The European Commission launched the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union. As the European Commission stated in its press release, the EHDS offers a consistent, trustworthy and efficient framework to use health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with the EU’s high data protection standards. It will also empower people to control and utilise their health data in their home country or in other Member States, and foster a genuine single market for digital health services and products. The proposal put forward by the European Commission will now be discussed by the Council and the European Parliament.

Gianna Tsakou, INCISIVE’s coordinator, highlights that “the INCISIVE project is closely linked to similar initiatives on data sharing, more so to the EHDS and may contribute to the EHDS through the INCISIVE data repository once the technical and operational specifications of the EHDS are defined and we understand how we can comply with these”. One of the two main goals of INCISIVE is to implement an interoperable pan-European federated repository of health images that will allow the donation and sharing of data in compliance with legal, ethical, privacy and security requirements, for AI-related training and experimentation. The repository will rely on hybrid federated/centralised data storage and will be operated on a Federated Learning basis, abiding to the highest data privacy and security standards.

Apart from that, INCISIVE may not only contribute to the EHDS but also benefit from it, as the second major goal of INCISIVE is the development of a toolbox for AI-enabled decision-support of healthcare professionals; such AI toolbox requires a large amount of training and validation data and the EHDS is expected to facilitate GDPR-compliant access to health data for AI research purposes similar to those of INCISIVE.

Main benefits of the EHDS

According to the European Commission, the EHDS will empower individuals to have control over their health data, enable health professionals to have access to relevant health data, assist policy makers and regulators in accessing relevant non-identifiable health data, and facilitate access to non-identifiable health data for researchers and innovators.

The growth potential expected of the health data economy is also very encouraging. The European Commission expects to raise 5.5 billion euros in savings for the EU over ten years from better access and exchange of health data in healthcare; 5.4 billion euros in savings for the EU over ten years from the better use of health data for research, innovation and policy making; and an additional 20-30% growth of the digital health market.

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