Real-world evidence (RWE) research is deeply influenced by the way healthcare systems are structured. Local regulations, institutions, reimbursement models, and IT infrastructure all shape how real-world data (RWD) are generated, collected, stored, and made accessible. By tracing the patient's journey through a country’s healthcare system, we can understand where data are generated, who controls them, and under what conditions they can be used for research.
In this article, I discuss how some European countries (France, Germany, Italy, Spain, and the Nordics) compare in terms of RWD availability, data custodianship, electronic medical record (EMR) systems, and regulatory environments.
1. Data Generation and Ownership Along the Patient Journey
In all systems, data are generated through patient interactions with general practitioners (GPs), hospitals, pharmacies, and laboratories. However, the data lifecycle (from generation to governance) can vary significantly.
In the Nordics, where healthcare is tax-funded and largely public, health data are managed by national or regional institutions and linked through unique patient identifiers. This allows to track a patient’s history across care settings and longitudinally.
France also has a strong national insurance system, and data are centralized through the SNDS, although clinical EMR data remain more fragmented. The SNDS is among the most comprehensive administrative health data repositories in the world.
Germany, by contrast, is highly decentralized. Data are collected by over 100 statutory health insurance (SHI) funds, and EMRs are fragmented across private systems used by individual providers or hospital groups. Patients often lack a consolidated health record unless specific data integration projects are implemented.
Italy and Spain fall somewhere in between. Both countries operate tax-funded national health systems (Servizio Sanitario Nazionale – SSN in Italy; Sistema Nacional de Salud – SNS in Spain) organized regionally. This regionalization leads to considerable heterogeneity in how data are collected and whether they can be reused. In Italy, regions such as Lombardy, Tuscany and Emilia-Romagna have advanced data infrastructures and established health data warehouses. Spain’s autonomous regions (e.g., Catalonia, Basque Country) vary significantly in EMR usage and data integration.
2. Key Institutions and Their Role in Data Stewardship
While data are generated at the point of care, the question of who manages and controls access to that data is shaped by institutional roles and national governance frameworks. Each country delegates stewardship responsibilities differently, some to national agencies, others to insurers, and often to regional health authorities. Understanding the key institutions involved in managing and granting access to RWD is critical for assessing feasibility, data quality, and regulatory alignment in RWE research. Below, we explore the main players in each country’s data stewardship landscape.
In France, the Health Data Hub (HDH) and Assurance Maladie (National Health Insurance) are the primary custodians of administrative health data, while CNIL oversees data privacy. The SNDS includes claims, hospitalization, and mortality data.
Germany lacks a single custodian; instead, each insurer and healthcare provider maintains its own dataset. The newly created FDZ Gesundheit (Research Data Center for Health) is expected to centralize health data access gradually.
In Italy, data stewardship is shared between national and regional bodies. The Agenzia Nazionale per i Servizi Sanitari Regionali (AGENAS) and the Ministero della Salute coordinate national data initiatives, but regional health authorities and data warehouses (e.g., Lombardy’s ARIA) remain key access points.
Spain has a similar structure. The Ministry of Health maintains the national minimum dataset (CMBD), but most clinical data reside in regional health services (e.g., SISCAT in Catalonia, Osakidetza in the Basque Country). Data harmonization projects such as BIFAP (managed by AEMPS, the Spanish drug regulatory agency) and Valtermed aim to centralize data for pharmacoeconomic and RWE research.
The Nordic countries operate some of the world’s most advanced data infrastructures, including national registries. Public institutions act as data stewards, supported by unique personal identifiers enabling seamless linkage.
3. EMR Vendors, Data Ownership, and Fragmentation in Clinical Practice
To understand who really “owns” the data and how accessible it is for RWE research, we also need to look closely at EMR systems. These are the operational data platforms used by hospitals, GPs, and clinics (often developed and maintained by private vendors) to collect data. These systems serve as the core infrastructure for capturing clinical interactions, diagnoses, procedures, prescriptions, and outcomes. The degree to which these systems are interoperable, standardized, and embedded in public infrastructure dramatically affects research feasibility.
In Germany, EMR systems are highly fragmented. Vendors like CGM, Medatixx, and Oracle Health dominate, but interoperability is limited. Physicians and hospitals often own their EMRs, and there is no mandate to share data for secondary use.
