avis-advies 9758

Ambiguities in the interpretation of the GDPR in the context of human body material for medical purposes and scientific research: potential consequences of an (overly) defensive position and need for clear practical guidelines


The introduction of GDPR legislation has a major impact on the management and transfer of medical data, so also in the case of human organ and tissue donation. Yet the availability and safety of human body material crucially depends on the proper transfer of information. Limited or incomplete access to data affects the entire chain, from donor to recipient. Ultimately, this is liable to result in sub-optimal patient care and undermine scientific research and (para)medical training. 

This problem statement is based on practical experience. In this advisory report, the Superior Health Council assembles the issues surrounding the GDPR into a number of specific questions. The discussions show a need for clear practical guidelines for this specific application and, by extension, for the broader medical context.

Only available in Dutch or French.