Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS 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 Regulation (EU) 2016/679. The relevant health data access body shall provide the necessary information at its disposal to that supervisory authority under Regulation (EU) 2016/679 in order to facilitate the assessment and investigation of the complaint.
Relevant Recitals for this Article
Without prejudice to any other administrative, judicial or non-judicial remedy, any natural or legal person should have the right to lodge a complaint with a digital health authority or with a health data access body, if the natural or legal person considers that his or her rights or interests under this Regulation have been affected. The investigation following a complaint should be carried out, subject to judicial review, to the extent appropriate in the specific case. The digital health authority or health data access body should inform the natural or legal person of the progress and the outcome of the complaint within a reasonable period. If the case requires further investigation or coordination with another digital health authority or health data access body, information on the progress made in dealing with the complaint should be given to the natural or legal person. In order to facilitate the submission of complaints, each digital health authority and health data access body should take measures such as providing a complaint submission form which can also be completed electronically, without excluding the possibility of using other means of communication. Where the complaint concerns the rights of natural persons related to the protection of their personal data, the digital health authority or health data access body should transmit the complaint to the supervisory authorities under Regulation (EU) 2016/679. Digital health authorities or health data access bodies should cooperate to handle and resolve complaints, including by exchanging all relevant information by electronic means, without undue delay.