Regulator reveals ‘concerns’ over Babylon’s ‘chatbot’

A regulator has admitted “concerns” over the software Babylon Healthcare uses in one of its digital health solutions and is exploring how to address this.

The Medicines and Healthcare products Regulatory Authority’s (MHRA) concerns relate to Babylon’s symptom checker “chatbot” tool. This is used by thousands of patients, including those registered with digital primary care practice GP at Hand.

Two senior figures within the agency set out the MHRA’s concerns about the tool in a letter, seen by HSJ, which was sent to consultant oncologist David Watkins following a meeting between the parties last October.

Dr Watkins has raised doubts over the tool’s safety for several years, including repeatedly documenting alleged flaws in the chatbot through videos posted online. However, last year, Babylon said only 20 of Dr Watkins’ 2,400 tests resulted in “genuine errors” being identified in the software.

In the letter, dated 4 December, the MHRA’s clinical director for devices Duncan McPherson and head of software related device technologies Johan Ordish said Dr Watkins’ “concerns are all valid and ones that we share”. 

In the letter to Dr Watkins, the two MHRA directors also said the regulator is further exploring some of the issues highlighted and the work could “be important as we develop a new regulatory framework for medical devices in the UK”.

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Source: HSJ, 4 March 2021