Making health data available for AI-driven innovation in biotechnology

The European Health Data Space (EHDS) is establishing a common European framework for the use of health data in research and innovation. However, significant technical, organisational and regulatory challenges remain between the legal possibilities for accessing data and the development of market-ready AI applications.

This is where the EU-funded project SCAILED (Scale-up Biotech AI Innovation by Leveraging Responsible Data Use under the European Health Data Space) comes in. The consortium comprises 50 project partners from 20 EU Member States. Together, they aim to explore how high-quality health data can be made available for AI-driven biotechnology innovation within the EHDS and how successful developments can be translated into practical applications.

From fragmented data infrastructures to a European innovation ecosystem

A key focus of the project is connecting existing health data infrastructures. These infrastructures are intended to work together in an interoperable and federated way, enabling data to be used for research and AI development without having to bring it together in a central location.

The kick-off meeting therefore focused on the project's methodological foundations and the pilot integration of data infrastructures into the EHDS. Using concrete biotechnology use cases, the project will investigate how data access, technical interoperability and responsible data use can work together under real-world conditions.

Another objective is to develop a so-called Pathfinder system. It is intended to help innovators navigate the various regulatory requirements, from the EHDS and the European AI Act to other regulations relevant to biotechnology applications.

In addition, SCAILED is exploring how successful AI pilot projects can be developed into scalable applications with the support of European AI Factories.

TMF promotes regulatory clarity and responsible data use

Together with other partners, TMF is responsible for the project's work package on Regulatory Clarity & Ethics. The focus is on the legal and organisational conditions under which existing and future health data infrastructures can be integrated into the EHDS. The aim is to develop practical guidelines and recommendations to help data infrastructures and other stakeholders navigate the implementation of European requirements. Alongside legal considerations, the project also addresses ethical aspects of health data use and the perspectives of different stakeholder groups. At the kick-off meeting, Irene Schlünder and Aleksandra Naydenova from TMF presented the planned activities in this area.

The two-day kick-off meeting in Luxembourg provided an opportunity to coordinate the project's various workstreams and define the next steps towards implementation. In addition to data infrastructures and regulatory requirements, the main areas of focus include collaboration with relevant stakeholders, concrete biotechnology use cases and the integration of AI Factories.

SCAILED thus pursues a comprehensive approach: the project aims not only to facilitate access to European health data, but also to establish the conditions needed to turn this data into responsibly developed and scalable AI innovations.

For TMF, one key priority is to translate the EHDS from regulation into practice and strengthen existing research data infrastructures to support legally compliant, interoperable and innovation-enabling data use.