New EU4Health contracts signed: support for the implementation of the new Substances of Human Origin Regulation and the European Health Data Space

The European Health and Digital Executive Agency (HaDEA) has signed two new contracts under the 2025 EU4Health work programme. 

Support for the implementation of the new Substances of Human Origin (SoHO) Regulation 

Following the call for tenders HADEA/2025/OP/0043, a direct contract was awarded to support the implementation of the new Substances of Human Origin (SoHO) Regulation 1938/2024. By developing training programmes, providing awareness and capacity building activities, technical assistance and supporting measures for SoHO professionals, this contract supports professionals in meeting new technical and regulatory requirements. 

Signed on 20 March 2026, this contract will have a duration of 30 months and an awarded budget of €3 499 828.50 under the EU4Health programme. 

Read more in the contract award notice. 

Support for the implementation of initiatives on digital health and the European Health Data Space  

This newly signed contract, following the call for tenders HADEA/2025/OP/0034, is set to provide administrative and secretarial support to Directorate General for Health and Food Safety in implementing the European Health Data Space (EHDS) and other initiatives such as the Biotech Act and the cybersecurity of hospitals, as well as others that may be defined in the future.    

This includes providing support to manage the groups and subgroups working on primary and secondary uses of data, including for instance the seamless organisation of stakeholder meetings, ensuring technical readiness and providing documentation. 

Signed on 23 February 2026, this contract will have a duration of 36 months and an awarded budget of €900 250 under the EU4Health programme. 

Read more in the contract award notice. 

Background  

EU4Health is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe. HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and calls for tenders from 2021 to 2027.