New action to tackle ethnic and other biases in medical devices

  • The plan comes in response to an independent report that identifies the extent and impact of ethnic and other biases in the design and use of published medical devices.
  • It is part of ongoing work to address disparities within the health system, including addressing issues from the design stage and additional funding for requests for new devices that work without bias.

The government announced today action to address potential biases in the design and use of medical devices, as it accepts recommendations from a First independent review in the UK.

The Department of Health and Social Care commissioned senior health experts to identify potential biases in these devices and recommend how to address them.

The government fully accepted the report's findings and has made a number of commitments, including ensuring that pulse oximeter devices used in the NHS can be used safely on a range of skin tones and removing racial bias from sets. of data used in clinical studies.

Minister of State Andrew Stephenson said:

I am enormously grateful to Professor Dame Margaret Whitehead for undertaking this important review.

Ensuring the healthcare system works for everyone, regardless of ethnicity, is fundamental to our values ​​as a nation. It supports our wider work to create a fairer and simpler NHS.

Ministers agree that unless appropriate measures are taken, ethnic and other unfair prejudices can occur throughout the life cycle of medical devices, from research, development and testing to approval, deployment and post-market monitoring, as well as the use of the devices once deployed.

As a result, important steps are already being taken to overcome potential disparities in medical device performance. This includes:

  • The Medicines and Healthcare products Regulatory Agency (MHRA) now requires approval applications for new medical devices to describe how they will address bias.

  • NHS guidance has been updated to highlight potential limitations of pulse oximeter devices in patients with darker skin tone.

  • The National Institute for Health Research (NIHR) is currently accepting applications for funding for research into smarter oximeters.

The government also:

  • Work with the MHRA to ensure that medical device regulations are safe for patients, regardless of their background, while allowing more innovative products to be brought to market in the UK market. This includes a commitment to ensuring that pulse oximeters are safe and effective for all patients, and work is being done to mitigate any inaccuracies in the devices.

  • Advance work to eliminate racial bias in data sets, including ensuring that diverse skin tones are included in data used by researchers for clinical studies.

  • Support ongoing work with NHS England to improve the skills of clinical professionals on issues including health equity.

  • Work with partners to improve the transparency of data used in the development of medical devices that use Artificial Intelligence (AI), as well as AI products that influence clinical decisions.

The government appointed Professor Margaret Whitehead, a professor of public health at the University of Liverpool, to lead the review. Professor Whitehead has extensive experience in tackling health inequalities and for many years she has led the work of the World Health Organization Collaborating Center for Policy Research on the Determinants of Health Equity.

The review arose after concerns that pulse oximeters, widely used during the Covid-19 pandemic to monitor blood oxygen levels, were not as accurate for patients with darker skin tones, which could have led to delays in treatment if oxygen levels were dangerously low in patients with darker skin tones. Skin tone was overlooked. However, the review found no evidence from studies in the NHS that this differential performance affects care.

The review of medical devices focused on three areas: optical devices such as pulse oximeters, AI-enabled devices, and polygenic risk scores (PRS) in genomics.

Professor Dame Margaret Whitehead, chair of the review, said:

The advancement of AI in medical devices could bring great benefits, but it could also bring harm due to inherent biases against certain population groups, particularly women, people from ethnic minorities and disadvantaged socioeconomic groups.

Our review reveals how existing biases and injustices in society can be inadvertently incorporated into every stage of the lifecycle of AI-enabled medical devices and then magnified in algorithm development and machine learning.

Our recommendations therefore call for system-wide action, requiring full government support. The UK would lead the way internationally by incorporating capital in AI-enabled medical devices into its global AI security initiatives.

The review also recommended ways to develop bias-free medical devices in the future and improve standards globally.

Dr June Raine, Chief Executive of MHRA, said:

The MHRA recognizes that inequalities may exist within medical devices and we therefore welcome the publication of Dame Whitehead's independent review.

We are deeply committed to ensuring equitable access to safe, effective and high-quality medical devices for all people, and the recommendations set out in this report will support and strengthen the impact of our ongoing work in this area.

We are committed to working collaboratively with government, regulatory bodies, healthcare professionals and stakeholders to address these issues effectively.

Work is being done to ensure that health care is equitable. In recent years, the government has created plans that provide targeted support for the cost of living and the Covid-19 pandemic and established the Office for Health Improvement and Disparities (OHID), a government unit dedicated to reducing negative health disparities across the country. We have commissioned works such as Core20Plus5a national approach from NHS England to inform action to reduce inequalities in healthcare, set out the Motherhood Disparities Task Forceand inverted £50 million worth of research into health inequalities for local authorities.

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