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.
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.
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.
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