France has promoted national solutions like the Dossier Médical Partagé (DMP), but uptake remains moderate. Vendors include Maincare, Dedalus, and Medasys, and adoption varies by hospital group.
Italy and Spain have invested in regional EMRs. In Italy, Dedalus and Engineering are key vendors, and some regions operate integrated health records (e.g., Lombardy’s FSE, or Fascicolo Sanitario Elettronico). However, national interoperability is still limited. In Spain, vendors such as Indra and DXC operate regionally. Some areas, like Catalonia, have developed centralized EMRs with high data reuse potential.
The Nordics use regionally standardized EMRs from vendors like Cambio, Epic, and Tietoevry, supporting population health management and registry integration. These systems are procured by counties or national authorities and aligned with public data strategies.
4. Regulatory and Ethical Frameworks for Data Use
Conducting RWE research requires navigating a complex web of regulatory and ethical requirements that differ substantially between countries. While the European Union’s General Data Protection Regulation (GDPR) provides a common legal baseline, each country interprets and implements it differently, especially when it comes to secondary use of health data.
In France, strict governance is enforced by CNIL, with mandatory ethical and privacy approvals for SNDS data. The HDH offers a secure analytics environment, but the approval process remains complex.
Germany is governed by GDPR and the Federal Data Protection Act. Each insurer or data provider may impose additional requirements, and researchers must often negotiate access separately. However, the Gesundheitsdatennutzungsgesetz (GDNG) is expected to simplify governance.
Italy follows GDPR, and research using regional data often requires multiple approvals from local ethics committees, regional data holders, and national privacy authorities (Garante per la Protezione dei Dati Personali). The process is not centralized.
In Spain, data reuse for research requires ethical committee approval and regional authorization. Projects like BIFAP and Valtermed offer more centralized pathways, particularly for drug-related RWE studies. However, sponsors might not have access to the data.
The Nordics provide more harmonized regulatory processes. Ethics committee approvals are still required, but national institutions provide streamlined pathways for data linkage and reuse. Public trust and transparency play an important role.
5. Comparative Summary
| Category | France | Germany | Italy | Spain | Nordics |
| Healthcare Model | Universal, mixed delivery | Insurance-based, decentralized | National Health System (regional) | National Health System (regional) | Tax-funded, public sector-driven |
| Data Custodians | SNDS, Assurance Maladie, HDH | Insurers, FDZ (in progress) | Regions, AGENAS, Ministry of Health | Regional health systems, Ministry | National health registries |
| EMR Structure | Partially integrated, DMP | Fragmented, vendor-owned | Regionally integrated, limited nat. | Regionally integrated, variable | National/regional interoperability |
| Key EMR Vendors | Dedalus, Maincare, Medasys | CGM, Medatixx, Oracle Health | Dedalus, Engineering, GPI | Indra, DXC, Oesia | Epic, Cambio, Tietoevry |
| Linkage Capability | Limited, hospital-claims ongoing | Minimal without specific consent | Varies by region, limited nat. ID | Regional (Catalonia strong), no nat. | Full via national ID |
| Research Access Process | CNIL + HDH approvals | Fund-by-fund + ethics | Region + ethics + Garante | Region + ethics + BIFAP/Valtermed | Streamlined via ethics + registry |
| Central Data Access System | Health Data Hub | FDZ (under construction) | No unified platform | BIFAP, Valtermed | National secure platforms |
Final Thoughts
The ability to conduct robust, multi-source RWE research is directly shaped by national healthcare infrastructures. While all countries generate valuable patient-level data, only some have the governance, technical integration, and legal frameworks to enable scalable and reproducible research.
The Nordics remain the gold standard in longitudinal RWD due to their integrated public systems and unified identifiers. France and Spain offer strong national claims or registry data, but integration with EMR systems is still maturing. Italy is advancing in select regions, but the lack of centralized governance hinders large-scale studies. Germany poses the greatest operational challenges for RWD research due to data silos and legal complexity, though reforms are on the horizon.
For researchers and organizations planning RWE studies across multiple countries, understanding these differences is essential. Feasibility, timelines, and even study design may hinge on which country holds the most appropriate, accessible, and linkable data for your research question.
