Health technology assessment (HTA) bodies have several sizable challenges on their hands when it comes to evaluating AI-enabled medtech. They must be able to account for changes in a product that have yet to take place, while the potential for AI to be biased poses significant ethical problems.
AI products are able to change over time – new data can be used to re-train the algorithm, and this can change its clinical efficacy, which impacts on the cost-effectiveness evaluation, Harriet Unsworth, senior partner at the Wellcome
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