Registration for Secondary Use Data Access under the European Health Data Space Regulation

Among issues dividing negotiators on the WHO Pandemic Agreement Annex on Pathogen Access and Benefit Sharing (PABS) are conditions imposed to obtain access to information through the system. One issue that seems basic is whether researchers will have to register to obtain access, a step that seems key to entering into an agreement or contract of any type concerning obligations on benefit sharing, at least under the current approach.

Some countries have argued that access should not be conditioned on registration, or that registration would be impractical to implement. Arianna Schouten has prepared a briefing note describing the role of registration and permits to obtain access to data under the European Health Data Space Registration, which was adopted by the European Union in 2025.

Registration for Secondary Use Data Access under the European Health Data Space Regulation

This briefing note outlines the legal framework and procedural requirements for registering and applying for access to electronic health data for secondary use under the European Health Data Space (EHDS) Regulation.

KEI Briefing Note 2026:1
Arianna Schouten
February 11, 2026
KEI-BN-2026-1