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- Ελληνικά
[/B]How it will make it easier for citizens and health professionals within and between Member States
The Council of the European Union (EU) and the European Parliament have reached an agreement in principle on a new law (regulation) that will make it easier to share and access citizens' health data at EU level. The National eHealth Authority informs that the agreement will now need to be ratified by both the Council and the Parliament before it can be implemented by Member States.
The proposed regulation for a European Health Data Space (EHDS) aims to improve access and control by individuals themselves over their electronic health data, while also allowing for the re-use of some data for public interest, policy formulation and support, and for scientific and research purposes. It envisages through the Regulation a health-specific data environment that will help promote a single market for e-health, care services and related support products.
The Regulation aims to facilitate access and exchange of health data across borders to support healthcare delivery, i.e. "primary data use", but also health research and policy making (data reuse), also referred to as "secondary data use". They will also have more control over how this data is used. EU Member States will be required under the Regulation to establish an independent National eHealth Authority to implement and oversee the new provisions and the new order in the European area, in order to realise the ultimate goal of a European Health Union.
Prospect of greater opportunities for research by building infrastructure and scientific capacity
The European Health Data Space (EHDS) will also provide researchers and policy makers with secure access to specific types of health data, allowing them to harness the huge potential that EU health data collectively offer to inform scientific research in the public interest. Advantage will be gained by biobanks of health data adapted to eHealth rules and integrated into their respective national health ecosystems.
Achieving and ensuring interoperability of health systems and health data exchange
Currently, the level of digitisation of health data in the EU varies between Member States, making it more difficult to share data across Member State borders. The proposed regulation requires all electronic health record systems to be compliant and the introduction of a single registry that is commonly accepted and interoperable with European defined specifications for the exchange of electronic health records.
Key features of the agreement in principle
The agreement reached on 15 March 2024 between the Council and the EU Parliament clarifies and highlights the Commission's original proposal with a number of key areas that were the negotiating points The Regulation will enter into force 20 days after its publication in the Official Journal of the EU. The aim is to complete all procedures before the upcoming European elections.
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