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.

This is an open access title available under the terms of a CC BY-NC-ND 4.0 License. It is free to read, download and share on Elgaronline, thanks to generous funding support from Hamad Bin Khalifa University (HBKU). The Research Handbook on Health, AI and the Law explores the use of AI in healthcare, identifying the important laws and ethical issues that arise from its use. Adopting an international approach, it analyses the varying responses of multiple jurisdictions to the use of AI and examines the influence of major religious and secular ethical traditions.

Wireless Body Area Networks (WBANs) are vulnerable to cyberattacks and security breaches that could unlock the door for cybercriminals to penetrate hospital networks. This book covers the fundamental concepts of security and privacy in WBANs including security requirements, issues, and challenges. Security, Privacy, and Trust in WBANs and E-Healthcare highlights the taxonomy of threats and attacks in WBANs and Internet of Medical Things (IoMT) and presents all technical aspects related to the security and privacy of WBANs. In addition to outlining viable solutions that take into account constrained resources at WBAN end-devices, hybrid network architecture, application characteristics, and communication protocols, the book covers the core concepts of WBAN security, privacy, and trust. It describes both theoretical and practical aspects for those working in security in the WBAN and IoMT, emphasizing the most significant potential WBAN security issues and challenges. The book also covers intrusion detection and security risk assessments in WBANs as well as lightweight security solutions for WBANs, blockchain-based solutions for WBANs, and authentication and access control in WBANs through various applications and case studies. This book is highly relevant to the graduate/postgraduate students, academicians, security system designers, security analysts, computer scientists, engineers, researchers, digital forensic experts, and other personnel working in information security, IoMT, and WBAN.

Genomic Data Sharing: Case Studies, Challenges, and Opportunities for Precision Medicine provides a comprehensive overview of current and emerging issues in genomic data sharing. In this book, international leaders in genomic data examine these issues in-depth, offering practical case studies that highlight key successes, challenges and opportunities. Sections discuss the eMERGE Network, Undiagnosed Disease Network, Vanderbilt Biobank, Marshfield Clinic Biobank, Minnesota Authorization, Rochester Epidemiology Project, NIH sponsored biobanks, GINA, and Global Alliance for Genomics and Health (GA4GH). In addition to these perspectives from the frontlines, the book also provides succinct overviews of ethical, legal, social and IT challenges.Clinician investigators, clinicians affiliated with academic medical centers, policymakers and regulators will also gain insights that will allow them to navigate the increasingly complex ethical, social and clinical landscape of genomic data sharing. - Covers both technical and ELSI (ethical, legal, and social implications) perspectives on genomic data sharing - Includes applied case studies of existing genomic data sharing consortia, including the eMERGE Network, Undiagnosed Disease Network, and the Global Alliance for Genomics and Health (GA4GH), among others - Features chapter contributions from international leaders in genomic data sharing

Professor Bartha Maria Knoppers stepped down from the Canada Research Chair in Law and Medicine at McGill University in April 2024, a post she held for more than 20 years. Professor Knoppers consistently prioritized “humanity” in her academic work and in policymaking. As such, she forged a strong intellectual legacy, notably through her work on the human right to science, genomic and health-related data sharing, genome editing, human reproductive technologies, stem cell research, the rights of children, and population health. This collection of essays honours her extraordinary academic contributions to law, policy, and medicine.

Public health guidelines and policies relating to digital public health are essential to ensuring the protection of the population. With this protection, there needs to be a consideration for the ethical challenges in public health. There is an obligation of care that comes with accessing health services, as well as a need for understanding the role of Artificial Intelligence and Machine Learning. As health challenges become more complex, there is a growing need to identify and address questions on existing public health policies, codes of conduct, and guidelines relating to the provision of medical care across the globe, in order to strengthen our understanding of the ethics of public health practices.

This book explores the emerging economic reality of health data pools from the perspective of European Union policy and law. The contractual sharing of health data for research purposes is giving rise to a free movement of research data, which is strongly encouraged at European policy level within the Digital Single Market Strategy. However, it has also a strong impact on data subjects' fundamental right to data protection and smaller businesses and research entities ability to carry out research and compete in innovation markets. Accordingly the work questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the work addresses the following sub-questions: i) which is the emerging innovation paradigm in digital health research?; ii) how are health data pools addressed at European policy level?; iii) do European data protection and competition law promote health data-driven innovation objectives, and how?; iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the work is that both branches of European Union law are key regulatory tools for the creation of a common European health data space as envisaged in the Commissions 2020 European strategy for data. It thus demonstrates that both European data protection law, as defined under the General Data Protection Regulation, and European competition law and policy set research enabling regimes regarding health data, provided specific normative conditions are met. From a further perspective, both regulatory frameworks place external limits to the freedom to share (or not share) research valuable data.

Biobanks are proliferating rapidly worldwide because they are powerful tools and organisational structures for undertaking medical research. By linking samples to data on the health of individuals, it is anticipated that biobanks will be used to explore the relationship between genes, environment and lifestyle for many diseases, as well as the potential of individually-tailored drug treatments based on genetic predisposition. However, they also raise considerable challenges for existing legal frameworks and research governance structures. This book critically examines the current governance structures in place for biobanks in England and Wales. It shows that the technologies, techniques and practices involved in biobanking do not always conform neatly to existing legal principles and frameworks that apply to other areas of medical research. Using a socio-legal approach, including interview data gathered from the scientific community, this book provides unique insights and makes recommendations about appropriate governance mechanisms for biobanking in the future. It also explores the issues around the secondary use of information, such as consent and how to protect privacy, when biobanks are accessed by a number of different third parties. These issues have relevance both within England and Wales and to a wide international audience, as well as for other areas where large datasets are used.

This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. Today, it is easy to donate blood or even organs, but it is virtually impossible to donate one’s own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes.