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

The book explores the emerging economic reality of health data pools from the perspective of European Union policy and law, addressing the legal conditions for the sharing of health data for research purposes under European data protection and competition law. It examines the innovation paradigm in digital health research, the European policy approach to health data pools, and the limits posed by these frameworks to the free pooling of health data. The underlying assumption is that both branches of European Union law are key regulatory tools for creating a common European health data space.

Format: Hardback
Length: 379 pages
Publication date: 15 April 2022
Publisher: Springer Nature Switzerland AG

This book delves into the evolving economic landscape of health data pools, examining them through the lens of European Union policy and law. The contractual exchange of health data for research purposes is fostering a seamless movement of research data, a key objective emphasized at the European policy level within the Digital Single Market Strategy. However, this phenomenon also exerts a significant influence on the fundamental rights of data subjects, as well as the capabilities of smaller businesses and research entities to engage in research and compete in innovation markets. Consequently, the book raises crucial questions regarding the conditions under which health data sharing is deemed lawful under European data protection and competition law. To address these objectives, the work explores the following sub-questions:

i) What is the emerging innovation paradigm in digital health research?
ii) How are health data pools addressed at the European policy level?
iii) Do European data protection and competition law promote the objectives of health data-driven innovation, and if so, how?
iv) What are the limitations imposed by the two frameworks on the free pooling of health data?

The central premise of this work is that both branches of European Union law play pivotal roles in shaping the development of a unified European health data space, as envisioned in the Commission's 2020 European strategy for data. By highlighting the interplay between European data protection law, as outlined in the General Data Protection Regulation, and European competition law and policy, the book demonstrates that these regulatory frameworks establish research-enabling regimes for health data, provided certain normative conditions are met. Furthermore, these frameworks impose external boundaries on the freedom to share (or not share) valuable research data.

Weight: 752g
Dimension: 235 x 155 (mm)
ISBN-13: 9783030954260
Edition number: 1st ed. 2022