What is the European Health Data Space? 

The European Health Data Space (EHDS) is an initiative by the European Union (EU) aimed at creating a unified framework for health data exchange across EU Member States. Its primary goal is to enhance access to health data while enabling certain data to be reused for public interest, policy support, and scientific research purposes. The regulation establishing the EHDS went into effect in late March 2025 and its first data exchanges are scheduled to begin in 2029. 

For pharmaceutical companies, real-world evidence (RWE) plays a pivotal role in regulatory submissions and health technology assessment, and the EHDS will offer access to real-world health data within a well-defined and unified legal framework, which could unlock huge benefits for health research. 

EHDS objectives and role in facilitating health data sharing 

The EHDS seeks to harmonize health data standards and facilitate secure sharing among stakeholders. Its objectives include improving patient outcomes, fostering innovation in healthcare, and supporting evidence-based policy decisions. By enabling cross-border data flows, it aims to overcome existing barriers in health data interoperability. The regulation establishes a primary use for EHDS by granting patients access and control over their electronic health data alongside a secondary use focused on research and policy making under strict regulatory conditions.  

Supporters believe the ability to analyze large-scale datasets in a centralized platform will enhance confidence in the credibility of data used for RWE analysis, thereby fostering applied research and innovation.  

HealthData@EU Central Platform 

The HealthData@EU Central Platform forms the backbone of EHDS, providing functionalities such as data cataloguing and access management. It is also intended to support RWE initiatives by enabling researchers and policymakers to securely access diverse datasets to inform clinical trials and public health strategies. Additionally, this platform hosts the Dataset Catalogue, which compiles metadata from member states, European institutions (e.g., the European Parliament, European Council), non-EU countries, and research infrastructures.  

EHDS data sources 

The EHDS is intended to enable secure and standardized access to health data from various sources, including electronic health records (EHRs), genomics data, and disease registries. To enhance interoperability and support data portability, the EHDS Regulation establishes a harmonized legal and technical framework for EHR systems. These standards aim to empower individuals with greater control over their electronic health information. Manufacturers of medical devices, in vitro diagnostic medical devices, or AI systems —classified as high-risk under the EHDS Regulation— that claim interoperability with EHR systems will be required to adhere to the relevant interoperability standards outlined in the EHDS Regulation.  

Additionally, EHDS will need to contend with differing national regulations governing health data management that may affect its rollout. Aligning these varied approaches will be vital to realizing smooth integration throughout Europe. 

How will entities access EHDS? 

Researchers, companies, or public institutions will access the EHDS through secure, regulated pathways that comply with the General Data Protection Regulation (GDPR) and additional EU frameworks, including the Data Governance Act, Data Act, and Network and Information Systems Directive. For secondary use, access to electronic health data will be granted for specific permitted purposes by Health Data Access Bodies, which will be established in all EU Member States. These bodies will cooperate at the EU level through a network or advisory group.  

How will the EHDS transform pharmaceutical companies’ data strategies? 

Pharmaceutical companies could gain substantial advantage from the EHDS by utilizing it for exploratoy research. However, despite the extensive data that will be available through EHDS, pharmaceutical companies may still seek additional variables not included in these public datasets. Private RWE collection is likely to remain essential due to proprietary interests in specific therapeutic areas or populations that are not adequately covered by EHDS.  

Next steps 

At Avalere Health, we actively partner with global real-world data providers and leverage our deep expertise to help organizations navigate the evolving European health data landscape. Our experience extends beyond EHDS to include comprehensive support in evaluating data partnerships, ensuring that manufacturers can maximize the value of both public and private datasets for research, regulatory, and commercial objectives.  

As the EHDS continues to transform access to health data across Europe, Avalere Health stands ready to guide companies through this new environment—helping them unlock opportunities, address compliance challenges, and realize the full potential of real-world evidence. Connect with us to learn more.