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 21. Right to lodge a complaint with a digital health authority
- 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 the competent digital health authority, provided that their rights or interests are negatively affected.
- 2.Where the complaint concerns the rights of natural persons pursuant to Articles 3 and 5 to 10 of this Regulation, the digital health authority shall transmit the complaint to the competent supervisory authorities under Regulation (EU) 2016/679. The digital health authority shall provide the necessary information at its disposal to the competent supervisory authority under Regulation (EU) 2016/679 in order to facilitate the assessment and investigation of the complaint.
- 3.The competent digital health authority with which the complaint has been lodged shall inform, in accordance with national law, the complainant of the progress made in dealing with the complaint, of the decision taken on the complaint, of any referral of the complaint to the competent supervisory authority under Regulation (EU) 2016/679 and, in cases of such a referral, that that supervisory authority is, from that moment on, to be the sole point of contact for the complainant in that matter.
- 4.Digital health authorities in the Member States concerned shall cooperate to handle and resolve complaints related to cross-border exchange of and access to personal electronic health data, including by exchanging all relevant information by electronic means, without undue delay.
- 5.Digital health authorities shall facilitate the submission of complaints and provide easily accessible tools for the submission of complaints.
Relevant Recitals for this Article
Without prejudice to any other administrative or non-judicial remedy, any natural or legal person should have the right to an effective judicial remedy against a legally binding decision of a digital health authority concerning them or where a digital health authority does not handle a complaint or does not inform the natural or legal person within three months about the progress or outcome of the complaint. Proceedings against a digital health authority should be brought before the courts of the Member States where the digital health authority is established.