EHDS, Article 53, DE

1. Health data access bodies shall only grant access to electronic health data referred to in Article 51 for secondary use to a health data user where the processing of the data by that health data user is necessary for one of the following purposes:

(a)

the public interest in the areas of public or occupational health, such as activities to protect against serious cross-border threats to health, public health surveillance or activities ensuring high levels of quality and safety of healthcare, including patient safety, and of medicinal products or medical devices;

(b)

policymaking and regulatory activities to support public sector bodies or Union institutions, bodies, offices or agencies, including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;

(c)

statistics as defined in Article 3, point (1), of Regulation (EC) No 223/2009, such as national, multi-national and Union-level official statistics, related to health or care sectors;

(d)

education or teaching activities in health or care sectors at vocational or higher education level;

(e)

scientific research related to health or care sectors that contributes to public health or health technology assessments, or ensures high levels of quality and safety of healthcare, of medicinal products or of medical devices, with the aim of benefiting end-users, such as patients, health professionals and health administrators, including:

(i)

development and innovation activities for products or services;

(ii)

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