Feedback on the European Commission's roadmap concerning the regulatory framework for a European Health Data Space - Feedback on the European Commission's roadmap concerning the regulatory framework for a European Health Data Space
CSC agrees with the objectives of the planned regulatory framework for a European Health Data Space and supports its establishment. However, it must be ensured that the sector-specific data spaces and their respective legislative frameworks do not become silos but are developed in coherence, making them interoperable and thus supporting the ultimate goal of creating one unified European data space.
Building infrastructures and tools for managing and processing health data is crucial for the wellbeing of European citizens, and it is of utmost importance to ensure the ability for researchers to access and use data across borders and institutions, to enable research and innovation that aims at more efficient treatments, personalized medicine and better cure for rare diseases. The EU is currently making remarkable investments in data management and high-performance computing capacities (e.g. EuroHPC), which will boost the research and innovation capacity also in the health field. It is important to leverage these investments and capacities.
To ensure coherence across European data spaces and all data related regulation, such as the Data Governance Act, the regulatory framework of the health data space must be based on the FAIR principles and the European Interoperability Framework. Particular attention must be paid to developing the processing of sensitive data in accordance with data protection rules and the MyData principles aiming to empower individuals by improving their right to self-determination regarding their personal data. On the other hand, it must be ensured that sensitive data can be used for the purposes of research and innovation, bearing in mind that there are technical means for securing anonymity and privacy of individuals.
Creating a European data space does not require storing data in one place or even moving it anywhere. Data can be accessed and processed in its original location, which is preferable from the point of view of information security. Therefore, the idea of federation is functional for the health data space: connecting existing infrastructures and making them interoperable, while also making systematic efforts to identify and fill the gaps they may have. At the same time, it is important to ensure that the federated infrastructures are run by operators possessing excellent ICT competences. Under no circumstances should European health data be stored outside the European Economic Area.
The regulatory framework of the health data space should only set a general framework within which the data space is created based on existing applications, such as the 1+ Million Genomes initiative. Any other existing data practices, policies and infrastructures should also be fully leveraged. Some of them are already mentioned in the roadmap, and in addition we suggest to include those developed in the framework of, for example, the Research Data Alliance, European Open Science Cloud and GAIA-X.
Digital infrastructures form an entity that must be developed in convergence, aiming at synergetic data ecosystems, which can pave the way for world-class research and innovation. This means for example, that linkages of the health data space with high-performance computing capacities and high-speed digital connections must be ensured. CSC is pleased to note that the Commission plans to also address digital health products and services, including AI systems, in the health data space legislation. This must be prepared in coherence with the upcoming European legal framework for AI.