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
Recital 66
(66) Health data access bodies should ensure that secondary use is transparent by providing public information about the data permits granted and their justifications, the measures taken to protect the rights of natural persons, the means for natural persons to exercise their rights in relation to secondary use, and the outcomes of secondary use including through links to scientific publications. Where appropriate, that information on the outcomes of secondary use should also include a lay summary to be provided by the health data user. Those transparency obligations complement the obligations laid down in Article 14 of General Data Protection Regulation (GDPR). The exceptions provided for in Article 14(5) of that Regulation could apply. Where such exceptions do apply, the transparency obligations established in this Regulation should contribute to ensuring fair and transparent processing as referred to in Article 14(2) of General Data Protection Regulation (GDPR), for example through providing information on the purpose of the processing and the data categories processed, thereby enabling natural persons to understand whether their data are being made available for secondary use pursuant to data permits.