spanning decades, intersectoral care and integrated health data remain controversial and are still in an embryonic phase in the country. Even more than 2 years after its launch, electronic health record ( ; ePA) users in Germany constitute only 1 per cent of the statutorily insured population, and ongoing political debates suggest that the path to broader coverage is fraught with complexities. By exploring the main stakeholders in the existing (fragmented) health system governance in Germany and their sectoral interests, this paper examines the implementation of ePA through the lens of corporatism, offering insights based on an institutional decision theory. The central point is that endeavours to better integrate health data for clinical care, scientific research and evidence-informed policymaking in Germany will need to address the roles of corporatism and self-governance

Burden of infectious disease studies in Europe and the United Kingdom: a review of methodological design choices

This systematic literature review aimed to provide an overview of the characteristics and methods used in studies applying the disability-adjusted life years (DALY) concept for infectious diseases within European Union (EU)/European Economic Area (EEA)/European Free Trade Association (EFTA) countries and the United Kingdom. Electronic databases and grey literature were searched for articles reporting the assessment of DALY and its components. We considered studies in which researchers performed DALY calculations using primary epidemiological data input sources. We screened 3053 studies of which 2948 were excluded and 105 studies met our inclusion criteria. Of these studies, 22 were multi-country and 83 were single-country studies, of which 46 were from the Netherlands. Food- and water-borne diseases were the most frequently studied infectious diseases. Between 2015 and 2022, the number of burden of infectious disease studies was 1.6 times higher compared to that published between 2000 and 2014. Almost all studies (97%) estimated DALYs based on the incidence- and pathogen-based approach and without social weighting functions; however, there was less methodological consensus with regards to the disability weights and life tables that were applied. The number of burden of infectious disease studies undertaken across Europe has increased over time. Development and use of guidelines will promote performing burden of infectious disease studies and facilitate comparability of the results

Burden of non-communicable disease studies in Europe : a systematic review of data sources and methodological choices

Background Assessment of disability-adjusted life years (DALYs) resulting from non-communicable diseases (NCDs) requires specific calculation methods and input data. The aims of this study were to (i) identify existing NCD burden of disease (BoD) activities in Europe; (ii) collate information on data sources for mortality and morbidity; and (iii) provide an overview of NCD-specific methods for calculating NCD DALYs. Methods NCD BoD studies were systematically searched in international electronic literature databases and in grey literature. We included all BoD studies that used the DALY metric to quantify the health impact of one or more NCDs in countries belonging to the European Region. Results A total of 163 BoD studies were retained: 96 (59%) were single-country or sub-national studies and 67 (41%) considered more than one country. Of the single-country studies, 29 (30%) consisted of secondary analyses using existing Global Burden of Disease (GBD) results. Mortality data were mainly derived (49%) from vital statistics. Morbidity data were frequently (40%) drawn from routine administrative and survey datasets, including disease registries and hospital discharge databases. The majority (60%) of national BoD studies reported mortality corrections. Multimorbidity adjustments were performed in 18% of national BoD studies. Conclusion The number of national NCD BoD assessments across Europe increased over time, driven by an increase in BoD studies that consisted of secondary data analysis of GBD study findings. Ambiguity in reporting the use of NCD-specific BoD methods underlines the need for reporting guidelines of BoD studies to enhance the transparency of NCD BoD estimates across Europe