+Article 51 1

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:

(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 (35), 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.

1. Ħarsa ġenerali

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Titlu Regolamentazzjoni

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti
Sors Rekwiżit

3. Standards relatati

Standards
Sors Rekwiżit