Recital 56

The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of health data users, while remaining limited to data related to health or known to influence health. They can also include relevant data from the health system, for example electronic health records, claims data, dispensation data, data from disease registries or genomic data, as well as data with an impact on health, for example data on consumption of different substances, socioeconomic status or behaviour, and data on environmental factors such as pollution, radiation or the use of certain chemical substances. The categories of electronic health data for secondary use include some categories of data that were initially collected for other 14/96 ELI: http://data.europa.eu/eli/reg/2025/327/oj purposes such as research, statistics, patient safety, regulatory activities or policymaking, for example, policymaking registries or registries concerning the side effects of medicinal products or medical devices. European databases that facilitate use or reuse of data are available in some areas, such as cancer (the European Cancer Information System) or rare diseases (for example, the European Platform on Rare Disease Registration and European reference networks (ERN) registries). The categories of electronic health data that can be processed for secondary use should also include automatically generated data from medical devices and person-generated data, such as data from wellness applications. Data on clinical trials and clinical investigations should also be included in the categories of electronic health data for secondary use when the clinical trial or clinical investigation has ended, without affecting any voluntary data sharing by the sponsors of ongoing trials and investigations. Electronic health data for secondary use should be made available preferably in a structured electronic format that facilitates their processing by computer systems. Examples of structured electronic formats include records in a relational database, XML documents or CSV files and free text, audios, videos and images provided as computer-readable files.