JMIR Publications

ABSTRACT

Genomic research relies on molecular and phenotypic data, on comparing findings within large data sets, on searchable metadata, and on translating research results into a clinical setting. These methods inevitably demand the processing of personal data across borders. International data sharing between the European Union / European Economic Area and third countries has accordingly become a cornerstone of genomics. Alongside this, the EU’s General Data Protection Regulation sets out rules that privilege data processing for genomic research purposes. Nevertheless, once such research involves data transfers to third countries, the privileged position of science is called into question. Currently, proposed solutions do not address the needs of genomic research to gain access to large data sets across local and regional cohorts and to jointly process data with the involvement of actors of different regulatory regions. Additionally, these solutions fail to counter the challenges that led to those very rules as a response to concerns about fundamental rights protection. This has resulted in a lack of appropriate, context-sensitive regulation for international genomic research. Regulatory intervention is needed instead of leaving researchers alone to find “cycle space” for their international data transfers. We think that the creation of the European Research and European Health Data Spaces, which are both emerging federated EU-wide data infrastructures, provides the opportunity to rehabilitate the value of international collaboration in genomic science. Such a “rescue” intervention is imperative to prevent both the devaluation of the social good of science and the jeopardization of our ability to successfully confront emerging health challenges for our global community.