Freedom of Information request on records of correspondence from doctors and other medical personnel to the MHRA about software that uses artificial intelligence or machine learning to diagnose illness (FOI 21-666)
Published 13 August 2021
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30th June 2021 FOI 21/666
Dear
Thank you for your information request, dated 15 June 2021, where you asked for records of correspondence from doctors and other medical personnel – including e-mails, letters or phone calls – to the MHRA about software that uses artificial intelligence or machine learning to diagnose illness or to point to a likely cause of symptoms. I’m interested in correspondence dating from March 2019, and the MHRA’s response. This type of software may be found on mobile applications used by patients at home, like that developed by Babylon Healthcare and similar companies, or be used internally by doctors within the NHS. If that’s not within the budget or time limits, please could you send me the most recent 100 records. I’d also like to request the minutes of any meetings the MHRA held to discuss concerns this correspondence raised. I understand that the MHRA can’t disclose records of specific companies, but I assume that names can be redacted.
Unfortunately, your enquiry is not specific enough for MHRA to be able to provide a response and, under Section 1(3) of the Freedom of Information Act 2000, we will not be able to respond to a request until the terms are made clearer. For example, it is not clear whether you are seeking information regarding general regulatory enquiries or reports of adverse incidents from ‘doctors and other medical personnel.’
Additionally, the nature of the devices for which you are seeking information on is too vague. There is a very wide range of software and apps that may utilise artificial intelligence or machine learning to diagnose illness or to point to a likely cause of symptoms. However, it is not possible to identify which ones use AI/ML to diagnose or point to a likely cause of symptoms upon receipt without fully investigating each one of these products, the claims made by the manufacturer and the product’s intended use.
MHRA has received very few adverse incident reports made by doctors and other medical personnel relating to the use of software as a medical device. Of the adverse incident reports relating to software as a medical device that MHRA has received from professional users, the products implicated are generally not symptom checkers or triaging devices. In those situations where MHRA has identified an issue for investigation which involves a symptom checker or a software device providing a diagnosis, we are unable to provide the details of those ongoing investigations involving specific companies under the exemption provided for in Section 44 FOIA 2000.
You may wish to contact the individual manufacturer(s) of specific products for which you require information.
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
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Yours sincerely
MHRA Customer Service Centre
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