EDPS releases comments on the proposed European Health Union package

The European Data Protection Supervisor (EDPS) has issued its formal comments on a package of three legislative proposals for a European Health Union. The EDPS welcomes a European unified approach to tackle cross-border health threats while respecting the role and competences of EU Member States’ national health systems. Regarding the proposal for a Regulation on a reinforced role for the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical device, the EDPS recommends that specific provisions on the application of data protection law are included in the proposal. Likewise, the role of the entities involved under data protection law should also be covered. As for the proposal on establishing a European Centre for Disease Prevention and Control (ECDC), the EDPS provides a series of recommendations, advising for instance that the categories of individuals who will have their personal data processed should be clearly demarcated alongside a description of the specific measures to protect the rights and freedoms of the individuals involved, in line with data protection legislation.