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.

WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive. This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population.

New technologies with the potential to improve the health of populations are continuously being introduced. But not every technological development results in clear health gains. Health technology assessment provides evidence-based information on the coverage and usage of health technologies, enabling them to be evaluated properly and applied to health care efficaciously, promoting the most effective ones while also taking into account organizational, societal and ethical issues. This book reviews the relationship between health technology assessment and policy-making, and examines how to increase the contribution such research makes to policy- and decision-making processes. By communicating the value and potential of health technology assessment to a wider audience, both within and beyond decision-making and health care management, it aims ultimately to contribute to improve the health status of the population through the delivery of optimum health services.

A timely work describing how localized hospital-based health technology assessment (HB-HTA) complements general, ‘arms-length’ HTA agency efforts, and what has been the collective global impact of HB-HTA across the globe. While HB-HTA has gained significant momentum over the past few years, expertise in the field, and information on the operation and organization of HB-HTA, has been scattered. This book serves to bring this information together to inform those who are currently working in the field of HTA at the hospital, regional, national or global level. In addition, this book is intended for decision-makers and policy-makers with a stake in determining the uptake and decommissioning of new and established technologies in the hospital setting. HTA has traditionally been performed at the National/Regional level by HTA Agencies, typically linked to governments. Yet hospitals are the main entry door for most health technologies (HTs). Hospital decision-makers must undertake multiple high stakes investment and disinvestment decisions annually for innovative HTs, usually without adequate information. Despite the existence of arms-length HTA Agencies, inadequate information is available to hospital decision-makers either because relevant HTA reports are not yet released at the time of entry of new technologies to the field, or because even when the report exists, the information contained is insufficient to clarify the contextualized informational needs of hospital decision makers. Therefore, there has recently been a rising trend toward hospital-based HTA units and programs. These units/programs complement the work of National/Regional HTA Agencies by providing the key and relevant evidence needed by hospital decision makers in their specific hospital context, and within required decision-making timelines. The emergence of HB-HTA is creating a comprehensive HTA ecosystem across health care levels, which creates better bridges for knowledge translation through relevance and timeliness.

This book disentangles the issues in connection with the advancement of Health Technology Assessment (HTA) and its interface with health policy. It highlights the factors that should shape its progress in the near future. Interdisciplinary and critical views from a number of professionals are put together in a prescient order to cast some light and make recommendations as to the next steps HTA should take to be fit for purpose. A wealth of documents dealing with HTA have been published over the last three decades. HTA allegedly is one of the bedrocks of regulation and medical decision making. However, counter vailing visions contend that geographical variations in the role that HTA is actually playing within countries pinpoints specific room for improvement. Given our social preferences, cherry-picking HTA’s features and successes over the last decades moves it away from its possibility frontier. Some of the most noteworthy hindrances that HTA faces, in several countries, to making headway towards its consolidation as an efficient tool for regulation and decision making are as follows: insufficient resources, delays in assessment, inadequate priority setting, regulatory capture, public distrust, actual influence on regulatory decisions, the need for strengthening international cooperation and harmony, the lack of sound and consistent assessments of diagnostic tests, medical devices and surgical innovations and limited dissemination. Time has come for HTA to take a renewed stand. There is a pressing need to submit HTA to in-depth critical scrutiny.

Representing the first book on the topic, this work offers the reader an introduction to the Japanese systems for health technology assessment (HTA) officially introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2016. Policy and guidelines are discussed, with the relevant methods and conditions of cost-effectiveness analysis explained alongside. Numerous instructive examples and exercises, ranging from basic to advanced, impart valuable knowledge and insight on the quantitative methods for economic evaluation, which will appeal to both beginners and experts. This guidebook is authored by Japan’s foremost expert in HTA and pharmacoeconomics, with a view to strengthening the reader’s expertise in value-based healthcare and decision-making. The methods presented are essential to informing regulatory, local and patient decisions; as such, the book is equally recommended to industry and government, as well as academia, and anyone with an interest in Japanese HTA.

The term health technology refers to drugs, devices, and programs that can improve and extend quality of life. As decision-makers struggle to find ways to reduce costs while improving health care delivery, health technology assessments (HTA) provide the evidence required to make better-informed decisions.This is the first book that focuses on the s

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.

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.