Women, people of colour and those from deprived communities have been “left out of medical devices”, experts have said, amid growing bias concerns.
Specialists have told Femtech World that there is currently no equity in medical devices, an issue which can put people at risk and exacerbate existing health inequalities.
Marissa Fayer, medical device expert and CEO of DeepLook Medical, said: “This has long been a problem in the field of medical devices and all areas of healthcare.
“Women, people of colour, people living in non-urban areas and mostly anyone except a white middle-aged man have been left out of medical devices.”
Minority ethnic people, women and people from deprived communities have been found to be at risk of poorer healthcare because of biases within medical tools and devices.
A review advising the UK government on the health impact of potential bias in medical devices, published this week, raised concerns over AI devices and tools that measure oxygen levels.
The Equity in Medical Devices: Independent Review confirmed concerns pulse oximeters overestimate the amount of oxygen in the blood of people with dark skin, noting that while there was no evidence of this affecting care in the NHS, harm has been found in the US with such biases leading to delayed diagnosis and treatment, as well as worse organ function and death, in Black patients.
Annie Thériault, managing partner at Cross-Border Impact Ventures, said this is unsurprising, since bias is pervasive in the medical field.
“The majority of innovations and surgical tools are meant to be used by larger white males and may be more difficult for a smaller person, such as a woman. Similarly, certain medical devices fit larger bodies and there is often no data on whether a smaller version is as effective on a smaller person.”
Dr Chung Looi, CEO of Ablatus Therapeutics, voiced similar concerns.
She said: “Development of medical devices is a long and expensive process. Women, people of diverse backgrounds, biological profiles and communities with limited resources have historically been overlooked and deprioritised.
“Being inclusive in the design, testing and market reach of medical devices is not only ethical, but also a smart investment to reduce the risk of widening health and wealth disparities, and ensure that benefits of technological advancements can be share by all.”
However, Gloria Kolb, co-founder and CEO of Elidah, said: “I don’t necessarily agree that there are biases in medical devices. The devices are just that – devices that take measurements, output signals, used as tools.
“I would suppose that the potential for biases may be more in diagnostics, as the data the diagnostic is based on may not be universally tested across races. Moreover, the biases come into play in how these tools and devices are being used or offered.”
To receive the Femtech World newsletter,sign up here.
Nearly six in ten young women get health and wellness advice from influencers, new research shows.
Women aged 18 to 29 were more likely than young men to use online influencers for health information.
The topics included beauty, alternative medicine, mental health, weight loss and fitness.
The Pew Research study found that 57 per cent of women aged 18 to 29 said they get health and wellness information from online influencers, 10 percentage points higher than young men.
While Americans still mostly rely on healthcare providers, the research suggests social media influencers also play a major role in how young people find health advice.
Among women who get health and wellness information from influencers, 51 per cent said they often hear about beauty and appearance, compared with 18 per cent of men.
Young women were also around twice as likely as young men to say they see content about alternative medicine, meaning treatments or health practices used outside mainstream medical care.
A third or more of both young men and young women said they often hear about mental health and weight loss from influencers.
Around half or more of both groups said they often see fitness content.
When asked why they seek health and wellness information from influencers, around half of young women said they wanted to make a change to their health or lifestyle.
That compared with 37 per cent of young men.
The research also found that 23 per cent of young women said hearing from people who share their background or beliefs was one reason they used influencers, compared with 14 per cent of young men.
A further 19 per cent of young women said they learnt about things they did not want to ask their doctor, compared with 10 per cent of young men.
Congress is being urged to invest US$20bn over 10 years to close the women’s health gap.
The American College of Obstetricians and Gynecologists, the Society for Women’s Health Research and the Women First Research Coalition have unveiled the National Strategy to Close the Women’s Health Gap.
The framework calls for a coordinated national effort to improve women’s health research, care and outcomes.
It says women make up more than half of the US population, but their health needs across conditions and life stages have been understudied and underserved for decades.
Kathryn Schubert, president and chief executive of the Society for Women’s Health Research, said: “The women’s health gap has persisted for far too long.
“This strategy offers Congress a road map to improve health outcomes, drive innovation, and build a healthier future for women, families, and communities.”
The strategy notes that Congress required women to be included in National Institutes of Health-funded clinical research through the NIH Revitalization Act in 1993.
However, it says major gaps remain in women’s health research, clinical care and how evidence is put into practice.
The plan proposes US$7bn for research and innovation, including expanded federal investment in women’s health research across the NIH, VA, DoD and the Advanced Research Projects Agency for Health.
It would also establish a Women’s Health Research Interdisciplinary Fund at the NIH and create a national network of Women’s Health Centers of Excellence.
The centres would aim to accelerate the translation of research into clinical care and serve as training sites for researchers and clinicians.
