On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”).  The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the design and use of medical devices.  The Government Response fully accepts, and in turn makes a series of commitments in response to, the findings of the Review (which is broken down into 18 recommendations, 51 sub-recommendations, and 3 further calls to action).  Importantly, the Government “wholeheartedly agrees…that medical technology should be unbiased and equitable.” 

Bias in the medical device space, and within healthcare more broadly is (quite rightly) a topic of growing importance to governments, regulators and industry alike.  We set out some key points of interest from both the Review and the Government Response below.  We look forward to seeing more developments and guidance in this area going forwards given its significance to patients and the delivery of healthcare.  

Equity in Medical Devices

The Review was commissioned in response to concerns that pulse oximeters used during the COVID-19 pandemic were not as accurate when used on patients with darker skin tones.  The Review therefore focused on pulse oximeters (and also “optical” medical devices more broadly), as well as artificial intelligence (“AI”) assisted medical devices; and polygenic risk scores (i.e., a measure of disease risk due to genetic factors).  The review considers the risk of bias for the lifecycle of a medical device from design through to deployment and suggests a number of solutions and next steps.

Key findings of the Review include:

  • Extensive evidence of poorer, less accurate performance of pulse oximeters for patients with darker skin tones.
  • AI-enabled medical devices show inherent bias against women, ethnic minority and disadvantaged socio-economic groups.  These biases are often incorporated at every stage of the lifecycle of AI-enabled medical devices and then magnified during algorithm development and machine learning.
  • Polygenic risk scores show established bias against groups with non-European genetic ancestry.

The Review suggests a concerted, system-wide approach is taken to tackling bias in medical devices that involves the Government, regulators, developers and the NHS as key stakeholders.

Government Response

The UK Government has responded in full to the review and acknowledges that “medical technology should be unbiased and equitable.”  The UK Government has made a series of commitments to overcome bias in medical devices.  These include:

  • The Medicines and Healthcare products Regulatory Agency (“MHRA”) has a new validation process for clinical investigations that requires applicants to demonstrate how they intend to address bias.
  • The National Institute for Health and Care Research (“NIHR”) is accepting funding applications for research into smarter oximeters.
  • A commitment to improve the transparency of datasets used in the development of medical devices using AI, as well as AI products which influence clinical decisions.

What Does This Mean for Medical Device Companies?

The Review together with the Government Response signals the UK Government’s strong intent to take action to ensure that bias in medical devices is tackled and that such devices are safe and clinically effective for use regardless of a patient’s ethnicity, sex or other attribute.

The Government Response forms part of a wider set of measures to tackle bias in medical devices.  These include ongoing work by the MHRA to develop new guidance and regulations to improve diversity in testing, investigating and developing medical devices.  In the clinical research space more broadly, the Health Research Authority (“HRA”) and MHRA intend to publish an “Inclusion and Diversity Plan” that will provide guidance on the design of clinical trials to help ensure “people underserved by research are not overlooked.”

Going forward, we expect to see more national and international guidance being published on bias in the lifecycle of a medical device and as such this is something all manufacturers, developers and deployers of medical devices should be considering.  Manufacturers and developers should consider bias early in the development process, including when designing clinical investigations and particularly ensuring data sets are accurate, inclusive and collected from a representative population.  For deployers, particularly those in a healthcare setting, frameworks and upskilling may be needed to mitigate inequities in care pathways in which medical devices are used.

If you have any queries concerning the material discussed in this blog or medical devices more broadly, please contact members of our Food, Drug, and Device practice.

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Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, and is the Graduate Recruitment Partner for Covington’s London office.

Sarah regularly advises on:

  • classification determinations for software medical devices, including on developments resulting from the implementation of the EU Medical Devices Regulation;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah’s pro bono work includes advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives, and assisting in a project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah has undertaken several client secondments, including to the in-house legal department of a multinational pharmaceutical company.

Tamzin Bond

Tamzin Bond is a Trainee Solicitor who attended BPP School of Law. Prior to joining the firm, Tamzin completed her Ph.D in Chemistry from Imperial College London.