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Data protection in the blood sector: challenges for European blood establishments

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09 March 2021
Strasbourg, France

A live, interactive webinar held on 17 February 2021 addressed the challenges that data protection presents for blood establishments (BEs), as a follow-up to the European Directorate for the Quality of Medicines & HealthCare (EDQM) Blood Quality Management (B-QM) conference “Keeping up with Reality and Quality: A Challenge for European Blood Establishments” (27-29 October 2020). Participants were provided with a forum to discuss data protection requirements in the blood sector, highlight challenges, and reflect on practical approaches and ways forward for implementing data protection measures in BEs.

Blood systems have been facing an increasing number of challenges in the rapidly evolving environment of recent years. They are now managing greater amounts of data, including sensitive health and personal data on blood donors, and data related to activities, traceability and quality management, which necessitates the use of secure computerised systems.

In Europe, the rapid expansion of information technology in recent decades, together with the increasing amount of data available, has made the establishment of new legal instruments for personal data protection necessary, prompting the modernisation in 2018 of the Council of Europe Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (Convention 108+) and the European Union (EU) General Data Protection Regulation 2016/679 (GDPR). These instruments include requirements on data minimisation, purpose limitation, data confidentiality and integrity, and the right to erasure (“right to be forgotten”). BEs are expected to comply not only with the data protection principles enshrined in the above instruments, but also with EU blood legislation, the Council of Europe Guide to the preparation, use and quality assurance of blood components (Blood Guide) and Good Practice Guidelines.

During the webinar, discussions focused on how EU and Council of Europe regulatory and technical requirements for quality management systems in the blood sector can be a solid and useful foundation for BEs in developing and implementing data protection measures. It was also concluded that while BEs are increasingly aware of data protection issues and the ensuing responsibilities, and are progressively integrating the matter in their routine processes and activities, defining clear arrangements for data processing and control in order to meet their broader responsibilities remains a significant objective.

The presentations and the recording of the webinar are available online. A summary of the webinar, including discussion points and ensuing recommendations will be published in 2021 as part of the B-QM conference proceedings and will serve as input for the future revision of EU blood, tissue and cell legislation, and to support BEs in achieving more compliant, resilient and sustainable systems.

Learn more about the activities of the EDQM in the field of blood transfusion in the conference e-brochure: 10 years of co-operation between the European Commission and the EDQM in the field of blood.

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