The government has launched a call for evidence to gather
insights from experts and organisations on the potential racial
and gender bias of medical devices.
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 the call for evidence which will be open for eight 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 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.
Patients can be reassured that the NHS is expert in providing the
best possible care, and the review is intended to accelerate the
process of improving the quality and availability of medical
devices to diverse communities.
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.
Background information
