The U.K. government has pledged to take action to address bias in medical devices after an independent review highlighted widespread concerns. The report identified potential biases in devices such as pulse oximeters, AI-enabled devices, and genomics.
Chair of the review, Professor Dame Margaret Whitehead, emphasized the importance of addressing biases that could harm certain groups in the population, including women, ethnic minorities, and disadvantaged socio-economic groups. The review revealed how existing biases in society can be unintentionally incorporated into AI-enabled medical devices, leading to potential injustices.
The report found that clinical trials and research excluded certain populations, leading to poorly worded regulations and standards in the design and development of medical devices. For example, pulse oximeters were found to be less accurate for patients with darker skin tones, potentially resulting in delays in treatment.
In response to the findings, the government has updated guidance on the use of pulse oximeters and is requesting applicants for new medical devices to address bias in their designs. Additionally, plans are in place to improve the transparency of data used in developing AI-based medical devices and products that influence clinical decisions.
Experts have welcomed the report and government response, with calls for further action to address inequalities in healthcare. Professor Chris Holmes has urged the government to appoint an expert panel to assess unintended consequences of AI in healthcare, emphasizing the need to incorporate equity considerations in medical devices.
While changes are necessary to address biases in medical devices, healthcare spokesperson Professor Peter Bannister has cautioned that implementing solutions, particularly in AI technologies, must be done carefully to avoid amplifying existing societal biases.
In conclusion, the U.K. government’s commitment to addressing bias in medical devices is a significant step towards promoting equity and fairness in healthcare. Collaboration with experts and stakeholders will be crucial in ensuring that future advancements in medical technology prioritize inclusivity and accuracy in patient care.
