Evidence generation plan for artificial intelligence (AI) technologies for assessing and triaging skin lesions referred to the urgent suspected skin cancer pathway
1 Purpose of this document
NICE's early value assessment on artificial intelligence (AI) technologies for assessing and triaging skin lesions recommends that Deep Ensemble for Recognition of Malignancy (DERM) can be used in the NHS during the evidence generation period. It can be used as an option in teledermatology services to assess and triage skin lesions referred to the urgent suspected skin cancer pathway.
This plan outlines the evidence gaps and what real-world 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 collecting 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 company is responsible for ensuring that data collection and analysis takes place.
Guidance on commissioning and procurement of the technology 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 company does not meet the conditions in section 4 on monitoring.
After the end of the evidence generation period (3 years), the company 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 technology can be routinely adopted in the NHS.
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