This study 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 thesis questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the thesis 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 whether and how European data protection and competition law promote health data-driven innovation objectives; iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the thesis 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 Commission’s 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. After having defined the features of emerging digital health research courses, the first chapter assesses the relevance of health data pooling practices as a means of concentrating high-technology resources and stirring innovation in the life sciences sector. In these regards, the practice of health data pools is regarded as an evolution of patent pools in the digital economy. The second chapter highlights the complex values and interests related to health data. The varied phenomenon of health data pools is proved by some case studies. The third chapter contextualises the practice of health data pools within the EU Digital Single Market Strategy. At European Union level digital health and the free flow of information are indeed identified as strategic areas in respect to the set goal of maximising the innovation potential of the digital internal market. The fourth chapter enquires the role of European Data Protection law in respect to the identified efficiency-oriented policy goal regarding health data sharing. The regulation of health data treatment under the GDPR enables health data pools under arts. 9(2) lett. j and 89 GDPR, setting a research exemption and establishing a special data protection regime for the processing of health data for research purposes. In this perspective, it is argued that the research exemption is a rule for the data economy, as the right to data portability, stimulating data mobility among platforms and thus directly serving innovation purposes. The fifth chapter demonstrates, that, similarly to the one under the GDPR, also European competition law entails a research exemption in the form of and outright block exemption for research and development agreements, also pursuing objectives of economic and technical progress resulting from the sharing of research precious information. The analysis shows how both European data protection and competition law establish specific access regimes regarding research valuable health data, thus enabling the contractual trading of such data. Against this backdrop, the last chapter thus explores data protection safeguards and competition remedies, which are relevant respectively for the ex ante and ex post design of health data pools.
Health Research as a Digital Business: Health Data Pools under European Data Protection and Competition Law
SCHNEIDER, GIULIA
2020
Abstract
This study 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 thesis questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the thesis 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 whether and how European data protection and competition law promote health data-driven innovation objectives; iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the thesis 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 Commission’s 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. After having defined the features of emerging digital health research courses, the first chapter assesses the relevance of health data pooling practices as a means of concentrating high-technology resources and stirring innovation in the life sciences sector. In these regards, the practice of health data pools is regarded as an evolution of patent pools in the digital economy. The second chapter highlights the complex values and interests related to health data. The varied phenomenon of health data pools is proved by some case studies. The third chapter contextualises the practice of health data pools within the EU Digital Single Market Strategy. At European Union level digital health and the free flow of information are indeed identified as strategic areas in respect to the set goal of maximising the innovation potential of the digital internal market. The fourth chapter enquires the role of European Data Protection law in respect to the identified efficiency-oriented policy goal regarding health data sharing. The regulation of health data treatment under the GDPR enables health data pools under arts. 9(2) lett. j and 89 GDPR, setting a research exemption and establishing a special data protection regime for the processing of health data for research purposes. In this perspective, it is argued that the research exemption is a rule for the data economy, as the right to data portability, stimulating data mobility among platforms and thus directly serving innovation purposes. The fifth chapter demonstrates, that, similarly to the one under the GDPR, also European competition law entails a research exemption in the form of and outright block exemption for research and development agreements, also pursuing objectives of economic and technical progress resulting from the sharing of research precious information. The analysis shows how both European data protection and competition law establish specific access regimes regarding research valuable health data, thus enabling the contractual trading of such data. Against this backdrop, the last chapter thus explores data protection safeguards and competition remedies, which are relevant respectively for the ex ante and ex post design of health data pools.File | Dimensione | Formato | |
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Descrizione: Health Research as a Digital Business: Health Data Pools under European Law
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