On Monday, 1 December 2025, Knowledge Ecology International (KEI) delivered the following statement on the 2025 European Health Data Spaces Regulation during the afternoon ession with Relevant Stakeholders which took place at WHO headquarters in Geneva from 16:45–17.15 CET.
IGWG 4 – KEI statement on the 2025 European Health Data Spaces Regulation
1 December 2025
We would like to shed further light on the European Health Data Spaces Regulation which entered into force on 26 March 2025. This regulation may be of interest to WHO negotiators on pathogen access and benefit-sharing. Contrary to what some have told the IGWG members, the regulation covers more than patient records, and also includes genomic information, including on pathogens, blood samples, prices, invoices, and clinical trial data, and other information.
The health data spaces regulation creates a highly regulated system of access for researchers who want to benefit from the system, for what is referred to as “secondary uses” of health data. This includes R&D on new products, training Artificial Intelligence systems, and policy analysis.
The data space regulation sets out a system for registration of users of the data and obligations to ensure that data is only used for authorized purposes, and to keep records and be subject to audits. These provisions may provide a useful model for some elements of the PABS.