EDPS issues comments on the proposed European Health Union package


On 18 March 2021, the European Data Protection Supervisor (“EDPS”) issued its formal comments on the package of the Commissions’ three legislative proposals for a European Health Union.

Among others, the EDPS recommended:

  • for the proposed regulation on the reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical device: to include the data protection role of the entities involved, a clear definition of the data generated outside the scope of clinical trials, as well as a clarification of the meaning of real world data – see the comments here;
  • for the proposal on establishing a European Center for Disease Prevention and Control: to be clearly demarcated the categories of individuals whose personal data will be processed, alongside a description of the specific measures to protect their rights and freedoms – see the comments here;
  • for the proposed regulation on serious cross-border threats to health: to provide further implementing or delegated acts that would lay down the roles of the actors involved in the processing of personal data via the use of IT tools and systems envisaged in the proposal – see the comments here.

The press release may be accessed here.