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 51
Minimum categories of electronic health data for secondary use
1. Health data holders shall make the following categories of electronic health data available for secondary use in accordance with this Chapter:
(a) electronic health data from EHRs;
(b) data on factors impacting on health, including socioeconomic, environmental and behavioural determinants of health;
(c) aggregated data on healthcare needs, resources allocated to healthcare, the provision of and access to healthcare, healthcare expenditure and financing;
(d) data on pathogens that impact human health;
(e) healthcare-related administrative data, including on dispensations, reimbursement claims and reimbursements;
(f) human genetic, epigenomic and genomic data;
(g) other human molecular data such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data;
(h) personal electronic health data automatically generated through medical devices;
(i) data from wellness applications;
(j) data on professional status, and on the specialisation and institution of health professionals involved in the treatment of a natural person;
(k) data from population-based health data registries such as public health registries;
(l) data from medical registries and mortality registries;
(m) data from clinical trials, clinical studies, clinical investigations and performance studies subject to Regulation (EU) No 536/2014, Regulation (EU) 2024/1938 of the European Parliament and of the Council , Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR);
(n) other health data from medical devices;
(o) data from registries for medicinal products and medical devices;
(p) data from research cohorts, questionnaires and surveys related to health, after the first publication of the related results;
(q) health data from biobanks and associated databases.
2. Member States may provide in their national law that additional categories of electronic health data are to be made available for secondary use pursuant to this Regulation.
3. Member States may establish rules for the processing and use of electronic health data containing improvements related to the processing of those data, such as correction, annotation or enrichment, based on a data permit pursuant to Article 68.
4. Member States may introduce stricter measures and additional safeguards at national level aimed at safeguarding the sensitivity and value of the data that fall under paragraph 1, points (f), (g), (i) and (q). Member States shall notify the Commission of those measures and safeguards and, without delay, of any subsequent amendment affecting them.