Wednesday 25 May 2022
La Cave
Standing Committee of European Doctors (CPME) (BE)

Panel Description

The European Commission is expected to adopt a proposal for a Regulation on the European Health Data Space (EHDS) in the first quarter of 2022. Personal data collected from primary care via the electronic health records could be linked to the EHDS system in order to be used for health research purposes and policy-making. This repurposing activity will be based on the data subject’s consent but might also be based on another legal basis, such as the performance of a task carried out in the public interest or a specific Union law considering the further processing as compatible and lawful. When consent is not the legal basis, and data are identifiable, the EHDS should foresee greater involvement of ethics committees. The same reasoning should exist for the establishment of databases concerning health used for research and policy-making. This panel will take a deep dive on what specific countries are doing in this area and discuss possible recommendations on how, where and when in the procedure ethic committees could be involved in the EHDS (e.g. one-stop-shop).

• How can the EHDS support the use of clinical data and public health data for health research and policy decision-making while protecting patients’ privacy? What does the EHDS proposal foresee?
• How can the ethical principles for digital health developed by the French Presidency provide protection in the context of the EHDS? What is being done at national level and what is the interplay with data protection authorities?
• What role should ethics committees play today in relation to personal data concerning health? Should their role to change in relation to the EHDS? Should they have enforcement powers?
• Why does it matter to consider the Declarations of Taipei and Helsinki of the World Medical Association for the EHDS?


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