EBOOK: Regulating Healthcare

EBOOK: Regulating Healthcare

Author: Kieran Walshe

Publisher: McGraw-Hill Education (UK)

Published: 2003-06-16

Total Pages: 276

ISBN-13: 0335228283

DOWNLOAD EBOOK

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.


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

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

Author: OECD

Publisher: OECD Publishing

Published: 2019-10-17

Total Pages: 447

ISBN-13: 9264805907

DOWNLOAD EBOOK

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.


To Err Is Human

To Err Is Human

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2000-03-01

Total Pages: 312

ISBN-13: 0309068371

DOWNLOAD EBOOK

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


Access to Health Care in America

Access to Health Care in America

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1993-02-01

Total Pages: 240

ISBN-13: 0309047420

DOWNLOAD EBOOK

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.


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

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

Author: Stephen M. Kanovsky

Publisher:

Published: 2020-09

Total Pages: 672

ISBN-13: 9781935065876

DOWNLOAD EBOOK

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.


Health Care Law and Ethics

Health Care Law and Ethics

Author: Mark A. Hall

Publisher: Aspen Publishing

Published: 2018-02-26

Total Pages: 2168

ISBN-13: 1454897651

DOWNLOAD EBOOK

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)


Medical Regulatory Affairs

Medical Regulatory Affairs

Author: Jack Wong

Publisher: CRC Press

Published: 2022-01-27

Total Pages: 806

ISBN-13: 1000440516

DOWNLOAD EBOOK

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.


Robots, Healthcare, and the Law

Robots, Healthcare, and the Law

Author: Eduard Fosch-Villaronga

Publisher: Routledge

Published: 2019-11-04

Total Pages: 247

ISBN-13: 042966415X

DOWNLOAD EBOOK

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.