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The Changing Economics of Medical Technology
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.
Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade
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.
Modern Methods of Clinical Investigation
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.
Crossing the Quality Chasm
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of perfor...
Technology and Health Care in an Era of Limits
The U.S. health care system is in a state of flux, and changes currently under way seem capable of exerting sizable effects on medical innovation. This volume explores how the rapid transition to managed care might affect the rate and direction of medical innovation. The experience with technological change in medicine in other nations whose health care systems have "single-payer" characteristics is thoroughly examined. Technology and Health Care in an Era of Limits examines how financing and care delivery strategies affect the decisions made by hospital administrators and physicians to adopt medical technologies. It also considers the patient's stake in the changing health care economy and the need for a stronger independent contribution of patients to the choice of technology used in their care. Finally, the volume explores the impact of changes in the demand for medical technology in pharmaceutical, medical device, and surgical procedure innovation.
Public Health Effectiveness of the FDA 510(k) Clearance Process
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.
EBOOK: Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality
"This thoughtful and comprehensive book represents the best work I have seen on the current situation concerning medication policies in the EU. It is not just that this is a very up-to-date compendium of facts and data across a wide variety of domains that impact on pharmaceutical regulation. The book is also strong on analysis of those facts as well." Jerry Avorn, Harvard Medical School. "This book offers a comprehensive examination of approaches to manage pharmaceutical expenditures in Europe. It is a must-read for those who seek to understand and navigate the changing regulatory environment for medicines in the European Union." Bernie O'Brien, McMaster University, Canada. The rising cost ...
Innovation in Medical Technology
This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.
Healthcare Technology Management Systems
Healthcare Technology Management Systems provides a model for implementing an effective healthcare technology management (HTM) system in hospitals and healthcare provider settings, as well as promoting a new analysis of hospital organization for decision-making regarding technology. Despite healthcare complexity and challenges, current models of management and organization of technology in hospitals still has evolved over those established 40-50 years ago, according to totally different circumstances and technologies available now. The current health context based on new technologies demands working with an updated model of management and organization, which requires a re-engineering perspec...
Best Care at Lower Cost
America's health care system has become too complex and costly to continue business as usual. Best Care at Lower Cost explains that inefficiencies, an overwhelming amount of data, and other economic and quality barriers hinder progress in improving health and threaten the nation's economic stability and global competitiveness. According to this report, the knowledge and tools exist to put the health system on the right course to achieve continuous improvement and better quality care at a lower cost. The costs of the system's current inefficiency underscore the urgent need for a systemwide transformation. About 30 percent of health spending in 2009-roughly $750 billion-was wasted on unnecessa...
