Freedom of Information request on the policies and stanards for evaluation of AI in medical and healthcare devices (FOI 22/678)
Published 22 March 2023
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FOI 22/678
30 May 2022
Dear
Thank you for your information request, dated 10/05/2022, where you asked “Please publish your policies and standards for the evaluation of AI in medical and healthcare devices.”
This is an area of work still in development. However, I am pleased to provide you with some of the information requested, see below.
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On the 16th of September 2021, we published our Software and AI as a Medical Device Change Programme, containing 11 work packages across 2 workstreams. Of particular interest to the evaluation of AI medical devices is work package 9 titled “AI Rigour”.
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Also on the 16th September 2021, we released our consultation on the future regulation of medical devices in the United Kingdom, the consultation closed on the 25th November 2021. Of particular interest to the evaluation of AI medical devices is Chapter 10:Software as a Medical Device, section 65:Artificial Intelligence as a/in a medical device (AIaMD).
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On the 27th October 2021, we published the Good Machine Learning Practice (GMLP) Principles in collaboration with the US Food and Drug Administration (FDA) and Health Canada.
Unfortunately, some of the information is exempt from release under section 22:
Section 22 – Information intended for future publication: the information you have requested is due to be published later on this year. Section 22 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from releasing policy positions. However, we consider that the public interest will be better served by releasing the information when it is in its complete form, rather than the Agency releasing an incomplete version of the document prematurely.
Additionally, some of this information is exempt from release under section 35:
Section 35 – Formulation of Government policy: the information you have requested is being withheld under section 35 of the FOI Act. Section 35 protects the internal deliberative process as it relates to Government policy making. In other words, the exemption is intended to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy formulation and development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions. Section 35 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from releasing our policy positions once finalised. However, given that the response to the above cited consultation is not yet published and that policy is still in development, we consider that the public interest will be better served by not releasing the information at this time, as premature disclosure of this sort of information would pre-empt our consultation response, could prejudice good working relationships, the neutrality of civil servants and, ultimately, the quality of Government.
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Yours sincerely
MHRA Customer Experience Centre