European Law And New Health Technologies

New health technologies promise great things but they also pose significant challenges for governments, particularly around safety concerns, effectiveness, and value for money. This collection analyses the defining features of the relationship between EU law and new technologies, and the roles of risk, rights, ethics, and markets.

What is the nature of the relationship between the fields of new technology and EU law? What challenges do new technologies pose for the internal market and the fundamental principles of the EU? The first part of the collection explores the EU's approach to the regulation of scientific and technological risk, and the link between the regulation of technology and the internal market. In detail, the chapters analyse the interaction between EU law, bioethics and medical and health technologies. The second part of the collection enhances on this, and the chapters scrutinize specific policy areas in order to explain the alternate ways in which EU policy and technology cooperate.

The steady expansion of the European Union’s involvement in health over the past 20 years has been accelerated by recent events. This handbook offers an up-to-date analytical overview of the most important topics in EU health law and policy. It outlines, as far as possible, the direction of travel for each topic and suggests research agenda(s) for the future.

The first holistic and thematic study of EU health law, and its implications, through its own internal logics.

Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volume provides comprehensive analysis of the law at EU level affecting the physician-patient relationship and the interaction of physicians with other healthcare providers and the healthcare system. Although the legal aspects of healthcare in Europe most often fall under national law, the past two decades have witnessed the emergence of a distinctive field of EU health law with its own underlying principles and structural coherence, founded in a series of directives and CJEU decisions. This book examines the areas in which EU law now must be taken into account in healthcare, including aspects of patients’ rights, recognition of professional qualifications and minimum training conditions, professional rules of conduct, clinical trials and investigations of medicinal products and medical devices, health and genetic data, and beginning and end of life issues. Succinct and practical, this book will prove to be of great value to professional organizations of physicians, nurses, hospitals, and relevant government agencies. Lawyers representing parties with interests in the European Union will welcome this very useful guide, and academics and researchers will appreciate its comparative value as a contribution to the study of health law and medical law in the international context.

The EU has only limited competence to regulate national health-care systems but recent developments have shown that health care is not immune from the effects of EU law. As Member States have increasingly experimented with new forms of funding and the delivery of health-care and social welfare services, health-care issues have not escaped scrutiny from the EU internal market and from competition and procurement rules. The market-oriented EU rules now affect these national experiments as patients and health-care providers turn to EU law to assert certain rights. The recent debates on the (draft) Directive on Patients’ Rights further underline the importance, but also the difficulty (and controversy), of allowing EU law to regulate health care. The topicality of the range of issues related to health care and EU law was addressed, in October 2009, at a conference held in Nijmegen, The Netherlands. The present volume contains inter alia the proceedings of this conference and invited essays. This volume follows the publication of The Changing Legal Framework for Services of General Interest in Europe. Between Competition and Solidarity (Krajewski M et al (eds) (2009) T.M.C. Asser Press, The Hague) and launches a new series: Legal Issues of Services of General Interest. The aim of the series is to sketch the framework for services of general interest in the EU and to explore the issues raised by developments related to these services. The book is compulsory reading for everyone who is engaged in issues relating to health care and EU law. Johan van de Gronden is Professor of European Law at the Law Faculty of the Radboud University Nijmegen, the Netherlands. Erika Szyszczak is a Jean Monnet Professor of European Law ad personam and Professor of European Competition and Labour Law at the University of Leicester, UK. Ulla Neergaard is Professor of EU law at the Law Faculty of the University of Copenhagen, Denmark. Markus Krajewski is Professor of International Public Law, Faculty of Law, University of Erlangen-Nuremberg, Germany.

This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Key features include: • Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers • Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges • Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market • Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.

This book deals with questions of democracy and governance relating to new technologies. The deployment and application of new technologies is often accompanied with uncertainty as to their long-term (un)intended impacts. New technologies also raise questions about the limits of the law as the line between harmful and beneficial effects is often difficult to draw. The volume explores overarching concepts on how to regulate new technologies and their implications in a diverse and constantly changing society, as well as the way in which regulation can address differing, and sometimes conflicting, societal objectives, such as public health and the protection of privacy. Contributions focus on a broad range of issues such as Citizen Science, Smart Cities, big data, and health care, but also on the role of market regulation for new technologies.The book will serve as a useful research tool for scholars and practitioners interested in the latest developments in the field of technology regulation. Leonie Reins is Assistant Professor at the Tilburg Institute for Law, Technology, and Society (TILT) in The Netherlands.