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.

This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Intellectual Property and Health Technologies Balancing Innovation and the Public's Health Joanna T. Brougher, Esq., MPH At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them. Intellectual Property and Health Technologies grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among forms of legal protection for inventors such as copyrights and patents, explains their limits, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies in terms of pricing, markets, and especially the tension between innovation and access, including: The patent-eligibility of genes The patent-eligibility of medical process patents The rights and roles of universities and inventors The balancing of access, innovation, and profit in drug development The tension between biologics, small-molecule drugs, and their generic counterparts International patent law and access to medicine in the developing world As these issues continue to shape and define the debate, Intellectual Property and Health Technologies enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine.

Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money. To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation. This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.

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

Although Europe has a significant legal data protection framework, built up around EU Directive 95/46/EC and the Charter of Fundamental Rights, the question of whether data protection and its legal framework are ‘in good health’ is increasingly being posed. Advanced technologies raise fundamental issues regarding key concepts of data protection. Falling storage prices, increasing chips performance, the fact that technology is becoming increasingly embedded and ubiquitous, the convergence of technologies and other technological developments are broadening the scope and possibilities of applications rapidly. Society however, is also changing, affecting the privacy and data protection landscape. The ‘demand’ for free services, security, convenience, governance, etc, changes the mindsets of all the stakeholders involved. Privacy is being proclaimed dead or at least worthy of dying by the captains of industry; governments and policy makers are having to manoeuvre between competing and incompatible aims; and citizens and customers are considered to be indifferent. In the year in which the plans for the revision of the Data Protection Directive will be revealed, the current volume brings together a number of chapters highlighting issues, describing and discussing practices, and offering conceptual analysis of core concepts within the domain of privacy and data protection. The book’s first part focuses on surveillance, profiling and prediction; the second on regulation, enforcement, and security; and the third on some of the fundamental concepts in the area of privacy and data protection. Reading the various chapters it appears that the ‘patient’ needs to be cured of quite some weak spots, illnesses and malformations. European data protection is at a turning point and the new challenges are not only accentuating the existing flaws and the anticipated difficulties, but also, more positively, the merits and the need for strong and accurate data protection practices and rules in Europe, and elsewhere.