5 Safety and monitoring

5.1 Safety

NICE's patient safety oversight group recommends additional data collection during the evidence generation process on the incidence of suicide and self-harm among users, to monitor the safety of the technologies.

NICE should be notified of any data collected that could indicate a safety concern, and the proposed response.

5.2 Monitoring

The technology developer is required to contact NICE:

  • within 6¬†months of evidence generation plan publication to confirm agreements are in place to generate the evidence specified

  • annually to confirm that the data is being collected and analysed as planned.

Technology developers should inform NICE at the earliest opportunity of anything that may affect ongoing evidence generation, including:

  • any substantial risk that the evidence will not be collected as planned

  • new safety concerns

  • the technology significantly changing in a way that affects the evidence generation process.

If data collection is expected to end later than planned, the technology developers should contact NICE to arrange an extension to the evidence generation period. NICE reserves the right to withdraw the guidance if data collection is delayed, or if it is unlikely to resolve the evidence gaps.