National Information Center on Health Services Research and Health Care Technology (NICHSR)
HTA 101: Introduction to Health Technology Assessment
- A. Origins of Technology Assessment
- B. Early Health Care Technology Assessment
- References for Chapter I
Technological innovation has yielded truly remarkable advances in health care during the last five decades. In recent years, breakthroughs in a variety of areas have helped to improve health care delivery and patient outcomes, including antivirals, anticlotting drugs, antidiabetic drugs, antihypertensive drugs, antirheumatic drugs, vaccines, pharmacogenomics and targeted cancer therapies, cardiac rhythm management, diagnostic imaging, minimally invasive surgery, joint replacement, pain management, infection control, and health information technology.
The proliferation of health care technology and its expanding uses have contributed to burgeoning health care costs, and the former has been cited as “culprit” for the latter. However, this relationship is variable, complex, and evolving (Cutler 2001; Cutler 2011; Goyen 2009; Medicare Payment Advisory Commission 2001; Newhouse 1992; Smith 2000). In the US, the Congressional Budget Office concluded that “roughly half of the increase in health care spending during the past several decades was associated with the expanded capabilities of medicine brought about by technological advances” (US Congressional Budget Office 2008).
Few patients or clinicians are willing to forego access to state-of-the-art health care technology. In the wealthier countries and those with growing economies, adoption and use of technology has been stimulated by patient and physician incentives to seek any potential health benefit with limited regard to cost, and by third-party payment, provider competition, effective marketing of technologies, and consumer awareness. Box I-1 shows some of the factors that influence demand for health technology.
Box I-1. Factors That Reinforce the Market for Health Technology
- Advances in science and engineering
- Intellectual property, especially patent protection
- Aging populations
- Increasing prevalence of chronic diseases
- Emerging pathogens and other disease threats
- Third-party payment, especially fee-for-service payment
- Financial incentives of technology companies, clinicians, hospitals, and others
- Public demand driven by direct-to-consumer advertising, mass media reports, social media, and consumer awareness and advocacy
- Off-label use of drugs, biologics, and devices
- “Cascade” effects of unnecessary tests, unexpected results, or patient or physician anxiety
- Clinician specialty training at academic medical centers
- Provider competition to offer state-of-the-art technology
- Malpractice avoidance
- Strong or growing economies
In this era of increasing cost pressures, restructuring of health care delivery and payment, and heightened consumer demand—yet continued inadequate access to care for many millions of people—technology remains the substance of health care. Culprit or not, technology can be managed in ways that improve patient access and health outcomes, while continuing to encourage useful innovation. The development, adoption, and diffusion of technology are increasingly influenced by a widening group of policymakers in the health care sector. Health product makers, regulators, clinicians, patients, hospital managers, payers, government leaders, and others increasingly demand well-founded information to support decisions about whether or how to develop technology, to allow it on the market, to acquire it, to use it, to pay for its use, to ensure its appropriate use, and more. The growth and development of health technology assessment (HTA) in government and the private sector reflect this demand.
HTA methods are evolving and their applications are increasingly diverse. This document introduces fundamental aspects and issues of a dynamic field of inquiry. Broader participation of people with multiple disciplines and different roles in health care is enriching the field. The heightened demand for HTA, in particular from the for-profit and not-for-profit private sectors as well as from government agencies, is pushing the field to evolve more systematic and transparent assessment processes and reporting to diverse users. The body of knowledge about HTA cannot be found in one place and is not static. Practitioners and users of HTA should not only monitor changes in the field, but have considerable opportunities to contribute to its development.
Technology assessment (TA) arose in the mid-1960s from an appreciation of the critical role of technology in modern society and its potential for unintended, and sometimes harmful, consequences. Experience with the side effects of a multitude of chemical, industrial and agricultural processes and such services as transportation, health, and resource management contributed to this understanding. Early assessments concerned such topics as offshore oil drilling, pesticides, automobile pollution, nuclear power plants, supersonic airplanes, weather modification, and the artificial heart. TA was conceived as a way to identify the desirable first-order, intended effects of technologies as well as the higher-order, unintended social, economic and environmental effects (Banta 2009; Brooks and Bowers 1970; Kunkle 1995; Margolis 2003).
The term “technology assessment” was introduced in 1965 during deliberations of the Committee on Science and Astronautics of the US House of Representatives. Congressman Emilio Daddario emphasized that the purpose of TA was to serve policymaking:
[T]echnical information needed by policymakers is frequently not available, or not in the right form. A policymaker cannot judge the merits or consequences of a technological program within a strictly technical context. He has to consider social, economic, and legal implications of any course of action (US Congress, House of Representatives 1967).
Congress commissioned independent studies by the National Academy of Sciences, the National Academy of Engineering (NAE), and the Legislative Reference Service of the Library of Congress that significantly influenced the development and application of TA. These studies and further congressional hearings led the National Science Foundation to establish a TA program and, in 1972, Congress to authorize the congressional Office of Technology Assessment (OTA), which was founded in 1973, became operational in 1974, and established its health program in 1975.
Many observers were concerned that TA would be a means by which government would impede the development and use of technology. However, this was not the intent of Congress or of the agencies that conducted the original TAs. In 1969, an NAE report to Congress emphasized that:
Technology assessment would aid the Congress to become more effective in assuring that broad public as well as private interests are fully considered while enabling technology to make the maximum contribution to our society's welfare (National Academy of Engineering 1969).
With somewhat different aims, private industry used TA to aid in competing in the marketplace, for understanding the future business environment, and for producing options for decision makers.
