On 24^th April, the European Parliament approved the regulation enabling the creation of the European Health Data Space (EHDS).

With the creation of the EHDS, the health information of users in the member states of the European Union (EU) will be able to be shared between them. This means health professionals in any member state will be able to access the clinical information of a European citizen, with the information being translated into the EU's 24 official languages.

This system involves two main forms of data usage:

• The primary use aims to empower digital access and control of the electronic personal health data of the respective users, both at national and EU level. In this sense, it supports their free circulation and promotes a single market for electronic health record systems, medical devices and high-risk AI systems.
• Secondary use aims to provide a coherent and efficient framework for the use of health data for research, innovation, policy-making and regulatory activities.

Consequently, citizens' anonymised data can also be used for research, with public universities and the national health system having free access to it. Other institutions wishing to use this data will have to submit a request which is then assessed by the respective mechanism in each country, under the terms of the General Data Protection Regulation (GDPR).

By default, citizens' data is made available in the system, but data subjects can request for that data to be removed from the respective database. However, explicit authorisation from citizens will be required for their genetic and proteomic data to be made available in this system.

With the MyHealth@EU structure, citizens will be able to access their health data immediately and free of charge in a European, digital and standardised format, allowing it to be shared with health professionals within the EU and facilitating access to health services within this scope. 

Additionally, users will be able to add information, rectify errors, restrict access and obtain information about the health professionals who have accessed their data.

It's important to emphasise that this legislation is based on the GDPR and, specifically, the rules applicable to special categories of data, which include health data.

The Regulation comes into force in 2026, but health records will only be accessible in 2028 and data sharing for research use will only be possible in 2030.