Call for evidence outcome

Equity in medical devices: independent review call for evidence

Updated 11 March 2024

This call for evidence will be open for 8 weeks and will close on Thursday 6 October 2022 at 11:45pm. Submissions can be anonymous.

This call for evidence aims to collect existing data and evidence as well as information on ongoing data collection and research or evaluation projects. This call will be particularly relevant to those who engage in any way in the design, development, evaluation and use of medical devices.

We also welcome views and insights from patients and the general public, but if patients have concerns about the health care received there are other dedicated channels and support available. To provide feedback or complain about the care received to date, contact NHS England.

To report to the Medicines and Healthcare products Regulatory Agency (MHRA) suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products, use Yellow Card.

About the equity in medical devices: independent review

One of the priorities for the UK government is to tackle health inequalities. As part of these efforts, the former Secretary of State for Health and Social Care commissioned an independent review on equity in medical devices to advise the government on any issues related to equity in medical devices used in the NHS and potential solutions to these.

The independent review aims to collect and review evidence as to whether the way in which some medical devices are designed, developed or used may lead to them not being equally effective or safe for different populations based on their ethnicity or other social or demographic characteristics, such as socio-economic status. To date the evidence is not yet conclusive. The independent review therefore aims to establish where and how potential ethnic and other unfair biases may arise in the entire lifecycle of medical devices, and the extent and impact of these, and to make recommendations for more equitable solutions.

The Equity in medical devices: independent review is chaired by Professor Dame Margaret Whitehead. By June 2023 the review panel aims to provide recommendations to the UK government regarding how to ensure the development and use of medical devices is equitable.

Guidance and definitions

Medical devices

In this document the definitions of medical devices and in vitro diagnostic devices are in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). A medical device is any type of physical device or software that is used specifically for diagnosis or therapeutic purposes and is intended by the manufacturer for use on human being. Similarly, in vitro diagnostic devices are devices intended for use by the manufacturer for the examination of specimens, including blood and tissues samples, derived from the human body for the purposes of providing information about those samples. This information includes issues such as diagnosis of illnesses or congenital abnormalities, to determine the safety and compatibility of blood and tissue donations and, to monitor the effectiveness of treatment regimes.

The review focuses on all types of medical device including for example:

• devices employing infrared light or imaging that may perform differently depending on skin pigmentation of the patient
• artificial intelligence (AI) enabled applications used in diagnostics and for making decisions about healthcare, which might have problems with the clinical algorithms built into them
• polygenic risk scores used for personalised medicine

Collecting evidence and insights

The review panel welcomes any data and evidence, including preliminary evidence but also information on ongoing data collection and research or evaluation projects, regarding existing equity concerns or biases with respect to ethnicity or other socio-demographic characteristics, and any mitigating solutions. This could include:

• data and evidence related to ethnic and other unfair biases in relation to the development and use of medical devices
• examples of effective, successful or evidence-based approaches currently in use to mitigate these types of unfair biases and risks
• suggestions and ideas for potential approaches to improving equity in the use of medical devices

While we would welcome input from all interested parties, we expect these topics to be of particular interest and relevance to members of the following groups:

• organisations representing diverse communities and patient groups, including charities
• community leaders
• academia, research, think tank and funding institutions
• clinicians and other healthcare professionals
• NHS and health improvement organisations
• industry, including medical device developers, manufacturers and innovators,
• device regulators and standard setters, including legal teams

Next steps

The submissions for this call of evidence will be reviewed by the independent panel chaired by Professor Dame Margaret Whitehead, who will consider them alongside other findings gathered as part of this review. Together with other evidence and insights, the findings from the call for evidence will help to shape the recommendations that the independent panel will make.

Questions

About your submission

Question

Which topic does your submission relate to? (Select all that apply)

• data and evidence related to ethnic and other unfair biases in the design or development of medical devices
• data and evidence related to ethnic and other unfair biases in the use of medical devices
• examples of evidence-based or successful approaches currently in use to limit ethnic and other unfair biases in the design or development of medical devices
• examples of evidence-based or successful approaches currently in use to limit ethnic and other unfair biases in the use of medical devices
• suggestions and ideas (but not evidenced yet) for potential future approaches to improving equity in the development or use of medical devices.
• other (please specify)

Question

Which type of medical device does your submission relate to? (Select all that apply)

• medical devices not enabled by artificial intelligence (AI), (for example, pulse oximeters, sensors, software as a medical device)
• AI-enabled devices (for example, devices that use algorithms and software for diagnosis or healthcare decision-making)
• polygenic risk scores or other applications of genomics used in diagnostics and personalised medicine
• none or I don’t know
• other (please specify)

Question

Which component of medical device or which aspect of a medical device’s life cycle does your submission relate to? (Select all that apply)

• research and innovation preceding development and manufacturing
• product design
• technical specifications
• device development or manufacturing
• clinical validation and testing
• pre-deployment testing, research, evaluation
• post-deployment testing, research, evaluation, monitoring
• marketing of medical devices
• training on the use of the devices or other relevant training for healthcare professionals
• use of the devices in the healthcare setting (with assistance from healthcare professionals)
• use of the devices at home (without assistance from healthcare professionals)
• regulation or standards
• datasets
• biobanks
• diagnosis
• treatment
• algorithms
• software
• hardware or physical properties of the devices (for example, sensors)
• none or I don’t know
• other (please specify)

Question

Which characteristics does your submission relate to?

