Objective The European Health Data Space (EHDS) shapes the digital transformation of healthcare in Europe. The EHDS regulation will also accelerate the use of health data for research, innovation, policy-making, and regulatory activities for secondary use of data (known as EHDS2). The Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance (IDERHA) project builds one of the first pan-European health data spaces in alignment with the EHDS2 requirements, addressing lung cancer as a pilot. Methods In this study, we conducted a comprehensive review of the EHDS regulation, technical requirements for EHDS2, and related projects. We also explored the results of the Joint Action Towards the European Health Data Space (TEHDAS) to identify the framework of IDERHA’s alignment with EHDS2. We also conducted an internal webinar and an external workshop with EHDS experts to share expertise on the EHDS requirements and challenges. Results We identified the lessons learned from the existing projects and the minimum-set of requirements for aligning IDERHA infrastructure with EHDS2, including user journey, concepts, terminologies, and standards. The IDERHA framework (i.e., platform architecture, standardization approaches, documentation, etc.) is being developed accordingly. Discussion The IDERHA's alignment plan with EHDS2 necessitates the implementation of three categories of standardization for: data discoverability: Data Catalog Vocabulary (DCAT-AP), enabling semantics interoperability: Observational Medical Outcomes Partnership (OMOP), and health data exchange (DICOM and FHIR). The main challenge is that some standards are still being refined, e.g., the extension of the DCAT-AP (HealthDCAT-AP). Additionally, extensions to the Observational Health Data Sciences and Informatics (OHDSI) OMOP Common Data Model (CDM) to represent the patient-generated health data are still needed. Finally, proper mapping between standards (FHIR/OMOP) is a prerequisite for proper data exchange. Conclusions The IDERHA's plan and our collaboration with other EHDS initiatives/projects are critical in advancing the implementation of EHDS2.

Background: Digitalization affects all areas of society, including the health care sector. However, the digitalization of health care provision is progressing slowly compared to other sectors. In the professional and political literature, physicians are partially portrayed as digitalization sceptics. Thus, the role of physicians in this process requires further investigation. The theory of “digital natives” suggests a lower hurdle for younger generations to engage with digital technologies.Objective: The objective of this study was to investigate the role of physicians in the process of digitalizing health care provision in Germany and to assess the age factor.Methods: We conducted a large-scale study to assess the role of this professional group in the progress of the digital transformation of the German health care sector. Therefore, in an anonymous online survey, we inquired about the current digital penetration of the personal working environment, expectations, attitude toward, and concerns regarding digitalization. Based on these data, we studied associations with the nominal variable age and variations across 2 age groups.Results: The 1274 participants included in the study generally showed a high affinity towards digitalization with a mean of 3.88 on a 5-point Likert scale; 723 respondents (56.75%) stated they personally use mobile apps in their everyday working life, with a weak tendency to be associated with the respondents’ age (η=0.26). Participants saw the most noticeable existing benefits through digitalization in data quality and readability (882/1274, 69.23%) and the least in patient engagement (213/1274, 16.72%). Medical practitioners preponderantly expect further improvements through increased digitalization across almost all queried areas but the most in access to medical knowledge (1136/1274, 89.17%), treatment of orphan diseases (1016/1274, 79.75%), and medical research (1023/1274, 80.30%).Conclusions: Respondents defined their role in the digitalization of health care provision as ambivalent: “scrutinizing” on the one hand but “active” and “open” on the other. A gap between willingness to participate and digital sovereignty was indicated. Thus, education on digitalization as a means to support health care provision should not only be included in the course of study but also in the continuing process of further and advanced training.

Zusammenfassung: Daten stellen eine strategische Ressource für die Wettbewerbsfähigkeit von Unternehmen und die Prosperität der Gesellschaft dar. Von der Nutzung von Daten vieler einzelner Akteure profitieren die Gemeinschaft, aber auch das Individuum. Beispiele hierfür liefern das Gesundheitswesen oder die Mobilität. Dabei sind die Interessen der Individuen in Bezug auf Datenschutz und Datensouveränität über Nutzungsvereinbarungen hinaus zu wahren und bestenfalls technologisch sicherzustellen. Datenräume, basierend auf verteilten Dateninfrastrukturen, stellen Datendienste und Datennutzungsregeln für Individuen und Organisationen bereit. Beispiele hierfür liefern die International-Data-Spaces(IDS)-Initiative oder die Initiative Gaia‑X zur Schaffung einer verteilten Dateninfrastruktur in Europa. Instanziierungen in den Bereichen Mobilität oder Smarthome zeigen Vorteile von Datenökosystemen für Individuen, die Gemeinschaft und die Gesamtheit der Dienstanbieter. Gleichzeitig werden Risiken wie die geeignete Interessensvertretung einzelner Nutzender deutlich. Anhand zweier Fallstudien werden offene ethische, rechtliche, betriebswirtschaftliche und technische Fragen bei der verteilten Umsetzung von Datenräumen und Dateninfrastrukturen unter Sicherstellung europäischer Wertevereinbarungen aufgezeigt.

