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 58
Obligations of health data access bodies towards natural persons
1. Health data access bodies shall make information on the conditions under which electronic health data are made available for secondary use publicly available, easily searchable through electronic means and accessible for natural persons. That information shall cover the following:
(a) the legal basis under which access to electronic health data is granted to the health data user;
(b) the technical and organisational measures taken to protect the rights of natural persons;
(c) the applicable rights of natural persons in relation to secondary use;
(d) the arrangements for natural persons to exercise their rights in accordance with Chapter III of General Data Protection Regulation (GDPR);
(e) the identity and the contact details of the health data access body;
(f) who has been granted access to datasets of electronic health data and to which datasets they were granted access and details of the data permit regarding the purposes for processing such data as referred to in Article 53(1);
(g) the results or outcomes of the projects for which the electronic health data were used.
2. If a Member State has provided for the right to opt out pursuant to Article 71 to be exercised through the health data access bodies, the relevant health data access bodies shall provide public information about the procedure to opt out and facilitate the exercise of that right.
3. Where a health data access body is informed by a health data user of a significant finding related to the health of a natural person, as referred to in Article 61(5), the health data access body shall inform the health data holder about that finding. The health data holder shall, under the conditions laid down by national law, inform the natural person or health professional treating the natural person concerned. Natural persons shall have the right to request not to be informed of such findings.
4. Member States shall inform the public at large about the role and benefits of health data access bodies.