Current regulations do not support the sharing of health data with medical researchers outside the European Union (EU) and the European Economic Area (EEA). Researchers of the University of Tartu have helped the European academy networks to seek solutions to facilitate the transfer and mediation of health data in both regions.
A working group of the academy networks made an appeal to policy-makers to eliminate impediments to the sharing of data to ensure efficient collaboration with public-sector research institutions. The working group included three members from the University of Tartu: Vice Dean of the Faculty of Medicine Külli Kingo, Head of Clinical Research Centre Katrin Kaarna, and Professor of Bioinformatics, member of the Academy of Sciences, Jaak Vilo.
In the report International Sharing of Personal Health Data for Research that was published yesterday, the European Federation of Academies of Sciences and Humanities (ALLEA), the European Academies’ Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM) call EU politicians for cooperation to overcome the barriers in sharing pseudonymised health data with researchers outside the EU and the EEA, under article 46 of the General Data Protection Regulation (GDPR).
Members of the working group underline that collecting and combining of health data is fundamental for the advancement of medical research, and improving diagnosis and treatment of diseases. To promote research, it is often essential that pseudonymised personal data are urgently and immediately shared between research groups, while ensuring the protection of personal data. Exchange of health data directly benefits all European citizens as it enables to make better use of the existing resources.
Külli Kingo and Katrin Kaarna said that research done elsewhere in the world is also relevant for European patients. The challenges in data transfer arise from the statutory conflict between the EU and other countries’ legislation. As it is not possible to sign contracts governed by the GDPR outside the EU, there is currently no workable legal mechanism for sharing data for public-sector research.
According to Jaak Vilo, Professor of Bioinformatics at the University of Tartu, one the vital problems of health and genetic data analysis is the reproducibility of data for different countries, nationalities and healthcare systems. “The only way to receive adequate knowledge is to create opportunities for international collaboration in pooling and combining of data analyses,” Vilo explained. “Health data can involve privacy risks but, for example, data describing the virus and its mutations and, more generally, scientific data collected with the support of public funding should be internationally accessible to many researchers. To protect health data, it is possible to use cryptographic techniques or standardised cohort networks, which are used for distributed data analysis without aggregating the underlying data across countries,” said Vilo.
“It is necessary to advance and facilitate the free movement of data to enhance the benefit to individuals and society, thanks to participants in the research,” Kingo and Kaarna explained. A solution is urgently needed both for ongoing collaborations as well as for new research.
The report of the three networks of European academies of sciences focuses on how global sharing of data promotes research, describes the challenges caused by data protection regulations, and offers possible solutions to adapt and develop existing laws and regulations.
Key points in the report
• Health research is crucial for all: for the benefit of patients, population health, for the development of healthcare systems, and for social cohesion and stability.
• Sharing pseudonymised personal health data for public-sector research is essential to make effective use of limited resources.
• Data must be shared safely and efficiently, taking into account patient privacy concerns.
• Bottlenecks in the legislation hinder data sharing with researchers outside the EU and EEA, and remote access to data from other locations.
• European Commission must commit to finding a solution to overcome the barriers in sharing data. The preferred option is to find a simple, comprehensive and workable solution under article 46 of the GDPR, giving priority to the protection of the data of EU and EEA citizens.
The report was prepared by consultation with experts of different fields nominated by the member academies of ALLEA, EASAC and FEAM.
European academy networks
European Federation of Academies of Sciences and Humanities (ALLEA) represents more than 50 academies from over 40 EU and non-EU countries.
European Academies’ Science Advisory Council (EASAC) is formed by the national science academies of the EU Member States, Norway, Switzerland and UK, to collaborate in giving advice to European policy-makers.
European Federation of National Academies of Medicine and Medical Sections of Academies of Sciences (FEAM) is an umbrella organisation joining 23 national academies representing thousands of scientists in Europe.
Külli Kingo, Vice Dean of the Faculty of Medicine, University of Tartu, 731 9706, kylli.kingo [ät] ut.ee
Katrin Kaarna, Head of the Clinical Research Centre, Unifersity of Tartu, 737 4119, katrin.kaarna [ät] ut.ee
Jaak Vilo, Professor of Bioinformatics, University of Tartu, 737 5483, jaak.vilo [ät] ut.ee