Health technology assessment (HTA) is the systematic evaluation of the properties and effects of a health technology, covering clinical effectiveness, cost effectiveness and often the broader social, ethical and organisational implications. Its purpose is to inform decisions about whether and how a technology should be funded and used within a health system.
HTA answers a different question from regulation. A regulator asks whether a product is safe and performs as claimed. An HTA body asks whether using it represents a worthwhile use of finite health system resources compared with what is already done. A device can be lawfully marketed and still fail to secure routine funding.
In England the National Institute for Health and Care Excellence (NICE) is the principal HTA body, with the Scottish Medicines Consortium and Healthcare Improvement Scotland performing comparable functions in Scotland. Internationally, bodies such as IQWiG in Germany, HAS in France and CADTH in Canada follow similar methods with nationally specific thresholds and processes.
HTA bodies want comparative evidence in populations that reflect real practice, ideally with outcomes that matter to patients rather than surrogate measures. For digital health and medical devices, evidence is often thinner than for pharmaceuticals, which has led to adaptive approaches such as NICE's early value assessment, where a technology can be used in the NHS while further evidence is generated under an agreed plan. Developers who design their clinical studies with the HTA question in mind, rather than only the regulatory one, generally reach funding decisions faster.
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