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Opinion

Regulating femtech: how embracing regulatory oversight can enhance women’s health innovation

By Bethany Corbin, healthcare innovation and femtech attorney

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Bethany Corbin

The tension between technological innovation and consumer protection has long dominated the digital health regulatory landscape.

As an attorney, I’m often privy to innovators’ concerns that enhanced regulation could stifle innovation, particularly in emerging markets. While it’s no secret that heavy-handed regulation could discourage desirable innovation, it’s also important to recognise the beneficial role that regulation plays for both consumers and innovators.

Given the constantly evolving femtech environment, many founders wonder how they can drive meaningful regulatory outcomes without creating unnecessary hurdles along their path to commercialisation. I believe femtech innovators can accomplish this objective by developing public-private partnerships with regulators to shape the future of women’s health regulation.

The first step to developing a meaningful public-private partnership with government regulators is to honestly identify and acknowledge the shortcomings in our beloved femtech industry.

In a world where start-up economics drive product development, it’s necessary to take a step back and identify the harms that lax regulatory frameworks can have on consumers of femtech products. By proactively pinpointing areas in which femtech is not living up to its potential, founders and femtech advocates can help shape future regulatory agendas.

In my opinion, there are at least two key areas of femtech that could benefit from enhanced regulatory oversight. The first area is data privacy, particularly in countries like the US, which do not have comprehensive privacy legislation.

Following the overturn of Roe v. Wade, many consumers lost trust in the femtech industry and deleted their femtech applications. This loss of trust was not only fueled by the lack of national privacy standards in the US, but also stemmed from companies’ downstream data sales to third parties—such as data brokers and social media giants.

To date, there has been little recognition that the heightened sensitivity of reproductive health data demands heightened data protection regulations, and many femtech apps operate in a regulatory void.

The second area craving regulation concerns the review and approval of femtech devices for accuracy before they hit the market.

While the majority of femtech companies offer consumer devices, applications, and software, many of these products are not subject to regulatory scrutiny (such as review by the Food and Drug Administration) because of the generally low risks they pose to consumers.

This means that a significant number of software-based femtech devices are not reviewed or regulated by government agencies prior to launch. This lack of pre-launch review means that many femtech devices are not required to satisfy safety and accuracy standards and that inaccurate devices can flood the market.

For example, the Organization for the Review and Care of Health Apps found that 85 per cent of the femtech industry’s most downloaded apps did not meet quality thresholds and had significant clinical assurance concerns. Yet, consumers have no method of vetting these femtech products or meaningfully choosing between accurate and inaccurate devices.

Acknowledging the need for heightened regulatory oversight of data privacy and device accuracy can benefit both consumers and femtech companies.

Consumers benefit by having stricter standards in place to protect their sensitive health data and ensuring a threshold level of device accuracy. This allows consumers to regain trust in the very industry that is meant to empower them.

Femtech companies, in turn, benefit not only from increased product adoption that accompanies enhanced consumer trust, but also from the fact that privacy and accuracy can now become market and product differentiators.

Companies that build privacy-centric and accurate products can capture significant market share by aligning their product designs with consumer values. This also helps to discourage “get rich quick” innovation in women’s health by companies that are not dedicated to women’s wellbeing.

Once femtech founders and advocates identify and acknowledge areas that are ripe for regulatory oversight, they should partner with the appropriate government entities to develop regulatory agendas in these areas.

Public-private partnerships are necessary to avoid top-down regulatory efforts that can inadvertently ignore the realities associated with developing, marketing, and scaling femtech products. Top-down regulation involves regulatory agendas set solely by government agencies, who oftentimes lack on-the-ground experience and expertise that founders and advocates bring to the table.

Collaboration can result in mutually beneficial outcomes, as the public and private sectors can capitalise on each other’s strengths and experiences to build the future of women’s health innovation together. When the femtech industry becomes an active participant in regulatory activities, it can integrate diverse perspectives and resources into the conversation and help develop solutions that can quickly adapt to technological change without stifling future femtech innovation.

In a world of constant change, I fully believe that femtech founders and advocates should be at the forefront of regulatory discussions that concern the femtech industry.

Our practical expertise is vital to helping regulators understand legislative gaps and weaknesses that can harm consumers, while also developing innovative solutions that won’t suppress innovation.

Only through public-private partnerships can we make our voices heard and become drivers of the standards and legislation that will someday govern our industry.

Bethany Corbin is a healthcare innovation and femtech attorney on a mission to help thought-leading companies revolutionise women’s health. Through her company, FemInnovation, Corbin partners with emerging companies at the forefront of healthcare transformation to ensure they are building robust, scalable, and legally compliant businesses focused on enhancing health equity. 

Opinion

‘We are not allowed to talk about our bodies’: why we need to address social media censorship

By Clio Wood, women’s health advocate and founder of &Breathe

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Social media censorship is just another example of women’s issues being sidelined and women being made, yet again, to feel small.

