European health data space, a new challenge for the EU?

The European Commission announces the European Health Data Space called EHDS (European Health Data Space). The project aims for citizens to monitor their health data in the European Union, but is also aimed at researchers in particular, to better use this data for research and innovation purposes.

“The European health data space will be a ‘new start’ for EU digital health policy, making health data work for people and for science. Today we are laying the foundations for safe and reliable access to health data, while fully respecting the EU’s core values”, says the Vice-President of the European Commission Margaritis Schinas.

The Covid-19 pandemic has accelerated the adoption of digital tools in the healthcare sector. However, the complexity of the rules, structures and processes in place in EU member states poses a problem in accessing and sharing health data, particularly outside their respective borders. Partly based on this observation, the European Commission decided to launch EHDS.

Concretely, EHDS will enable the European Union to change the way healthcare is delivered to Europe’s citizens. Thanks to this project, citizens will have instant and free access to their health data in electronic form. Moreover, they will be able to easily share this data with health professionals in and between Member States in order to improve the delivery of care. A single true marketplace for digital health products and services will be created.

The proposal submitted by the European Commission will now be examined by the Council and the European Parliament.

research and innovation

EHDS promotes medical advancement and wishes to establish a legal framework for the use of health data for research, innovation, public health, policy-making, and regulatory purposes.

Thus, to access this data, researchers, companies or institutions will have to request permission from the body responsible for accessing health data, which must be established in each member state.

The bodies responsible for accessing health data will be linked to the EU’s new decentralized infrastructure for secondary data use, HealthData@EU, which will be set up to support cross-border projects.

A topic likely to be discussed at Santexpo, which will take place May 17-19, 2022: https://www.santexpo.com

Data security guarantee

Of course, the European Commission wants to register EHDS as an extension of the General Data Protection Regulation (GDPR). As part of this step, citizens will be able to exercise complete control over their data.

Therefore, interoperability and data security will be ensured by a common European format. For example, in order to ensure the protection of citizens’ data, all member states will designate digital health authorities. They will have to participate in the cross-border digital infrastructure, MyHealth@EU.