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EU regulatory register · EHDS

Article 81Right to lodge a complaint with a health data access body

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 a health data access body, 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-81 · 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 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.

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