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Advancing Real-World Evidence Through a Federated Health Data Network (EHDEN): Descriptive Study.

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Summary
This summary is machine-generated.

The European Health Data & Evidence Network (EHDEN) harmonized 210 European real-world data sources across 30 countries using the OMOP Common Data Model (CDM). This federated network supports robust health research and regulatory decision-making.

Keywords:
data governancedata qualityelectronic health recordsepidemiologyhealth informaticsreal-world dataregistries

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Area of Science:

  • Health Informatics
  • Real-World Evidence Generation
  • Data Harmonization

Background:

  • Real-world data (RWD) are crucial for assessing interventions in routine care but face challenges due to European healthcare system heterogeneity.
  • The European Health Data & Evidence Network (EHDEN) was established to overcome these challenges by creating a federated data infrastructure.

Purpose of the Study:

  • To describe the composition and characteristics of EHDEN's harmonized databases as of September 2024.
  • To enhance transparency regarding available RWD and their potential for collaborative research and regulatory use.

Main Methods:

  • EHDEN recruited data partners and provided funding and technical support for data harmonization to the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM).
  • Certified SMEs assisted in the extract-transform-load process, and data quality was assessed using a dedicated dashboard.
  • Metadata, including country, care setting, and data capture methods, were compiled in the EHDEN Portal.

Main Results:

  • As of September 1, 2024, EHDEN includes 210 harmonized data sources from 30 countries, with significant representation from Italy, Great Britain, and Spain.
  • Data sources vary in size (median 457,664 individuals) and care setting (46.7% secondary care, 42.4% mixed, 11% primary care).
  • Electronic health records (EHRs) are the most common data capture method (74.7%), often used exclusively, with laboratory data also utilized in a substantial portion of sources.

Conclusions:

  • EHDEN represents Europe's largest federated network for standardized, GDPR-compliant RWD analysis across diverse settings and populations.
  • This descriptive summary enhances transparency and supports the scaling of federated research.
  • The network's data potential facilitates collaborative studies and the generation of trusted evidence for public health and regulatory purposes.