REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847

 

The aim of this Regulation is to establish the European Health Data Space (EHDS) in order to improve natural persons’ access to and control over their personal electronic health data in the context of healthcare, as well as to better achieve other purposes involving the use of electronic health data in the healthcare and care sectors that would benefit society, such as research, innovation, policymaking, health threats preparedness and response, including preventing and addressing future pandemics, patient safety, personalised medicine, official statistics or regulatory activities.

In addition, this Regulation’s goal is to improve the functioning of the internal market by laying down a uniform legal and technical framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values. The EHDS will be a key element in the creation of a strong and resilient European Health Union.