EBOOK: Regulating Healthcare

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Publisher : McGraw-Hill Education (UK)
ISBN 13 : 0335228283
Total Pages : 276 pages
Book Rating : 4.3/5 (352 download)

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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.

Medical Regulatory Affairs

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Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)

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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.

Access to Health Care in America

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Publisher : National Academies Press
ISBN 13 : 0309047420
Total Pages : 240 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Access to Health Care in America by : Institute of Medicine

Download or read book Access to Health Care in America written by Institute of Medicine and published by National Academies Press. This book was released on 1993-02-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans are accustomed to anecdotal evidence of the health care crisis. Yet, personal or local stories do not provide a comprehensive nationwide picture of our access to health care. Now, this book offers the long-awaited health equivalent of national economic indicators. This useful volume defines a set of national objectives and identifies indicatorsâ€"measures of utilization and outcomeâ€"that can "sense" when and where problems occur in accessing specific health care services. Using the indicators, the committee presents significant conclusions about the situation today, examining the relationships between access to care and factors such as income, race, ethnic origin, and location. The committee offers recommendations to federal, state, and local agencies for improving data collection and monitoring. This highly readable and well-organized volume will be essential for policymakers, public health officials, insurance companies, hospitals, physicians and nurses, and interested individuals.

Medical Device Design and Regulation

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Publisher : Quality Press
ISBN 13 : 0873898168
Total Pages : 369 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Medical Device Design and Regulation by : Carl T. DeMarco

Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Improving Health Care Safety and Quality

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Publisher : Ashgate Publishing, Ltd.
ISBN 13 : 1409497496
Total Pages : 349 pages
Book Rating : 4.4/5 (94 download)

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Book Synopsis Improving Health Care Safety and Quality by : Dr Judith Healy

Download or read book Improving Health Care Safety and Quality written by Dr Judith Healy and published by Ashgate Publishing, Ltd.. This book was released on 2013-02-28 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: Responding to the public concern caused by recent hospital scandals and accounts of unintended harm to patients, this author draws on her experience of analysing the health care systems of over a dozen countries and examines whether greater regulation has increased patient safety and health care quality. The book adopts a new approach to mapping developments in health care systems in Europe, North America and Australia and pieces together evidence of which regulatory strategies and mechanisms work well to ensure safer patient care. It identifies the regulatory bodies, the regulatory principles and the implementation strategies adopted to improve governance in health care systems and suggests a conceptual framework for responsive regulation. The book will be of interest to government actors, health care professionals and medico-legal scholars.

Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies

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Publisher : OECD Publishing
ISBN 13 : 9264805907
Total Pages : pages
Book Rating : 4.2/5 (648 download)

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Book Synopsis Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by : OECD

Download or read book Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

EBOOK: Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality

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Author :
Publisher : McGraw-Hill Education (UK)
ISBN 13 : 0335226558
Total Pages : 390 pages
Book Rating : 4.3/5 (352 download)

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Book Synopsis EBOOK: Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality by : Elias Mossialos

Download or read book EBOOK: Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality written by Elias Mossialos and published by McGraw-Hill Education (UK). This book was released on 2004-06-16 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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 of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care.Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers. The editors: Elias Mossialos is Brian Abel-Smith Professor of Health Policy at the London School of Economics and Political Science and a Research Director of the European Observatory on Health Systems and Policies. Monique Mrazek is a Health Economist (Europe and Central Asia region) for the World Bank and formerly a Research Officer in Health Economics for the European Observatory on Health Systems and Policies. Tom Walley is Professor of Clinical Pharmacology at the University of Liverpool and Director of the UK National Health Technology Assessment Programme. Contributors: Julia Abelson, Christa Altenstetter, Vittorio Bertele’, Christine Bond, Marcel L. Bouvy, Colin Bradley, Steve Chapman, Anna Dixon, Michael Drummond, Pierre Durieux, Edzard Ernst, Armin Fidler, Eric Fortess, Richard Frank, Silvio Garattini, Leigh Hancher, Ebba Holme Hansen, Steve Hudson, Kees de Jonchere, Panos Kanavos, Sjoerd Kooiker, Jean-Marc Leder, Graham Lewis, Donald W. Light, Alistair McGuire, Elias Mossialos, Monique Mrazek, Maria Pia Orru', Govin Permanand, Guenka Petrova, Munir Pirmohamed, Dennis Ross-Degnan, Frans Rutten, Steven Soummerai, David Taylor, Sarah Thomson, Tom Walley.

