Council adopts new regulation improving cross-border access to EU health data

The Council of the EU has adopted a new law that will make it easier to exchange and access health data at EU level, paving the way for it to come into force.

 

 

The European Health Data Space (EHDS) regulation aims to improve individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for research and innovation purposes for the benefit of European patients. It provides for a health-specific data environment that will ensure cross-border access to digital health services and products within the EU.

The digital transformation of healthcare in Europe is a key priority for Polish Presidency. The adoption of the European Health Data Space (EHDS) marks a crucial step in this process, empowering EU citizens to access their health data anywhere in the EU. EHDS will enhance the quality and efficiency of medical care, while ensuring that our health system remains resilient to future challenges.

Izabela Leszczyna, Polish Minister of Health

Easier access to health data for individuals

Under the new rules, individuals will have faster and easier access to electronic health data, regardless of whether they are in their home country or another member state. They will also have greater control over how that data is used. EU countries will be required to set up a digital health authority to implement the new provisions.

Greater research potential

The EHDS will also provide researchers and policy-makers with access to specific kinds of anonymised, secure health data, enabling them to tap into the vast potential provided by the EU’s health data to inform scientific research, develop better treatments, and improve patient care.

Ensuring interoperability

Currently, the level of digitalisation of health data in the EU varies from one member state to another, making it more difficult to share data across member-state borders. The new regulation requires all electronic health record (EHR) systems to comply with the specifications of the European electronic health record exchange format, ensuring that they are interoperable at EU level.

Next steps

The regulation will now be formally signed by the Council and the European Parliament. It will enter into force 20 days after publication in the EU’s Official Journal.

Background

On 3 May 2022 the European Commission published a proposal for a regulation creating a European Health Data Space (EHDS). The proposal is the first of nine European sector- and domain-specific data spaces set out by the Commission in its 2020 communication, ‘A European strategy for data’. The Council and the European Parliament reached a provisional agreement on the regulation on 15 March 2024.

The aim of the EHDS is to make it easier to access and exchange health data across borders, both to support healthcare delivery (‘primary use of data’) and inform health research and policy-making (re-use of data, also referred to as ‘secondary use of data’). It is considered a key pillar of the European Health Union.

 

Further information: Council of the European Union.