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 102
(102) In order to strengthen the enforcement of the rules of this Regulation, penalties, including administrative fines, should be imposed for any infringement of this Regulation, in addition to, or instead of, appropriate measures imposed by health data access bodies pursuant to this Regulation. The imposition of penalties, including administrative fines, should be subject to appropriate procedural safeguards in accordance with the general principles of Union law and the Charter of Fundamental Rights of the European Union, including effective judicial protection and due process.