European Union: Adopted LIBE and ENVI position on Regulation establishing a European Health Data Space (EHDS) including rules for portability and sharing of health data

On 28 November 2023, the European Parliament's Committee on Environment, Public Health and Food Safety (ENVI) and the Committee on Civil Liberties, Justice and Home Affairs (LIBE) adopted their position on the Regulation on the European Health Data Space (EHDS). The Regulation would allow both patients and healthcare professionals to access patients' data, such as patient summaries, electronic prescriptions, medical imagery, and laboratory results. Furthermore, under the regulation, the data obtained through wellness applications will be included in the "categories of electronic data for secondary use", enabling entities collecting data to share it for research purposes. EHDS would set regulations for the quality and security of data for providers of Electronic Health Records (EHR) systems in the EU, which will be monitored by the national market surveillance authorities. The EHDS allows the sharing of collective health data for public health purposes, with strict limitations on certain uses and rules regarding anonymisation, patient consent, and citizens' rights. Explicit authorisation for use will be required, while citizens should have the right to contest decisions by a health data access body. Additionally, non-profit organisations would be allowed to file complaints on their behalf. The European Parliament will vote on the LIBE and ENVI position in the plenary session in December.