+Article 51 1
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Article 51 1
1. Health data holders shall make the following categories of electronic health data available for secondary use in accordance with this Chapter:
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(a)
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electronic health data from EHRs;
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(b)
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data on factors impacting on health, including socioeconomic, environmental and behavioural determinants of health;
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(c)
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aggregated data on healthcare needs, resources allocated to healthcare, the provision of and access to healthcare, healthcare expenditure and financing;
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(d)
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data on pathogens that impact human health;
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(e)
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healthcare-related administrative data, including on dispensations, reimbursement claims and reimbursements;
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(f)
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human genetic, epigenomic and genomic data;
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(g)
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other human molecular data such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data;
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(h)
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personal electronic health data automatically generated through medical devices;
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(i)
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data from wellness applications;
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(j)
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data on professional status, and on the specialisation and institution of health professionals involved in the treatment of a natural person;
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(k)
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data from population-based health data registries such as public health registries;
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(l)
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data from medical registries and mortality registries;
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(m)
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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;
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(n)
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other health data from medical devices;
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(o)
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data from registries for medicinal products and medical devices;
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(p)
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data from research cohorts, questionnaires and surveys related to health, after the first publication of the related results;
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(q)
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health data from biobanks and associated databases.
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1. Yleiskatsaus
1.1 Viittaukset
1.2 Tunnistetut vaatimukset
1.3 Liittyvät standardit
2. Tunnistetut vaatimukset
Vaatimukset
| Lähde |
Vaatimus |
3. Liittyvät standardit
Standardit
| Lähde |
Vaatimus |
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