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With the support of TEHDAS and SITRA

Want to dive in more depth into the European Data Space Regulation announced on 3 May 2022?

European legislation is understandably detailed and covers many complexities. This Regulation is no different. Yet emerging materials and activities can all help Europeans navigate this detail at different levels.

The 95-page proposed Regulation document – with its further 20 pages of financial statements – is accompanied by plenty of other useful materials.

  • On the shorter side, these include a press release, a short factsheet, and an 11-question question-and-answer (“Q+A”) document.
  • On the longer side, they are composed of an 18-page Communication and a detailed impact assessment. For further information, the Regulation’s announcement was accompanied by outputs from several studies, undertaken in recent years, on the potential of the space itself, on artificial intelligence (AI), on infrastructure, and on the 2016 General Data Protection Regulation.


You can also take a look at what other European projects and activities have to say about the proposed Regulation.

Clearly, European are being encouraged to examine the proposition and its implications.

Since February 2021, the development of the space has been accompanied closely by activities and insights that have emerged or arisen from a number of initiatives.

xhealth logoAmong these are the Joint Action, Towards the European Health Data Space (known as TEHDAS), which works on the secondary use of data, and X-eHealthwhich focuses on the primary use of data. EHTEL is a collaboration partner in both initiatives.

Already, on 9 May 2022, six days after the publication of the draft Regulation, TEHDAS organised a debate on what the space has to offer. Several types of stakeholders gave their immediate views on its opportunities. In summary, TEHDAS stakeholders expressed broad support for the European health data space in harnessing the benefits of data. Yet, they also stated reservations relating to the implementation of the Regulation, and the means of ensuring the representativeness of the people/institutions who/that will sit on the European health data space board.

By mid-May 2022, TEHDAS had also come up with some suggestions for ensuring health data quality through a data quality assurance framework in relation to the space.

Similarly, by early June 2022, X-eHealth, a European coordination and support action, had explored the implications of the space for the creation of further standard templates (other than patient summaries and e-Prescriptions) for documents such as laboratory results, medical imaging, and hospital discharge reports that might help to underpin the work of the future space. While EHTEL is a collaborative partner in the initiative, a number of EHTEL members, such as the Czech Republic’s ministry of health; gematik (Germany); Nictiz (Netherlands); and Tic Salut Social (Catalonia, Spain) are actual partners in this project.

Other projects and initiatives are also examining different aspects of the Regulation. Purely as examples:


  • The IN-4-AHA coordination and support action focuses on innovation for active and healthy ageing. In a 9 June 2022 online stakeholder workshop, it examined how data regulations may impact on service provision in health and care. Among the topics covered relevant to the space: making data available on mobile devices; improving procedures in data management; standardising data sharing agreements; ensuring trust and FAIR data (Article 56), examining the role of “data intermediaries”; labelling data; and considering future roles of Reference Sites, hubs, and clusters. It also highly recommended to take a look at the 16 May 2022 European Council of the Data Governance Act. An easy-to-read European web-page on data governance will soon be available. Read EHTEL’s first views of 2021-2022 proposed legislation, including the data space Regulation.

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  • EFA (the European Federation of Allergy and Airways Diseases’ Patients Associations) is an example of an organisation with a keen interest in a specific field of conditions: in its case, allergies and airways diseases. A recent members’ event the association took an advanced look at what the data space will mean for people with respiratory conditions. Given the impact that COVID-19 has had for people with respiratory conditions on their use of digital equipment and data, the opportunities now offered by the Regulation on the European health data space for patients and health and care professionals are especially meaningful.


EHTEL itself is keen to explore the options offered by the space for health data governance. More on this topic in autumn 2022.


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