Current Health Data Landscape

The current health data landscape in the EU is characterized by fragmented and protected data silos and systems, much of which is on paper. This makes it challenging for patients to access and control their health records across providers and for third parties to access health data for research and innovation. Complex ethical and legal barriers, particularly the varied application of the General Data Protection Regulation (GDPR) across Europe, further complicate data sharing. This leads to the majority of data being underused.

Figure 1. Limitations of data sharing in the current health data landscape

Reshaping the health data landscape

The EU’s action seeks to address the above problems and use data to power healthcare, research and economic growth across the bloc. It will reshape the landscape via the following initiatives:

Figure 2. EU data sharing initiatives and their impacts

1. Data Governance Act (DGA)

The DGA, applicable in 2023, aims to improve data-sharing by laying down rules and mechanisms:

• Facilitating access to and reuse of protected public sector data: The DGA introduces conditions and mechanisms to enable access to and reuse of protected public sector data, such as health data, including a searchable database. While the Act does not create an obligation for public sector bodies to allow the reuse of protected public sector data, it sets forth basic conditions under which such data reuse may be permitted. This aims to make valuable data more accessible while ensuring privacy and security.
• Member States must establish technical capabilities for secure data processing, including the capability for anonymization, pseudonymization, and establishing secure data processing environments.
• Enabling data altruism organizations: The Act encourages citizens and stakeholders to make their data available for common good causes like research, healthcare, and education, by codifying data altruism organizations into law.
• Regulating data intermediaries to ensure secure data sharing: The DGA sets out measures to establish and regulate data intermediaries who connect data holders with data users and host infrastructure for data sharing. These intermediaries will be subject to strict requirements to prevent data misuse and ensure secure data sharing.

2. Data Act

The Data Act will become applicable in September 2025, it addresses legal and technical barriers to data use by:

• Granting users access to data generated by their connected devices: Users will have the right to access raw data generated by their connected devices and related services, such as medical devices, and share it with third parties. This aims to support innovation and aftermarket services.
• Protecting SMEs from unfair data-sharing contracts: The Act includes provisions to protect small and medium-sized enterprises (SMEs) from unfair terms in data-sharing contracts imposed by larger entities. Model contract terms will be provided to help SMEs negotiate fair deals.
• Allowing public sector access to private sector data in emergencies: Public sector bodies will be able to access and use source data held by private entities during exceptional circumstances, such as emergencies. This ensures that critical data is available when needed most.
• Facilitating easier switching between cloud services: The Act introduces measures to make it easier for users to switch between data service providers, including interoperability standards and contractual obligations. This aims to prevent vendor lock-in and promote competition.

3. European Health Data Space (EHDS)

The EHDS, the most revolutionary of the initiatives, which entered into force in March 2025, aims to create a single digital health data infrastructure across the EU, which includes:

• Accessible electronic health records for data use: interoperability and access requirements will be put on electronic health records, enabling individuals to control their health records and seek care across providers and EU countries.
• Liberalising access to all health data for data re-use: The EDHS provides mechanisms, and legal frameworks for accessing health data held by individuals and organisations, with few exceptions, for research, policy informing and innovation purposes. This includes data from health records, clinical trials, wellness applications and administrative data, promoting innovation and improving healthcare outcomes. More information on how the EHDS will affect organisations can be found here.

While individuals have the right to opt-out of their data being used or re-used, emergency situations may override this, and Member States can apply additional safeguards for sensitive data. Access to personal health data will involve stricter restrictions and safeguards to ensure privacy. In contrast, non-personal health data is envisioned to be much more accessible, via a central database(s). Existing data sharing contracts and processes will not be directly affected by the EHDS, which adds rather than replaces data sharing rules and infrastructure.

Implementing EHDS will be challenging: there is a balancing act between protecting intellectual property rights and enabling data access, as companies are required to share commercially confidential data; overcoming the technical barriers of anonymising patient data from diverse sources, and establishing the administrative capacity for data sharing.

4. European Open Science Cloud (EOSC)

Being implemented over the next few years, the EOSC aims to enhance research data sharing and utilization by creating a federated, multi-disciplinary, Open Science digital platform. Although participation is largely voluntary, there is an increasing requirement by funders that researchers adhere to open science policies, which the EOSC facilitates. It links existing data infrastructures and research data into a single platform, enabling researchers to publish, find, and reuse data across disciplines and countries. This should promote collaboration and accelerate scientific discovery. While they are separate initiatives, as the EHDS expands the availability of health data, a streamlined integration with the EOSC will further create data access for health researchers, supporting more effective data-driven research.

5. EU Initiatives for Biobanks

Prominent initiatives like BBMRI-ERIC and EuroBioBank aim to improve and integrate biobanks across Europe, supporting research in genomics, disease biomarkers, and personalized medicine by harmonizing and standardizing biobanking practices and providing comprehensive directories.