European-wide big health data analytics under the GDPR

• Published in: Health Data Privacy under the GDPR pp. 56 - 70
• Main Authors: Dumortier, Jos, Piéchaud Boura, Mahault
• Format: Book Chapter
• Language: English
• Published: Routledge 2021
• Edition: 1
• Subjects: Big Data Analytics; European Union Legal Instruments; Data Protection Law; Member State Law; Archiving Purposes; Medical Research Involving Human Subjects; Health Data; CNIL; Collecting Health Data; Fundamental Research; Historical Research Purposes; Research Purposes; Data Subject; National Data Protection Law; Data Protection Rights; Chronic; Data Protection; Identifiable Data; Data Subject Rights; Personal Data Processing; Personal Data; Electronic Health Records; Dynamic Consent; GDPR; Scientific Research Purposes
• ISBN: 0367632608; 9780367632601; 0367077140; 9780367077143
• DOI: 10.4324/9780429022241-5

Under which rules and conditions can health data be brought together on a European-wide platform for the purpose of Big Data analytics? To investigate this question, national legal experts from 30 European countries were asked to draft a report on the status of the legal framework in their country. The reports, collected in the framework of the Horizon 2020 funded AEGLE project, describe the national rules and procedures applicable to the use of health data for research purposes before and after the entry into force of the GDPR. The main lesson learnt from this legal research is that the GDPR has not resulted in a harmonised regulatory framework for researchers who wish to perform research based on health data to be collected in multiple European countries. The study also shows that the complexity and fragmentation of the regulatory landscape is not in the first place a consequence of the GDPR having failed to reach its ambitions. Rules and procedures to be respected by researchers planning to use health data for research purposes are not exclusively imposed by data protection law but they are more often related to data ownership. In practice, researchers are requested to meet the conditions set by the health data owners, in the first place by healthcare institutions and private or public health data repositories. To overcome the complexity to which researchers are confronted, recent initiatives of the European Commission to promote the creation of European-wide repositories, for example of health images or digital pathology slides, must be welcomed. If successful, such initiatives can shift the burden of bringing health data from different countries together from the researcher to the repository owners. This chapter focuses on Big Data analytics for health research purposes. Under which rules and conditions can health data be brought together on a European-wide platform for the purpose of Big Data analytics? To investigate this question, national legal experts from 30 European countries were asked to draft a report on the status of the legal framework in their country. The reports, collected in the framework of the Horizon 2020 funded AEGLE project, describe the national rules and procedures applicable to the use of health data for research purposes before and after the entry into force of the General Data Protection Regulation (GDPR). The GDPR serves multiple objectives at the same time and the ultimately adopted version is, as usual for European Union legal instruments, the result of a political compromise. One of the key objectives of the GDPR is to foster innovation while strengthening the data protection rights of individuals.