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HTA of MDs
Health Technology Assessment of Medical Devices


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.



Library of Assessments on MDs (1999-2019)

40 Entries into category "other"

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Basic Principles of Health Technology Assessment, Economic Evaluation, and Costing of Healthcare Programs

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 […]

Briefing on Health Technology Assessment in the European Union

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 […]

Health Technology Assessment in Serbia

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 […]

Commission communication in the framework of the implementation of the Council Directive 93/ 42/EEC concerning medical devices

 Publication of titles and references of harmonised standards under Union harmonisation legislation

Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment Update

 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 […]

Static Automated External Defibrillators for Opportunistic Use by Bystanders

Aims and Scope The first research question submitted to KCE concerned the clinical- and cost-effectiveness of the provision of publicly accessible automated external defibrillators (AED) intended for opportunistic use by bystanders who witness a cardiac arrest. The report focuses on the use of AEDs as a standalone intervention, i.e. not incorporated into a coordinated public access defibrillation (PAD) programme (see section […]

Health Technology Implementation Roadmap in Central and Eastern European Countries

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 […]

Conceptual model for early health technology assessment of current and novel heart valve interventions

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.

Mitral Valve Clip for Treatment of Mitral Regurgitation: An Evidence-Based Analysis

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 […]

Harmonization of HTA-based reimbursement and regulatory activities

 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 […]