Abstract
NICE’s evidence standards framework (ESF) was published in 2019 to help innovators and commissioners understand what good levels of evidence for digital health technologies (DHTs) look like. Since then, these technologies have evolved with many now utilising artificial intelligence. Also, regulators have started to develop clearer regulation criteria for medical device software. NICE therefore is updating the ESF to reflect these developments and improve its useability. Here we present the foundations of the updated framework.
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