Published on 14.09.2023 14.09.2023

EU-wide collaboration needed to optimise health data use for research and innovation

The European health data space (EHDS) will bring about a major change in the way health data is used in the European Union and therefore affects us all. Thanks to the Sitra-led TEHDAS project, the use of health data for research and innovation in the EU has already taken a major step forward. The successful realisation of EHDS will require broad collaboration.

The capacity of different EU countries to facilitate the use of health data for research and innovation varies widely, according to the results of the joint action Towards the European Health Data Space (TEHDAS). For the EU-wide use of health data to be successful and sustainable, EU and national legislation need to be clarified.

Currently, European researchers, policy-makers and businesses face many obstacles to accessing health data nationally and across borders. At present, data cannot be fully used, to the detriment of health policy and innovation such as the development of more effective medicines and treatments.

The main obstacle is different interpretations of the General Data Protection Regulation (GDPR). In addition, practices for collecting and processing health data vary from one EU country to another because of differences in their national legislation.

Although the EHDS plans to harmonise the secondary use of health data by creating a common legal framework, the results clearly indicate that all member states need to take steps to meet the requirements of the EHDS.

Enabling secure access to quality data

In the future, decisions on using health data will be taken by a specialised authority in each country, a health data access body. Access to data would only be allowed for specific purposes.

The TEHDAS project developed a data quality framework which aims to ensure that health data collected across Europe and reused for policymaking, regulation and research is reliable enough and fit for purpose.

The project also produced recommendations on secure data processing environments and related practices across national borders. The European Commission’s proposal for a regulation on the EHDS in 2022 includes these recommendations. Protecting people’s privacy will be enhanced by defining common practices for data sharing and use across Europe.

Stakeholder engagement at the heart of the project

TEHDAS fostered dialogue with policymakers and other key stakeholders at national and EU level to raise awareness of the profound changes that are expected once the EHDS regulation enters into force. This has increased the readiness of the member states and the Commission to establish the EHDS.

Public engagement showed that people are interested in sharing their health data but with clear safeguards for privacy and security.

Throughout the project, TEHDAS prioritised stakeholder engagement by hosting forums and other events and participating in almost 300 speaking engagements across Europe. The main TEHDAS events attracted about 2000 European stakeholders to discuss the use of health data in Europe.

A lasting contribution to EU regulation

In TEHDAS, 25 European countries have developed policy options and recommendations needed to make people’s health data more seamlessly and securely accessible. The aim has been to improve the secondary use of health data in the EU to enable better health for all.

The project has been led by Sitra and is part of a wider EHDS initiative, where health data would be available on request for both research and for patient care, wherever patients are in Europe.

In May 2022, the European Commission issued a proposal for a regulation on the EHDS. The TEHDAS results laid the groundwork for the proposal and the implementation of the regulation.

“I would like to thank all TEHDAS partners for their hard work and express my gratitude to the member states, the European Commission, stakeholders and external advisors for their valuable input. The impact of the TEHDAS project can be seen in the EHDS proposal, which will benefit Europe for decades to come,” explains Markus Kalliola, Project Director at Sitra, who led the European collaborative project.

Towards EHDS in collaboration

The legislative process is in full swing. Negotiations are ongoing in the European Parliament and in the Council of the European Union. The final legal text is expected in 2024 and, once adopted, will enter into force after a transitional period.

The work towards better health and care is not yet complete, but thanks to the TEHDAS project, the secondary use of health data in the EU has taken a major step forward. This work will continue, focusing on the successful implementation of the EHDS, which will require broad collaboration throughout Europe.

The TEHDAS joint action, funded by the EU and 25 countries, ended this July. A follow-up joint action is planned to begin in mid-2024.

This TEHDAS report summarises the main findings of the project in a single document to serve European health data stakeholders and the public.