The gender data gap is huge and, if you’ve ever read the great Caroline Criado Perez’s book, Invisible Women, you’ll know what I mean. It touches every day of a female life.

That impact includes social media too. Because while the social media platforms are notoriously secretive about their internal workings, it’s a pretty safe bet that social media algorithms, like most of the rest of life, are built on male data and trained on male behaviours.

This means that as long as women have different behaviours and priorities of what they want to see on these platforms, we’re going to find it a struggle.

Meta and Tiktok are silencing women’s health and sexual wellbeing content. Censorship harms women’s health: it increases women’s pain, and disempowers women, which in turn means the gender health gap cannot close. What annoys you when you’re on your phone scrolling has long-lasting impact for us and our children.

I’ve experienced this censorship first hand on Instagram, with my reach being restricted for simply posting a body confidence reel of me dancing in a bikini.

That in itself – one example of many – is infuriating, but what’s especially galling is that everyday men’s health topics are left uncensored, and hyper sexualised women’s bodies, unsolicited “dick pics” and fake accounts using nearly naked female profile pictures are making their way into social media feeds and inboxes unchecked. The hypocrisy of the situation is clear.

All the while charities are being forced to use male nipples instead of female ones, and female-led period brands are losing hundreds of thousands of pounds when their ad accounts get deleted.

Creators, charities, medical practitioners and brands are being censored constantly through algorithms picking up words like sex, vagina, vulva, or period. Which are all normal human functions or body parts and integral to these creators’ missions. You can’t be a period care brand without talking about periods.

CensHERship aims to alter the trajectory of the current algorithms and end the routine censorship of women’s health content online

Creators end up using written symbols and numbers to disguise these words and bleep them out in speech to try to get around this censorship.

It’s examples like this that finally led me – after many years of finding this situation ridiculous – to do something about it.

Together with Anna O’Sullivan, we’ve created CensHERship, a campaign which aims to alter the trajectory of the current algorithms and hopefully restore some balance to what is allowed on social media. Our ultimate aim is to bring the platforms to the table for discussion by this time next year.

We launched a survey in late January 2024 to try to collect as much information as we can about the incidences of muting and censorship that female creators are experiencing, whether they are educators, charities, brands or medical professionals. The results emphasised that this is a widespread issue taking in all of women’s health and sexual wellbeing.

In tandem we hosted an intimate roundtable to launch the CensHERship campaign and found, to our astonishment, that the problem goes much deeper than social media. Women’s health and sexual wellbeing brands are being refused bank accounts, insurance and being kicked off payment platforms without warning.

Social media censorship is just the tip of the iceberg. It’s just one more example of women’s issues being sidelined and women being made, yet again, to feel small.

We’re not being allowed the freedom to talk about our own bodies and health, because speaking up goes against the male-gaze archetype of the female role and body. Let’s end CensHERship once and for all.

Clio Wood is a women’s health advocate, journalist, author and Founder of &Breathe.

Anna O’Sullivan is a communications and marketing professional and writes FutureFemHealth 

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Opinion

Revolutionising women’s health: the rise of femtech innovations

By Jo Barnard, founder and creative director of Morrama

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In the fast-evolving landscape of female technology, 2024 is poised to mark a pivotal year in growth and innovation.

Investors are increasingly recognising the vast potential of a typically overlooked audience, which encompasses 45+ year-old women with disposable income and actively seeking solutions.

As the femtech sector continues to gain momentum, we can anticipate the introduction of innovative features, products and services – such as intelligent menstrual cups, connected pads addressing menstrual cramps and wearables with hot flush detection capabilities, all with an growing focus on the unique needs of the individual.

Removing the guesswork through data

Whilst we mustn’t devalue leading medical advice on female health – including period complications, fertility, and menopause – they can feel like one-size-fits-all treatments that are only offered in the more severe cases. In reality, women’s health is a very personal and nuanced journey. The next few months promise the advent of smarter versions of pre-existing products, in an effort to help women understand their bodies better.

Take Emm, for instance. The company created a menstrual cup embedded with sensors to track menstrual flow, providing users with valuable insights into their menstrual health.

Similarly, wearables such as FemSense utilise advanced algorithms to predict ovulation with 99.7 per cent accuracy. These cutting-edge digital and physical devices help unlock new insights into the complexities of the female body, paving the way for more informed decision-making and improved health outcomes.

Addressing gaps in conventional treatments

While the femtech sector continues to push the boundaries of innovation, it also seeks to address long-standing gaps in the provision of medical solutions for various female health issues.

Conventional treatments, such as contraceptive pills for managing period pains, IVF for fertility problems or hormone replacements for menopause often fall short in meeting the diverse needs of women.

Against this backdrop, femtech brands are pioneering a more specialised and inclusive approach – as highlighted by brands like Tina, which I explore into more detail below – tailoring products to specific demographics, including people of colour, individuals with physical constraints and those with distinct religious beliefs.

