This law school casebook focuses on the regulation of medical technology. Encompasses not just legislative and administrative agency controls on the creation and use of such technology, but also less direct controls mediated through the systems of tort law, insurance, and intellectual property regimes, among others. This work is organized thematically rather than sequentially in reference to a product's life-cycle, and consider the many ways in which society attempts to manage the production and application of medical technologies, tracing the research and development process from laboratory to use in the treatment of patients.

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

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

This text analyses a variety of issues concerning medicine and the application of law governing its practice, education, and research. The author addresses them in the light of recent developments in technology and views them from a comparative perspective by focusing on Indian case law and jurisdictions from other countries.

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.

Essential, required reading for doctors and patients alike: A Pulitzer Prize-winning author and one of the world’s premiere cancer researchers reveals an urgent philosophy on the little-known principles that govern medicine—and how understanding these principles can empower us all. Over a decade ago, when Siddhartha Mukherjee was a young, exhausted, and isolated medical resident, he discovered a book that would forever change the way he understood the medical profession. The book, The Youngest Science, forced Dr. Mukherjee to ask himself an urgent, fundamental question: Is medicine a “science”? Sciences must have laws—statements of truth based on repeated experiments that describe some universal attribute of nature. But does medicine have laws like other sciences? Dr. Mukherjee has spent his career pondering this question—a question that would ultimately produce some of most serious thinking he would do around the tenets of his discipline—culminating in The Laws of Medicine. In this important treatise, he investigates the most perplexing and illuminating cases of his career that ultimately led him to identify the three key principles that govern medicine. Brimming with fascinating historical details and modern medical wonders, this important book is a fascinating glimpse into the struggles and Eureka! moments that people outside of the medical profession rarely see. Written with Dr. Mukherjee’s signature eloquence and passionate prose, The Laws of Medicine is a critical read, not just for those in the medical profession, but for everyone who is moved to better understand how their health and well-being is being treated. Ultimately, this book lays the groundwork for a new way of understanding medicine, now and into the future.