EHDS Dataset categories (Art. 51)

Minimum categories of electronic health data for secondary use:

(a) electronic health data from EHRs;

(b) data on factors impacting on health, including socio-economic, 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 Council34, Regulation (EU) 2017/745 and Regulation (EU) 2017/746;

(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.