Robots, Healthcare, and the Law

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Publisher : Routledge
ISBN 13 : 042966415X
Total Pages : 237 pages
Book Rating : 4.4/5 (296 download)

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Book Synopsis Robots, Healthcare, and the Law by : Eduard Fosch-Villaronga

Download or read book Robots, Healthcare, and the Law written by Eduard Fosch-Villaronga and published by Routledge. This book was released on 2019-11-04 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt: The integration of robotic systems and artificial intelligence into healthcare settings is accelerating. As these technological developments interact socially with children, the elderly, or the disabled, they may raise concerns besides mere physical safety; concerns that include data protection, inappropriate use of emotions, invasion of privacy, autonomy suppression, decrease in human interaction, and cognitive safety. Given the novelty of these technologies and the uncertainties surrounding the impact of care automation, it is unclear how the law should respond. This book investigates the legal and regulatory implications of the growing use of personal care robots for healthcare purposes. It explores the interplay between various aspects of the law, including safety, data protection, responsibility, transparency, autonomy, and dignity; and it examines different robotic and AI systems, such as social therapy robots, physical assistant robots for rehabilitation, and wheeled passenger carriers. Highlighting specific problems and challenges in regulating complex cyber-physical systems in concrete healthcare applications, it critically assesses the adequacy of current industry standards and emerging regulatory initiatives for robots and AI. After analyzing the potential legal and ethical issues associated with personal care robots, it concludes that the primarily principle-based approach of recent law and robotics studies is too abstract to be as effective as required by the personal care context. Instead, it recommends bridging the gap between general legal principles and their applicability in concrete robotic and AI technologies with a risk-based approach using impact assessments. As the first book to compile both legal and regulatory aspects of personal care robots, this book will be a valuable addition to the literature on robotics, artificial intelligence, human–robot interaction, law, and philosophy of technology.

Health Care Law and Ethics

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Publisher : Aspen Publishing
ISBN 13 : 1454897651
Total Pages : 2303 pages
Book Rating : 4.4/5 (548 download)

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Book Synopsis Health Care Law and Ethics by : Mark A. Hall

Download or read book Health Care Law and Ethics written by Mark A. Hall and published by Aspen Publishing. This book was released on 2018-02-26 with total page 2303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health Care Law and Ethics, Ninth Edition offers a relationship-oriented approach to health law—covering the essentials, as well as topical and controversial subjects. The book provides thoughtful and teachable coverage of every aspect of health care law. Current and classic cases build logically from the fundamentals of the patient/provider relationship to the role of government and institutions in health care. The book is adaptable to both survey courses and courses covering portions of the field. Key Features: New authors Nick Bagley and Glenn Cohen Incorporated anticipated changes to the Affordable Care Act More current cases and more streamlined notes, including ones on medical malpractice, bioethics, and on finance and regulation More coverage of “conscientious objection” and “big data” - Discussion of new “value based” methods of physician payment - Expanded coverage of “fraud and abuse” Current issues in public health (e.g., Ebola, Zika) and controversies in reproductive choice (e.g., Hobby Lobby) Coverage of cutting-edge genetic technologies (e.g., gene editing and mitochondrial replacement)

Healthcare Research Ethics and Law

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Publisher : Routledge
ISBN 13 : 1135309272
Total Pages : 233 pages
Book Rating : 4.1/5 (353 download)

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Book Synopsis Healthcare Research Ethics and Law by : Hazel Biggs

Download or read book Healthcare Research Ethics and Law written by Hazel Biggs and published by Routledge. This book was released on 2009-10-16 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject. Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.

