The book is a good read due to its well-integrated form, its comparative approach, its empirical case descriptions and its ability to encourage readers to approach the field of regulatory innovation. Estrid Sørensen, Science Studies Much hype has been generated about the importance of innovation for public and private sector organisations. Regulatory Innovation offers the first detailed study of regulatory innovation in a multiplicity of countries and domains. This book draws on in-depth studies of innovation in regulatory instruments and practices across high- and low-technology sectors, across different countries and from the early to the late 20th century. Highlighting different worlds of regulatory innovation those of the individual, the organization, the state, the global polity, and innovation itself, this book offers a fresh perspective and valuable insights for the practice and study of regulatory innovation. The explicit comparative focus of the case studies and the worlds of regulatory innovation approach make this book essential reading for academic researchers and students interested in regulation.

From social media to mortgage-backed securities, innovation carries both risk and opportunity. Groups of people win, and lose, when innovation changes the ground rules. Looking beyond formal politics, this new book by Cristie Ford argues that we need to recognize innovation, and financial innovation in particular, as a central challenge for regulation. Regulation is at the leading edge of politics and policy in ways that we have not yet fully grasped. Seemingly innocuous regulatory design choices have clear and profound practical ramifications for many of our most cherished social commitments. Innovation is a complex phenomenon that needs to be understood not only in technical terms, but also in human ones. Using financial regulation as her primary example, Ford argues for a fresh approach to regulation, which recognizes innovation for the regulatory challenge that it is, and which binds our cherished social values and our regulatory tools ever more tightly together.

Digital Innovation in Financial Services' is a comprehensive legal assessment of FinTech or digital financial innovation covering its potential applications to payments, securities clearing and settlement, crowd-funding, and central banking. It is the first systematic attempt at proposing a conceptual framework against which to consider the most advisable regulatory policy approach vis-à-vis this incipient phenomenon. Consumer behaviour is rapidly trending towards the use of digital devices as instruments through which to transact day-to-day business. This book shows how the global digitisation trend and the steadily rising consumer demand for innovation in the field of financial services create new opportunities not only for retail consumers but also for financial service providers, regulators, and central banks. The author offers a comprehensive overview of these opportunities and their countervailing legal and regulatory challenges.

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

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

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Environmental regulation has come of age in recent decades as the blunt methods of command-and-control have been subjected to trenchant criticism from both economists and lawyers in the United States and Europe. As a result of this intellectual development, as well as continuing and increasing severity of environmental problems, there is a need for fresh thinking about regulatory methods that are rational from both economic and legal points of view. This book focuses on the viability of one particular regulatory innovation--the use of agreements or contracts for environmental regulation--as it has been practised in the United States and Europe. The various contributions explore the general idea that certain kinds of environmental problems may best be addressed through contracts among interested parties, including representatives of various levels of government, business, local community and employment representatives, and public interest groups. The parties get together to discuss a particular problem and then agree to an agreement or contract designed to address key issues and interests. At least in some situations, this approach may yield greater flexibility, stronger commitment, and more creative outcomes than traditional command-and-control regulation. Experiments in the use of environmental contracts have begun on both sides of the Atlantic, a fact which makes the comparative study offered here especially timely and valuable.