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
Article 81
Right to lodge a complaint with a health data access body
1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint in relation to the provisions laid down in this Chapter, individually or, where relevant, collectively, with a health data access body, provided that their rights or interests are negatively affected.
2. The health data access body with which the complaint has been lodged shall inform the complainant of the progress made in dealing with the complaint and of the decision taken on the complaint.
3. Health data access bodies shall provide easily accessible tools for the submission of complaints.
4. Where the complaint concerns the rights of natural persons pursuant to Article 71 of this Regulation, the complaint shall be transmitted to the competent supervisory authority under General Data Protection Regulation (GDPR). The relevant health data access body shall provide the necessary information at its disposal to that supervisory authority under General Data Protection Regulation (GDPR) in order to facilitate the assessment and investigation of the complaint.