HTA is multi-disciplinary field of policy analysis that examines the medical, economic, social and ethical implications of the incremental value, diffusion and use of a health technology in health care.
The term Health Technology refers to application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life.
Finding the equilibrium between raising demand for healthcare services and increasing cost containment pressures needed to guarantee the sustainability is the main challenge of healthcare systems around the world. In this context, health economic studies provide information to decision makers for efficient use of available resources for maximizing health benefits. Economic evaluation is one part of […]
WHO compendium of innovative health technologies for low – resource settings 2016-2017 provides information about novel advancements that offer a new solution to address unmet health needs. It celebrates the work of those who create inexpensive tools that can be used effectively even in challenging care delivery environments. Contained in the compendium are summaries of innovative […]
The need for a briefing document on Health Technology Assessment (HTA) arose during the course of 2016 when the European Commission launched the initiative “Strengthening EU cooperation on Health Technology Assessment”1. The initiative included a public consultation, an impact assessment and study that together would inform the drafting of a legislative proposal2. The European Patients’ Forum […]
Objectives: This study provides an overview of the Republic of Serbia healthcare system and describes the process of developing and conducting health technology assessment (HTA). Methods: The authors performed pragmatic, nonsystematic literature review based on available statistical data, legislation, and studies. Results: Healthcare law creates conditions that allow implementation of the principle “value for money.” The […]
Publication of titles and references of harmonised standards under Union harmonisation legislation
Retinitis pigmentosa is an eye disease people are born with. People who have it slowly lose their vision. The Argus II retinal implant is the only treatment approved by Health Canada for retinitis pigmentosa. A device is implanted in a patient’s eye, and it works with a special set of glasses to restore some vision to […]
This publication addresses medical devices that can be used for management of cancer and specifcally describes medical devices for six types of cancer: breast, cervical, colorectal, leukemia, lung and prostate. This publication is the outcome of a project developed by the World Health Organization (WHO) in response to the need for a model reference list of […]
Health technologies are essential for a functioning health system. Medical devices in particular are crucial in the prevention, diagnosis and treatment of illness and disease, as well as patient rehabilitation. Recognizing this important role of health technologies, the World Health Assembly adopted resolution WHA60.29 in May 2007. The resolution covers issues arising from the inappropriate deployment […]
The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).
In this book, part of the Medical device technical series, WHO presents the different roles the biomedical engineer can have in the life cycle of a medical device, from conception to use. It is recognized that medical devices are becoming ever more indispensable in health-care provision and among the key specialists responsible for their design, development, […]