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 30
(30) Member States should designate relevant digital health authorities for the planning and implementation of standards for access to and transmission of electronic health data and the enforcement of the rights of natural persons and health professionals, as separate organisations or as part of already existing authorities. The digital health authority staff should not have any financial or other interests in industries or economic activities which could affect their impartiality. Digital health authorities already exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. When carrying out their tasks, digital health authorities should cooperate in particular with the supervisory authorities established pursuant to General Data Protection Regulation (GDPR) and supervisory bodies established pursuant to eIDAS Regulation (Electronic Identification). Digital health authorities can also cooperate with the European Artificial Intelligence Board established by AI Act of the European Parliament and of the Council , the Medical Device Coordination Group established by Medical Devices Regulation (MDR) of the European Parliament and of the Council , the European Data Innovation Board established pursuant to Data Governance Act (DGA) of the European Parliament and of the Council and the competent authorities under Data Act of the European Parliament and of the Council . Member States should facilitate the participation of national actors in the cooperation at Union level, the conveying of expertise and the provision of advice on the design of solutions necessary to achieve the goals of the EHDS.