This ground-breaking book addresses the challenge of regulatory delivery, defined as the way that regulatory agencies operate in practice to achieve the intended outcomes of regulation. Regulatory reform is moving beyond the design of regulation to address what good regulatory delivery looks like. The challenge in practice is to operate a regulatory regime that is both appropriate and effective. Questions of how regulations are received and applied by those whose behaviour they seek to control, and the way they are enforced, are vital in securing desired regulatory outcomes. This book, written by and for practitioners of regulatory delivery, explains the Regulatory Delivery Model, developed by Graham Russell and his team at the UK Department for Business, Energy and Industrial Strategy. The model sets out a framework to steer improvements to regulatory delivery, comprising three prerequisites for regulatory agencies to be able to operate effectively (Governance Frameworks, Accountability and Culture) and three practices for regulatory agencies to be able to deliver societal outcomes (Outcome Measurement, Risk-based Prioritisation and Intervention Choices). These elements are explored by an international group of experts in regulatory delivery reform, with case studies from around the world. Regulatory Delivery is the first product of members of the International Network for Delivery of Regulation.

This book explores the regulation of emerging technologies. Developments such as bitcoin (based on blockchain technology), artificial intelligence, quantum computing, and other technical advances have the potential to revolutionize many aspects of everyday life. As with other significant occurrences, especially when coupled by financial rewards, there are the inevitable attempts to reap gains unlawfully. This book examines the legal and regulatory enactments that attempt to undermine the risks to society as well as the dangers to individual freedoms that the technologies present when abused by governmental and non-governmental authorities. Included are discussions of the dangers to the right of privacy posed by facial recognition, physical location tracking, automated license plate recognition (ALPR) and other evolving applications of technology. This book is an invaluable resource for those interested in the regulation of emerging technologies particularly as they relate to blockchain, artificial intelligence, and the most current advances in quantum computing. Emphasis is focused on invasion of privacy, particularly by government authorities, antitrust implications of private companies and the efforts of international entities to counter alleged abuses by them.

The Regulatory Technology Handbook The transformational potential of RegTech has been confirmed in recent years with US$1.2 billion invested in start-ups (2017) and an expected additional spending of US$100 billion by 2020. Regulatory technology will not only provide efficiency gains for compliance and reporting functions, it will radically change market structure and supervision. This book, the first of its kind, is providing a comprehensive and invaluable source of information aimed at corporates, regulators, compliance professionals, start-ups and policy makers. The REGTECH Book brings into a single volume the curated industry expertise delivered by subject matter experts. It serves as a single reference point to understand the RegTech eco-system and its impact on the industry. Readers will learn foundational notions such as: • The economic impact of digitization and datafication of regulation • How new technologies (Artificial Intelligence, Blockchain) are applied to compliance • Business use cases of RegTech for cost-reduction and new product origination • The future regulatory landscape affecting financial institutions, technology companies and other industries Edited by world-class academics and written by compliance professionals, regulators, entrepreneurs and business leaders, the RegTech Book represents an invaluable resource that paves the way for 21st century regulatory innovation.

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

Hopes are high that stem cell (SC) research will lead to treatments and cures for some of the most serious diseases affecting humankind today. SC science has been used in a treatment setting in the replacement of patients’ windpipes and in restoring sight to patients who were blind in one eye and in future it is hoped that when the body is injured it will be able to be stimulated to produce those types of SCs necessary to repair the particular damage caused. In the meantime, research into specific treatments for a wide range of serious conditions is being undertaken including Alzheimer’s disease, cancer, and diabetes. The book considers the regulatory governance of stem cell research, setting out a readily understandable account of the science and the challenges it poses for regulators as the research is increasingly being clinically applied. It provides a critical account of those elements of a regulatory system which will be required for any jurisdiction aiming to facilitate innovative and productive SC research while maintaining appropriate ethical and legal controls. The book addresses the specific failings in the current regulatory approach to SC research in the UK and goes on to look at the regulatory approaches in the US. The book systematically analyses the roles and responsibilities of the three key participants who collaborate in this process: regulators, scientists and tissue providers, arguing that a regulatory system which fails to recognise and facilitate the vital role which each of these three groups plays runs the risk of impairing the chances of the hopes for SC research being realised. The book places a particular emphasis on ensuring that those who contribute their bodily tissues to this endeavour are treated fairly, involving a recognition that their tissues are their property.

The variety, pace, and power of technological innovations that have emerged in the 21st Century have been breathtaking. These technological developments, which include advances in networked information and communications, biotechnology, neurotechnology, nanotechnology, robotics, and environmental engineering technology, have raised a number of vital and complex questions. Although these technologies have the potential to generate positive transformation and help address 'grand societal challenges', the novelty associated with technological innovation has also been accompanied by anxieties about their risks and destabilizing effects. Is there a potential harm to human health or the environment? What are the ethical implications? Do this innovations erode of antagonize values such as human dignity, privacy, democracy, or other norms underpinning existing bodies of law and regulation? These technological developments have therefore spawned a nascent but growing body of 'law and technology' scholarship, broadly concerned with exploring the legal, social and ethical dimensions of technological innovation. This handbook collates the many and varied strands of this scholarship, focusing broadly across a range of new and emerging technology and a vast array of social and policy sectors, through which leading scholars in the field interrogate the interfaces between law, emerging technology, and regulation. Structured in five parts, the handbook (I) establishes the collection of essays within existing scholarship concerned with law and technology as well as regulatory governance; (II) explores the relationship between technology development by focusing on core concepts and values which technological developments implicate; (III) studies the challenges for law in responding to the emergence of new technologies, examining how legal norms, doctrine and institutions have been shaped, challenged and destabilized by technology, and even how technologies have been shaped by legal regimes; (IV) provides a critical exploration of the implications of technological innovation, examining the ways in which technological innovation has generated challenges for regulators in the governance of technological development, and the implications of employing new technologies as an instrument of regulatory governance; (V) explores various interfaces between law, regulatory governance, and new technologies across a range of key social domains.

