1st Edition
The European Health Data Space Examining A New Era in Data Protection
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. Including contributions from some of the leading scholars in this area, this ground-breaking book will be key reading for students and researchers across Law and Public Health.
Part I
Chapter One Introduction: Transformation of electronic health data governance through the EHDS
Santa Slokenberga, Katharina Ó Cathaoir, Mahsa Shabani
Chapter Two The EHDS and Electronic Health Records: GDPR+ or transforming patients’ rights?
Katharina Ó Cathaoir
Chapter Three 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
Andelka M. Phillips
Chapter Four European Health Data Space: A breakthrough in user control over health data in wellness apps?
Petra Müllerová
Part II: Secondary Use: Legal basis, confidentiality and commercial uses
Chapter Five Transforming the secondary use of patient data in the European Health Data Space: A challenge for the patient’s right to medical confidentiality?
Daniela Spajić
Chapter Six Striking the Balance: Genomic Data, Consent and Altruism in the European Health Data Space
Eila El Asry, Juli Mansnérus, Sandra Liede
Chapter Seven Fair enough? Exploring the role of fairness in secondary uses of health data in the European Health Data Space
Patricia Cervera de la Cruz and Mahsa Shabani
Chapter Eight The European Health Data Space: A New Paradigm for Secondary Uses of Health Data for Scientific Research?
Enrique Santamaría Echeverría
Part III Adequate safeguards and Data Governance through Health Data Access Bodies
Chapter Nine Secondary use of health data in the EHDS: public interest and the role of HDABs
Tjasa Petročnik
Chapter Ten Administrative tools for balancing societal and individual interests – data protection safeguards and administrative procedural guarantees in secondary use in the European Health Data Space
Jane Reichel
Chapter Eleven Federated networks and secondary uses of health data – challenges in ensuring appropriate safeguards for sharing health data under the GDPR and EHDS
Magdalena Kogut-Czarkowska and Mahsa Shabani
Chapter Twelve EHDS: Transforming the role of technological platforms for health data analysis
Hrefna D Gunnarsdóttir
Chapter Thirteen Conclusion: tracing key transformations in light of the primary and secondary use
Mahsa Shabani, Santa Slokenberga and Katharina Ó Cathaoir
Biography
Santa Slokenberga is an associate professor in medical law and a senior lecturer in administrative law at the Faculty of Law, Uppsala University, Sweden.
Katharina Ó Cathaoir is an Associate Professor of Law at the Faculty of Law, University of Copenhagen and a Pro Futura Scientia Fellow at the Swedish Collegium for Advanced Studies, Sweden.
Mahsa Shabani is an associate professor in health privacy law and innovation at the University of Amsterdam.
