Timo Minssen – författare

This timely book addresses pressing questions such as: how do national biobanks best contribute to translational research?; What are the opportunities and challenges that current regulations present for translational use of biobanks?; How does inter-biobank coordination and collaboration occur on various levels?; and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated? Identifying that biobanks foundational and operational set-ups should be legally and ethically sound, while at the same time reflecting the hopes and concerns of all the involved stakeholders, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.

Academics in the fields of law and ethics, health law and biomedical law, as well as biobank managers and policymakers will find this insightful book a stimulating and engaging read.

Contributors include: T. Bossow, T.A. Caulfield, B.J. Clark, Å. Hellstadius, J.R. Herrmann, K. Høyer, M. Jordan, J. Kaye, N.C.H. Kongsholm, K. Liddell, J. Liddicoat, M.J. Madison, T. Minssen, B. Murdoch, W. Nicholson Price II, E. Ortega-Paino, M. Prictor, M.B. Rasmussen, K. Sargsyan, J. Schovsbo, A.M. Tupasela, E. van Zimmeren, F. Vogl, H. Yu, P.K. Yu

Featuring both EU and wider international perspectives, chapters examine the Directive''s aim of harmonizing legislation on the protection of trade secrets across the EU, and discuss how this has been implemented by member states. Contributors also explore the effects of the new regime on contentious issues and crucial sectors such as medicine, big data and AI, as well as considering its relationship with US law in particular.

Scholars and students of patent law, innovation, and EU law and governance, particularly those with an interest in the topic of information freedom, will find this book of great significance in their research. Practitioners working in trade secrets and intellectual property more broadly will also find this book''s comprehensive analysis of the Directive and its practical implications invaluable.

Contributors include: T. Aplin, R. Arnold, N. Bruun, R. Cooper Dreyfuss, B. Díaz Alaminos, B. Domeij, N. Lee, T. Minssen, A. Nordberg, A. Ohly, N. Rajam, T. Riis, S.K. Sandeen, J. Schovsbo, J.S. Sherkow, H. Udsen, B. van der Donk, M. van Eechoud

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.