This book offers an edited volume for all readers who wish to gain an in-depth grasp of the economic analysis of recent developments in energy law and policy in Europe and the United States. In response to waning resources and heightened environmental awareness, many countries are now seeking to redefine their energy mix. Several energy sources are available: coal and oil, natural gas, and a variety of renewables. Yet which of them are capable of addressing core energy-related concerns? Reliability, security, affordability, fairness, and sustainability all have to be taken into account. Further, once a target mix has been identified, two challenges remain for legal scholars: what role does the law play in achieving a specified energy mix, and, how can the law best fulfill that role? The essential energy concerns are just as important in defining the way we shape our energy mix as they are in defining the mix itself. An example of current challenges in energy law and policy can be seen in the pursuit by the German and Swiss governments of the so-called “Energiewende” (energy transition). These policies are intended to enable the transition from a non-sustainable use of fossil and nuclear energy to a more sustainable approach based on renewable energies. On the one hand, the goal is to achieve a decarbonization of the energy economy by reducing the use of fossil energy sources such as petroleum, carbon and natural gas. On the other, and in response to the Fukushima nuclear accident, a phase out is intended to eliminate the dangers of nuclear technologies. Achieving these goals poses tremendous challenges for the two countries’ energy policies – partly because the energy transition will not only affect energy production, but also energy consumption. From a Law and Economics perspective, a number of questions arise: to what extent is it justifiable to rely on markets and continued technological innovation, especially with regard to the present exploitation of scarce resources? To what extent is it necessary for states to intervene in energy markets? Regulatory instruments are available to create and maintain more sustainable societies: command and control regulations, restraints, Pigovian taxes, emission certificates, nudging policies, and more. If regulation in a certain legal field is necessary, which policies and methods will most effectively spur the sustainable consumption and production of energy in order to protect the environment while mitigating any potential negative impacts on economic development? Do neoclassical and behavioural economics provide us with a suitable framework for predicting the market’s complex reactions to a changing energy policy? This book provides theoretical insights as well as empirical findings in order to answer these vital questions.

"The Case for the Digital Platform Act" is a new book from Harold Feld, Senior Vice President of Public Knowledge and longtime communications industry advocate, in collaboration with Public Knowledge and the Roosevelt Institute. This book aims to guide policymakers on what government can do to preserve competition and empower individual users in the huge swath of our economy now referred to as "Big Tech." Many Americans now wonder how they can reassert control over their lives after ceding so many decisions about our economy and our public discourse to private actors like Facebook, Google, and Amazon. But as Feld points out, we have faced similar challenges from new technologies before. Looking at more than a century of disruptive communications technologies from the telegraph to television to Twitter, Feld picks out patterns of what approaches have worked (and what hasn't) to promote competition, empower consumers and protect democracy. "The Case for the Digital Platform Act" provides a deep dive for policymakers on everything from specific recommendations on how to promote competition to a "First Amendment checklist" for content moderation, while remaining accessible to the general reader looking to participate in the debate over our digital future. Feld explains the need for a "Digital Platform Act" and for an agency specifically charged to regulate digital platforms on an ongoing basis. He proposes a new method of assessing a platform's dominance for purposes of new regulation. He also addresses questions around content moderation rights and responsibilities for companies that have found themselves policing the new public square, all while preserving the best things about digital platforms for their users. Praise for "The Case for the Digital Platform Act": "[...] a tour de force of the issues raised by the digital economy and internet capitalism. Whether you agree or disagree with Harold, these thoughts will stretch your intellect and stimulate your thinking." -Tom Wheeler, Former Chairman of the Federal Communications Commission, Visiting Fellow at The Brooking Institution "You'd be shortchanging yourself by not reading the book of such a principled advocate." -Hal Singer, Managing Director at Econ One Research, Adjunct Professor at Georgetown University's McDonough School of Business, Senior Fellow at George Washington's Institute of Public Policy "I'd bet you can't listen to Harold Feld talk about the Digital Platform Act and not think we need it as law right now. I'm glad Harold Feld and Public Knowledge are making the case for government to do the job Silicon Valley won't." -Chris Savage, Eclectablog

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

At the same time that the pace of science and technology has greatly accelerated in recent decades, our legal and ethical oversight mechanisms have become bogged down and slower. This book addresses the growing gap between the pace of science and technology and the lagging responsiveness of legal and ethical oversight society relies on to govern emerging technologies. Whether it be biotechnology, genetic testing, nanotechnology, synthetic biology, computer privacy, autonomous robotics, or any of the other many emerging technologies, new approaches are needed to ensure appropriate and timely regulatory responses. This book documents the problem and offers a toolbox of potential regulatory and governance approaches that might be used to ensure more responsive oversight.