Recital 61

The secondary use of health data under the EHDS should enable public, private and not-for-profit entities, as well as individual researchers, to have access to health data for research, innovation, policymaking, educational activities, patient safety, regulatory activities or personalised medicine, in line with the purposes as set out in this Regulation. Access to data for secondary use should contribute to the general interest of society. In particular, the secondary use of health data for research and development purposes should contribute to benefiting society in the form of new medicines, medical devices, and healthcare products and services at affordable and fair prices for Union citizens, as well as to enhancing access to and the availability of such products and services in all Member States. Activities for which access in the context of this Regulation is lawful could include using the electronic health data for tasks carried out by public sector bodies, such as the exercise of public duty, including public health surveillance, planning and reporting duties, health policymaking, and ensuring patient safety, quality of care and the sustainability of healthcare systems. Public sector bodies and Union institutions, bodies, offices and agencies might need to have regular access to electronic health data for an extended period of time, including in order to fulfil their mandate, as is provided for in this Regulation. Public sector bodies could carry out such research activities by using third parties, including sub-contractors, as long as the public sector body remains at all times the supervisor of those activities. The provision of the data should also support activities related to scientific research. The notion of scientific research purposes should be interpreted in a broad manner, including technological development and demonstration, fundamental research, applied research and privately funded research. Activities related to scientific research include innovation activities such as training of AI algorithms that could be used in healthcare or the care of natural persons, as well as the evaluation and further development of existing algorithms and products for such purposes. It is necessary that the EHDS also contribute to fundamental research, and, although its benefits to end-users and patients might be less direct, such fundamental research is crucial for societal benefits in the longer term. In some cases, the information of some natural persons, such as genomic information of natural persons with a certain disease, could contribute to the diagnosis or treatment of other natural persons. There is a need for public sector bodies to go beyond the scope of ‘exceptional need’ of Chapter V of Regulation (EU) 2023/2854. However, health data access bodies should be allowed to provide support to public sector bodies when processing or linking data. This Regulation provides for a channel for public sector bodies to obtain access to information that they require for fulfilling the tasks assigned to them by law, but does not extend the mandate of such public sector bodies. 16/96 ELI: http://data.europa.eu/eli/reg/2025/327/oj