States, Regulation and the Medical Profession

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Publisher :
ISBN 13 : 9780335157495
Total Pages : 150 pages
Book Rating : 4.1/5 (574 download)

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Book Synopsis States, Regulation and the Medical Profession by : Michael Moran

Download or read book States, Regulation and the Medical Profession written by Michael Moran and published by . This book was released on 1993-01-01 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt:

To Err Is Human

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Publisher : National Academies Press
ISBN 13 : 0309068371
Total Pages : 312 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis To Err Is Human by : Institute of Medicine

Download or read book To Err Is Human written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-01 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine

The Privatization of Health Care Reform

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Publisher : Oxford University Press
ISBN 13 : 0199770026
Total Pages : 245 pages
Book Rating : 4.1/5 (997 download)

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Book Synopsis The Privatization of Health Care Reform by : M. Gregg Bloche

Download or read book The Privatization of Health Care Reform written by M. Gregg Bloche and published by Oxford University Press. This book was released on 2002-10-17 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: Markets, not politics, are driving health care reform in America today. Inventive entrepreneurs have transformed medicine over the past ten years, and no end to this period of rapid change is in sight. Consumer anxieties over managed care are mounting, and medical costs are again soaring. Meanwhile, the federal government remains mostly on the health policy sidelines, as it has since the collapse of the Clinton administration's campaign for health care reform. This book addresses the changes that the market has wrought- and the challenges this transformation poses for courts and regulators. The law that governs the medical marketplace is an incomplete, overlapping patchwork, conceived mainly without medical care specifically in mind. The ensuing confusion and incoherence are a central theme of this book. Fragmentation of health care lawmaking has foreclosed coordinated, system-wide policy responses, and lack of national consensus on many of the central questions in health care policy has translated into legal contradiction and bitter controversy. Written by leading commentators on American health law and policy, this book examines the widely-perceived failings of managed care and the law's relationship to them. Some of the contributors treat law as a cause of trouble; others emphasize the law's potential and limits as a corrective tool when the market disappoints. The first two chapters present contrasting overviews of how the doctrines and decision-makers that constitute health law work together, for better or worse, to constrain the medical marketplace. The next six chapters address particular market developments and regulatory dilemmas. These include the power of state versus federal government in the health sphere, conflict between insureres and patients and providers over medical need, financial rewards to physicians for frugal practice, the role of antitrust law in the organization of health care provision and financing, the future of public hospitals, and the place of investor-owned versus non-profit institutions. Acknowledging the health sphere's complexities, the authors seek remedies that fit this country's legal, political, and cultural constraints and can contribute to reasoned regulatory goverance. Within limits they believe a measure of rationality is possible.

Regulatory Affairs for Biomaterials and Medical Devices

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Publisher : Elsevier
ISBN 13 : 0857099205
Total Pages : 202 pages
Book Rating : 4.8/5 (57 download)

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Book Synopsis Regulatory Affairs for Biomaterials and Medical Devices by : Stephen F. Amato

Download or read book Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato and published by Elsevier. This book was released on 2014-10-27 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

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Publisher :
ISBN 13 : 9781935065876
Total Pages : 672 pages
Book Rating : 4.0/5 (658 download)

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Book Synopsis A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition by : Stephen M. Kanovsky

Download or read book A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

The Regulation of Healthcare Professionals

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Publisher :
ISBN 13 : 9780414067110
Total Pages : 2284 pages
Book Rating : 4.0/5 (671 download)

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Book Synopsis The Regulation of Healthcare Professionals by : David Gomez

Download or read book The Regulation of Healthcare Professionals written by David Gomez and published by . This book was released on 2019 with total page 2284 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Q Solutions

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Publisher :
ISBN 13 : 9780985833640
Total Pages : 54 pages
Book Rating : 4.8/5 (336 download)

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Book Synopsis Q Solutions by : Diane S. Brown

Download or read book Q Solutions written by Diane S. Brown and published by . This book was released on 2012-11-11 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: