Call for evidence issued in Dame Margaret Whitehead’s UK medical devices bias review

In brief: 

The UK government-commissioned ‘Equity in medical devices: Independent review’ panel has launched a call for evidence to inform its evidence gathering process, which closes on 6 October.

The call for evidence (and related terms of reference) clarifies that all medical devices are in scope of the review, including AI-enabled applications, and that a range of diversity measures will be under the spotlight, in addition to ethnicity. The results are expected to inform the panel’s recommendations to the UK government which is due by June 2023.

In detail: 

At the end of last year, the UK government commissioned an independent ‘rapid’ review into whether there may be systemic bias inherent in medical devices on the market in the UK. This review forms part of an ongoing stated priority to tackle health inequalities, some of which were highlighted or exacerbated by the global pandemic (see our analysis here for further details).

Professor Dame Margaret Whitehead was subsequently appointed to chair the ‘Equity in medical devices: Independent review,’ and the terms of reference were released in April providing further details, including studies suggesting the existence of a possible ethnicity gap in medical devices in the UK, for example with respect to the efficacy of pulse oximeters for darker skin. Additionally, the terms of reference note concerns that AI algorithms may be inadequate for particular groups eg, women and persons of low socio-economic status who are not as well represented in data sources as other groups.  

The review has now entered a new phase with a call for evidence, launched on 11 August 2022. The call for evidence states that the evidence is ‘not yet conclusive’ as to whether the design, development or use of medical devices may lead to differences in safety or effectiveness based on diversity characteristics. The panel welcomes ‘any data and evidence’ concerning equity or bias concerns, as well as suggestions and ideas for potential solutions. The panel seeks views from interested groups, including: community leaders; diverse patient groups; industry and device regulators; and standard setters.

The accompanying guidance clarifies that all types of medical devices are in scope including AI-enabled applications. It also clarifies that the review is considering diversity metrics based on social or demographic characteristics, in addition to ethnicity.

The review panel aims to provide recommendations to government by June 2023 on how to ensure that the development and use of medical devices is equitable. For those interested in responding, the call for evidence is open for eight weeks and will close on 6 October (the link for the online response survey is here).

Comment: 

• The timing of this review, with recommendations to government not now due until the middle of next year has slipped since it was first commissioned as a ‘rapid review’ last year. However, we nevertheless expect the results, when they are announced, to be taken seriously. Addressing health inequalities and mitigating biases through the medical device lifecycle is one of the five core pillars of the UK government’s plans for the new UK medical device regulatory regime, with new regulations intended to come into force in 2023 (see our analysis of the consultation outcome published in June here).
• It may well be that issues related to health inequality and bias in medical devices (flowing from this review) will be dealt with subsequently to the new medical devices regulations, potentially in the form of ‘softer’ guidance and standards.
• With respect to AI and its potential inherent biases, these issues are well-travelled and are already being considered from a number of angles, including internationally (see for example the NHS pilots around tackling bias in healthcare datasets; and at a European level see here). It will be interesting to see what this review will add specifically in terms of medical devices.