The Department of Health and Social Care in the UK announced an action plan in response to an independent report identifying the impact of ethnicity and other biases in the design and use of medical devices. The UK government recognizes the report’s main argument that bias on ethnicity can occur throughout the entire medical device life cycle. A series of commitments (18) were made by the government to overcome potential disparities in the performance of medical devices including:
What has already been implemented?
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- MHRA now requests that approval applications for new medical devices describe how they will address bias.
- NHS guidance is already updated to highlight potential limitations of pulse oximeter devices on patients with darker skin tone.
- NIHR is currently accepting funding applications for research into smarter oximeters.
What will be implemented in the future?
The government will also:
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- Work with MHRA to ensure regulations for medical devices are safe for patients regardless of their ethnicity.
- Work towards removing racial bias in datasets in clinical studies.
- Continuing upskill of clinical professionals on issues including health equity.
- Improving the transparency of data with partners in the development of medical devices using AI including AI products which influence clinical decisions.