EU documents on EHDS (and the regulation process)

The EU commission’s proposal of a regulation on the European Health Data Space (EHDS)

The first version of a comittee report on the draft EHDS regulation (1 March 2023), consisting of proposed amendments.
The parliament’s comittees involved are Civil Liberties, Justice and Home Affairs (LIBE) and Environment, Public Health and Food Safety (ENVI).
Major proposed changes include:

  • more stakeholder participation: representatives of health care stakeholders, including patient and health professional organisations, need to be included in the decision-making structures of the digital health authorities (primary use) and the health data access bodies (secondary use)
  • right to legal remedies: Remedies and even court proceedings should be possible against a digital health authority (primary use) or a health data access body (secondary use); right to judicial remedy on suspicion of violation of rights under the regulation in the processing of personal data.
  • right to opt out of secondary data use (no change request to allow opt out from primary use, which contradicts at the very least German legislation)
  • right of the data subjects to know who has used their data for primary as well as secondary use
  • requirement to store data in the EU (but: data exchange with international institutions and third countries may be possible if their organisational and technical infrastructure meets EU requirements (primary use) and their data are available to EU actors under the same conditions (secondary use))
  • the EHDS committee should consist not only of representatives of the digital health authorities and access points of member states, but also representatives of the European Data Protection Board, the European Data Protection Supervisor, the European Medicines Agency and the European Centre for Disease Prevention and Control, as well as representatives from health professional, patient and health industry organisations.
  • additional responsibilities of the EHDS Committee should include
    – supervising the digital health authorities (primary use)
    – ensuring the coherent provision of a secure processing environment and enforcing it in Member States (secondary use)
    – funding studies and initiatives for the development of the EHDS

Joint Opinion of the European Data Protection Board and the European Data Protection Supervisor on the Proposal for a regulation on the European Health Data Space

The EU parliament’s time schedule for processing the EHDS regulation proposal

European Commission: Study supporting the impact assessment of policy options for an EU initiative on a European health data space, Final Report

EU page with further information on the EHDS

Information on the European Health Data Space