The Law and Ethics of Data Sharing in Health Sciences (Perspectives in Law, Business and Innovation)

Data sharing – broadly defined as the exchange of health-related data among multiple controllers and processors – has gained increased relevance in the health sciences over recent years as the need and demand for collaboration has increased. This includes data obtained through healthcare provisions, clinical trials, observational studies, public health surveillance programs, and other data collection methods. The practice of data sharing presents several notable challenges, however. Compliance with a complex and dynamic regulatory framework is essential, with the General Data Protection Regulation being a prominent example in a European context. Recent regulatory developments related to clinical trial transparency, trade secrecy, data access, AI training data, and health data spaces further contribute to the difficulties. Simultaneously, government initiatives often encourage scientists to embrace principles of “open data” and “open innovation.” The variety of regulations in this domain has the potential to impede widespread data sharing and hinder innovation. This edited volume, therefore, compiles comparative case studies authored by leading scholars from diverse disciplines and jurisdictions. The book aims to outline the legal complexities of data sharing. By examining real-world scenarios from diverse disciplines and a global perspective, it explores the normative, policy, and ethical dilemmas that surround data sharing in the health sciences today. Chapter Patient Perspectives on Data Sharing, Chapter Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data after Schrems II are available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. Preface Contents Editors and Contributors The Dynamic Context and Multiple Challenges of Data Sharing 1 Introduction 2 A Fast-Moving Regulatory Landscape 3 Book Structure and Chapters 4 Conclusion References The GA4GH Regulatory and Ethics Work Stream (REWS) at 10: An Interdisciplinary, Participative Approach to International Policy Development in Genomics 1 Introduction 2 Creation of the GA4GH’s Framework for Responsible Sharing of Genomic and Health-Related Data 3 GA4GH Policies, Standards, and Tools 4 Conclusion: GA4GH 10th Anniversary—A Shift Towards Maturity? Appendix 1 References Assessing Public and Private Rights of Action to Police Health Data Sharing 1 Introduction 2 Policing Medical Data Sharing Using Public Rights of Action 3 Policing Medical Data Sharing Using Private Rights of Action 4 Designing Regulation for Health Data Through Public and Private Enforcement 4.1 Public Versus Private Enforcement Under Public Law 4.2 Private Enforcement Under Private Law 4.3 Changing Public Laws to Cover More Health Data 5 Conclusion References Patient Perspectives on Data Sharing 1 Introduction 2 Patient Perspective on Data Sharing 2.1 Patient Motivations for Data Sharing 2.2 Patient Concerns About Data Sharing 2.3 Patient Views on Privacy, Trust, Distrust and Conditions for Sharing 2.4 Patient Views on Sharing of Data for Secondary Uses 2.5 Patient Views on Data Sharing for Artificial Intelligence or Machine Learning 3 The Patient Perspective in a Changing Context of Data Sharing 3.1 The Changing Context 3.2 The Fit of Patient Perspectives with the Changing Context of Data Sharing 4 Concluding Remarks and Future Perspectives References Operationalizing the Use of Existing Data in Support of Biomedical Research and Innovation: An Inclusive and Sustainable Approach 1 Introduction 2 The Problem of Under Utilization 3 European Data Strategy—the Legal Approach 4 Citizen Science and RRI 5 Discussion 6 Conclusion References Dobbs in a Technologized World: Implications for US Data Privacy 1 Introduction 2 PHI, ePHI, and Other Health Care Data 3 Financial Data 4 Tracking 5 Social Media 6 Conclusion References Consent and Retrospective Data Collection 1 Introduction 2 Retrospective and Prospective Data Collection 3 Legal Implications 4 Consent (Article 6(1)(a) GDPR) 5 Exemptions for Processing of Health Data in Research 6 Further Processing 7 An Ethical Perspective on Consent 7.1 Definition of Ethical Consent 7.2 Relationship Between GDPR-Based Consent and Ethical Consent 7.3 Looking at Specific Elements of Informed Consent from an Ethical Perspective 7.4 Practical Application 8 Conclusion References Enabling Secondary Use of Health Data for the Development of Medical Devices Based on Machine Learning 1 Introduction: Why the Development of ML-Based Medical Devices Needs Secondary Use of Health Data 2 Secondary Use of Health Data for ML Under the GDPR 2.1 The Concept of “Scientific Research” and Its Applicability to the Development of ML-Based Medical Devices 2.2 Compatibility of Initial Purpose and Purpose of Secondary Use 2.3 Why the Obligations of the GDPR on Secondary Use for ML Are Insufficient 3 Enabling Secondary Use for the Development of ML-Based Medical Devices: Conducive Approaches 3.1 Explicit Legal Bases for the Processing of Health Data for the Development of ML-Based Medical Devices 3.2 Infrastructure and Intermediary: Extension of the Concept for the Use of Research Data 3.3 Standards of Data Preparation 4 EHDS: A Way Forward? 4.1 Secondary Use of Health Data for the Development of ML-Based Medical Devices: An Overview of Legal Bases and Procedures 4.2 Enabling Secondary Use of Health Data for ML: Implications from the EHDS 4.3 Does the EHDS Introduce a New Perspective on Data (Sharing)? 5 Conclusion References Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data After Schrems II 1 Introduction 2 A Critical Appraisal of Schrems II 3 Post-Schrems II Developments 3.1 National Regulatory Responses 3.2 The EDPB Guidelines 3.3 The New Standard Contractual Clauses 4 A Critical Analysis of Supplementary Measures 5 Conclusion References The Internal Network Structure that Affects Firewall Vulnerability 1 Introduction 2 The Intrinsic Vulnerabilities of a Firewall 2.1 Reasons for Using Models to Study Firewall Vulnerabilities 2.2 The Assumptions of the Simple Models 2.3 Examination of Firewall Vulnerabilities Using Simple Models 2.4 Suggestions 3 Graphical Model of Information Flow 3.1 Simple Examples 3.2 A Model of Firewalls 3.3 Numerical Simulation 3.4 Limitation of Our Model 4 An Information Flow Model with Information Source and Monitor 4.1 Simple Example 4.2 Numerical Simulation: Effects of Source and Monitor Position 5 Conclusion References Index