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Regulating Medical Work by Judy Allsop,Linda Mulcahy Pdf
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.
Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Publisher : National Academies Press Page : 141 pages File Size : 42,7 Mb Release : 2010-10-04 Category : Medical ISBN : 9780309162906
Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf
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.
Medical Devices Law and Regulation Answer Book by Susan Onel,Karen M. Becker Pdf
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Health, the Medical Profession, and Regulation by Peter Zweifel Pdf
Health, The Medical Profession, and Regulation presents new evidence concerning health and the environment, inequality of health in many countries, and the compatibility of different quality of life measurements, along with new solutions to problems of health policy. The book is grouped into three sections. Section I, comprising six papers, looks into the determinants of people's health. Section II consists of three papers and deals with the supply side of the market for health care services. Finally, Section III contains three contributions devoted to health regulation. The intended market for this volume includes, but is not limited to, health economists, policy makers, insurers, and governmental advisors who need to stay abreast of the latest developments in health services research worldwide.
Institute of Medicine,Board on Health Care Services,Committee on the Health Professions Education Summit
Author : Institute of Medicine,Board on Health Care Services,Committee on the Health Professions Education Summit Publisher : National Academies Press Page : 191 pages File Size : 42,7 Mb Release : 2003-07-01 Category : Medical ISBN : 9780309133197
Health Professions Education by Institute of Medicine,Board on Health Care Services,Committee on the Health Professions Education Summit Pdf
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.
Regulating the Health Professions by Judith Allsop,Mike Saks Pdf
`It has particular appeal for health-care professionals and managers with an interest in corporate and clinical governance' - British Journal of Perioperative Nursing In recent years the health professions have been subject to unprecedented regulatory changes. Exposure of poor practice provoked widespread criticism of self-regulation and calls for a system in which the interests of health care consumers and employers are more fully recognized. Examining the historical and contemporary context, Regulating the Health Professions provides an in-depth analysis of professional self-regulation and the implications of regulatory change for the future of health care. Part One sets out general regulatory issues in the healthcare arena with chapters covering the impact of globalization on the professions, the purpose of professional regulation, the legal context of regulation and the significance of professional codes of ethics. In Part Two, issues specific to the different professions are explored through chapters on medicine, nursing, dentistry, the professions allied to medicine, clinical psychology and alternative medicine. This extremely topical book will be of interest to students, educators and researchers in a wide range of disciplines including sociology, social policy, politics and health studies, and to healthcare professionals and their managers.
Author : Robert I. Field Publisher : Oxford University Press, USA Page : 353 pages File Size : 43,8 Mb Release : 2007 Category : Medical ISBN : 9780195159684
Health Care Regulation in America by Robert I. Field Pdf
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.
Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule
Author : Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule Publisher : National Academies Press Page : 334 pages File Size : 54,8 Mb Release : 2009-03-24 Category : Computers ISBN : 9780309124997
Beyond the HIPAA Privacy Rule by Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule Pdf
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.
The Sociology of Medical Regulation by John Martyn Chamberlain Pdf
This book provides a comprehensive examination of the complex issues surrounding the regulation of the medical profession. It offers up-to-date information on the current legislative framework and institutional arrangements surrounding the regulation in the United Kingdom. Well organized and written in an accessible way, it offers an insight into key sociological theories surrounding medical regulation. It gives a historically situated analysis of the contemporary relationship between medicine, the state and the public, and an overview of relevant social scientific research. Case studies highlight the practical or applied circumstances in which issues can occur. Readers will gain insight into possible future directions for medical governance.
Committee for the Study of the Future of Public Health,Division of Health Care Services,Institute of Medicine
Author : Committee for the Study of the Future of Public Health,Division of Health Care Services,Institute of Medicine Publisher : National Academies Press Page : 240 pages File Size : 43,5 Mb Release : 1988-01-15 Category : Medical ISBN : 9780309581905
The Future of Public Health by Committee for the Study of the Future of Public Health,Division of Health Care Services,Institute of Medicine Pdf
"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.
Author : David A. Johnson,Humayun J. Chaudhry Publisher : Federation of State Medical Boards Page : 391 pages File Size : 46,9 Mb Release : 2012-08-10 Category : Medical ISBN : 9780739174401
Medical Licensing and Discipline in America by David A. Johnson,Humayun J. Chaudhry Pdf
Medical Licensing and Discipline in America traces the evolution of the U.S. medical licensing system from its historical antecedents in the 18th and 19th century to its modern structure. David A. Johnson and Humayun J. Chaudhry provide an organizational history of the Federation of State Medical Boards within the broader context of the development of America’s state-based system. As the national organization representing the interests of the individual state medical boards, the Federation has been at the forefront of developments in licensing, discipline, and regulation impacting the medical profession, medical education, and health policy within the United States. The narrative shifts between micro- and macro-level developments in the evolution of America’s medical licensing system, blending national context with state-specific and Federation initiatives. For example, the book documents such milestones as the national shift toward greater public accountability by state medical boards as evidenced by California’s inclusion of public members on its medical board, New Mexico’s requirement for continuing medical education by physicians as a condition for license renewal and the Federation’s policy development work advocating for both initiatives among all state medical boards. The book begins by examining the 18th and 19th century origins of the modern state-based medical regulatory system, including the reinstitution of licensing boards in the latter part of the 19th century and the early challenges facing boards, e.g., license portability, examinations, physician impostors, inter-professional tensions among physicians, etc. Medical Licensing and Discipline in America picks up the story of the Federation and its role in the major issue of licensing and discipline in the 20th century: uniformity in medical statute, evaluation of international medical graduates, nationally administered examinations for licensure, etc.
WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices by World Health Organization Pdf
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.
United States. Congress,United States House of Representatives,Committee on Energy and Commerce
Author : United States. Congress,United States House of Representatives,Committee on Energy and Commerce Publisher : Createspace Independent Publishing Platform Page : 206 pages File Size : 48,9 Mb Release : 2017-12-20 Category : Electronic ISBN : 1981861238
Impact of Medical Device Regulation on Jobs and Patients by United States. Congress,United States House of Representatives,Committee on Energy and Commerce Pdf
Impact of medical device regulation on jobs and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, February 17, 2011.
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
