Freedom of Information request on adverse incident reports and records of more informal complaints and concerns from health-care professionals, specifically regarding smartphone apps that patients can use to diagnose or check their symptoms (FOI 21-786)
Published 27 April 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-2-august-2021/freedom-of-information-request-on-adverse-incident-reports-and-records-of-more-informal-complaints-and-concerns-from-health-care-professionals-specif
4th August 2021 FOI 21/786
Dear
Thank you for your clarification to the original FOI request 21/786, dated 12 July 2021, where you asked for:
“I’m interested in both adverse incident reports and records of more informal complaints and concerns from health-care professionals, specifically regarding smartphone apps that patients can use to diagnose or check their symptoms from home. I’d like to see records – including emails, letters and phone calls – as well as the MHRA’s response with the appropriate protected identifying details redacted.
I’m interested in records dating from January 2020 or the most recent 100 records the MHRA has.
If this request is still too broad, please may I request assistance under Section 16 into what information on this topic is available.”
MHRA has reviewed the adverse incident reports received from professional users and healthcare professionals concerning smartphone apps that patients can use to diagnose or check symptoms from home in the period that you requested. Less than five reports relate to a smart phone app that is used by a patient to check their symptoms. In the situation 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 the investigation involving specific companies under the exemption provided for in Section 44 FOIA 2000.
MHRA investigates all complaints whether they are formally or informally reported. MHRA is unable to provide details of any subsequent investigation whether it be formally or informally reported as that information is exempt under Section 44 FOIA 2000.
Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.
The MHRA is satisfied that the information you have requested: • constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
In the course of our work, MHRA receives intelligence from a variety of sources including social media, professional bodies and journals, healthcare professionals and occasionally members of the public involving software as a medical device. We consider these signals as part of our ongoing risk/benefit assessment of devices.
Per your request for Section 16 assistance, we have provided such assistance noting what information is available on this topic above. MHRA would like to note that we cannot assist the enquirer if the intent is to gain disclosure of Section 44 exempt or other exempt information under FOIA 2000.
MHRA now consider this matter closed and note that further requests that are substantively similar will result in those requests being treated as repeated requests under Section 14(2) FOIA 2000.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/ If you have a query about the information provided, please reply to this email
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU