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.
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).
The WHO technical specifications of Neonatal Resuscitation Devices was developed under the framework of the World Health Assembly Resolution WHA66.7, (5) which is at the foundation of the United Nations Commission on Life-Saving Commodities (UNCLSC) for Women and Children (Annex 10). The mandate of the UNCLSC is to promote and assure the availability of 13 safe, […]
The future promises many technological advances in the field of heart valve interventions, like tissue-engineered heart valves (TEHV). Prior to introduction in clinical practice, it is essential to perform early health technology assessment. We aim to develop a conceptual model (CM) that can be used to investigate the performance and costs requirements for TEHV to become cost-effective.
The opportunity cost of inappropriate health policy decisions is greater in Central and Eastern European (CEE) compared with Western European (WE) countries because of poorer population health and more limited healthcare resources. Application of health technology assessment (HTA) prior to healthcare financing decisions can improve the allocative efficiency of scarce resources. However, few CEE countries have a clear roadmap […]
Total hip replacement (THR) involves the replacement of a damaged hip joint with an artificial hip prosthesis. Resurfacing arthroplasty (RS) involves replacement of the joint surface of the femoral head with a metal surface covering. The objective of this review was to undertake clinical effectiveness and cost-effectiveness analysis of different types of THR and RS for the treatment of pain […]
The objective of this project was to list the medical devices required to provide the essential reproductive, maternal, newborn and child health interventions defined by existing WHO guidelines and publications, in order to improve access to these devices in low- and middle-income countries, support quality of care, and strengthen health-care system. The medical devices are allocated […]
This report provides a literature-based review of medical devices needed by older people. The results have been used to create lists of devices categorized in terms of whether they are preventive, diagnostic or therapeutic. Broad clinical safety and effectiveness information has also been provided when available.
Many of the 500,000 North American patients with chronic mitral regurgitation may be poor candidates for mitral valve surgery. The objective of this study was to investigate the comparative effectiveness, harms, and cost-effectiveness of percutaneous mitral valve repair using mitral valve clips in candidates at prohibitive risk for surgery. Primary studies were sought from existing systematic reviews that […]
ABSTRACT Background Regulatory approval and reimbursement are necessary to bring health technologies to market. As both are distinct processes, the lack of interaction between regulators and payers has been criticized for resulting in health system inefficiencies. Objectives This study describes the experiences of health system stakeholders on the development and implementation of initiatives to better harmonize […]
Colorectal cancer, a leading cause of mortality and morbidity in Ontario, can be prevented through early diagnosis and removal of precancerous polyps. Colon capsule endoscopy is a relatively new, minimally invasive test for detecting colorectal polyps. The objectives of this analysis were to evaluate the diagnostic accuracy and safety of colon capsule endoscopy for the detection of […]