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Medical devices can be prone to biases: Report

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Pulse oximeters record higher readings in people with certain skin tones, or AI-enabled medical devices may have a bias against some population groups – these are some of the findings of an independent review of medical devices.

The government has announced measures to tackle such biases in the design and use of medical devices commonly used in the NHS, and removing racial bias from data sets used in clinical studies.

The announcement was made after the health ministry accepted the recommendations of an independent review chaired by Professor Dame Margaret Whitehead of Liverpool university.

The Department of Health and Social Care commissioned senior health experts to identify inherent biases in these devices and ways to tackle them.

The review focused on three areas – optical devices such as pulse oximeters, AI-enabled devices, and polygenic risk scores in genomics.

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The study found that pulse oximeters (blood oxygen monitors) – widely used during the Covid-19 pandemic – can overestimate the amount of oxygen in the blood of people with darker skin tones.

Professor Whitehead pointed out that even the new-age tools like AI are not free from bias.

She said AI in medical devices could bring great benefits, “but it could also bring harm through inherent bias against certain groups in the population, notably women, people from ethnic minorities and disadvantaged socio-economic groups.”

She said during their review they found that “existing biases and injustices in society can unwittingly be incorporated at every stage of the lifecycle of AI-enabled medical devices, and then magnified in algorithm development and machine learning.”

She called for a system-wide action, with full government support, to tackle the problem.

Junior health minister Andrew Stephenson said the government was committed towards making sure that healthcare system works for everyone, regardless of ethnicity.

He said the study would help in the creation of a “fairer and simpler NHS”.

The government will also support NHS England’s ongoing efforts to upskill clinical professionals on issues including health equity.

The government will work with Medicines and Healthcare products Regulatory Agency (MHRA) to ensure regulations for medical devices are safe for all patients.

Welcoming the report, MHRA chief executive Dr June Raine acknowledged that inequities can exist within medical devices.

“We are committed to working collaboratively with Government, regulatory bodies, healthcare professionals, and stakeholders to address these issues effectively,” Dr Raine added.

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