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Regulating Medical Work
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Book Synopsis Medical Devices Law and Regulation Answer Book by : Suzan Onel
Download or read book Medical Devices Law and Regulation Answer Book written by Suzan Onel and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Future of Drug Safety by : Institute of Medicine
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Book Synopsis Innovation and Protection by : I. Glenn Cohen
Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Book Synopsis Regulating Medical Work by : Judy Allsop
Download or read book Regulating Medical Work written by Judy Allsop and published by . This book was released on 1996 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines the formal and informal regulations of medical work in the health service. The text explores two major issues - firstly the boundaries between state-sanctioned self regulation and other regulatory systems, secondly, the relationship between formal and informal controls.
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :Committee for the Study of the Future of Public Health Publisher :National Academies Press ISBN 13 :0309581907 Total Pages :240 pages Book Rating :4.3/5 (95 download)
Book Synopsis The Future of Public Health by : Committee for the Study of the Future of Public Health
Download or read book The Future of Public Health written by Committee for the Study of the Future of Public Health and published by National Academies Press. This book was released on 1988-01-15 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Nation has lost sight of its public health goals and has allowed the system of public health to fall into 'disarray'," from The Future of Public Health. This startling book contains proposals for ensuring that public health service programs are efficient and effective enough to deal not only with the topics of today, but also with those of tomorrow. In addition, the authors make recommendations for core functions in public health assessment, policy development, and service assurances, and identify the level of government--federal, state, and local--at which these functions would best be handled.
Book Synopsis Health Care Regulation in America by : Robert I. Field
Download or read book Health Care Regulation in America written by Robert I. Field and published by Oxford University Press, USA. This book was released on 2007 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulation shapes all aspects of America's fragmented health care industry. While the health and lives of patients as well as almost one-sixth of the national economy depend on its effectiveness, health care regulation in America is bewilderingly complex. 'Health Care Regulation in America' is a guide to this regulatory maze.
Book Synopsis Medical Device Safety by : G.R Higson
Download or read book Medical Device Safety written by G.R Higson and published by CRC Press. This book was released on 2001-10-29 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
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 2011-10-25 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 EBOOK: Regulating Healthcare by : Kieran Walshe
Download or read book EBOOK: Regulating Healthcare written by Kieran Walshe and published by McGraw-Hill Education (UK). This book was released on 2003-06-16 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare organizations in the UK and the USA face a growing tide of regulation, accreditation, inspection and external review, all aimed at improving their performance. In the US, over three decades of regulation by state and federal government, and by non-governmental agencies, has created a complex, costly and overlapping network of oversight arrangements for healthcare organizations. In the UK, regulation of the government-run National Health Service is central to current health policy, with the creation of a host of new national agencies and inspectorates tasked with overseeing the performance of NHS hospitals and other organizations. But does regulation work? This book: . explores the development and use of healthcare regulation in both countries, comparing and contrasting their experience and drawing on regulatory research in other industries and settings . offers a structured approach to analysing what regulators do and how they work . develops principles for effective regulation, aimed at maximising the benefits of regulatory interventions and minimising their costs Regulating Healthcare is aimed at all with an interest or involvement in health policy and management, be they policy makers, healthcare managers or health professionals. It is particularly suitable for use on postgraduate health and health-related programmes.
Book Synopsis The Future of Nursing by : Institute of Medicine
Download or read book The Future of Nursing written by Institute of Medicine and published by National Academies Press. This book was released on 2011-02-08 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Nursing explores how nurses' roles, responsibilities, and education should change significantly to meet the increased demand for care that will be created by health care reform and to advance improvements in America's increasingly complex health system. At more than 3 million in number, nurses make up the single largest segment of the health care work force. They also spend the greatest amount of time in delivering patient care as a profession. Nurses therefore have valuable insights and unique abilities to contribute as partners with other health care professionals in improving the quality and safety of care as envisioned in the Affordable Care Act (ACA) enacted this year. Nurses should be fully engaged with other health professionals and assume leadership roles in redesigning care in the United States. To ensure its members are well-prepared, the profession should institute residency training for nurses, increase the percentage of nurses who attain a bachelor's degree to 80 percent by 2020, and double the number who pursue doctorates. Furthermore, regulatory and institutional obstacles-including limits on nurses' scope of practice-should be removed so that the health system can reap the full benefit of nurses' training, skills, and knowledge in patient care. In this book, the Institute of Medicine makes recommendations for an action-oriented blueprint for the future of nursing.
Book Synopsis International Health Regulations (2005) by : World Health Organization
Download or read book International Health Regulations (2005) written by World Health Organization and published by World Health Organization. This book was released on 2008-12-15 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt: In response to the call of the 48th World Health Assembly for a substantial revision of the International Health Regulations, this new edition of the Regulations will enter into force on June 15, 2007. The purpose and scope of the Regulations are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." The Regulations also cover certificates applicable to international travel and transport, and requirements for international ports, airports and ground crossings.
Book Synopsis Healthcare Information Security and Privacy by : Sean P. Murphy
Download or read book Healthcare Information Security and Privacy written by Sean P. Murphy and published by McGraw Hill Professional. This book was released on 2015-01-09 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Secure and protect sensitive personal patient healthcare information Written by a healthcare information security and privacy expert, this definitive resource fully addresses security and privacy controls for patient healthcare information. Healthcare Information Security and Privacy introduces you to the realm of healthcare and patient health records with a complete overview of healthcare organization, technology, data, occupations, roles, and third parties. Learn best practices for healthcare information security and privacy with coverage of information governance, risk assessment and management, and incident response. Written for a global audience, this comprehensive guide covers U.S. laws and regulations as well as those within the European Union, Switzerland, and Canada. Healthcare Information and Security and Privacy covers: Healthcare industry Regulatory environment Privacy and security in healthcare Information governance Risk assessment and management
Book Synopsis Medical Device Development by : Jonathan S. Kahan
Download or read book Medical Device Development written by Jonathan S. Kahan and published by . This book was released on 2020 with total page 658 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Regulatory Affairs by : Jack Wong
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Book Synopsis WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices by : World Health Organization
Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Book Synopsis Regulating Managed Care by : Stuart H. Altman
Download or read book Regulating Managed Care written by Stuart H. Altman and published by Jossey-Bass. This book was released on 1999-06-25 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: What should be government's role in a market-oriented health caresystem? What's the appropriate amount of regulation? Who should regulate-states, federal government, or marketforces? What role do the courts play in this regulation? Are there existing models that might guide leaders in designing aneffective regulatory structure? Welcome to the great managed care debate. In Regulating ManagedCare, twenty-six of the nation's leading health policy experts givehealth care administrators, clinicians, and policy makers insightinto the issues behind this critical exchange and provide leaderswith a road map to assess the policy options available to protectthe quality of our health care delivery system. "This collection of papers, from an extraordinary group of authors,makes a valuable contribution to the ongoing policy debate and willbe of interest to anyone concerned with the future of our healthcare system."---Charles A. Sanders, retired chairman and CEO GlaxoInc. and former general director, Massachusetts General Hospital