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Impact Of Medical Device Regulation On Jobs And Patients
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Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :216 pages Book Rating :4.:/5 (319 download)
Book Synopsis Impact of Medical Device Regulation on Jobs and Patients by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Impact of Medical Device Regulation on Jobs and Patients written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2011 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis Does Regulation Kill Jobs? by : Cary Coglianese
Download or read book Does Regulation Kill Jobs? written by Cary Coglianese and published by University of Pennsylvania Press. This book was released on 2014-01-06 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: As millions of Americans struggle to find work in the wake of the Great Recession, politicians from both parties look to regulation in search of an economic cure. Some claim that burdensome regulations undermine private sector competitiveness and job growth, while others argue that tough new regulations actually create jobs at the same time that they provide other benefits. Does Regulation Kill Jobs? reveals the complex reality of regulation that supports neither partisan view. Leading legal scholars, economists, political scientists, and policy analysts show that individual regulations can at times induce employment shifts across firms, sectors, and regions—but regulation overall is neither a prime job killer nor a key job creator. The challenge for policymakers is to look carefully at individual regulatory proposals to discern any job shifting they may cause and then to make regulatory decisions sensitive to anticipated employment effects. Drawing on their analyses, contributors recommend methods for obtaining better estimates of job impacts when evaluating regulatory costs and benefits. They also assess possible ways of reforming regulatory institutions and processes to take better account of employment effects in policy decision-making. Does Regulation Kills Jobs? tackles what has become a heated partisan issue with exactly the kind of careful analysis policymakers need in order to make better policy decisions, providing insights that will benefit both politicians and citizens who seek economic growth as well as the protection of public health and safety, financial security, environmental sustainability, and other civic goals. Contributors: Matthew D. Adler, Joseph E. Aldy, Christopher Carrigan, Cary Coglianese, E. Donald Elliott, Rolf Färe, Ann Ferris, Adam M. Finkel, Wayne B. Gray, Shawna Grosskopf, Michael A. Livermore, Brian F. Mannix, Jonathan S. Masur, Al McGartland, Richard Morgenstern, Carl A. Pasurka, Jr., William A. Pizer, Eric A. Posner, Lisa A. Robinson, Jason A. Schwartz, Ronald J. Shadbegian, Stuart Shapiro.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :124 pages Book Rating :4.:/5 (319 download)
Book Synopsis The Impact of Medical Device and Drug Regulation on Innovation, Jobs, and Patients by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book The Impact of Medical Device and Drug Regulation on Innovation, Jobs, and Patients written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2012 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Activity Report of the Committee on Energy and Commerce of the U.S. House of Representatives ... Together with Dissenting Views by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Activity Report of the Committee on Energy and Commerce of the U.S. House of Representatives ... Together with Dissenting Views written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2011 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :76 pages Book Rating :4.:/5 (319 download)
Book Synopsis Medical Devices by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book Medical Devices written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2014 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Patient Safety and Quality by : Ronda Hughes
Download or read book Patient Safety and Quality written by Ronda Hughes and published by Department of Health and Human Services. This book was released on 2008 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/
Book Synopsis Artificial Intelligence in Healthcare by : Adam Bohr
Download or read book Artificial Intelligence in Healthcare written by Adam Bohr and published by Academic Press. This book was released on 2020-06-21 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data
Book Synopsis The Ethical Challenges of Emerging Medical Technologies by : Arthur L. Caplan
Download or read book The Ethical Challenges of Emerging Medical Technologies written by Arthur L. Caplan and published by Routledge. This book was released on 2020-09-10 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection of essays emphasizes society’s increasingly responsible engagement with ethical challenges in emerging medical technology. Expansion of technological capacity and attention to patient safety have long been integral to improving healthcare delivery but only relatively recently have concepts like respect, distributive justice, privacy, and autonomy gained some power to shape the development, use, and refinement of medical tools and techniques. Medical ethics goes beyond making better medicine to thinking about how to make the field of medicine better. These essays showcase several ways in which modern ethical thinking is improving safety, efficacy and efficiency of medical technology, increasing access to medical care, and empowering patients to choose care that comports with their desires and beliefs. Included are complimentary ethical approaches as well as compelling counter-arguments. Together, the articles demonstrate how improving the quality of medical technology relies on every stakeholder -- not just medical researchers and scientists -- to assess each given technology’s strengths and pitfalls. This collection also portends one of the next major issues in the ethics of medical technology: developing the requisite moral framework to accompany shifts toward patient-centred personalized healthcare.
Book Synopsis Medical Devices: FDA Should Enhance Its Oversight of Recalls by : Marcia Crosse
Download or read book Medical Devices: FDA Should Enhance Its Oversight of Recalls written by Marcia Crosse and published by DIANE Publishing. This book was released on 2011 with total page 57 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies: (1) the numbers and characteristics of medical device recalls and FDA's use of this info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.
Book Synopsis The Medical Device R&D Handbook by : Theodore R. Kucklick
Download or read book The Medical Device R&D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2012-12-05 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designer
Book Synopsis Health Professions Education by : Institute of Medicine
Download or read book Health Professions Education written by Institute of Medicine and published by National Academies Press. This book was released on 2003-07-01 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine study Crossing the Quality Chasm (2001) recommended that an interdisciplinary summit be held to further reform of health professions education in order to enhance quality and patient safety. Health Professions Education: A Bridge to Quality is the follow up to that summit, held in June 2002, where 150 participants across disciplines and occupations developed ideas about how to integrate a core set of competencies into health professions education. These core competencies include patient-centered care, interdisciplinary teams, evidence-based practice, quality improvement, and informatics. This book recommends a mix of approaches to health education improvement, including those related to oversight processes, the training environment, research, public reporting, and leadership. Educators, administrators, and health professionals can use this book to help achieve an approach to education that better prepares clinicians to meet both the needs of patients and the requirements of a changing health care system.
Book Synopsis Evidence-Based Medicine and the Changing Nature of Health Care by : Institute of Medicine
Download or read book Evidence-Based Medicine and the Changing Nature of Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2008-09-06 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.
Book Synopsis New Medical Devices by : Institute of Medicine
Download or read book New Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 1988-01-01 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Author :United States. Federal Trade Commission. Bureau of Consumer Protection Publisher : ISBN 13 : Total Pages :32 pages Book Rating :4.:/5 (31 download)
Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Driving Innovation and Job Growth Through the Life Sciences Industry by : United States. Congress. Joint Economic Committee
Download or read book Driving Innovation and Job Growth Through the Life Sciences Industry written by United States. Congress. Joint Economic Committee and published by . This book was released on 2011 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.