European Health Data Space: Adoption Complete, All Eyes on Execution
Yesterday, the European Health Data Space (EHDS) was finally published in the Official Journal of the European Union.
The EHDS Regulation is a key pillar of the European Health Union, and in just 20 days, this law will come into effect, laying the groundwork for EU citizens to fully benefit from a safe and secure system for exchanging, using, and reusing health data. Ultimately, this regulatory framework promises to enhance outcomes for patients, empower researchers, and drive innovation.
The EHDS is the culmination of years of work and advocacy, including by EURORDIS, to establish a robust and inclusive framework for health data management. Its enactment marks a major step in tackling long-standing challenges in health data use and sharing across Europe.
As we celebrate this progress, we reflect on the EHDS, its purpose, and its potential impact on rare diseases.
What exactly is the European Health Data Space?
The EHDS is a regulatory framework aimed at enabling the secure access, sharing, and use of health data across Member States.
By improving access to health data for primary (healthcare) and secondary purposes (e.g., research and policymaking), the EHDS is aspiring to empower patients, advance research, and improve healthcare delivery across the EU.
Why was the EHDS proposed?
The European Commission proposed the EHDS in response to several persistent challenges in healthcare data management. Until now, health data in the EU has largely been fragmented, with different countries using varying standards and systems that complicate data sharing and hinder cross-border healthcare. This has negatively impacted patient care, medical research, and healthcare policymaking.
The EHDS seeks to address these issues by establishing a cohesive, EU-wide system for health data that will enable data to be used more effectively and ethically for the benefit of all EU citizens.
Improving healthcare for EU citizens
The EHDS is poised to revolutionise healthcare delivery by making health data more accessible and usable for patients, healthcare providers, and researchers. For EU citizens, this means gaining immediate access to their own health data, including critical information like patient summaries, prescriptions, and lab results. This will allow patients to take a more active role in managing their health and making informed decisions about their care.
Health professionals will also be able to access patients’ data securely, even if that data originates from another Member State. This is particularly important for those receiving specialised treatments abroad or requiring emergency care while travelling.
Additionally, the EHDS will create opportunities for innovation, supporting the development of personalised treatments, and a stronger evidence base for health policy decisions.
A game-changer for rare diseases
Over 30 million Europeans with rare diseases face diagnostic delays and limited treatments. The EHDS can change this by connecting healthcare providers with comprehensive patient information that is often fragmented within individual countries.
Broader access to data will enable faster diagnoses, earlier interventions, and better outcomes. Importantly, it will also help build larger patient cohorts for research, accelerating the discovery and development of new therapies for rare diseases.
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EURORDIS’ advocacy reflected in the EHDS
EURORDIS has long championed the development of a European Health Data Space that meets the needs of Europe’s rare disease community.
Our October 2022 position paper outlined comprehensive recommendations to ensure the EHDS prioritises interoperable electronic health records, ethical and secure data use, and robust governance to protect patient rights.
We have consistently advocated for greater digital health literacy, empowering patients with control over their data, and the adoption of FAIR principles – ensuring health data is Findable, Accessible, Interoperable, and Reusable.
Central to our vision, of course, has also been the inclusion of patients and civil society.
The final EHDS Regulation has incorporated many of the priorities that EURORDIS has successfully championed.
Key provisions in the new Regulation include enabling EU citizens to access prescriptions, lab results, and imaging electronically across borders, promoting strong privacy safeguards, and allowing patients to opt out of secondary data use. Additionally, the focus on privacy and cross-border management ensures a secure and fair system.
As we noted in our March and April 2024 media statements, these included measures hold potential for improving care, accelerating research, and delivering better outcomes for those with rare diseases.
What’s next for the EHDS?
While preparations for its infrastructural and technical implementation have been underway across the Union for some time, the EHDS Regulation formalises a gradual timeline for its rollout over the coming years.
Exchanges under the EHDS are set to begin in 2028 for all Member States, with additional data categories scheduled for inclusion by 2030.
In the meantime, Member States will establish Health Data Access Bodies (HDABs) and Digital Health Authorities (DHAs) to oversee the EHDS at the national level. These bodies will play a crucial role in enforcing the Regulation and ensuring data is shared securely and used responsibly.
Over the next two years, the European Commission will also develop secondary legislation to specify the minimum dataset requirements and define technical standards for the EHDS infrastructure.
Looking ahead
The EHDS coming into law is just the beginning.
Its success depends on collaboration among governments, providers, researchers, and patients. For the rare disease community, it represents a vital opportunity to create a more equitable and effective health data ecosystem that genuinely addresses their needs.
EURORDIS stands ready to continue engaging with EU policymakers, national authorities, healthcare professionals, and patient organisations to ensure that the EHDS delivers on its promise of better healthcare for all.
Together, we can make the EHDS a tool that empowers patients and transforms the future of healthcare in Europe.
Julien Poulain, Communications Manager