Preparing for the European Health Data Space

The EHDS explained: What is it and why does Europe need a data sharing infrastructure for health?

With political agreement now reached by the European Union on a new data sharing governance framework for health – the EHDS, we explore what exactly this means for patients, clinicians, researchers and policymakers in Europe. 

What is the European Health Data Space? 

Back in 2020, the European Commission set out the European Strategy for Data as part of Europe’s Digital Decade. The strategy aims to create a single market for data and introduced plans to establish several common European Data Spaces in areas such as health, mobility, and agriculture, among others. Health is set to be the first common European Data Space introduced and will allow for movement of electronic health information within the European Union (EU).  

It is envisioned that under the European Health Data Space (EHDS) individuals would have access to, and control over, their personal electronic health data, including when travelling within the EU. Additionally, certain anonymised datasets could be made available for research, innovation, and policymaking purposes. It provides for a health-specific data environment that will help foster a single market for digital health services and products in Europe. 

The legislative proposal was adopted by the European Commission in May 2022, with political agreement on a draft legislative text recently agreed by the European Parliament and Council of the EU.  

Why is the EHDS needed? 

A data sharing governance framework for health has the potential to …

Empower citizens 

• Access to personal health information places power in the hands of citizens, including when they travel in Europe. Through technologies such as sensors and mobile apps, they can monitor their own health and see how improvements in lifestyle impact health status. 

Optimise public health decision making 

• Policymakers can access relevant health data to identify trends and patterns for better and faster decision-making in public health. 

Accelerate innovation 

• Secure exchange of health data across borders enables evidence-based research into diseases from diverse datasets, accelerating the pace of innovation into new, potentially life-saving, treatments. This can boost Europe’s competitiveness on the global stage. 

Personalise medicine 

• Healthcare professionals can use data to create safe, personalised treatment plans, deliver more prompt diagnoses, and improve wait times across the system.

How will the EHDS be implemented? 

Successful implementation relies on the standardisation of electronic health record (EHR) systems across Europe. MyHealth@EU is a new digital communication channel which facilitates the secure, electronic exchange of patients’ health data, such as ePrescriptions and Patient Summaries, rapidly and efficiently across member states.  

The HealthData@EU platform is being established to facilitate the cross-border use of health data for secondary purposes such as research, innovation, and policymaking. This will be managed via national health data access bodies. The HealthData@EU infrastructure is currently being piloted across five use cases, in nine countries, led by the Health Data Hub – France’s health data access body.  

How EIT Health supports EHDS implementation 

As part of EIT Health’s Think Tank thought-leadership forum, eleven national Roundtable discussions were hosted across Europe in 2023, and various thought-leaders interviewed to assess readiness for implementation of the EHDS. On foot of these discussions, national reports were published which set out recommendations for both EU policymakers and national governments on how to move forward with the EHDS.  

In Ireland, 17 experts from across the health ecosystem took part in interviews and a national Roundtable discussion to share their position on the EHDS and set recommendations for implementation in Ireland. A report based on these findings was published by EIT Health Ireland-UK in November 2023.  

Find out what key steps can be taken to adopt this framework in Ireland: ‘Implementing the EHDS in Ireland’  

For 2024, EIT Health Ireland-UK plans to support implementation activities locally via awareness building and knowledge sharing activities. The first initiative will be a panel bringing key stakeholders and decision makers together at Healthtech Ireland’s annual symposium to discuss next steps.