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Purposes for which electronic health data can be processed for secondary use

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) training, testing and evaluation of algorithms, including in medical devices, in vitro diagnostic medical devices, AI systems and digital health applications;

(f) improvement of the delivery of care, of the optimisation of treatment and of the provision of healthcare, based on the electronic health data of other natural persons.

2. Access to electronic health data for the purposes referred to in paragraph 1, points (a), (b) and (c), shall be reserved for public sector bodies and Union institutions, bodies, offices and agencies exercising the tasks conferred on them by Union or national law, including where processing of data for carrying out those tasks is done by a third party on behalf of those public sector bodies or of Union institutions, bodies, offices and agencies.