EU Council Adopts European Health Data Space Regulation

The Council of the EU has adopted the European Health Data Space (EHDS) regulation, marking a significant step in the digital transformation of healthcare across Europe. This regulation aims to enhance individuals’ access to their electronic health data, allowing them to have greater control over its usage. By facilitating cross-border access to digital health services, the EHDS seeks to improve the quality and efficiency of medical care while ensuring the resilience of health systems against future challenges.

Under the new EHDS regulation, EU citizens will experience easier and faster access to their health data, irrespective of their location within member states. The regulation mandates the establishment of digital health authorities in each EU country to oversee the implementation of these provisions. This initiative will empower individuals with more control over their health data and its applications, ensuring that personal data remains secure and accessible.

The EHDS also presents significant opportunities for research and innovation by providing access to anonymized and secure health data for researchers and policymakers. This aspect of the regulation is designed to leverage the vast potential of EU health data to support scientific research, develop innovative treatments, and enhance patient care. By ensuring interoperability through compliance with the European electronic health record exchange format, the EHDS aims to overcome the current disparities in health data digitalization across member states.

Following an agreement reached between the Council and the European Parliament, the regulation is set to be formally signed and will come into force 20 days after its publication in the EU’s Official Journal. As a key pillar of the European Health Union, the EHDS will facilitate the primary and secondary use of health data, supporting both healthcare delivery and informed policy-making.