Health technology assessment of medical devices
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World Health Organization
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xii, 58 p.
This publication provides an updated overview of health technology assessment (HTA) for medical devices and its role in supporting evidence-informed decision-making within health systems. Developed as part of the WHO medical device technical series, the document examines the contribution of HTA to the selection, adoption, procurement, management and reassessment of medical devices in the context of universal health coverage. It describes the policy and governance frameworks supporting HTA, outlines the relationship between regulation, assessment and health technology management, and reviews global initiatives and WHO mandates related to medical devices and in vitro diagnostics. Particular attention is given to the needs and challenges of low- and middle-income countries, including capacity-building, governance, financing and data limitations. The document discusses methodological approaches for the assessment of medical devices, including rapid HTA, adaptive HTA, horizon scanning, multi-criteria decision analysis and the use of real-world data and evidence. It also addresses emerging topics such as digital health technologies, artificial intelligence, additive manufacturing and emergency preparedness. Emphasis is placed on stakeholder engagement, institutional collaboration and transparent decision-making processes to support equitable access to safe, effective and appropriate medical technologies.
This publication provides an updated overview of health technology assessment (HTA) for medical devices and its role in supporting evidence-informed decision-making within health systems. Developed as part of the WHO medical device technical series, the document examines the contribution of HTA to the selection, adoption, procurement, management and reassessment of medical devices in the context of universal health coverage. It describes the policy and governance frameworks supporting HTA, outlines the relationship between regulation, assessment and health technology management, and reviews global initiatives and WHO mandates related to medical devices and in vitro diagnostics. Particular attention is given to the needs and challenges of low- and middle-income countries, including capacity-building, governance, financing and data limitations. The document discusses methodological approaches for the assessment of medical devices, including rapid HTA, adaptive HTA, horizon scanning, multi-criteria decision analysis and the use of real-world data and evidence. It also addresses emerging topics such as digital health technologies, artificial intelligence, additive manufacturing and emergency preparedness. Emphasis is placed on stakeholder engagement, institutional collaboration and transparent decision-making processes to support equitable access to safe, effective and appropriate medical technologies.
Keywords
Technology Assessment, Biomedical, Equipment and Supplies, Health Policy, Universal Health Insurance, Evidence-Based Practice, Health Services Needs and Demand, Decision Making, Decision Support Techniques, Biomedical Engineering, Biomedical Technology, Developing Countries, Health Priorities, Data Collection, Artificial Intelligence, Printing, Three-Dimensional, Telemedicine, Digital Health, International Cooperation, Stakeholder Participation, Cost-Benefit Analysis, Needs Assessment, Health Services Accessibility