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Evidence generation plan for artificial intelligence (AI) software to help clinical decision making in stroke

1 Purpose of this document

1 Purpose of this document

NICE's assessment of artificial intelligence (AI) software to help clinical decision making in stroke recommends that further evidence is generated for e-Stroke (Brainomix), RapidAI (Ischemaview) and Viz (Viz.ai), while they are being used in the NHS. Other AI software is recommended only for use in research and is not covered in this plan.

This plan summarises 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 protocol but suggests an approach to generating the information needed to address the evidence gaps.

The Department of Health and Social Care and NHS England have launched several initiatives that will support the generation of more evidence for the use of AI technologies. This includes:

  • The AI Diagnostic Fund: In June 2023, DHSC announced funding for the creation of a ring-fenced £21 million AI diagnostics fund. DHSC, the National Institute for Health and Care Research (NIHR) and NHS England are collaborating to support 'in-service evaluations'. These evaluations, alongside plans for national collation of data and metrics from the deployments across multiple imaging networks, aim to answer the evidence gaps set out in the guidance and evidence generation plan.

  • The AI Deployment Platform: DHSC is piloting a platform to help deploy multiple AI imaging technologies in radiology, in 2 NHS imaging networks. As part of this work, a mechanism will be set up to support the post-market surveillance of these AI models in clinical practice.

The companies are responsible for ensuring that data collection and analysis takes place. An approach to evidence generation is through the formation of a consortium bringing analytical partners and implementation sites together with technology developers.

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.

When suitable evidence has been generated, the developers 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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