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.

Offers a global perspective on ethical, regulatory and legal developments on data sharing in the health sciences Provides innovative practical suggestions for leveraging the potential of data sharing in the health sciences Pursues an interdisciplinary approach that blends technical insights

Autorentext
Marcelo Corrales Compagnucci is Associate Professor and Associate Director at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL), Faculty of Law, University of Copenhagen in Denmark. He specializes in information technology, privacy and data protection law. His research interests are the legal issues involved in disruptive innovation technologies and biomedicine. His past activities have included working as a consultant and lawyer for law firms and IT companies, and international organizations such as the OECD and the World Bank. He was also a research associate with the Institute for Legal Informatics (IRI) at Leibniz Universität Hannover in Germany, and a visiting research fellow in various research centers around the world, including the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the Max Planck Institute for Comparative and International Private Law (Hamburg), the Max Planck Institute for Innovation and Competition (Munich), the SCRIPT research center at the University of Edinburgh in Scotland, and the Academia Sinica in Taiwan. He has a Doctor of Laws (LL.D.) degree from Kyushu University in Japan. He also holds a Master of Laws (LL.M.) in international economics and business law from Kyushu University, and an LL.M. in law and information technology and an LL.M. in European intellectual property law, both from the University of Stockholm in Sweden. He has several publications in the field of IT Law. His most recent book collections co-edited with various authors include AI in eHealth: Human Autonomy, Data Governance and Privacy in Healthcare (Cambridge University Press, 2022), Smart Contracts: Technological, Business and Legal Perspectives (Hart Publishing, 2021); Legal Design: Integrating Business, Design and Legal Thinking with Technology (Edward Elgar Publishing, 2021).

Timo Minssen is Professor of Health andLife Science Innovation Law at the University of Copenhagen (UCPH), the Founding Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL), and LML Research Affiliate at the University of Cambridge. Professor Minssen is also the principal investigator and the Novo Nordisk Foundation grant-holder of both the CeBIL program, and the Inter-CeBIL program. His research, supervision, teaching & part-time advisory practice concentrates on Intellectual Property-, Competition & Regulatory Law, with a special focus on the law and ethics of new technologies, big data and artificial intelligence in the health & life sciences. Originating from Germany, he holds master degrees and doctoral degrees from the Universities of Göttingen, Uppsala and Lund. In addition to gaining practical experience in German Courts and international law firms, Timo has been a visiting scholar and research fellow at Harvard University, the Universities of Oxford and Cambridge, the Chicago-Kent College of Law, the Max Planck Institute for Innovation and Competition Law, and the Pufendorf Institute for Advanced Studies. He is a member of several international committees and regularly advises the WHO, WIPO, EU Commission, various research organizations, companies, national governments and law firms. He presents his research at international symposia, major law firms, the Universities of Oxford, Cambridge, Hong Kong & Tokyo, Harvard Law School, Harvard Business School, Stanford Law School, Yale, MIT, the Broad institute, as well as at the WHO, WIPO, European Medicines Agency and National Ethics Councils etc. His publications comprise 6 books, as well as 200+ articles, book chapters and internet publications. Timo's research has been featured in i.a. The Economist, The Financial Times, El Mundo, Politico, WHO Bulletin, Times of India & Times Higher Education, and is published in both leading legal journals, as well as in top "wet-science" journals, such as Science, NEJM Catalyst, Harvard Business Review, JAMA, Nature Biotechnology, Nature Genetics, Nature Electronics, Nature PJ Digital Medicine, The Lancet Digital Health, and PLoS-Computational Biology. He is also a regular contributor on Harvard Law School's "Bill of Health" blog. ****

Mark Fenwick is Professor of International Business Law at the Faculty of Law, Kyushu University, Fukuoka, Japan. His primary research interests are in the fields of business regulation in a networked age, and white-collar and corporate crime. Recent publications include New Technology, Big Data & the Law (Springer, 2017: co-edited with M. Corrales Compagnucci and N. Forgó), Robotics, AI and the Future of Law (Springer, 2018: co-edited with M. Corrales Compagnucci and N. Forgó), Smart Contracts: Business, Legal & Technological Perspectives (Hart/Bloomsbury, 2021: co-edited with M. Corrales Compagnucci and S. Wrbka), and Organizing-for-Innovation: Corporate Governance in a Digital Age (Springer, 2023: co-authored with E.P.M. Vermeulen and T. Kono). He has a master's and Ph.D. from the Faculty of Law, University of Cambridge (Queens' College) and has been a visiting professor at Cambridge University, Chulalongkorn University, Duke University, the University of Hong Kong, Shanghai University of Finance & Economics, the National University of Singapore, Tilburg University and Vietnam National University. He has also conducted research for the EU, OECD and the World Bank and is a contributor to the International Corporate Governance Network Yearbook.****

Mateo Aboy is Director of Research in Biomedical Innovation, AI & Law at the Faculty of Law, University of Cambridge. He is a member of the Centre for Law, Medicine & Life Sciences (LML) and the Centre for IP & Information Law (CIPIL) at University of Cambridge. His multidisciplinary background includes a combination of law, engineering, …