The relation between EHDS and OHDSI OMOP CDM

The European Health Data Space (EHDS) and the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) are both key initiatives aimed at enabling the interoperability, secondary use, and harmonization of health data across Europe. However, they serve different but complementary roles.

  1. Overview of the European Health Data Space (EHDS)
    1. The EHDS is a European Union (EU) initiative designed to:
      • Improve the use and exchange of health data across EU member states.
      • Enhance healthcare delivery and research by enabling cross-border access to electronic health records (EHRs), genomic data, and registries.
      • Ensure data privacy and security under GDPR (General Data Protection Regulation) and other European legal frameworks.
      • Promote a federated data-sharing ecosystem, where different institutions can securely access and analyze health data without centralized storage.
    2. Key Components of EHDS:
      1. Primary use of health data: Facilitates healthcare delivery across borders.
      2. Secondary use of health data: Enables research, policymaking, and innovation using de-identified patient data.
      3. MyHealth@EU: A secure platform for health data exchange across the EU.
      4. HealthData@EU: Supports researchers and policymakers in accessing health datasets.
  2. Overview of the OMOP Common Data Model (CDM)
    1. The OMOP CDM, developed by the Observational Health Data Sciences and Informatics (OHDSI) initiative, is:
      • A standardized model for observational healthcare data, enabling harmonization of patient records from different databases.
      • Widely adopted for secondary use of health data, including real-world evidence (RWE), pharmacoepidemiology, and clinical research.
      • Structured to support federated analytics, making it a natural fit for EHDS goals.
      • Used globally, including in European projects like EHDEN (European Health Data & Evidence Network) and DARWIN EU (Data Analytics and Real-World Interrogation Network).
    2. Key Features of OMOP:
      • Schema for harmonizing EHR, claims, and registry data.
      • Standardized vocabularies for disease classification, medications, and procedures.
      • Federated data analysis using OHDSI tools (e.g., ATLAS, ACHILLES, DataQualityDashboard).
  3. Relationship Between EHDS and OMOP CDM
    1. OMOP as a Standard for EHDS Data Interoperability
      • EHDS requires standardized formats to ensure interoperability between different national and institutional databases.
      • OMOP CDM is one of the leading models for standardizing observational data, aligning with EHDS’s goal of harmonized health data exchange.
    2. EHDS & OMOP Promote Federated Research
      1. EHDS envisions a federated data-sharing ecosystem, where institutions keep data locally but allow research through secure data access protocols.
      2. OMOP supports federated analytics, allowing researchers to run standardized analytical queries without transferring raw data.
    3. OMOP Facilitates Secondary Use of EHDS Data
      • EHDS encourages the use of health data for research and innovation, which aligns with OHDSI’s mission of real-world evidence generation.
      • EU projects like EHDEN and DARWIN EU already use OMOP CDM to analyze European health data.
    4. Compliance with EU Regulations (GDPR & EHDS Legal Framework)
      • EHDS mandates data protection and privacy-compliant sharing, which OMOP CDM can support by:
      • De-identifying patient data before sharing.
      • Using federated approaches to minimize data movement.
      • Implementing standardized vocabularies (e.g., SNOMED CT, LOINC) for seamless integration.
  4. European Projects Bridging EHDS and OMOP. Several European initiatives are integrating OMOP CDM within the EHDS framework:
    1. EHDEN (European Health Data & Evidence Network)
      • Aims to harmonize 100 million patient records across Europe to the OMOP CDM.
      • Supports federated research, aligning with EHDS principles.
    2. DARWIN EU (EMA's Real-World Evidence Platform)
      • Uses OMOP CDM for real-world evidence generation on drug safety & effectiveness.
      • A pilot for how EHDS could facilitate regulatory research.
    3. IMI ConcePTION & European Health Research and Innovation Cloud (HRIC)
      • Use OMOP CDM to standardize maternal and child health data.
      • Demonstrates how OMOP can power EHDS secondary data use cases.
  5. Challenges and Future Considerations. While OMOP aligns well with EHDS, some challenges exist:.
    1. Legal Barriers: EHDS needs strong governance frameworks to enable cross-border OMOP CDM adoption while ensuring compliance with GDPR.
    2. Harmonization of Data Sources: Different European countries use varying data models; transitioning to OMOP CDM requires significant investment.
    3. Scalability & Adoption: Not all EU institutions currently use OMOP; EHDS must promote standard adoption strategies.
  6. Conclusion: OMOP as a Key Enabler for EHDS
    1. EHDS and OMOP CDM share common goals in facilitating standardized, privacy-preserving health data exchange and secondary use.
    2. OMOP is one of the leading candidates for structuring EHDS health data, especially for research, real-world evidence, and federated analytics.
    3. EU-funded initiatives (EHDEN, DARWIN EU, HRIC) are already proving OMOP’s viability in EHDS implementation.
    4. Next Steps:
      1. EHDS policymakers should formally recognize OMOP as a reference model for secondary use of health data.
      2. European institutions should invest in OMOP data transformations to ensure EHDS alignment.
      3. Stronger governance & legal frameworks are needed to balance privacy, interoperability, and usability.


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