TA methodology drew upon a variety of analytical, evaluative, and planning techniques. Among these were systems analysis, cost-benefit analysis, consensus development methods (e.g., Delphi method), engineering feasibility studies, clinical trials, market research, technological forecasting, and others. TA practitioners and policymakers recognized that TA is evolving, flexible, and should be tailored to the task (US Congress, Office of Technology Assessment 1977). Box I-2 shows various definitions of TA.
Box I-2. Some Definitions of Technology Assessment
[Technology assessment is] the systematic study of the effects on society, that may occur when a technology is introduced, extended, or modified, with emphasis on the impacts that are unintended, indirect, or delayed (Coates 1976).
Technology assessment (TA) is a category of policy studies, intended to provide decision makers with information about the possible impacts and consequences of a new technology or a significant change in an old technology. It is concerned with both direct and indirect or secondary consequences, both benefits and disbenefits, and with mapping the uncertainties involved in any government or private use or transfer of a technology. TA provides decision makers with an ordered set of analyzed policy options, and an understanding of their implications for the economy, the environment, and the social, political, and legal processes and institutions of society (Coates 1992).
Technology assessment ultimately comprises a systems approach to the management of technology reaching beyond technology and industrial aspects into society and environmental domains. Initially, it deals with assessment of effects, consequences, and risks of a technology, but also is a forecasting function looking into the projection of opportunities and skill development as an input into strategic planning. In this respect, it also has a component both for monitoring and scrutinizing information gathering. Ultimately, TA is a policy and consensus building process as well (UN Branch for Science and Technology for Development 1991).
Technology assessment is a form of policy research that examines short- and long-term social consequences (for example, societal, economic, ethical, legal) of the application of technology. The goal of technology assessment is to provide policy-makers with information on policy alternatives (1993).
Technology Assessment is a concept, which embraces different forms of policy analysis on the relation between science and technology on the one hand, and policy, society and the individual on the other hand. Technology Assessment typically includes policy analysis approaches such as foresight; economic analysis; systems analysis; strategic analysis etc. … Technology Assessment has three dimensions: the cognitive dimension ─ creating overview on knowledge, relevant to policy-making; the normative dimension ─ establishing dialogue in order to support opinion making; the pragmatic dimension ─ establish processes that help decisions to be made. And TA has three objects: the issue or technology; the social aspects; the policy aspects (European Parliamentary Technology Assessment 2013).
Health technologies had been studied for safety, effectiveness, cost, and other concerns long before the advent of HTA. Development of TA as a systematic inquiry in the 1960s and 1970s coincided with the introduction of some health technologies that prompted widespread public interest in matters that transcended their immediate health effects. Health care technologies were among the topics of early TAs. Multiphasic health screening was one of three topics of “experimental” TAs conducted by the NAE at the request of Congress (National Academy of Engineering 1969). In response to a request by the National Science Foundation to further develop the TA concept in the area of biomedical technologies, the National Research Council conducted TAs on in vitro fertilization, predetermination of the sex of children, retardation of aging, and modifying human behavior by neurosurgical, electrical or pharmaceutical means (National Research Council 1975). The OTA issued a report on drug bioequivalence in 1974 (Drug bioequivalence 1974), and the OTA Health Program issued its first formal report in 1976.
Since its early years, HTA has been fueled in part by emergence and diffusion of technologies that have evoked social, ethical, legal, and political concerns. Among these technologies are contraceptives, organ transplantation, artificial organs, life-sustaining technologies for critically or terminally ill patients, and, more recently, genetic testing, genetic therapy, ultrasonography for fetal sex selection, and stem cell research. These technologies have challenged certain societal institutions, codes, and other norms regarding fundamental aspects of human life such as parenthood, heredity, birth, bodily sovereignty, freedom and control of human behavior, and death (National Research Council 1975).
Despite the comprehensive approach originally intended for TA, its practitioners recognized early on that “partial TAs” may be preferable in circumstances where selected impacts are of particular interest or where necessitated by resource constraints (US Congress, Office of Technology Assessment 1977). In practice, relatively few TAs have encompassed the full range of possible technological impacts; most focus on certain sets of impacts or concerns. Indeed, the scope of HTA reports has been diversified in recent years by the use of “horizon scanning” and the demand for “rapid HTAs,” which are described later in this document.
Box I-3. Some Definitions of Health Technology Assessment
We shall use the term assessment of a medical technology to denote any process of examining and reporting properties of a medical technology used in health care, such as safety, efficacy, feasibility, and indications for use, cost, and cost-effectiveness, as well as social, economic, and ethical consequences, whether intended or unintended (Institute of Medicine 1985).
Health technology assessment ... is a structured analysis of a health technology, a set of related technologies, or a technology-related issue that is performed for the purpose of providing input to a policy decision (US Congress, Office of Technology Assessment 1994).
Health Technology Assessment asks important questions about these technologies [drugs, devices, procedures, settings of care, screening] such as: When is counselling better than drug treatment for depression? What is the best operation for aortic aneurysms? Should we screen for human papilloma virus when doing cervical smears? Should aspirin be used for the primary prevention of cardiovascular disease? It answers these questions by investigating four main factors: whether the technology works, for whom, at what cost, how it compares with the alternatives (UK NHS National Institute for Health Research Health Technology Assessment Programme 2013).
HTA is a field of scientific research to inform policy and clinical decision making around the introduction and diffusion of health technologies…. HTA is a multidisciplinary field that addresses the health impacts of technology, considering its specific healthcare context as well as available alternatives. Contextual factors addressed by HTA include economic, organizational, social, and ethical impacts. The scope and methods of HTA may be adapted to respond to the policy needs of a particular health system (Health Technology Assessment International 2013).
Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method (European network for Health Technology Assessment 2013).
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