Establish a space for sharing patient health data with the rest of Europe and to prevent common regulations, standards and practices, create infrastructure and establish a governance framework for the primary and secondary use of electronic health data. This is the aim of the European Health Data Space just approved by EU Council representatives, a system that will make it easier to exchange and access health data at European level.

The Covid 19 pandemic crisis that almost brought healthcare systems around the world to their knees set a precedent that alarmed the European institutions. One of the objectives of the EHDS is to ensure a cohesive, reliable and efficient regulation for the use of health data for research and scientific innovation, also in anticipation of new global crises such as the one just passed. At present, cross-border access to health data is very complex and varies between EU member states. The new regulations will allow, for example, a Spanish tourist to obtain a prescription in a German pharmacy or doctors to access the health information of a Belgian patient being treated in Italy.

According to Mónica García, Spanish Health Minister and one of the promoters of the European Health Data Space, thanks to the EHDS “people will have quicker and easier access to electronic health data, regardless of whether they are in their own country or in another Member State. This will benefit EU citizens by facilitating more informed decisions and the provision of safer healthcare across borders. They will also have more control over how the data is used’.

The existing HealthData@EU infrastructure will therefore be enhanced to facilitate the international exchange of electronic health data. In the meantime, the EU countries will also have to create a digital health authority capable of implementing the new provisions. Indeed, at present, the degree of digitisation of health data varies widely among EU Member States, making the sharing of information across national borders truly complex. The proposed regulation requires all electronic health record (EHR) systems to comply with the European Electronic Health Record (EHR) exchange format specifications, thus ensuring interoperability at European level. These solutions also include artificial intelligence-based approaches, which derive their analysis and prediction capabilities precisely from access to large datasets.

Annalisa Tardino, co-rapporteur of the Committee on Civil Liberties in the European Parliament, commented ‘The European Health Data Space will contribute to providing state-of-the-art healthcare to patients across the European Union. We have achieved a balance between exchanging health data for life-saving treatment and research and protecting the privacy of sensitive and personal data”.

The initiative is supported by the ‘Joint Action for the European Health Data Space’ (TEHDAS – Towards the European Health Data Space), launched in 2021 with the participation of 26 European countries. This initiative aims to promote the development of EHDS by involving all stakeholders interested in the use and re-use of health data.