Abstract OBJECTIVES: Several models of hospital-based health technology assessment (HTA) have been developed worldwide, for the introduction of innovative medical devices and support evidence-based decision making in hospitals. Two such models, the HTA unit and...

Abstract Rationaleaims and objectives Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high‐quality clinical data when...

Objectives: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in...

Background Scientific evidence supports decision-making on the use of implantable medical devices (IMDs) in clinical practice, but IMDs are thought to be far less investigated than drugs. In the USA, studies have shown that approval process of high-risk medical...

Objectives: The objective of this study is to review the implementation of health technology assessment (HTA) at the local and hospital levels in low- and middle-income countries (LMIC). This review will provide a starting point for identifying the conditions for HTA...

Early stage Health Technology Assessment (HTA) of biomedical devices requires different methods than those usually employed for pharmaceuticals. This paper re- views widely-used methods for HTA, discusses their limits for early stage evaluation of biomedical devices...

Background: Health technology assessments (HTA) generally, and economic evaluations (EE) more specifically, have become an integral part of health care decision making around the world. However, these assessments are time consuming and expensive to conduct. Evaluation...

Abstract Health Technology Assessment developed out of pharmacoeconomy; although it is routinely used for all health technologies incl. therapeutic interventions, preventive measures etc., its methodology fits best for drugs. Medical devices have their specificities...

Abstract OBJECTIVES: Synthesizing qualitative research is an important means of ensuring the needs, preferences, and experiences of patients are taken into account by service providers and policy makers, but the range of methods available can appear confusing. This...

Background: The relationship between regulatory approval on the one hand and health technology assessment (HTA) and coverage on the other is receiving growing attention. Those responsible for regulatory approval, HTA, and coverage have different missions and their...