The Law and Ethics of Data Sharing in Health Sciences / Perspectives in Law, Business and Innovation (PDF)
- Lastschrift, Kreditkarte, Paypal, Rechnung
- Kostenloser tolino webreader
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 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.
Chapter Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data after Schrems II is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.
Timo Minssen is Professor of Health and Life Science Innovation Law at the University of Copenhagen
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, regulatory science, and management experience. He holds degrees in electrical & computer engineering (BS, BSEE, MSECE, MPhil/DEA, PhD ECE), law (LLB, SJD/PhD/LLD), and international management (MBA), as well as professional registrations as a Professional Chartered Engineer (CEng, EU/ES COIT), Certified Licensing Professional (CLP), Patent Practitioner with a Bar Admission/licensed to practice in patent cases before the United States Patent Office (USPTO), Fellow of Information Privacy (FIT, IAPP), Certified Privacy Information Professional (CIPP/E), Certified Privacy Manager (CIPM), Lead Implementer of Information Security Management Systems-ISMS (ISO 27001), Lead Auditor of Medical Device Quality Management Systems (ISO 13485), Lead Implementer of Privacy Information Management Systems - PIMS (ISO 27701), and Certified Data Protection Officer (C-DPO). His research investigates the intersection of digital innovation, IP policy and economics of healthcare by exploring the key tenets of innovation with a focus on the digital health, biotech, and pharmaceutical industries. This includes investigating the transformation of medical technology, drug development and healthcare delivery, as well as the associated legal, regulatory, policy and strategy questions raised by the growth of medical AI/ML/QC and biotech innovations for personalized medicine. Mateo's research seeks to understand the drivers of technology-based innovation, IP incentives, and the determinants of how emergent medical technologies are protected, regulated, funded, developed, adopted and used in practice.
He is author of more than 150 scholarly articles published in leading scientific, engineering and legal journals. His professional experience includes work in various senior roles both in private sector and in academia. As a Licensed Patent Practitioner, he has successfully prosecuted numerous cases before the USPTO, focusing primarily on medical device and computer-implemented inventions. He holds over 20 patents as an inventor.
Kathleen Liddell is the Director of the Centre for Law, Medicine and Life Sciences (LML), and the Herschel Smith Professor of Intellectual Property and Medical Law at the Faculty of Law, University of Cambridge. Her research focuses on innovations in health, medicine and society, with the aim of understanding and improving the legal frameworks that govern and support these fields. Professor Liddell has been the principal investigator for several large projects on intellectual property and information law, including in relation to genomics, precision medicine, repurposing pharmaceuticals, and antimicrobial resistance. Professor Liddell has worked on policy reports for national health departments, national ethical advisory commissions, and the European Commission. She is the recipient of grants from (for example) the Wellcome Trust, the Philomathia Foundation, the Cambridge ESRC-Impact Acceleration Account, and the Novo Nordisk Foundation. Her expertise extends to other areas of life sciences including national and international regulation of clinical trials, medical negligence, biomaterials (including human tissue, cells, organs), pharmaceuticals, diagnostics, and personalized and regenerative medicine. She studied law and natural sciences at the University of Melbourne before undertaking her doctorate in law at the University of Oxford and a Masters of Bioethics at Monash University. In addition to academia, Dr Liddell has worked in private legal practice and in the civil service.
- 2024, 1st ed. 2024, 200 Seiten, Englisch
- Herausgegeben: Marcelo Corrales Compagnucci, Timo Minssen, Mark Fenwick, Mateo Aboy, Kathleen Liddell
- Verlag: Springer Nature Singapore
- ISBN-10: 9819965403
- ISBN-13: 9789819965403
- Erscheinungsdatum: 02.01.2024
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
- Dateiformat: PDF
- Größe: 4.50 MB
- Ohne Kopierschutz
- Vorlesefunktion
Schreiben Sie einen Kommentar zu "The Law and Ethics of Data Sharing in Health Sciences / Perspectives in Law, Business and Innovation".
Kommentar verfassen