• ethnicity
• other social or demographic characteristics (please specify)
• none or I don’t know

Potential issues in the design and development of medical devices

Question

Do you have any data or evidence related to ethnic and other unfair biases in the design or development of medical devices, which could affect their effectiveness or safety for different populations?

• yes
• no

If you answered yes, please be as specific as possible in your answer and explain the evidence you are submitting on how and why the design or development may not be equally effective or safe for all the intended patient groups. If relevant, provide:

• the device type, name and brand or manufacturer, in as much detail as possible
• the intended use of this device
• the patient population on which it is used or intended for
• detailed explanation of the evidence you are submitting on how and why it may not be equally effective or safe for all the intended patient groups

If you answered no, do you have any insights or views about the design or development of medical devices that might make them not equitable (that is, not equally effective or safe) for all persons in the population, especially if it’s based on their ethnicity or other social or demographic characteristics?

• yes
• no

If you answered yes, please be as specific as possible when sharing your insights or views about potential issues in the design or development of medical devices, but do not include any personal or identifiable information.

Potential issues in the use of medical devices

Question

Do you have any data or evidence related to ethnic and other unfair biases in the use of medical devices, which could affect their effectiveness or safety for different populations?

• yes
• no

If you answered yes, please be as specific as possible in your answer and explain the evidence you are submitting on how and why it may not be equally effective or safe for all the intended patient groups. If relevant, provide:

• the device type, name and brand or manufacturer, in as much detail as possible
• the intended use of this device
• the patient population on which it is used or intended for
• detailed explanation of the evidence you are submitting on how and why it may not be equally effective or safe for all the intended patient groups

If you answered no, do you have any insights or views about the use of medical devices that might make them not equitable (that is, not equally effective or safe) for all persons in the population, especially if it’s based on their ethnicity or other social or demographic characteristics?

• yes
• no

If you answered yes, please be as specific as possible when sharing your insights or views about potential issues in the use of medical devices, but do not include any personal or identifiable information.

Potential solutions in the design and development of medical devices

Question

Do you have examples of evidence-based or successful approaches currently in use during the design or development of medical devices to mitigate potential or actual risks and unfair biases that may affect their effectiveness and safety for different patient groups?

• yes
• no

If you answered yes, please provide information about the existing solutions in the design or development of medical devices to make them more equitable. Be as specific as possible and include information about the medical device type or specific name and manufacturer, what the potential or known risk of bias is, and how it is being addressed now.

If you answered no, do you have any suggestions for designing or developing medical devices that might make them more equitable (that is, equally effective or safe) for all persons in the population, especially if it’s based on their ethnicity or other social or demographic characteristics?

• yes
• no

If you answered yes, please provide suggestions for the design or development of medical devices that could make them more equitable (that is, equally effective or safe) for all persons in the population, especially if it’s based on their ethnicity or other social or demographic characteristics.

Potential solutions in the use of medical devices

Question

Do you have examples of evidence-based or successful approaches currently in use during the use of medical devices to mitigate potential or actual risks and unfair biases that may affect their effectiveness and safety for different patient groups?

• yes
• no

If you answered yes, please provide information about the existing solutions in the use of medical devices to make them more equitable. Be as specific as possible and include information about the medical device type or specific name and manufacturer, what the potential or known risk of bias is, and how it is being addressed now.

If you answered no, do you have any suggestions for the use of medical devices that might make them more equitable (that is, equally effective or safe) for all persons in the population, especially if it’s based on their ethnicity or other social or demographic characteristics?

• yes
• no

If you answered yes, please provide suggestions for the use of medical devices that could make them more equitable (that is, equally effective or safe) for all persons in the population, especially if it’s based on their ethnicity or other social or demographic characteristics. Be as specific as possible but do not include any personal or identifiable information.

Final comments

Question

Do you have any other comments, suggestions or ideas for potential future approaches to improving equity in the development or use of medical devices?

• yes
• no

If you answered yes, please provide any comments, other suggestions or ideas for potential future approaches to improving equity during the design, development or use of medical devices.

