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Real World Evidence (RWE) 201…THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU

RWE 201 – THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU

In our real world evidence (RWE) 201 series we have been exploring the regional regulatory and data access frameworks that have been implemented to support access to clinical experience data (real world data | RWD), which is crucial if we are to use this RWD to generate RWE.
 
The European Union (EU) is making significant strides in advancing healthcare through a series of interconnected initiatives. The EU4Health Program aims to bolster health systems, focusing on crisis preparedness and disease prevention. The European Health Data Space is an effort to ensure secure access and exchange of health data across EU countries, enhancing healthcare quality and research. Complementing this, the Data Governance Act seeks to foster trust and facilitate data sharing for societal benefits. The European Medicines Agency (EMA)’s 2025 Vision for Real World Evidence (RWE) and the EMA RWE Framework to Support Regulatory Decision Making are pivotal in integrating real-world data (RWD) and RWE into regulatory processes, improving drug development and monitoring. The EU’s Action Plan for RWD & RWE further emphasizes the use of real-world healthcare data in policy and decision-making. Finally, the incorporation of RWD/RWE into the new EU Medicines Regulations marks a significant shift towards evidence-based, data-driven approaches in the pharmaceutical sector, aiming to enhance patient outcomes and healthcare efficiency across the EU.
 
The following posts provide more details and visual summaries:
 
•  EU – EU4Health Program: https://lnkd.in/dFkkfp8Y
•  EU – The European Health Data Space: https://lnkd.in/dVMFrvD2
•  EU – The Data Governance Act: https://lnkd.in/dhGW5euQ
•  EU – EMA’s 2025 Vision for RWE: https://lnkd.in/d-quNktH
•  EU – EMA RWE Framework to Support Regulatory Decision Making:
•  EU – EU’s Action Plan for Real-World Data (RWD) & RWE: https://lnkd.in/d4TwfXM7
•  EU – RWD/RWE is Embedded into the New EU Medicines Regulations: https://lnkd.in/dxEZ55AT

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Real World Evidence (RWE) 201…THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU2023-12-08T14:58:47+00:00

EU – The European Health Data Space

RWE 201 – EU – The European Health Data Space

[Image Source: https://tehdas.eu/results/tehdas-identifies-user-journey-for-cross-border-health-data-sharing/]

EHDS: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en

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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EU – The European Health Data Space2023-10-14T10:05:45+00:00

Real World Evidence (RWE) 101 – The European Health Data Space (EHDS)

RWE 101 – The European Health Data Space (EHDS)

The European Health Data Space (EHDS) is a proposed initiative by the European Union to create a secure and cross-border platform for the sharing and use of health data in the European Union. The EHDS aims to improve the quality and accessibility of health data, promote innovation in healthcare, and support research and innovation in the field of health.

The EHDS will build on existing initiatives and policies related to health data in the EU, including the General Data Protection Regulation (GDPR), the Electronic Health Record Exchange Format (EHRxf), and the European Health Insurance Card (EHIC). The initiative will also leverage emerging technologies, such as artificial intelligence and blockchain, to enhance the security, interoperability, and utility of health data.

The EHDS will focus on several key areas of health data, including electronic health records (EHRs), patient registries, medical imaging data, genomic data, and health administrative data. The initiative will establish a legal and technical framework for the sharing and use of this data, while ensuring that data privacy and security are maintained.

One of the key objectives of the EHDS is to promote the use of health data for research and innovation in healthcare. The initiative will facilitate the sharing of health data across borders and promote collaboration among researchers, clinicians, and industry partners. This is expected to lead to the development of new treatments, therapies, and medical devices, as well as improvements in healthcare delivery and outcomes.

The EHDS will also aim to improve the quality and accessibility of healthcare services by providing clinicians and patients with access to comprehensive and up-to-date health information. This will support more effective and personalized treatment decisions, as well as more efficient and coordinated healthcare delivery.

Overall, the European Health Data Space is an ambitious initiative that seeks to leverage the potential of health data to improve healthcare and drive innovation in the field. While the initiative is still in its early stages, it has the potential to transform healthcare in the European Union and to establish the EU as a leader in the use of health data for the public good.

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Real World Evidence (RWE) 101 – The European Health Data Space (EHDS)2023-08-07T23:07:39+00:00
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