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.
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 447 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.
Download or read book The Regulation of Cosmetic Procedures written by Melanie Latham and published by Routledge. This book was released on 2020-04-30 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the legal, ethical and regulatory debates surrounding the rise of the cosmetic procedures industry. In the past, cosmetic procedures were often seen as limited to a small number of wealthy older women. Today, such procedures have gone mainstream, partly facilitated by the rise of ‘non-invasive’ techniques, such as the use of Botox and Dermal Fillers. While still a business dominated by the female consumer, there is also an increasing number of males undertaking cosmetic procedures as social expectations around appearance and ageing are challenged. At the same time, the rapid expansion of this business and the incoherent, diverse approach to its regulation have given rise to concern. It has been seen as a ‘Wild West’. If cosmetic procedures go wrong, such procedures give rise to real risks of harm. This book examines the historical backdrop, current practice and risks associated with cosmetic procedures. It discusses the ethical and regulatory challenges for this area. It also examines the current legal frameworks concerning people, practitioners and products in the UK. The book also draws lessons from regulatory approaches in other jurisdictions with particular reference to the United States, Brazil and France. It then sets out a legal and regulatory framework that might better protect and empower the cosmetic consumer, now and in the future. The book is likely to be of particular interest to those working in the areas of health and medical law, socio-legal studies and political science.
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 2011-11-25 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.
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).
Download or read book Sensor Technologies written by Michael J. McGrath and published by Apress. This book was released on 2014-01-23 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sensor Technologies: Healthcare, Wellness and Environmental Applications explores the key aspects of sensor technologies, covering wired, wireless, and discrete sensors for the specific application domains of healthcare, wellness and environmental sensing. It discusses the social, regulatory, and design considerations specific to these domains. The book provides an application-based approach using real-world examples to illustrate the application of sensor technologies in a practical and experiential manner. The book guides the reader from the formulation of the research question, through the design and validation process, to the deployment and management phase of sensor applications. The processes and examples used in the book are primarily based on research carried out by Intel or joint academic research programs. “Sensor Technologies: Healthcare, Wellness and Environmental Applications provides an extensive overview of sensing technologies and their applications in healthcare, wellness, and environmental monitoring. From sensor hardware to system applications and case studies, this book gives readers an in-depth understanding of the technologies and how they can be applied. I would highly recommend it to students or researchers who are interested in wireless sensing technologies and the associated applications.” Dr. Benny Lo Lecturer, The Hamlyn Centre, Imperial College of London “This timely addition to the literature on sensors covers the broad complexity of sensing, sensor types, and the vast range of existing and emerging applications in a very clearly written and accessible manner. It is particularly good at capturing the exciting possibilities that will occur as sensor networks merge with cloud-based ‘big data’ analytics to provide a host of new applications that will impact directly on the individual in ways we cannot fully predict at present. It really brings this home through the use of carefully chosen case studies that bring the overwhelming concept of 'big data' down to the personal level of individual life and health.” Dermot Diamond Director, National Centre for Sensor Research, Principal Investigator, CLARITY Centre for Sensor Web Technologies, Dublin City University "Sensor Technologies: Healthcare, Wellness and Environmental Applications takes the reader on an end-to-end journey of sensor technologies, covering the fundamentals from an engineering perspective, introducing how the data gleaned can be both processed and visualized, in addition to offering exemplar case studies in a number of application domains. It is a must-read for those studying any undergraduate course that involves sensor technologies. It also provides a thorough foundation for those involved in the research and development of applied sensor systems. I highly recommend it to any engineer who wishes to broaden their knowledge in this area!" Chris Nugent Professor of Biomedical Engineering, University of Ulster
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Download or read book Beautyscapes written by Ruth Holliday and published by Manchester University Press. This book was released on 2019-07-04 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: Beautyscapes explores the global phenomenon of international medical travel, focusing on patient-consumers seeking cosmetic surgery outside their home country and on those who enable them to access treatment abroad, including surgeons and facilitators. It documents the journeys of those who travel for treatment abroad, as well as the nature and power relations of the IMT industry. Empirically rich and theoretically sophisticated, Beautyscapes draws on key themes of interest to students and researchers interested in globalisation and mobility to explain the nature and growing popularity of cosmetic surgery tourism. Richly illustrated with ethnographic material and with the voices of those directly involved in cosmetic surgery tourism, Beautyscapes explores cosmetic surgery journeys from Australia and China to East-Asia and from the UK to Europe and North Africa.
Download or read book European Union Health Law written by Tamara K. Hervey and published by Cambridge University Press. This book was released on 2015-11-12 with total page 749 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first holistic and thematic study of EU health law, and its implications, through its own internal logics.
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Download or read book Arbitrary and Capricious written by Gary Elvin Marchant and published by American Enterprise Institute. This book was released on 2004 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study examines how the European Union has used the precautionary principle in legal decisions.
Download or read book Tolerable upper intake levels for vitamins and minerals written by European Commission. Scientific Committee on Food and published by . This book was released on 2006 with total page 478 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Health United States 2016 with Chartbook on Long Term Trends in Health written by National Center for Health Statistics and published by Government Printing Office. This book was released on 2017-08-16 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: This annual overview report of national trends in health statistics contains a Chartbook that assesses the nation's health by presenting trends and current information on selected measures of morbidity, mortality, health care utilization and access, health risk factors, prevention, health insurance, and personal health-care expenditures. Chapters devoted to population characteristics, prevention, health risk factors, health care resources, personal health care expenditures, health insurance, and trend tables may provide the health/medical statistician, data analyst, biostatistician with additional information to complete experimental studies or provide necessary research for pharmaceutical companies to gain data for modeling and sampling. Undergraduate students engaged in applied mathematics or statistical compilations to graduate students completing biostatistics degree programs to include statistical inference principles, probability, sampling methods and data analysis as well as specialized medical statistics courses relating to epidemiology and other health topics may be interested in this volume. Related products: Your Guide to Choosing a Nursing Home or Other Long-Term Services & Supports available here: https://bookstore.gpo.gov/products/your-guide-choosing-nursing-home-or-other-long-term-services-supports Health Insurance Coverage in the United States, 2014 available here: https://bookstore.gpo.gov/products/health-insurance-coverage-united-states-2014 "Some System of the Nature Here Proposed": Joseph Lovell's Remarks on the Sick Report, Northern Department, U.S. Army, 1817, and the Rise of the Modern US Army Medical Department can be found here: https://bookstore.gpo.gov/products/some-system-nature-here-proposed-joseph-lovells-remarks-sick-report-northern-department-us Guide to Clinical Preventive Services 2014: Recommendations of the U.S. Preventive Services Task Force (ePub) -Free digital eBook download available at the US Government Online Bookstore here: https://bookstore.gpo.gov/products/guide-clinical-preventive-services-2014-recommendations-us-preventive-services-task-force --Also available for FREE digital eBook download from Apple iBookstore, BarnesandNoble.com (Nook Bookstore), Google Play eBookstore, and Overdrive -Please use ISBN: 9780160926426 to search these commercial platforms.
Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
