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Therefore, CSC warmly welcomes the Commission’s proposal for a Regulation on the European Health Data Space (EHDS) and urges using its rules, common standards and practices, infrastructures and governance framework as a basis for the development of the other sector-specific data spaces in order to pave the way towards the ultimate goal of creating one unified European data space.

In summary, CSC recommends:

  1. Paying attention to advancing interoperability at all its levels (legal, organisational, semantic, technical) with particular emphasis on interoperability of metadata which is key for the findability of data from data users’ perspective;
  2. Allocating sufficient time and other resources to bringing all datasets in all data repositories in compliance with the interoperability requirements of the EHDS;
  3. Making use of existing projects, practices, policies and infrastructures related to cross-border use of health data;
  4. Setting the technical and organisational measures and security and interoperability requirements of processing environments (Art. 50) based on the existing practices, striking an appropriate balance between security and functionality;
  5. Creating a functional structure for stakeholder engagement, e.g. by further incentivising expert and stakeholder involvement in the European Health Data Space Board (Chapter VI), with particular emphasis on including the views of the research community;
  6. Assessing carefully the implications of the anonymisation and pseudonymisation requirements (Art. 44(3)) for research;
  7. Re-assessing the suggestion to issue data permits automatically in case a health data access body fails to provide a decision within the time limit set in the Regulation (Art. 46(3));
  8. Further specifying the obligation for data users to make public the results or output of the secondary use of electronic health data (Art. 46(11)) to ensure that publication behind a paywall will not be considered sufficient for reaching the intended level of openness;
  9. Creating a comprehensive and harmonized method for data subjects to practice data altruism (Art. 40), ideally a machine-readable Europe-wide consent form;
  10. Ensuring linkages of the EHDS with the other data spaces as well as the high-performance computing capacities and high-speed digital connections that the EU is currently developing.

You can read the statement in full here (pdf).