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Dissertation
Immaterialgüter- und Wettbewerbsrecht

Health as a Digital Business: Health Data Pools Under European Data Protection and Competition Law

The thesis enquires the regulatory framework for data sharing in digital health innovation markets. It identifies carrots and sticks for the creation of health data pools, set by Digital Single Market Policies and by normative access regimes under European data protection and competition law.

Last Update: 15.11.19

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.
The second chapter highlights the complex value and interests related to health data. The varied phenomenon of health data pools is proved by three cases, respectively involving health data sharing between Google DeepMind and Royal Free Hospital; IBM and Italy; Google and Sanofi.
The third section 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 appears to uphold such policy objective under the art. 9(2) lett. j GDPR, setting a research exemption and establishing a special data protection regime for the processing of health data for research purposes. In this perspective, the research exemption reveals itself as a rule for the data economy, as the right to data portability, stimulating data mobility among platforms and thus directly serving innovation purposes.
Likewise, health data pools find legal grounds for flourishing under the competition law regime regarding R&D agreements, similarly pursuing objectives of economic and technical progress resulting from the sharing of research precious information. The fifth chapter thus enquires the applicability of art. 101.3 TFUE and the related R&D Block Exemption to the case of health data pools.
In view of the market-oriented nature of the exceptions regarding the processing of health data for research purposes, the study explores data protection safeguards and competition remedies, which could be relevant respectively for the ex ante and ex post design of health data pools. The unrestricted flow of information could indeed create legal uncertainty negatively affecting both data subjects/consumers and the “merchants” of these sensitive data. In this perspective, the acknowledgment of the framework enabling the sharing of health data for research purposes, triggers the reflection over the regulatory tools needed to assure that health data sharing practices are compliant to patients’ fundamental rights to data protection and to non-commodification of research valuable health data as well as to research entities’ economic freedom and right to non-discrimination. These concerns have been upheld by Commissioner Vestager, stressing how the European Commission welcomes the pooling of data “as long as companies do it in a way that protects people’s privacy and doesn’t hurt competition”.

Persons

Doctoral Student

Giulia Schneider

Doctoral Supervisor

Prof. Federico Ghezzi

Main Areas of Research

II.3 Vernetzte Datenwirtschaft