This book explores the emerging economic reality of health data pools from the perspective of European Union policy and law. The contractual sharing of health data for research purposes is giving rise to a free movement of research data, which is strongly encouraged at European policy level within the Digital Single Market Strategy. However, it has also a strong impact on data subjects' fundamental right to data protection and smaller businesses and research entities ability to carry out research and compete in innovation markets. Accordingly the work questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the work addresses the following sub-questions: i) which is the emerging innovation paradigm in digital health research?; ii) how are health data pools addressed at European policy level?; iii) do European data protection and competition law promote health data-driven innovation objectives, and how?;iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the work is that both branches of European Union law are key regulatory tools for the creation of a common European health data space as envisaged in the Commissions 2020 European strategy for data. It thus demonstrates that both European data protection law, as defined under the General Data Protection Regulation, and European competition law and policy set research enabling regimes regarding health data, provided specific normative conditions are met. From a further perspective, both regulatory frameworks place external limits to the freedom to share (or not share) research valuable data.

Provides a comprehensive review of the rapidly expanding field of health data exchanges and health data pools Includes in-depth discussions on the regulatory challenges of the emerging European health data space Includes in-depth discussions on how research over health data is addressed under the GDPR

Autorentext

Giulia Schneider, PhD, is assistant professor in economic law at the Catholic University of the Sacred Heart in Milan. She holds a PhD in International Law & Economics from Bocconi University in Milan and has been postdoc researcher at the Lider Lab of at Sant Anna School of Advanced Studies in Pisa. Her research interests focus on the interesections between business law and technology. In this respect, she has been enquiring the regulation of digital markets from the perspective of European data protection, intellectual property law and competition law. More recently, she is questioning the reflexes of digital transformations onto businesses' organization and social responsibilities. She graduated in law from Sant AnnäSchool of Advanced Studies in Pisa. She has published several papers in peer-reviewed journals and presented her research findings in international conferences both in Europe and the USA. She has been visiting researcher at LSE (London), ENS (Paris) and ETH (Zürich) and visiting fellow at Max Planck Institute for Innovation and Competition in Munich. She is member of the editorial staff of the peer-reviewed open Access Journal Opinio Juris in comparatione- Studies in comparative and national law . She is an Italian qualified lawyer and lecturer at the Department of Economics of the University of Pisa, where she teaches Business & Commercial law, and at the Faculté de Droit of the Université Catholique de Lille, where she teaches Corporate Governance

Inhalt
Introduction: Object, Methodology and Structure of the Research.- Digital Health.- Research and Health Data Pools.- Health Data Pools: Case-Studies and Involved Interests.- Health Data Pools Under the Digital Single Market Strategy.- Health Data Pools Under European Data Protection Law.- Health Data Pools under European Competition Law.- Designing Health Data Pools: Data Protection Safeguards and Competition Remedies.- Research Results and Conclusions.