art_51__para_1

1. Health data holders shall make the following categories of electronic health data available for secondary use in accordance with this Chapter: electronic health data from EHRs; data on factors impacting on health, including socioeconomic, environmental and behavioural determinants of health; aggregated data on healthcare needs, resources allocated to healthcare, the provision of and access to healthcare, healthcare expenditure and financing; data on pathogens that impact human health; healthcare-related administrative data, including on dispensations, reimbursement claims and reimbursements; human genetic, epigenomic and genomic data; other human molecular data such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data; personal electronic health data automatically generated through medical devices; data from wellness applications; data on professional status, and on the specialisation and institution of health professionals involved in the treatment of a natural person; data from population-based health data registries such as public health registries; data from medical registries and mortality registries; 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 (35), Regulation (EU) 2017/745 and Regulation (EU) 2017/746; other health data from medical devices; data from registries for medicinal products and medical devices; data from research cohorts, questionnaires and surveys related to health, after the first publication of the related results; health data from biobanks and associated databases.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.