When Medical Devices Don’t Work Equally: Report summary

This independent review examines how bias in the design, testing, and deployment of medical devices can lead to unequal healthcare outcomes across racial, ethnic, sex, and socio-economic groups. Triggered by concerns over pulse oximeter accuracy during COVID-19, the report expands its scope to optical devices, AI-enabled medical technologies, and genomic tools. It provides a systems-level analysis of how inequities are embedded across the entire medical device lifecycle and offers concrete regulatory and governance recommendations to address them.

Report name

Equity in Medical Devices: Independent Review (2023)

Who wrote this report?

The report was commissioned by the UK Secretary of State for Health and Social Care and led by Professor Dame Margaret Whitehead, alongside an independent expert panel including academics, clinicians, and policy specialists. It was supported by the Department of Health and Social Care and involved extensive engagement with regulators, manufacturers, health professionals, patients, and the public.

Best quote:

“Unfair bias in medical devices is largely unintentional, but can arise at multiple points across the device lifecycle, from design and testing through to deployment and use.”

Key Takeaways

• Bias is systemic, not incidental: Unfair bias often enters medical devices unintentionally, through unrepresentative datasets, hardware limitations, or skewed testing populations. These biases can be compounded across design, regulation, procurement, and clinical use.
• Physical bias has real clinical consequences: The report documents strong evidence that pulse oximeters overestimate blood oxygen levels in people with darker skin tones, with studies from the US linking this to delayed treatment and worse outcomes. Similar risks are identified in other optical and AI-enabled devices.
• Equity must be assessed across the full device lifecycle: Addressing bias requires action from early research and testing through to post-market surveillance, procurement standards, and clinical training—not just better algorithms.
• Regulation and procurement are powerful policy levers: The review highlights the role of regulators and public buyers (such as the NHS) in setting minimum equity standards, requiring representative validation, and mandating post-deployment monitoring.
• AI and genomics present future equity risks: AI-enabled devices and polygenic risk scores risk amplifying existing inequities if developed using biased data or narrow definitions of risk, underscoring the need for anticipatory governance

What's in this report?

The report synthesises evidence from academic literature, commissioned reviews, stakeholder engagement, and a public call for evidence to assess how bias arises in medical devices. It focuses on three high-risk categories: optical devices (such as pulse oximeters and dermatological tools), AI-enabled medical devices, and genomic technologies using polygenic risk scores.

Across these areas, the panel identifies how historical inequities, unrepresentative data, and weak regulatory standards can lead to devices that function less accurately for certain groups. The report sets out 18 recommendations, including strengthened validation requirements, equity impact assessments, post-market surveillance with disaggregated data, improved clinician training, and better resourcing for regulators.

Why should you read this report?

This review reframes health equity as a safety and governance issue, not just an ethical concern. It shows how technical design choices and regulatory blind spots can reproduce structural inequalities at scale, and how policy tools—standards, procurement rules, and oversight mechanisms—can mitigate these risks. For policymakers, it provides a practical roadmap for embedding equity into innovation rather than retrofitting it after harm occurs.

Who is this report for?

This report is particularly relevant for health policymakers, regulators, digital health leaders, procurement authorities, and public sector innovators working on medical devices, AI governance, and health equity—both within national health systems and in global policy contexts.

Read the full report here