FOI release

Freedom of Information request on Contract Award Notice 2020 / S207-506291 - AI Software package and information system. (FOI 21/1176)

Published 26 May 2022

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-15-november-2021/freedom-of-information-request-on-contract-award-notice-2020-s207-506291-ai-software-package-and-information-system-foi-211176

FOI 21/1176

15th November

Dear,

Thank you of your email dated 1st November where you requested information in relation to the Contract Award Notice 2020 / S207-506291 - AI Software package and information system. The following information was requested:

  1. The date MHRA received the AI software package and information system, and

  2. The date the AI software package and information system was operational in the UK.

  3. Generic information regarding the outputs / reports available from the new software. I stress, no personal data should be provided to ensure compliance with the GDPR and Data Protection Act 2018.

The MHRA awarded the AI contract in September 2020 and this was subsequently deployed in December 2020.

MHRA purchased the AI tool in order to support processing of suspected adverse reactions to COVID-19 vaccines and to ensure information from the reaction text was added into structured data. The tool is used in combination with manual case review where reports are subjected to robust quality assurance processes and amended, where necessary. The AI tool is limited to processing of reports and is not used in the assessment of the data.

A summary of the data received is available in the Coronavirus (COVID-19) vaccines adverse reactions summary which is published weekly.

I hope the information provided is helpful, but 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 of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division

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