The European Health Data Space Explained in 5 questions

DATE July 22nd, 2022

The European Health Data Space (EHDS) is a major policy initiative of the European Commission that aims to improve access to healthcare by making healthcare data accessible to citizens, researchers and policymakers across the EU. University Hospitals play an important role in this, because being healthcare providers and research institutes they hold, guard and use a lot of patient and healthcare data. EUHA’s Digital Health and Data Network, therefore, is an advisory stakeholder in the creation of the EHDS. In this blog post, we explain the main features and challenges of the EHDS through answering 5 key questions.

1. What is the European Health Data Space?

The European Commission launched the so-called European Health Data Space (EHDS) at the beginning of May 2022. This is a data space within the European Union that makes it possible to use health data throughout Europe both for the direct care of patients, but also for research and for shaping health policy. The overall aim is to improve access to healthcare for all European citizens.

2. What is the concrete improvement for citizens?

Improvements are expected in three relevant areas:

  1. Uniform infrastructure and technology: this will enable important care services to be provided throughout Europe in the future. For example, citizens will be able to provide their important data to local physicians while on vacation, and they will be able to fill their electronic prescriptions at any pharmacy within the EU’s borders.
  2. Interoperability and high data quality: health data can be exchanged and used on a secure basis across countries without any loss of quality, especially without time-consuming reworking or translations. This improves medical care in both individual cases and research.
  3. Governance: national healthcare systems are not yet able to collaborate efficiently which hindered the development of a unified strategy during the COVID pandemic; drug development would have been even faster if data were collected and used uniformly.

3. How is my data safeguarded? – each person has control over his/her data

Control over data lies with the citizens of the member states. It is possible for citizens to add information, correct incorrect information, restrict access and even find out how and why data is being used. Access to data is only granted to those who can reliably prove that the requested data will be used for predefined purposes in closed, secure environments and without revealing the identity of the individual.

4. What are the challenges?

In addition to the regulations on data protection (based on the European General Data Protection Regulation), a major hurdle is the interoperability of data, which is still largely lacking today. In each member state, data must be recorded according to the same schemas and in the same formats so that data from a member state such as France can also be used in Germany and all other affiliated countries. Member states are responsible for ensuring this interoperability; for example, electronic patient records, medication data, electronic prescriptions, images and laboratory results must be issued in a common European format.

5. What’s next?

All member states must designate authorities (and have already done so in some cases) to ensure that the conditions for the EHDS are coordinated and created and that the rights of citizens are respected in the process. These authorities are also obliged to participate in the concrete development of the cross-border digital infrastructure and to support patients in using the EHDS. Initial solutions are currently being developed in pilot projects. The goal is to have laid the foundations for the Single European Health Data Space by 2025.

How EUHA is involved with the EHDS

The EUHA Digital Health and Data Network has successfully applied to the EU-funded project TEHDAS (Towards the European Health Data Space) as a so-called stakeholder for participation in two working groups of this project led by the Finnish SITRA. DHDN members regularly participate and contribute to the workshops of these working groups.

In addition, the DHDN is assessing the ability to make the International Patient Summary (IPS) available to the EUHA. For background context, the electronic patient summary file is intended to be accessible for the EHDS as one of the first interoperable structured documents. This is based on the structures of the IPS. In Germany, the first version of the electronic patient summary file was specified in June 2022 and is ready to be implemented. In the first stage of development, it will primarily contain an internationally comprehensible emergency data record, contributing significantly to the provision of better care.