Safety considerations

Safety considerations

The risk of such assistive technologies is 2-fold. Too many false positives could lead to referring people inappropriately to secondary care, causing unnecessary anxiety to the person and exposing them to potentially unnecessary procedures. Too many false negatives pose a potentially greater safety concern; they could lead to a delay in diagnosis and worse patient outcomes. Moreover, the technologies have not been tested on all skin cancers and, as such, there is a possibility that less common diagnoses, particularly rare skin cancers, could be missed. Experts advised there is also a lack of training and testing of these technologies in people with black and brown skin.

The British Association of Dermatologists, a professional membership body for UK dermatologists, has produced a position statement on AI interventions highlighting that AI technologies have the potential to improve clinical care and optimise processes through using clinical data to inform best practice and outcomes. However, it reports that a robust regulatory framework is needed and notes the following considerations:

  • The technologies should have a clinical evaluation, and evidence presented should adequately support the intended use of the technology; studies should be done in the same clinical setting and in the same population as their intended use.

  • All technologies must be accompanied by information needed to use them safely and properly, considering training and knowledge of intended users. Manufacturers' statements on labelling should be consistent with any promotional material.

  • The technologies should be classified as Class IIa if they are intended for diagnosis or indicative diagnosis in the context of use by patients.