A further US$1bn would be used for regulatory coordination and modernisation, including cross-agency collaboration and work to address sex differences in drug and treatment approvals.
Sex differences are biological differences between females and males that can affect disease risk, symptoms, treatment response and side-effects.
The funding would also support updated NIH tracking systems for women’s health research investment and publication standards on how sex as a biological variable is considered in research.
The strategy calls for US$4bn for data and evidence infrastructure, including a public-private partnership focused on women’s midlife health data.
It would also convene a public workshop to review existing women’s health research datasets and develop common data elements to fill gaps and make datasets more widely available.
Another US$7bn would go towards strengthening the clinical and research workforce.
This would include career pathways, loan repayment programmes, a women’s health clinical workforce loan repayment programme modelled on the National Health Service Corps and interdisciplinary training.
The workforce measures would include particular emphasis on rural and underserved areas.
The final US$1bn would support public awareness and education campaigns to improve health literacy, preventive care and participation in women’s health research.
Health literacy means a person’s ability to find, understand and use health information to make decisions about care.
The campaigns would use digital and traditional media developed in consultation with patient advocacy organisations and relevant medical societies.
Sandra E Brooks, chief executive of the American College of Obstetricians and Gynecologists, said: “Closing the women’s health gap requires not only funding research, but also investment in the people who conduct that research and those who translate research findings and discoveries into better patient care.
“Strengthening the women’s health research and clinical workforce is critical to accelerating the innovation needed to improve health outcomes for women.”
The strategy says women have higher annual out-of-pocket healthcare costs than men and live 25 per cent of their lives in poorer health.
Supporters say this strengthens the economic and public health case for long-term congressional investment.
The framework has been endorsed by organisations across women’s health, ageing, heart disease, autoimmune disease, cancer, reproductive medicine and neurological conditions, including the Women’s Alzheimer’s Movement at Cleveland Clinic, the National MS Society and UsAgainstAlzheimer’s.
Stardust shared sensitive period tracking data with third-party analytics firms, according to new privacy research from Mozilla.
The findings expose a privacy divide in femtech, where users often trust apps with highly sensitive reproductive health information.
The research was carried out by Mozilla’s Privacy Not Included team, which tested several period tracking apps.
It found that Stardust, a period tracker used by millions, shared users’ reproductive health data with analytics companies, a practice the research said contrasted with its privacy-first marketing.
Analytics companies collect and examine information about how people use digital products, often to help businesses understand user behaviour or improve marketing.
The findings raise questions about whether privacy promises made by health apps match what happens to users’ data.
According to research reported by TechCrunch, one other period tracking app tested by Mozilla received what researchers called a “squeaky clean” rating, suggesting similar services can operate without sharing sensitive health data in the same way.
Period tracking apps have come under greater scrutiny in the US since the 2022 overturning of Roe v Wade, which removed federal constitutional protection for abortion.
Some users and privacy advocates have warned that menstrual and reproductive health data could potentially be sought in legal cases.
The research also points to a broader regulatory problem for consumer health apps.
In the US, many health apps are not covered by HIPAA, the health privacy law that applies to medical providers and some healthcare organisations.
That means some consumer apps may be able to collect, share or monetise sensitive health data under rules that differ from traditional healthcare privacy protections.
The femtech market, estimated in the report at US$50bn, has grown quickly, but privacy regulation has not always kept pace with app development.
Stardust had not publicly responded to Mozilla’s findings at the time of the original report, and its privacy policy remained live on its website.
The issue is particularly sensitive for period tracking because the data can reveal patterns around fertility, pregnancy, contraception and reproductive health.
Mozilla’s wider Privacy Not Included initiative has examined consumer technology products for privacy and security concerns since launching in 2017, including connected devices, children’s toys and health apps.
The findings come as US lawmakers continue to debate stronger federal privacy rules for sensitive health information collected by consumer apps.
The American Data Privacy and Protection Act, which has been stalled in Congress since 2023, includes provisions addressing sensitive health information collected by consumer apps.
Experts have also warned that anonymised health data can sometimes be re-identified when combined with other information, such as location data.
Re-identification means linking supposedly anonymous data back to a specific person.
A 2019 study found that menstrual cycle data combined with location information could identify individual users with high accuracy.
State-level privacy laws in places such as California, Virginia and Colorado have also given consumers new rights around personal data, although enforcement can vary.
Privacy advocates say the research underlines the need for clearer data practices, stronger safeguards and greater transparency in femtech.
For users, the findings are a reminder that health apps do not automatically protect health information in the same way as healthcare providers.
The report suggests period tracker companies that put privacy first may be better placed to build trust in a market where long-term use depends on confidence.
Mozilla’s investigation suggests privacy promises in femtech do not always match practice, and that period trackers can function without sharing sensitive user data in the same way.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checkbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
6 Comments