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 74
(74) As their resources are limited, health data access bodies should be allowed to apply prioritisation rules, for instance prioritising public institutions over private entities, but they should not discriminate between the national organisations and organisations from other Member States within the same category of priorities. A health data user should be able to extend the duration of the data permit in order, for example, to allow access to the datasets to reviewers of scientific publications or to enable additional analysis of the dataset based on the initial findings. This should require an amendment of the data permit and could be subject to an additional fee. However, in all cases, the data permit should reflect such additional uses of the dataset. Preferably, the health data user should mention them in their initial health data access application. In order to ensure a harmonised approach between health data access bodies, the Commission should support the harmonisation of data permits.