Article 34, Purposes for which electronic health data can be processed for secondary use, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:
(a) activities for reasons of public interest in the area of public and occupational health, such as protection against serious cross-border threats to health, public health surveillance or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices;
(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;
(c) to produce national, multi-national and Union level official statistics related to health or care sectors;
(d) education or teaching activities in health or care sectors;
(e) scientific research related to health or care sectors;
(f) development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;
(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to the public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;
(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.
2. Access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant fulfils one of the purposes referred to in points (a) to (c) of paragraph 1 shall only be granted to public sector bodies and Union institutions, bodies, offices and agencies exercising their tasks conferred to them by Union or national law, including where processing of data for carrying out these tasks is done by a third party on behalf of that public sector body or of Union institutions, agencies and bodies.
3. The access to privately held data for the purpose of preventing, responding to or assisting in the recovery from public emergencies shall be ensured in accordance with Article 15 of the Regulation […] [Data Act COM/2022/68 final].
4. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall take all specific measures necessary to preserve the confidentiality of such data.