1 Purpose of this document

NICE recommends that artificial intelligence (AI)-derived software to analyse chest X-rays alongside clinician review for suspected lung cancer should only be used in research. Further evidence is needed to assess the risk and benefits of the technology in routine care.

This plan outlines the evidence gaps for the technology and what real-world data needs to be collected for a NICE review of the technology again in the future. It is not a study protocol.

The technology developers 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 developers.

The Department of Health and Social Care (DHSC) and NHS England have launched several initiatives that will support the generation of more evidence for 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. One area of focus of the fund is AI to support radiologists to read chest X-rays. DHSC, the National Institute for Health and Care Research (NIHR) and NHS England are collaborating to support the winning trusts to do '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. This may include those for chest X-rays. As part of this work, a mechanism will be set up to support the post-market surveillance of these AI models in clinical practice.

Guidance on commissioning and procurement of the technology will be provided by NHS England. NHS England is developing a digital health technology policy framework that will further outline commissioning pathways.

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.