European Health Data Space Regulation has now been adopted

The European Health Data Space (EHDS) Regulation has as its primary aim the establishment of a secure, interoperable, and patient-focused framework for managing health data across the EU.

The regulation seeks to empower individuals by enabling them to take control of their health data. It ensures that patients can easily and securely access their health records, regardless of where they are in the EU, and facilitates the portability of such data. 

Another key objective of the EHDS is to enhance the delivery of healthcare by promoting the interoperability of health data systems. By establishing uniform standards across member states, the regulation simplifies data sharing between healthcare providers, reducing administrative burdens and inefficiencies while supporting the provision of high-quality care. This is particularly significant for cross-border healthcare services, as it ensures medical professionals can access relevant patient data promptly.

The regulation also focuses on the secondary use of health data to support research, innovation, and policymaking. It establishes a legal framework that allows health data to be used for scientific research, the development of medical treatments, public health improvements, and the creation of innovative health technologies.

The next step is the formal signing of the Regulation by the Council and the European Parliament. Following this, the Regulation will be published in the European Union's Official Journal. Although the Regulation will enter into force 20 days after publication in the Official Journal, implementation will follow a staged approach, with the Regulation's general provisions finding application gradually over the coming years and more specific provisions - namely those on interoperability of the EHDS infrastructure with third countries - will be applied at a later point in the future.

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If you have any questions, please contact Plesner's Life Science team.