The UK government is launching an independent review into potential biases built into medical devices and how they affect patients of different genders and ethnicity.
The Department for Health and Social Care (DHSC) noted the Covid-19 had exposed health disparities across the country.
It said there were concerns the way medical devices and technologies were designed and used could mean a patient’s diagnosis and treatment was affected by their gender or ethnic background, exacerbating existing inequalities.
The independent review will look at devices such as oximeters, which are used to measure oxygen levels, to identify potential discrepancies in how they work for different ethnic groups.
“As part of this, the review will consider whether existing regulations mean there is a systemic bias inherent in medical devices,” the DHSC said.
“For example, some research has concluded darker skinned patients who might need to be hospitalised are at greater risk of inaccurate results from oximeters due to a tendency for this group to present higher levels of oxygen in their blood.”
Details of who will be leading the review will be set out in due course the department said, with hopes the initial findings will be published by the end of January.
“While current UK regulations set out clear expectations, they do not currently include provisions to ensure that medical devices are equally effective regardless of demographic factors, such as ethnicity,” it added.
The review will examine medical devices currently on the market to identify areas of concerns in these products, and aims to:
- take forward work on identifying where systematic bias and risk exist with existing approved devices,
- make recommendations on how these issues should be tackled in the creation of a medical device from design to use, including potentially via regulation, and
- be future-focused and consider the enhanced risk of bias in the emerging range of algorithmic based data and artificial intelligence tools.
