1st Edition

The European Health Data Space Examining A New Era in Data Protection

    366 Pages
    by Routledge

    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


    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.