On March 15, 2024, the European Parliament and the Council of the European Union announced that they reached an agreement on the text of the new Regulation on the European Health Data Space (EHDS).
The EHDS aims to ensure improvements in access to and control over individuals’ electronic health data, thus allowing individuals to access their medical records in any Member State. Another crucial aspect is the ability, provided by the EHDS, to reuse health data collected initially for treatment purposes for scientific research purposes. In this regard, it is noteworthy that patients are offered an opt-out for data reuse rather than an opt-in, meaning that data reuse would be automatic upon consent, with patients having the opportunity to object ex post (opt-out).
The new EHDS text aims to:
- Provide individuals with greater digital access to their personal electronic health data and ensure greater control over them, also enabling rapid sharing, both nationally and across Europe, with the healthcare professionals concerned, where necessary;
- Promote a unified and simplified market for electronic health record systems, relevant medical devices, and high-risk AI systems;
- Provide a reliable and efficient system for the use of health data for research, innovation, policy-making, and regulatory activities (known as secondary use of data).
It is necessary to await a final version of the text to better understand the approaches to be taken with the existing provisions of EU Regulation 2016/679 and, consequently, the various implementations that national legislators may choose to adopt.