FOI release

Freedom of Information request on the use of artificial intelligence (AI) in our Yellow Card system, when it went live and the impact it has had on reporting and concomitant investigations. (FOI 22/494)

Published 1 June 2022

FOI 22/494

18th March 2022

Dear

Thank you of your email dated 21st February where you requested information on the use of artificial intelligence (AI) in our Yellow Card system, when it went live and the impact it has had on reporting and concomitant investigations.

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

The AI tool has helped us by reducing the amount of manual coding for each report, thereby saving resource in processing cases and ensuring they are rapidly available for scientific analysis. The tool is not used for assessment of data, but to help ensure that all the information provided in narrative text from the reporter is well captured to support analysis and is subject to robust quality assessment.

The MHRA are working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues. To provide reassurance as to the ongoing benefit and risk assessment of available vaccines the MHRA publishes details of all suspected reactions reported in association with available COVID-19 vaccines, along with our assessment of the data, on a regular basis in our weekly report

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

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information.

For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 4-T, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Copyright notice

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder.