Health Data Pools under European Policy and Data Protection Law: Research as a New Efficiency Defence?

Abstract

The increasing employment of artificial intelligence and machine learning in the biomedical sector as well as the growing number of partnerships aimed at pooling together different types of digital health data, stress the importance of an effective regulation and governance of data sharing in the health and life sciences. This paper explores the emerging economic reality of health data pools from the perspective of European Union policy and law. The goal of the study is to validate the role of the internal market integration objective in the data protection framework of special categories of data, and thus to unveil the alignment of the General Data Protection Regulation’s research exemption with the broader policy goals of the Digital Single Market Strategy. After having described the phenomenon of health data pools as a primary means to conduct research in digital health markets, the study first contextualizes health data sharing practices at European policy level, with specific reference to the Digital Single Market Strategy. Here, both the digital health sector and the free-flow of information are emerging as strategic areas of European intervention. Against this backdrop, the second section will enquire the regulatory framework regarding the processing of special categories of data for research purposes under the General Data Protection Regulation. As will be demonstrated, this framework partly disavows fundamental rights protection objectives, in order to promote research based on health data and related market objectives.