Susana Solís

European Health Data Space

Susana Solís MEP urges the Commission to take into account the different degrees of decentralisation across the EU’s health systems when setting up the European Health Data Space

• Susana Solís stresses that “Europe could be a forceful competitor to the United States and China in the application of Artificial Intelligence in healthcare — but it must start by developing an innovative Digital Single Market”

Susana Solís asked to adopt a decentralised approach in the European Health Data Space, during a discussion she organised centred on the opportunity posed to the EU by digitalisation and the deployment of Artificial Intelligence in the healthcare sector.

Solís thanked the EU Commission for its efforts to push ahead with the European Health Data Space. Nevertheless, the Commission has followed the centralised Finnish health system as a model and is therefore not applicable to countries such as Spain or Germany, in which health competences are held by regional entities. “In some highly decentralized Member States the information is barely available at national level. The data is not interoperable so how are national contact points expected to access and manage all the relevant information?”

In response, Solís has suggested implementing a decentralized approach, closer to a sandbox logic, and managed by the relevant health centres, health institutions, industrial players and research institutions according to the norms and guidelines set by the respective national competent authority. She already submitted a Written Question to the Commission last month to ensure a well-functioning health data exchange system.

According to Solís, “Europe could be a forceful competitor to the United States and China in the application of Artificial Intelligence in healthcare — but it must start by developing an innovative Digital Single Market”. Europe’s health data is as powerful as those of the major players, but the lack of a harmonised regulatory framework leads to a dissociation of data between the European Health Data Space, the Artificial Intelligence Act and the Medical Devices Regulation.

“If we manage to align the AIA, DGA and MDR, it will be a big win for our industry. We will be able to provide legal certainty and clarity. The opportunity to be pioneers in healthcare is there, we simply need to take steps towards a more efficient coordination and harmonisation amongst national systems”, she continued.

She concluded by pointing out the key challenges of the healthcare sector, such as the need to have a model for sharing protected health information and providing healthcare professionals with relevant input or to make sure that we use the potential of data of the European Health Data Space to reduce inequalities.

📸 Press kit: https://www.dropbox.com/scl/fo/ngnso1tqz7yh0z127ilt2/h?dl=0&rlkey=pz2bx2cxe3zslt7t2aidczmco