Comprehensive Market And Regulatory Strategies For Medical Care

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Access to Health Care in America

Author : Institute of Medicine,Committee on Monitoring Access to Personal Health Care Services
Publisher : National Academies Press
Page : 240 pages
File Size : 41,7 Mb
Release : 1993-02-01
Category : Medical
ISBN : 9780309047425

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Access to Health Care in America by Institute of Medicine,Committee on Monitoring Access to Personal Health Care Services Pdf

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 Regulations

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 43,5 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Innovation and Protection

Author : I. Glenn Cohen,Timo Minssen,W. Nicholson Price II,Christopher Robertson,Carmel Shachar
Publisher : Cambridge University Press
Page : 295 pages
File Size : 55,8 Mb
Release : 2022-04-07
Category : Law
ISBN : 9781108838634

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Innovation and Protection by I. Glenn Cohen,Timo Minssen,W. Nicholson Price II,Christopher Robertson,Carmel Shachar Pdf

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

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 : 45,8 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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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.

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

Author : OECD,World Health Organization
Publisher : OECD Publishing
Page : 128 pages
File Size : 40,8 Mb
Release : 2019-10-17
Category : Electronic
ISBN : 9789264805903

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Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by OECD,World Health Organization Pdf

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.

Modern Methods of Clinical Investigation

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 43,7 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864

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Modern Methods of Clinical Investigation by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Health System Efficiency

Author : Jonathan Cylus,Irene Papanicolas,Peter C. Smith
Publisher : Health Policy
Page : 264 pages
File Size : 54,5 Mb
Release : 2016-12-15
Category : Medical
ISBN : 9289050411

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Health System Efficiency by Jonathan Cylus,Irene Papanicolas,Peter C. Smith Pdf

In this book the authors explore the state of the art on efficiency measurement in health systems and international experts offer insights into the pitfalls and potential associated with various measurement techniques. The authors show that: - The core idea of efficiency is easy to understand in principle - maximizing valued outputs relative to inputs, but is often difficult to make operational in real-life situations - There have been numerous advances in data collection and availability, as well as innovative methodological approaches that give valuable insights into how efficiently health care is delivered - Our simple analytical framework can facilitate the development and interpretation of efficiency indicators.

Strategies in Pharmacoeconomics and Outcomes Research

Author : Albert I Wertheimer,Reinhard Rychlik
Publisher : CRC Press
Page : 0 pages
File Size : 54,7 Mb
Release : 2002-10-21
Category : Medical
ISBN : 0789015846

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Strategies in Pharmacoeconomics and Outcomes Research by Albert I Wertheimer,Reinhard Rychlik Pdf

Get a healthy perspective on pharmaceutical economics! Strategies in Pharmacoeconomics and Outcomes Research presents a comprehensive introduction to the economic aspects of the health sector, focusing on strategies for the development and marketing of healthcare products. A much-needed addition to this relatively new field, the book narrows health economics into the sub-discipline of pharmacoeconomics, bridging the gap between different interest groups in the pharmaceutical industry-research and development at one end, sales and marketing at the other. Using basic terminology and practical examples with descriptive tables and figures, it analyzes the implications of projecting costs of pharmaceutical products as a method of determining the viability of their development. Written from an international perspective, Strategies in Pharmacoeconomics and Outcomes Research examines the costs of drug therapy on health care systems and society through global marketing and modeling strategies, including clinical research and trial examples. Through the interlinked concepts of clinical research, outcomes research and pharmacoeconomics, the book evaluates the effectiveness of health technologies under “real world” circumstances or “normal” medical practice to achieve the optimum benefit from the resources available. The research process follows the economics of a drug?s efficacy (how it works under ideal circumstances) to its effectiveness (how it does in “real” life) to its efficiency (how cost-effective it is) in determining the baseline effects of a disease on economic and humanistic parameters. Strategies in Pharmacoeconomics and Outcomes Research also examines: resources and cost benefits (direct, indirect, intangible, and quality of life) health economical models (decision-tree analysis, Markov-model) reimbursement differences between countries due to the rate of currency exchange drug monitoring and regulation . . . and includes an extensive glossary! At a time when health economics has become increasingly important, Strategies in Pharmacoeconomics and Outcomes Research is an essential tool for the pharmaceutical, diagnostic, and medical device industries to ensure the most efficient use of limited resources. The book?s practical tone and common-sense methods provide a realistic approach that will benefit pharmaceutical and medical professionals, product managers, business development managers, drug regulatory affairs officials, and clinical study coordinators in making strategic and operational decisions about pharmaceutical development, production, or consumption.

To Err Is Human

Author : Institute of Medicine,Committee on Quality of Health Care in America
Publisher : National Academies Press
Page : 312 pages
File Size : 51,7 Mb
Release : 2000-03-01
Category : Medical
ISBN : 9780309068376

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To Err Is Human by Institute of Medicine,Committee on Quality of Health Care in America Pdf

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

Beyond 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 : 47,7 Mb
Release : 2009-03-24
Category : Computers
ISBN : 9780309124997

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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.

A Primer on Competitive Strategies for Containing Health Care Costs

Author : United States. General Accounting Office
Publisher : Unknown
Page : 64 pages
File Size : 44,7 Mb
Release : 1982
Category : Medical care, Cost of
ISBN : SRLF:D0010168466

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A Primer on Competitive Strategies for Containing Health Care Costs by United States. General Accounting Office Pdf

Health-Care Utilization as a Proxy in Disability Determination

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Health Care Utilization and Adults with Disabilities
Publisher : National Academies Press
Page : 161 pages
File Size : 40,5 Mb
Release : 2018-04-02
Category : Medical
ISBN : 9780309469210

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Health-Care Utilization as a Proxy in Disability Determination by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Health Care Utilization and Adults with Disabilities Pdf

The Social Security Administration (SSA) administers two programs that provide benefits based on disability: the Social Security Disability Insurance (SSDI) program and the Supplemental Security Income (SSI) program. This report analyzes health care utilizations as they relate to impairment severity and SSA's definition of disability. Health Care Utilization as a Proxy in Disability Determination identifies types of utilizations that might be good proxies for "listing-level" severity; that is, what represents an impairment, or combination of impairments, that are severe enough to prevent a person from doing any gainful activity, regardless of age, education, or work experience.

Price Setting and Price Regulation in Health Care

Author : OECD,World Health Organization,Barber Sarah L,Lorenzoni Luca,Ong Paul
Publisher : OECD Publishing
Page : 298 pages
File Size : 50,5 Mb
Release : 2019-06-26
Category : Electronic
ISBN : 9789264508866

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Price Setting and Price Regulation in Health Care by OECD,World Health Organization,Barber Sarah L,Lorenzoni Luca,Ong Paul Pdf

The objectives of this study are to describe experiences in price setting and how pricing has been used to attain better coverage, quality, financial protection, and health outcomes. It builds on newly commissioned case studies and lessons learned in calculating prices, negotiating with providers, and monitoring changes. Recognising that no single model is applicable to all settings, the study aimed to generate best practices and identify areas for future research, particularly in low- and middle-income settings. The report and the case studies were jointly developed by the OECD and the WHO Centre for Health Development in Kobe (Japan).