European Health Data Space Regulation
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Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
Recital 1
(1) 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.
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