Smartphone apps that use artificial intelligence (AI) to spot skin cancer are endangering the public, many of whom trust that these apps are safe to use, experts at the British Association of Dermatologists (BAD) have warned. This trust, along with a failure of many such apps to meet the appropriate regulatory standards, is putting users at risk.
This warning, from the BAD AI Working Party Group, follows a recent YouGov survey that has found that 41% of people in the UK would trust a smartphone application that employs AI to spot potential skin cancers.
While many people would trust apps which use AI to diagnose skin cancer, only 4% of respondents said they would be “very confident” in their ability to judge whether apps can do what they claim. Over half (52%) said they would not be confident in their ability to judge this.
The BAD AI Working Party Group position is that the published evidence to support that AI can be used safely and effectively to diagnose skin cancer is weak, putting people at risk of misdiagnosis and missed cancer diagnoses.
All apps that use AI for medical diagnosis or treatment are classified as ‘medical devices’ by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA). This means that they must undergo an authorisation process to make sure that they are safe and perform with the accuracy that they claim to achieve.
All medical devices sold in the UK must be certified by one of three marks: the CE (Conformité Européene), UKCA (UK Conformity Assessed) or UKNI (UK Northern Ireland). Class IIa and above marks confirm that they have undergone an official authorisation process overseen by national or international health authorities. The CE or UKCA mark may be applied by the manufacturer for Class I self-certified products but these products will not have undergone independent scrutiny.
The BAD has produced a guide to help the public spot potential warning signs when using diagnostic skin cancer apps.
The results of this survey are concerning. The public has an understandable belief that these AI-based skin cancer detection apps are safe to use. The reality is that many don’t meet the standards required by regulators to diagnose medical conditions. The MHRA has made it clear that the only smartphone apps which are appropriate for diagnostic purposes are Class IIa or higher medical devices and should be CE, UKNI or UKCA marked, demonstrating that they meet the relevant essential requirements of the medical device regulations.
Part of the problem is how easy it is for AI diagnostic apps which don’t meet the regulatory requirements, produced by developers around the world, with wildly varying levels of expertise and experience, to be promoted alongside perfectly legitimate apps. These apps often have slick branding but if you look closer there is little evidence for their effectiveness.
It is all too common to see apps which claim to be able to check moles, which then follow these assertions with a disclaimer that the app is not a diagnostic device. These sort of small print U-turns on advertised features are not only dishonest but are clearly not permitted by the regulators.
While AI has immense potential to improve healthcare, it is important that AI is rolled out in a manner that is safe for the public.”
Dr Rubeta Matin, Chair of the BAD Working Party Group
The BAD is working closely with UK regulatory bodies to address these concerns.
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