Guideline for data users on how to use data in a secure processing environment

This TEHDAS2 expert guideline supports the implementation of the European Health Data Space (EHDS). The aim of this guideline is to provide support to those who plan to access personal electronic health data for secondary use purposes through the infrastructure set up by the European Health Data Space (EHDS) regulation, the “HealthData@EU” infrastructure. The guideline is designed to support data users, specifically reflecting their activities from the moment they gain access to the approved datasets within a Secure Processing Environment (SPE) until the completion of their analysis and the export of results. An SPE is a secure digital workspace where authorised users can process electronic health data in a highly controlled manner. The guideline takes the perspective of the data user and is intended to be consulted already from the project planning phase, i.e., before starting the data application process, after the access application form has been submitted, or granted. This is advisable since certain fees apply already when the data user, as data applicant, submits a data access application to a Health Data Access Bodies (HDAB). The data applicant will benefit from assessing the feasibility of conducting their analyses in an SPE at an early stage. In addition, the data applicant may state in the data access application which SPE appears to be suitable for analysing the requested data. The proposal of a certain SPE must be justified in the application and will be part of the data permit. It should be noted that drawing up a definitive guideline for data users remains challenging at this stage, as the implementation of the EHDS regulation (Regulation (EU) 2025/327, in force since 26 March 2025) by the HDABs is still evolving. The HDABs will be responsible for interpreting and applying the regulation in practice, and key implementation tools – such as guidelines and technical specifications – are still being developed. This document will therefore need to be updated as further implementing guidance becomes available.