JMIR Publications

ABSTRACT

Background:

The European Health Data & Evidence Network (EHDEN) is the largest federated health data network in Europe, designed to harmonize diverse real-world data (RWD) sources to the OMOP Common Data Model (CDM). By addressing challenges in data interoperability, governance, and quality assurance, EHDEN enables large-scale, high-quality real-world evidence (RWE) generation to support research and regulatory decision-making.

Objective:

This paper provides an overview of the EHDEN network, examining its data harmonization efforts, quality control processes, and the range of data sources included in the network.

Methods:

EHDEN recruited data partners across Europe through structured calls, providing financial and technical support for data harmonization. A network of certified small-to-medium enterprises (SMEs) assisted data partners in the extract, transform, and load (ETL) process. Data quality was systematically assessed using standardized tools, including the Data Quality Dashboard (DQD). Data sources were categorized by country, care setting, data capture method, and patient inclusion criteria.

Results:

As of September 2024, EHDEN has harmonized 210 data sources from 30 countries, representing over 450 million individuals. The network encompasses diverse healthcare settings, including primary, secondary, and mixed care, and integrates various data capture methods such as electronic health records, claims, and registries. The standardized data have been used in large-scale observational studies, including research on medicine shortages and regulatory initiatives like DARWIN EU.

Conclusions:

EHDEN has transformed the European RWD landscape, making standardized, high-quality data accessible for research and regulatory purposes. The transition to the EHDEN Foundation marks a new phase, emphasizing evidence generation and network sustainability to further enhance the utility and impact of real-world data across Europe.