As part of an Independent Review on Equity in Medical Devices, led by Professor Dame Margaret Whitehead, the Government is seeking to tackle disparities in healthcare by gathering new evidence on how medical devices and technologies may be biased against patients of different ethnicities, genders and other socio-demographic groups.
Through a call for evidence, which will be open for 8 weeks, it hopes to hear from those who work most closely with medical devices such as oxygen measuring devices and infrared scanners and related software and hardware, including databases and instructions. This applies across a device’s entire life cycle – from evaluation to marketing and implementation – to identify potential biases at each and every stage.
For example, some devices employing infrared light or imaging may not perform as well with patients with darker skin pigmentation, which has not been accounted for in the development and testing of the devices, and has led to patients being recruited with only a limited range of lighter skin tones.
The independent review, which the call for evidence will feed into, aims to reduce the potential for medical devices to worsen existing healthcare disparities, ensuring people can receive the best-possible care throughout their patient experience regardless of their ethnicity or gender.
Health Minister Gillian Keegan said: "I am committed to ensuring all patients receive high-quality, innovative healthcare without discrimination. The independent review is part of our vital work to tackle healthcare inequalities, and I invite the industry to share their expertise in the call for evidence so we can ensure medical devices are free of any form of bias."
Members of expert and professional groups and organisations, including academics, researchers, engineers, healthcare professionals and industry representatives, are invited to submit evidence and insights regarding potential disparities and proposed solutions, with this evidence informing the independent review. Members of the public, patients and carers can also contribute their views and insights on these topics.
Research suggests the way some medical devices are designed and used may be failing to account for differences related to ethnic background, gender or other characteristics such as disabilities – potentially exacerbating existing inequalities in healthcare. While current UK regulations set out clear expectations on medical devices and technologies, they do not currently include provisions to ensure that medical devices are working equally well for different groups in the population based on their social or demographic characteristics.
The independent review will cover different types of medical devices, including devices enabled by artificial intelligence (AI) used in diagnosing illness and determining therapy pathways, as well as risk-scoring systems using genomics to make decisions about personalised medicine.
It will consider in what ways existing or future regulations could successfully address any biases in medical devices that arise at any stage of their design, development, evaluation, implementation and use.
Professor Dame Margaret Whitehead, chair of the independent review, said: "We aim to establish where and how potential ethnic and other unfair biases may arise in the design and use of medical devices, and what can be done to make improvements.
"We especially encourage health, technology and industry experts and researchers to share their views and any evidence concerning medical devices in order to help us tackle inequalities in healthcare."
The review chair will issue the panel’s report to the Secretary of State for Health and Social Care setting out clear options for consideration by spring 2023 with interim findings expected in winter 2022.