Evidence generation plan
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1 Purpose of this document
NICE's early value assessment of artificial intelligence technologies to help detect fractures on X-rays in urgent care recommends that BoneView, RBfracture, Rayvolve and TechCare Alert can be used in the NHS while more evidence is generated. The other technology considered in the guidance can only be used in research and is not covered in this plan.
This plan outlines the evidence gaps and what data needs to be collected for a NICE review of the technologies again in the future. It is not a study protocol but suggests an approach to generating the information needed to address the evidence gaps. For assessing comparative treatment effects, well-conducted randomised controlled trials are the preferred source of evidence if these are able to address the research gaps.
The companies are responsible for ensuring that data collection and analysis takes place.
Guidance on commissioning and procurement of the technologies will be provided by NHS England, who are developing a digital health technology policy framework to further outline commissioning pathways.
NICE will withdraw the guidance if the companies do not meet the conditions in section 4 on monitoring.
After the end of the evidence generation period (2 years), the companies should submit the evidence to NICE in a form that can be used for decision making. NICE will review all the evidence and assess whether the technologies can be routinely adopted in the NHS.
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