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Session 4 | Digital health strategies, governance, and implementation of European Health Data Space: Challenges and opportunities

The European Commission proposal for a European Health Data Space is an ambitious one. Implementing its provisions is thought by many people to be a considerable challenge. This is particularly so for national and regional digital health infrastructure(s) and their approaches to governance. Countries are likely to have to require complex adaptations, strategies, and new legal frameworks. Other critical voices consider another challenge to be that the space is being built on an old-fashioned approach to digital health. As a result, it potentially misses out on some ground-breaking opportunities.

This session offered the opportunity to hear the voices of several  organisations and people engaged in the implementation of national and regional digital health strategies. Speakers came from three health ministries and agencies around Europe. Discussions covered several of the challenges and opportunities that underpin the data space proposal.

The first speaker, Isabelle Zablit Schmitz, Ministry of Health and Solidarity, France, outlined how the country has so far been tackling the approach towards the European Health Data Space. France has been on a “long journey”, one in which it is nevertheless important to take “small steps”. As one of the first European countries to start exploring the use of such a data space, France used its presidency of the European Union, in the first half of 2022, as an opportunity to drive the data space initiative forward. France anticipates playing a similar lead role, regarding the space, in the future. The country’s national roadmap is currently “preparing the floor” for the space, just as its investment in the Resilience and Recovery Facility (plan) is “building the bricks” for interoperability. The country considers it to be important to “get the support of the entire ecosystem”. Hence, in 2022 France has organised a series of webinars to inform people of future directions with the space. Planning is currently underway for a timeline of activities that will last up to around 2028.

Cátia Sousa Pinto, Shared Services for Ministry of Health (SPMS), Portugal, described what is happening in Portugal. As part of its digital health strategy, the country is implementing a universal health record. Portugal is leading the X-eHealth project, on the exchange of electronic health records, that is working on the foundations for electronic health record interoperability. The country has been helped by its collaboration at an international level. It is reaching its goal of having a strong use of secondary data by first having a good use of primary health data. The country’s data strategy entails ultimately the development of a data lake for research. Overall, Portugal wants to have a “next generation” national health service. It wants its “native data” to be responsive to its people’s needs; to service its multi-disciplinary professional teams; to engage with/offer AI services; and to be based on “business intelligence”.


Last, but certainly not least, Michael Peolsson, Swedish eHealth Agency (eHälsomyndigheten), Sweden, reported on Sweden’s perspective on the opportunities offered and challenges posed by the European Health Data Space. Sweden has been a leader in various parts of the Towards the European Health Data Space (TEHDAS) project, at the same time as the country has been preparing nationally for the data space. Sweden currently faces several challenges in this regard. One involves creating a nationally coherent infrastructure for health data. (A Swedish authority will be chosen to be responsible partly for setting up a national node for both primary and secondary use of health data, and partly for describing how all the country's health data sources can work together.) Other challenges include the legal perspective and interoperability. Sweden has recently been involved in mapping the Swedish health data landscape, through which it has uncovered 27 useful data-related organisations. In 2023, Mr. Peolsson recommended looking out for the 12 country reports (including one from Sweden) that the TEHDAS project will soon publish.


This session was chaired by Eugeni Fernandez Gonzalez of TICSalutSocial in Catalunya, Spain. It was offered to the Symposium by the health and care cluster of the OPEN DEI project. It was also supported by EHTEL’s Imagining 2029 programme.

🗣️ Discussion: Discussion was kicked off by Enrique Bernal-Delgado, Institute for Health Sciences, in Aragon, Spain. He emphasised the importance of seeing the relationship(s) that exist between the primary use of data and the secondary use of data, as in the bridge between MyHealth@EU and HealthData@EU. He also outlined the need to understand the content of such roles as the “data owner”, “data user”, “data provider”, and “data access bodies”. Wider discussion focused on the need for mobilisation of activities on/around the European Health Data Space, even if some clarification is still needed with regard to e.g., accreditation/certification; and the synchronisation of national roadmaps with an overall European roadmap. Other aspects of the space e.g., telemedicine are likely to be dropped before the eventual regulation is formalised. Overall, the building and development of trust was a core item throughout the discussion –  an issue to be explored further in later parts of the Symposium.

Useful publications on the European Health Data Space were cited by an EIT Health representative on:

  • Real-world challenges and enablers to the creation of the European Health Data Space”: This is a report that contains four specific use cases that may help to address ongoing challenges such as roles and relationships; rules and regulations; and policies and practices.
  • A Statement (dated 5 May 2022) on the European Health Data Space proposal related to three items: the Space’s governance framework and involvement of stakeholders; data interoperability requirements; and the interplay among several other areas of proposed and actual legislation as well as the Space’s proposal itself.


✅ ePoll: Attendees offered their views on what they see as being the main opportunities offered by the European Health Data Space for their organisation.

Some 39 responses were received. Four main opportunities were outlined. The data space was largely perceived as:

  • A political driver.
  • An opportunity for implementation.
  • Achievement of a “cross-border view of healthcare”.
  • Possibilities of domains for data re-use and training of AI use.


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