The purpose of our research project is to examine the legal issues that arise in relation to the collection and processing of Big Health Data, with an emphasis on Big Genetic Data. Big Health Data are large-scale data collections that are subject to automated processing to find trends, patterns, and health status. The processing of health metadata brings new challenges to data protection law. Specifically, it will be examined whether big health data can actually be classified as “personal data”, which obligations are imposed to those who process them, and whether the processing of health data undermines the fundamental rights of data subjects, as guaranteed by data protection law. In the face of this challenge, scientific research aims to provide structured and prioritized answers, on the basis of the GDPR (Regulation 2016/679) as well as national EU Member States law.