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European CNILs take a view on the European Health Data Area and strengthen their cooperation on strategic cases

European CNILs take a view on the European Health Data Area and strengthen their cooperation on strategic cases

Shared opinion on the European Health Data Area

The European Data Protection Council, together with the European Data Protection Supervisor, has adopted an opinion on the European Commission’s proposal on regulating the creation of a European Health Data Area (European health data space where EHDS in English).

In this view, they drew the attention of the participating legislators to a number of key concerns related to this project, and called on the participating legislators to:

  • to talk about Localization of health data on the territory of the European Union They fall within the scope of the proposal in particular because of their sensitivity and the size they represent (500 million European citizens).
  • Clarify the interactions between this proposal and the GDPR In order to ensure a coherent application of the two texts in particular with regard to the rights of the persons concerned;
  • hold the The exclusive competence of the data protection authorities to handle any matter relating to the protection of personal data ;
  • Strictly limit the exceptions to the rights of data subjects guaranteed by the GDPR;
  • Exclude data collected by wellness apps and other digital apps from the scope of the proposal;
  • Respect the principle of minimization by limiting access to health data to the stringent needs of health professionals involved in primary uses of health data;
  • better define the objectives pursued in the context of secondary uses of health data, in particular by demonstrating an adequate link to social protection and public health issues;
  • Define a coherent relationship between the tasks of the new EHDS Committee and the tasks of the “shared responsibility groups”, whose names are, moreover, confusing.
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Procedure for identifying cross-border cases of strategic importance

During the plenary session, the EDPS adopted an indicative list of criteria for identifying cross-border strategic situations for which compliance actions should be prioritized. It has also selected the first three pilot strategic cases in which the cooperation of data protection authorities will be enhanced.

This work is a continuation of Declaration on European Cooperation The European Union authorities have reiterated their commitment to it Closer and more team collaboration across borders, particularly with the goal of faster and more structured action against major digital players.

To be identified as a strategy, cases must meet one or more of the criteria below:

  • The case was related to a structural or recurring problem in many Member States, particularly if it raises a general legal question regarding the interpretation, application or implementation of the GDPR;
  • The issue in question lies at the intersection of data protection and other areas of law;
  • A large number of people are affected in many Member States;
  • Numerous complaints were received in several member states;
  • The case raises a fundamental question regarding the EDPS strategy;
  • The situation may lead to a high risk under the GDPR, particularly if:
    • sensitive data is processed;
    • Vulnerable people, such as minors, are concerned;
    • A Data Protection Impact Assessment (DPIA) is required for the respective processing.

In practice, a data protection authority, such as the CNIL, may submit a case that meets one of these criteria to its EDPS counterparts, who will then decide whether the case in question can be considered a strategy.

The second document defines the selection procedure, which consists of two distinct phases:

  • The stage of rapid selection of experimental cases before the summer period with the aim of quickly experimenting with cooperation procedures;
  • A second phase, more structural and iterative, for the annual selection of strategic cases, which will begin in the summer of 2022.
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