Overcoming ethical and legal obstacles to data linkage in health research
In recent years, using, re-using, linking, sharing, and analysing health and genomic data has occurred on an unprecedented scale, and is expected to only keep expanding. Researchers can maximise the use of existing data collections effectively by using data linkage techniques. But, optimising the use of data poses challenges on ethical and legal levels, and raises questions and concerns regarding privacy and data protection.
A new qualitative study conducted by researchers at the Julius Centre for Health Sciences and Primary Care at the University Medical Centre Utrecht in the Netherlands, suggests that a large part of the ethical and legal obstacles as perceived by various stakeholders could be overcome by providing a more thorough understanding of the existing laws and making better use of the flexibilities within it. The focus needs to move away from trying to adapt the current laws and regulations, or even designing new laws, towards considering how best to work with what already exists.
Through interviewing a variety of stakeholders, who have practical experience of linking different datasets, the team were able to pinpoint experienced obstacles and explore solutions. Researchers are currently manoeuvring a complicated legal landscape which hinders progress in health research. It appears that there is a lack of interoperability between policies and processes in various countries and institutions. According to the stakeholders, researchers are frequently hindered by ambiguity regarding the ‘correct’ interpretation of the law, fragmentation of policies governing the processing of personal health data, and the demandingness of legal requirements.
However, the authors argue that perhaps the true problem lies not such much in the design of the current laws governing data linkage, as in the failure to understand and make proper use of flexibilities within those laws.
Julie-Anne Smit who led the study summarized that “If we solely focus on the fragmentation and confusion that the laws bring, the advantages are being overlooked. The fast-evolving field of data intensive health research requires a certain degree of flexibility for the law to be congruent with the continuous changes and advancements in the field. It is time to shift our focus from enforcing new laws, into making proper use of the existing legislation. In order to do this, we should start by clarifying the current laws governing data linkage by issuing authoritative interpretations and strengthen ethical-legal oversight bodies.”
Julie-Anne Smit (LLM), Department of Bioethics and Health Humanities, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht
Smit, J.-A., van der Graaf , R., Mostert , M., Vaartjes , I., Zuidgeest , M., Grobbee, D. and van Delden, J. (2023) “Overcoming ethical and legal obstacles to data linkage in health research: stakeholder perspectives”, International Journal of Population Data Science, 8(1). doi: 10.23889/ijpds.v8i1.2151.