The Department of Health and Social Care has published the final report on an independent review into equity in medical devices, making 18 recommendations designed to address “unfair biases” identified through the course of the review.
The recommendations centre a number of key topics including AI-assisted medical devices, pulse oximeters and optical medical devices.
Eight of the 18 recommendations focus on AI-assisted devices, with recommendations including the need for developers and stakeholders to engage with diverse groups for co-design purposes; encouragement for government to commission an “online and offline academy” to increase understanding among all stakeholders of equity in AI-assisted medical devices; and a suggestion that UK regulatory bodies should be provided with long-term resources “to develop agile and evolving guidance” to assist innovators, businesses and data scientists in building processes to reduce unfair biases.
Additionally, the report states that research commissioners should prioritise diversity and inclusion, with the pursuit of equity as a “key driver of investment decisions and project prioritisation”. Regulators should be “properly resourced” by the government when it comes to preparing and planning for the disruption that foundation models and generative AI “will bring to medical devices”, along with their potential impact on equity.
On pulse oximeters, the report raises a need to ensure that existing devices can be used equitably across the NHS for all patient groups and skin tones. It notes that the MHRA should strengthen guidance on the accuracy and performance of these devices, including guidance on interpreting readings from patients with different skin tones; and co-design is raised again, with a recommendation that innovators, researchers and manufacturers collaborate with the public to design “better, smarter oximeters using innovative technologies to produce devices that are not biased by skin tone”. It is suggested that this could include development of enhanced algorithms to address measurement bias, and the exploration of “multi-wavelength systems which measure and correct for skin pigmentation”.
Regarding equity of optical medical devices, the report highlights a need for professional practice bodies in the UK to carry out an equity audit of optical devices in common use within the NHS; and encourages “renewed efforts” in increasing skin tone diversity in medical imaging databanks used in developing and testing devices, as well as improving the tools for measuring skin tone that are incorporated into optical devices.
The report states that these improvements “now need to be implemented as a matter of priority with full government support”.
The 18 recommendations can be found in full here, along with insight into topics deemed out of scope for this review but “nevertheless [raising] important equity issues for the future”, including considerations around equity for wearable devices and access to devices.
Last week, HTN covered the government’s budget for long-term growth, including funding for digital transformation in the NHS.
In February, we highlighted DHSCs announcement that £10 million would be made available in funding and used in part to support eight selected health tech companies in bringing innovative solutions to market.
