February 27, 2025
The European Health Data Space (EHDS) is a groundbreaking initiative which forms part of the European Union’s data strategy, aimed at transforming the use, sharing, and governance of health data throughout the union. Through creating a harmonized framework across Member States, the EHDS seeks to address long-standing challenges in interoperability, data accessibility, and privacy. The objective of the initiative is to unlock the potential of health data, to enhance healthcare delivery, accelerate research, drive innovation, and shape informed public policies.
This article explores the intricacies of the EHDS, examining its primary and secondary uses, the mechanisms underpinning its implementation, and the broader implications for Europe’s health ecosystem. Additionally, we reference related regulatory frameworks, such as the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), to understand their collective impact on the life sciences sector.
Primary Use of Health Data: A Focus on Patient-Centred Care
The primary use of health data under the EHDS is centred on improving healthcare delivery and ensuring that patients and providers have access to accurate, real-time information. This focus addresses the significant inefficiencies and inconsistencies in the current system and paves the way for a more integrated healthcare environment.
Key Components of Primary Use
Secondary Use of Health Data: Catalysing Research and Innovation
Secondary use refers to the application of health data for purposes beyond direct patient care. This includes research, policy-making, technological development, and offers immense potential in advancing medicine and improving public health.
Mechanisms Enabling Secondary Use
- 1. Health Data Access Bodies
- 2. Extensive Data Catalogues
- 3. Ethical & Legal Safeguards
- 4. Implementation's Challenges
Central to the EHDS’s secondary use framework are the Health Data Access Bodies. These entities facilitate secure, ethical, and transparent data access by:
- Evaluating and approving data access requests according to strict criteria,
- Managing a comprehensive catalogue of datasets,
- Ensuring data is provided in pseudonymized formats and accessed within secure environments.
The EHDS requires all health data holders to contribute to a centralised data catalogue which consists of:
- Electronic health records (EHRs),
- Genomic, epigenomic, and molecular data,
- Behavioural, environmental, and socio-economic health factors,
- Data from wellness apps and medical devices,
- Research cohorts and biobanks.
This expansive inventory supports diverse use applications, from AI algorithm development to public health policy evaluation.
The EHDS imposes strict rules to ensure ethical data use. Some of the permitted purposes include:
- Public health initiatives, such as pandemic preparedness,
- Scientific research focused on advancing healthcare technologies,
- Educational programs for healthcare professionals.
Accordingly, there are clear prohibited uses which include marketing, discriminatory practices, and activities detrimental to individuals or groups.
The secondary use framework faces several obstacles to overcome:
- Data Quality: Ensuring high-quality, standardised datasets is critical for reliable research outcomes.
- Operational Complexity: Establishing and maintaining HDABs and secure data environments require significant investment.
- Public Trust: Transparency and effective communication are vital to gain public confidence in secondary data use.
Linking DGA, GDPR, and EHDS: Implications for the Life Sciences Sector
The EHDS is not a standalone system as it works alongside other key regulatory frameworks, such as the DGA and GDPR, each addressing distinct but complementary aspects of data management.
- Focuses on enabling secure data sharing across sectors,
- Establishes frameworks for data altruism and intermediaries,
- Supports secondary use of public sector data, particularly for research and innovation.
- Provides the foundational legal framework for personal data protection,
- Emphasizes consent, transparency, and individual rights,
- Balances data access with privacy and security.
- Builds on GDPR principles to ensure secure health data sharing,
- Introduces dedicated mechanisms for health data reuse, such as HDABs,
- Enhances cross-border interoperability, critical for collaborative life sciences research.
Implications for the European Health Ecosystem
The European Health Data Space (EHDS) is a groundbreaking initiative set to profoundly transform Europe’s healthcare and research landscape. By fostering a culture of data-driven decision-making, it paves the way for significant advancements in the operation, innovation, and delivery of health services.
The EHDS has the potential to accelerate medical research by providing secure and streamlined access to diverse datasets. Enabling researchers to develop personalised medical approaches by analysing genetic, clinical, and behavioural data to tailor treatments to individual patients’ needs. Moreover, access to high-quality, large-scale datasets will support the validation and refinement of AI-driven diagnostic tools, enhancing their accuracy and fairness. Clinical trials will also benefit from this harmonized environment, as it will facilitate patient recruitment, improve trial design, and accelerate the delivery of new treatments to the market.
In terms of public health, the EHDS is an essential tool for analysing and then managing health trends. It will provide insights into population health dynamics, allowing for a better understanding of emerging health issues and disparities across the Member States and regions. Policymakers will be able to evaluate the effectiveness of public health interventions and adjust them based on real-world evidence. Disease surveillance systems will also be strengthened, enhancing the ability to detect and respond swiftly to outbreaks, thereby building a more resilient public health infrastructure.
The initiative will foster an environment which promotes innovation in healthcare technologies. Access to real-world data creates opportunities for the development of connected devices, such as wearable technologies that monitor health in real-time and alert users to potential issues. It also enables the creation of digital health applications, addressing a variety of needs, from remote monitoring to virtual consultations, further integrating technology into everyday healthcare.
Equity is a central pillar of the EHDS, ensuring that all EU citizens benefit from high-quality healthcare. Through identifying and addressing disparities in health service delivery, the initiative will help reduce regional inequalities and promote inclusive strategies. Resources can be allocated to underserved areas and populations, and targeted interventions can address the specific needs of marginalised groups, fostering a more equitable healthcare landscape.
Through unlocking the potential of health data, the EHDS not only facilitates collaboration and innovation but also enhances the health and well-being of individuals across Europe. This initiative aligns with the European Union’s broader digital agenda and reinforces its leadership in leveraging data for societal benefit.
Challenges and Future Directions
While the EHDS represents a major step forward, its success hinges on overcoming several critical challenges. One of the most significant is the harmonisation of regulations. Aligning national laws with EU-level directives is essential to ensure consistent implementation across Member States. Without a
coherent legal framework, disparities in local legislative standards and rules may hinder the seamless sharing and use of health data.
Financial sustainability is another key concern. Establishing Health Data Access Bodies (HDABs), maintaining secure data environments, and ensuring equitable participation—especially for smaller data holders—requires substantial funding. Adequate financial support will be critical to building the infrastructure needed for the EHDS to function effectively and inclusively.
Finally, the success of the EHDS relies on active stakeholder engagement. A coalition representative of the patients, researchers, policymakers, and other stakeholders must be formed to foster collaboration and build trust. The public needs assurance that their data will be used ethically and securely, while researchers and policymakers require confidence in the system’s reliability and accessibility. Creating an environment of transparency and mutual understanding is vital for the EHDS to achieve its full potential.
The European Health Data Space is poised to revolutionize health data use, offering transformative benefits for patients, researchers, and society at large. By enabling secure, ethical, and transparent data sharing, the EHDS has the potential to set a global benchmark for health data governance. However, its success hinges on addressing operational, legal, and ethical challenges through sustained investment, cross-border collaboration, and public engagement. As the EHDS evolves, it promises to unlock new possibilities for a healthier, more equitable Europe.
Victoria Derumier