Privacy notice

Over the course of August to October 2022, the Department of Health and Social Care (DHSC) will seek the views of individuals and organisations through a call for evidence, to inform the recommendations of the Equity in medical devices: independent review. This notice sets out how data collected through this call for evidence will be used and respondents’ rights under Articles 13 and/or 14 of the General Data Protection Regulation (GDPR).

Data controller

The Department of Health and Social Care (DHSC) is the data controller.

What personal data we collect

You can respond to the call for evidence through our public survey, which can be completed online.

We will collect data on:

• whether you are responding as an individual sharing personal or professional views, or on behalf of an organisation

If volunteered by you, we will also collect data on:

• where you live in the UK (country) or outside of it or where you or your organisation provide services in the UK (country) or outside of it
• your personal characteristics (including your age in 3 categories of 18 to 24, 25 to 64, and 65 and over, and ethnicity)
• your email address, title, name and surname
• if you respond in a professional capacity or on behalf of your organisation then also the type of organisation, group or profession you represent, the area of your expertise or your organisation’s focus, the name of your organisation, and your role or job title
• any other personal data you volunteer by way of evidence or example in your response to open-ended questions in the survey

We will also be asking open questions with free text answer boxes. Please do not include any information that could directly identify you in these boxes. For example, some people might give their name or their exact age as context for a response. If we receive any responses which include information that we think may directly identify you, we will seek to remove this information where possible.

How we use your data (purposes)

Your data will be treated in the strictest of confidence.

We collect your personal data as part of the call for evidence process to use for the following purposes:

• if you need to contact us about deleting your response – the only way we can verify that it is your response is via your email address
• if you didn’t have time to finish the survey, we can send you a reminder before it closes
• if we have follow-up questions for you regarding your submission
• if the panel has follow-up questions for you, and you have agreed to be contacted by them
• if there will be additional stakeholder engagement activities or updates regarding the review that may be relevant to you, and you have agreed to be contacted about them
• for statistical purposes, for example, to understand how representative the results are

Legal basis for processing personal data

The legal basis for processing your personal data is to perform a task carried out in the public interest, that of consulting the public.

The legal basis for processing your sensitive personal data is that it is necessary for reasons of public interest in the area of public health.

Data processors and other recipients of personal data

All responses to the call for evidence will be seen by:

• the Secretariat team of the Equity in medical devices: independent review at DHSC and DHSC members working on the call for evidence
• DHSC’s third-party supplier (SocialOptic), who is responsible for running and hosting the online survey
• DHSC digital team who manages the online survey

DHSC may also share your anonymised responses with:

• members of the independent panel on the Equity in medical devices: independent review
• individuals supporting this project within DHSC’s executive agencies and/or executive non-departmental public bodies, such as NHS England
• other government departments
• external researchers if additional support is required to analyse the responses received

International data transfers and storage locations

Storage of data by DHSC is provided via secure computing infrastructure on servers located in the European Economic Area (EEA). Our platforms are subject to extensive security protections and encryption measures.

Storage of data by SurveyOptic is provided via secure servers located in the United Kingdom (UK).

Retention and disposal policy

DHSC will only retain your personal data for as long as either:

• it is needed for the purposes of the call for evidence
• the law requires us to

This means that personal data will be held by DHSC for a minimum of 1 year and a maximum of 8 years.

SurveyOptic will securely erase the data held on their system 5 years after the call for evidence online survey closes, or when instructed to do so by DHSC if the data has served its intended purpose (whichever happens earlier).

Data retention will be reviewed on an annual basis. Anonymised data will be kept indefinitely.

How we keep your data secure

DHSC use appropriate technical, organisational and administrative security measures to protect any information we hold in our records from loss, misuse, unauthorised access, disclosure, alteration and destruction. We have written procedures and policies which are regularly audited and reviewed at a senior level.

SocialOptic is Cyber Essentials certified.

Your rights as a data subject

By law, you have rights as a data subject. Your rights under the General Data Protection Regulation and the UK Data Protection Act 2018 apply.

These rights are:

• the right to get copies of information – individuals have the right to ask for a copy of any information about them that is used
• the right to get information corrected – individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected
• the right to limit how the information is used – individuals have the right to ask for any of the information held about them to be restricted, for example, if they think inaccurate information is being used
• the right to object to the information being used – individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case
• the right to get information deleted – this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme, should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioner’s Office. Their website address is www.ico.org.uk and their postal address is:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

How to respond

Respond through our online consultation survey.

If you have technical problems with using the online survey or if you cannot send your response via the online portal, please log the issue by emailing device-equity-review@dhsc.gov.uk. Do not send any personal information to this email address.

Or you can post your queries to:

Secretariat for the Equity on medical devices: independent review
Medical Technology Directorate
Department of Health and Social Care
Victoria Street
London
SW1H 0EU