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 77
Dataset description and dataset catalogue
1. Health data access bodies shall, through a publicly available and standardised machine-readable dataset catalogue, provide a description in the form of metadata of the available datasets and their characteristics. The description of each dataset shall include information concerning the source, scope, main characteristics, and nature of the electronic health data in the dataset and the conditions for making those data available.
2. The dataset descriptions in the national dataset catalogue shall be available in at least one official language of the Union. The dataset catalogue for Union institutions, bodies, offices and agencies provided by the Union health data access service shall be available in all official languages of the Union.
3. The dataset catalogue shall be made available to single information points established or designated under Article 8 of Data Governance Act (DGA).
4. By 26 March 2027, the Commission shall, by means of implementing acts, set out the minimum elements health data holders are to provide for datasets and the characteristics of those elements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).