The Guild sets recommendations to improve access to health data for research purposes

The Guild voices its concerns regarding the existing regulatory frameworks on health data which are putting medical research in Europe under a threat. Access to a large volume and diverse range of data is crucial for the improvement of diagnostic techniques and treatments, and for preventive and health strategies.

We need to enhance collaborative medical research across borders to ensure scientists can develop new vaccines, medicines and treatments effectively and speedily, for the welfare of all citizens. However, at present the General Data Protection Regulation (GDPR) and the interpretation of some of its provisions impose limitations on the sharing and reuse of health data for research purposes.

The Guild fully acknowledges the crucial importance of protecting the privacy and sensitive personal data of citizens. However, the uncertainties around the extent to which the exemptions for research in the GDPR apply to health data, and the different interpretations of the GDPR rules in the Member States, have caused researchers to avoid sharing and reusing health data for research purposes to ensure compliance with the GDPR rules. This poses major challenges for conducting collaborative data-intensive medical research projects, including critical clinical studies.

Last month, the European Commission launched an open public consultation on its proposal for a regulation on the European Health Data Space (EHDS), a common data space which is planned to be operational by the end of 2021. The Guild endorses the specific objective of the EHDS to facilitate health data sharing and reuse for research purposes.

To address the obstacles data-intensive medical research is facing, The Guild calls on the Commission to pay attention to the following points when shaping the EHDS:

  • Clarify GDPR provisions, especially those introducing exemptions for the use and processing of personal data for the purpose of (medical) research.
  • Ensure that the degree of data protection required is commensurate with the actual sensitivity of the data.
  • Revise the rules relative to patients’ consent to data processing and transfer.
  • Consider data federation aspects allowing for federation to different levels: national nodes, individual institutes, and individual citizens.
  • Support the development of privacy enhancing technologies.
  • Develop an approach based on risk-benefit/value assessment.
  • Increase citizens’ trust by raising their awareness of the potential benefits of data sharing and being transparent on the reuse of health data.

The Guild is committed to continuing to work with the Commission in the implementation of the EHDS.

Jan Palmowski, Secretary-General of The Guild, said: “For European medical research to remain internationally competitive, we need to be able to share data from medical research. It is critical that the European Commission develops a balanced approach that enables this sharing to proceed, for the benefit of European citizens.”

Read The Guild position paper “Proposals for the European Health Data Space”.