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 70
(70) Health data access bodies should be allowed to charge fees, taking into account the horizontal rules provided by Data Governance Act (DGA), in relation to their tasks. Such fees could take into account the situation and interest of small and medium-sized enterprises (SMEs), individual researchers or public sector bodies. In particular, Member States should be able to establish measures for health data access bodies in their jurisdiction which make it possible to charge certain categories of health data users reduced fees. Health data access bodies should be able to cover the costs of their operations with fees set up in a proportionate, justified and transparent manner. This could result in higher fees for some health data users, if handling their health data access applications and health data requests requires more work. Health data holders should be allowed to also ask for fees for making data available which reflect their costs. Health data access bodies should decide on the amount of such fees, which could also include the fees requested by health data holders. The health data user ought to be charged such fees by the health data access body in a single invoice. The health data access body should then transfer the relevant part of the paid fees to the health data holder. In order to ensure a harmonised approach concerning fee policies and structure, implementing powers should be conferred on the Commission. Article 10 of Data Act should apply to fees charged under this Regulation.