EESC publishes an opinion on the European Health Data Space

On 12 September 2022, the European Economic and Social Committee (EESC) published its draft opinion on the European Health Data Space (EHDS)

While welcoming the Commission's Communication on the European Health Data Space and acknowledging the potential of safe and secure exchange of health data for improving the quality of health services, the EESC opinion points to a number of issues that should be taken into consideration by legislators.
The document, echoing what was expressed by the European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) in a Joint opinion published in July, puts particular emphasis on the need for more clarity on the use of secondary data and the interoperability between the differences of implementation of the EU’s General Data Protection Regulation in Member States.

An additional input on the dossier was provided earlier this month by the European Cancer Organisation (ECO), which published an action report - :The European Health Data Space and Cancer: Applying Lessons Learnt for Successful Implementation – addressing key priorities on the file.
With this regard, it is very likely that the upcoming discussions in LIBE and ENVI will substantially focus on this as well as on other aspects stressed by the bodies.

Key highlights

  • The rapporteur for the EESC’s opinion is Gonçalo Lobo Xavier.
  • The EESC, while acknowledging the potential of the EHDS for increasing citizens’ quality of life, by e.g., boosting the development of new medicines, urges the Commission to carefully consider the benefits and drawbacks of the initiative before proceeding, most notably when it comes to the differences among Member States' health systems.
  • The opinion draws attention to the fact that over half of Member States do not have legislation on re-using electronic health data, and rely on the general provisions of the GDPR, often using consent for processing health data. Not all Member States have a competent body for health data access, but where such a body exists, requests to use it for research or policy-making projects are rapidly increasing.
  • In order to boost citizens’ trust in the initiative, the EESC stresses the need to clarify the use of primary and secondary data, what body will control and validate the data, and what sanctions are in place in case of non-compliance. To this end, the EESC highlights the potential role of civil society organisations and social partners as well as general practitioners and treating physicians in conveying these messages. For this reason, the EESC recommends that these entities and professionals should be particularly involved in the communication strategy surrounding the launch of the EHDS.
  • The EESC calls on the Commission to consistently invest in cybersecurity systems and stresses the need to involve citizens and stakeholders in the continuous investment in national health systems.
Next steps
  • Only one amendment has been submitted, removing EESC’s recommendation to review the absolute prohibition on the use of secondary data by insurers.The opinion was adopted with no vote against it.
  • A debate with Margaritis Schinas (VicePresident of the European Commission in charge of Promoting our European Way of Life) linked with the adoption of the opinion has been held during the last EESC’s plenary session on Thursday, 22 September. EESC’s opinion INT/990reflects the needs identified by the Commission, especially regarding the crucial link between the success of the scheme and public trust. Ensuring strong organizational and technical safeguards as well as cybersecurity guarantees will be pivotal in this sense.
  • As the EHDS proposal moves forward also in the European Parliament, we have heard from insiders that:
    • The EPP rapporteur on the EHDS from the ENVI committee is likely to be Tomislav Sokol (Croatia).
    • The S&D shadow rapporteur on the EHDS, from the ENVI committee, is highly likely to be Sara Cerdas (Portugal).
    • Please note that the fact these names have been put forward does not mean they will receive the file, as there is wide interest on this topic, but indicates a high level of interest which is very useful for our upcoming outreach activities.


Date: 27/09/2022 | Tag: | News: 1364 of 1634
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