Background: Digital health interventions (DHIs) have the potential to enable public end users, such as citizens and patients, to manage and improve their health. Although the number of available DHIs is increasing, examples of successfully established DHIs in public health systems are limited. To counteract the nonuse of DHIs, they should be comprehensively evaluated while integrating end users. Unfortunately, there is a wide variability and heterogeneity according to the approaches of evaluation, which creates a methodological challenge. Objective: This scoping review aims to provide an overview of the current established processes for evaluating DHIs, including methods, indicators, and end-user involvement. The review is not limited to a specific medical field or type of DHI but offers a holistic overview. Methods: This scoping review was conducted following the JBI methodology for scoping reviews based on the framework by Arksey & O’Malley and complies with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Three scientific databases (PubMed, Scopus, and Science Direct) were searched in April 2023. English and German studies between 2008 and 2023 were considered when evaluating DHIs that explicitly address public end users. The process of study selection was carried out by several researchers to avoid reviewer bias. Results: The search strategy identified 9618 publications, of which 160 were included. Among these included articles, 200 evaluations were derived and analyzed. The results showed that there is neither a consensus on the methods to evaluate DHIs nor a commonly agreed definition or usage of the evaluated indicators, which results in a broad variety of evaluation practices. This aligns with observations of the existing literature. It was found that there is a lack of references to existing frameworks for the evaluation of DHIs. The majority of the included studies referred to user-centered approaches and involved end users in the evaluation process. As assistance for people developing and evaluating DHIs and as a basis for thinking about appropriate ways to evaluate DHIs, a results matrix was created where the findings were combined per DHI cluster. Additionally, general recommendations for the evaluators of DHIs were formulated. Conclusions: The findings of this scoping review offer a holistic overview of the variety and heterogeneity according to the approaches of evaluation of DHIs for public end users. Evaluators of these DHIs should be encouraged to reference established frameworks or measurements for justification. This would ease the transferability of the results among similar evaluation studies within the digital health sector, thereby enhancing the coherence and comparability of research in this area.

Background: The digitalization and integration of data are increasingly relevant for hospitals. Several methods exist to assess and structurally develop digital maturity. However, it is notable that German hospitals lag behind the European average with respect to digitalization. Objective: We hypothesized that: (a) the perspective of hospital managing directors regarding the state of digitalization in German hospitals plays an important role in the investigation of barriers, and (b) the Hospital Future Act in 2020 may help to surmount those barriers. Methods: Aligned with the Checklist for Reporting Results of Internet E-Surveys (CHERRIES), two online surveys were conducted, one in 2019 and one in 2021. Results: The first study covered 184/344 hospitals and the second, 83/344. The responsibility for deciding on the implementation of digitalization lay with the management (115/184; 62.5%). About 54.9% (101/184) of the managing directors desired digitally supported workflows, together with employees or users. In total, 74.7% (62/83) of hospital managing directors expressed an increase in digitization compared to 2019, with a percentage increase of 25.4% (SD 14.41). In some cases, we analyzed the data using an ANOVA, chi-squared test and Pearson’s correlation, but there was no significant relation identified among the variables. Conclusions: This online-based survey study demonstrated that the development of a digitalization strategy is still strongly tied to or dominated by the attitude of the management. One could assume a lack of acceptance among employees, which should be surveyed in future research. The Hospital Future Act, as well as the COVID-19 pandemic, has positively influenced the digital maturity of hospitals.

Aim: To gather information about the structure of cooperatives in health and social care, in general, and data cooperatives, in particular, to derive implications for their future implementation. Subject and methods: Health and social care systems are currently under pressure due to rising costs and demands. Many hopes lie on digitization, digitalization, and the potentials of health data. A scoping review was conducted searching nine databases and grey literature. Data on information about aim, type, and structure of the cooperatives, member structure, founding process, and their way of financing were extracted. Results: All searches resulted in 9080 articles and websites. Overall, we included 26 cooperatives and categorized them as follows: (1) worker cooperatives with focus on workers’ rights and service provision to clients, (2) consumer cooperatives, (3) consumer and worker cooperatives, (4) cooperatives of institutions, (5) general practitioner (GP) cooperatives, (6) cooperatives as health insurance models, and (7) health data cooperatives. Conclusions: Information provided on (data) cooperatives differed greatly in detail. Their common goal is to tackle and overcome existing barriers in their field such as working conditions or unequal health care. We identified five challenges: (1) salary structures; (2) cooperating with other providers and surrounding institutions; (3) building an identity and recruiting potential members; (4) motivation of members to participate actively; and (5) distinction from other types. Benefits are: (1) improvement of conditions; (2) being stronger together; (3) support of research; and (4) data governance. When successful and competent, (data) cooperatives can be powerful tools on public, scientific, and political levels.