This timely volume provides a comprehensive examination of how the proposed new European Health Data Space (EHDS) legislation will impact upon health and genetic data, individual privacy and providers of health services.
With the current legal framework recognised as insufficient in protecting data-related rights, the book spotlights the opportunities and challenges posed by the EHDS in balancing the interests of individuals with policymakers and researchers. It considers the impact on individual EU member states while highlighting issues such as changes to patients rights, wearable technology, developments in e-health and the secondary use of medical data. Critically, it also examines how the EHDS will operate within existing legal frameworks, including the General Data Protection Regulation, the Data Governance Act and the Data Act.
Including contributions from some of the leading scholars in this area, this groundbreaking book will be key reading for students and researchers across law and public health.
Chapters 2, 10 and 11 have been made available under a Creative Commons Attribution-NonCommercial-NoDerivatives (CC-BY-NC-ND) 4.0 license. Chapter 5 has been made available under a Creative Commons Attribution (CC-BY) 4.0 license.
Part I. 1.Introduction: Transformation of electronic health data
governance through the EHDS. 2.The EHDS and Electronic Health Records: GDPR+
or transforming patients rights? 3.The right to insert and add information
to my health record does my doctor need to know this? A critical discussion
of the right to insert information in an EHR using the example of data from
direct-to-consumer genetic testing. 4.European Health Data Space: A
breakthrough in user control over health data in wellness apps?Part
II.Secondary Use: Legal basis, confidentiality and commercial uses.
5.Transforming the secondary use of patient data in the European Health Data
Space: A challenge for the patients right to medical
confidentiality?6.Striking the Balance: Genomic Data, Consent and Altruism in
the European Health Data Space. 7.Fair enough? Exploring the role of fairness
in secondary uses of health data in the European Health Data Space. 8.The
European Health Data Space: A New Paradigm for Secondary Uses of Health Data
for Scientific Research? Part III.Adequate safeguards and Data Governance
through Health Data Access Bodies. 9.Secondary use of health data in the
EHDS: public interest and the role of HDABs. 10.Administrative tools for
balancing societal and individual interests data protection safeguards and
administrative procedural guarantees in secondary use in the European Health
Data Space. 11.Federated networks and secondary uses of health data
challenges in ensuring appropriate safeguards for sharing health data under
the GDPR and EHDS. 12.EHDS: Transforming the role of technological platforms
for health data analysis. 13.Conclusion: tracing key transformations in light
of the primary and secondary use.
Santa Slokenberga is Associate Professor in medical law and Senior Lecturer in administrative law at the Faculty of Law, Uppsala University, Sweden.
Katharina Ó Cathaoir is Associate Professor of Law at the Faculty of Law, University of Copenhagen, and Pro Futura Scientia Fellow at the Swedish Collegium for Advanced Studies, Sweden.
Mahsa Shabani is Associate Professor in health privacy law and innovation at the University of Amsterdam.
