RWE 201 – EU – The European Health Data Space

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The European Health Data Space (EHDS) is an initiative by the European Commission to foster the exchange and usage of health data in the European Union (EU) for the purposes of healthcare provision, health research, and health policymaking. Its core concepts and the relation to Real-World Data (RWD) are as follows:

  1. Key Concepts:
    • Interoperability: The EHDS aims to ensure that health data can be easily and effectively shared across borders and systems within the EU. This is to be achieved by adopting common data formats, standards, and protocols.
    • Trust and Security: A central pillar of the EHDS is to ensure that health data is shared and used in a secure manner, with stringent measures in place to protect patient confidentiality and data privacy.
    • Data Quality: Ensuring the reliability and quality of health data is crucial. The EHDS focuses on ensuring that the data used is of high quality and is reliable for the purposes of health research and policymaking.
    • Infrastructure: The initiative emphasises the need for robust data infrastructures to store, manage, and analyse the vast amounts of health data.
  1. Support for Access to RWD:
    • RWD is data derived from sources other than traditional clinical trials, such as electronic health records (EHRs), claims and billing data, and patient registries. The EHDS’s emphasis on interoperability and data sharing naturally supports the access and utilisation of RWD.
    • By facilitating the sharing of data across the EU, the EHDS allows for the aggregation of vast amounts of RWD from diverse sources, making it a rich resource for health research.
  1. Data Access for Researchers:
    • Researchers will have access to the data through secure platforms, ensuring that only authorised personnel can access the necessary datasets.
    • With the EHDS, researchers across the EU can tap into a broader and more diverse dataset, which can potentially lead to more accurate and generalisable research findings.
  1. Governance and Regulation:
    • The use and sharing of health data within the EHDS will be governed by EU regulations, such as the General Data Protection Regulation (GDPR) and the Data Governance Act (DGA).

In summary, the European Health Data Space aims to revolutionise the way health data is used and shared in the EU, providing a reliable and secure platform for accessing real-world data for the purposes of health research, healthcare provision, and policymaking. The governance and regulatory frameworks in place ensure that data privacy and security are upheld, while still allowing for the effective use of this invaluable resource.

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