Data sharing restrictions are hampering precision health in the European Union

Abstract

Contemporary healthcare is undergoing a transition, shifting from a population-based approach to personalized medicine on an individual level¹. In October 2023, the European Partnership for Personalized Medicine was officially launched² to communicate the benefits of this approach to citizens and healthcare systems in member countries. The main debate revolves around the inconsistency in regulatory changes within personal data access and its potential commercialization. Moreover, the lack of unified consensus within European Union (EU) countries is leading to problems with data sharing to progress personalized medicine. Here we discuss the integration of biological data with personal information on a European scale for the advancement of personalized medicine, raising legal considerations of data protection under the EU General Data Protection Regulation (GDPR)³.

Personalized medicine is a data-driven approach, for which ‘big data’ and its accessibility are of key importance. Big data can be based on epidemiological information and increasingly on ‘-omics’ data⁴, particularly genomics, transcriptomics, proteomics and metabolomics. Integrating ‘-omics’ profiles with clinical data makes it possible to study an individual’s molecular makeup. However, compliance with the GDPR, along with varying country-specific interpretations, presents obstacles to the deposition of health-related ‘-omics’ data. Additionally, most such data repositories operate beyond EU borders, in the USA, the UK and Japan. There is a pressing need for a GDPR-approved data repository within EU borders to streamline ‘-omics’-driven personalized medicine.