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

This book explores the emerging economic reality of health data pools from the perspective of European Union policy and law. It questions under which conditions health data sharing is lawful under European data protection and competition law, addressing the innovation paradigm, European policy level, and the limits posed by the two frameworks. The underlying assumption is that both branches of European Union law are key regulatory tools for creating a common European health data space.

Format: Paperback / softback
Length: 379 pages
Publication date: 16 April 2023
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 proceeds to examine 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 foster health data-driven innovation objectives, 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 the 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 underscores the existence of research-enabling regimes concerning health data, contingent upon the fulfillment of specific normative conditions.

Furthermore, this analysis takes a broader perspective, recognizing that both regulatory frameworks establish external boundaries on the freedom to share (or not share) valuable research data. This exploration sheds light on the complex dynamics between the pursuit of scientific advancements and the protection of individual rights, as well as the balance between promoting innovation and ensuring fair competition within the healthcare sector.

In conclusion, this book offers a comprehensive examination of the emerging economic reality of health data pools, providing valuable insights into the interplay between European Union policy and law. By exploring the legal frameworks governing health data sharing, it sheds light on the potential benefits and challenges associated with this practice, ultimately contributing to the development of a robust and inclusive data ecosystem in Europe.

Weight: 599g
Dimension: 235 x 155 (mm)
ISBN-13: 9783030954291
Edition number: 1st ed. 2022