Assessing Evidence Readiness

#Define the use and the claim first

NICE's digital health evidence framework asks for the intended purpose and target population, the current care pathway and the proposed pathway using the technology. Its standards distinguish design, performance, value and deployment considerations. The overview says it was updated in August 2022, including for AI and adaptive algorithms.

Readiness should be tied to a particular claim and decision, not treated as a permanent label for a product. Identify who is meant to use it and what would change in the care process. NICE's framework concerns digital technologies in NHS and social care evaluation; it is not a worldwide approval rule or a Mynd assessment service.

Evidence: NICE: digital health evidence framework overview / NICE: digital health evidence standards

#Match effectiveness evidence to claimed benefits

For tier C digital technologies, NICE's standard 14 asks for evidence of effectiveness relevant to the intended purpose and claimed benefits. It says study design should follow those claims and that comparative studies are generally more informative than non-comparative studies. It also asks how evidence from a similar technology applies to the actual technology being considered.

A strong-looking technical result should not be silently translated into a different health-benefit claim. Read the population, setting, comparison and outcomes alongside the result. This page explains questions from a specific framework; it does not rate a product, set a clinical threshold or establish regulatory status.

Evidence: NICE: digital health evidence standards

#Keep deployment evidence and remaining gaps separate

NICE's standards 15 and 16 address whether claimed benefits can be realised in practice and how usage and performance changes will be measured over time. Its deployment standards also cover input data, infrastructure, training and communication. These are different questions from whether an intervention's claimed effect has been established.

Record which questions the evidence answers and which remain open for the proposed setting. A plan for later monitoring is not evidence that monitoring has already happened. Changes in intended use or care process can change what must be checked. Mynd has not cleared a technology for care or provided a clinical review here.

Evidence: NICE: digital health evidence standards

Source note

The sections above were checked against the linked sources. No clinical review has been performed. This is general research education, not a clinical guideline.