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EU regulatory register · EHDS

Article 21Right to lodge a complaint with a digital health authority

CELEX 32025R0327 · Read on 2026-08-31

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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.

Verbatim from the article. Source: NovaCopilot · https://legal.exploreworldai.com/eu/rattsakter/helsodata-2025-327/artikel-21 · Short answer as data · Official text

Official text

Read from the EU Publications Office for this CELEX number. The wording stands as published; nothing here is rewritten or summarised.

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.

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