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 69
(69) In order to support secondary use, health data holders should refrain from withholding the data, requesting unjustified fees that are not transparent or proportionate to the costs of making the data available or, where relevant, to marginal costs of data collection, requesting the health data users to co-publish the research or other practices that could dissuade the health data users from requesting the data. Where a health data holder is a public sector body, the part of the fees linked to its costs should not cover the costs of the initial collection of the data. Where ethical approval is necessary for providing a data permit, the evaluation related to ethical approval should be based on its own merits.