Prioritising design, technology, and user experience

Central to the femtech revolution is a strategic focus on design and technology, aimed at enhancing the quality of life for women across the globe. Leading brands such as Emm, Embr and Tina are at the forefront of this movement, developing solutions that not only empower women but also drive positive societal change.

Tina’s aim, for example, is to create inclusive design for all bodies and abilities, engineered with anatomy in mind. Their tampon applicator takes into account correct angles and depth, and prides itself in being “first-period friendly”, reducing the stigma surrounding women’s health for the next generations.

These brands can only achieve this by opening up the conversation and incorporating feedback from diverse communities in order to deliver products that resonate with women from all walks of life.

In addition, this year’s Consumer Electronics Show (CES) in January offered valuable insights into the evolving landscape of femtech, where innovation is not solely defined by radical disruptions but by incremental improvements to existing products and services.

Highlights from the show included: Movano Health’s Evie Ring, a smart health ring utilising AI to analyse women’s menstrual and sleep data; and Vivoo’s new at-home smart UTI test, showing that a dipstick test can be beautiful and utilising the capabilities of smartphones to give more accurate readings.

With femtech brands historically focusing on function over aesthetics, it’s positive to see companies considering smarter delivery mechanisms, more thoughtful design and more personalised educational pathways. The result is that women feel more empowered and valued as individuals.

Importance of research and evidence-based practice

However, as femtech continues to grow and develop, it’s also crucial not to lose sight of the importance of scientific rigour and evidence-based practice. For every truly science-based solution there will inevitably be a flood of lower quality copycats and brands promoting products that serve only as a placebo.

Building trust in femtech solutions requires a commitment to transparency, accountability and continuous improvement. Only by investing in rigorous scientific enquiry can we ensure that femtech products and services meet the highest standards of safety, efficacy and reliability.

A bright future for femtech

I’m excited for the future of femtech. As we look ahead to the next few months and beyond, let us embrace innovation, inclusivity, open-mindedness and evidence-based practice as our guiding principles.

More than ever, the industry has the potential to usher in a new era of personalised, proactive and women-centred healthcare, making a meaningful impact on women’s quality of life as well as the broader population as well.

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Opinion

How the UK’s ‘pharmacy first’ policy will change women’s healthcare

By Katherine Bridges, head of brand and clinical lead at the pharmacy app Charac

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On the January 31, the UK government will roll out its long-awaited “pharmacy first” policy, a measure designed to cut the size of the NHS backlog – which currently stands at around 7.6 million patients.

With “pharmacy first”, patients suffering from various lesser ailments – such as sore throats and shingles – will be directed to their local pharmacy as their first port of call.

Pharmacies will also be able to supply certain prescription medicines. It is hoped that this will ease pressure on Britain’s seriously overstretched hospitals and GPs.

The policy is set to transform healthcare provision in the UK, which is important for women’s health across the country. If the policy can be carried through successfully, women’s access to NHS will improve in a number of ways. The success of “pharmacy first” will, however, rely on a big technological upgrade to Britain’s 11,500 high-street pharmacies.

Improving women’s access

This shift of several key medical functions to Britain’s pharmacies will give women easier access to important medicines and treatments. For instance, under “pharmacy first” patients will be able to pick up prescription medicine for urinary tract infections (UTIs) from pharmacies; previously this required a GP appointment beforehand.

This change will be especially valuable for women, given that this ailment disproportionately affects women, with roughly 50 per cent experiencing one over the course of their lives.

Crucially, under the new policy, women will also be able to purchase contraceptive pills at their pharmacies without seeing a GP. It is vitally important, but easily prescribed and administered medications such as this that will see “pharmacy first” freeing up countless of hours of GP and hospital time.

Further, the reduction of pressure on GPs and hospitals will improve women’s access to critical medical procedures and treatments. For instance, the policy will put a dent in the NHS’s mastectomies backlog, which is currently putting thousands of women in the UK at a greater risk of breast cancer.

Femtech critical to making a success of “pharmacy first”

Of course, “pharmacy first” represents a very large administrative and operational task for Britain’s high-street pharmacies.

It is uncertain whether these pharmacies, in their current state, will be able to meet the challenge. Community pharmacies are often small and family run. As such, they find it difficult to afford key labour-saving technologies that cut costs and free up time.

These pharmacies’ internal systems are often ramshackle and antiquated. Many still run on paper, making everything from prescriptions to payroll arduous and time-consuming.

It is clear that these pharmacies will need to undergo a big technological upgrade as the policy is rolled out this year. Femtech will play a key role in this effort.

Femtech technologies could help pharmacists manage the transition to a greater scope of provision. For instance, femtech companies, such as Vivoo’s at-home women’s UTI test, could help pharmacists manage the task of treating this common women’s ailment.

Another would be the online self-assessment system Tuune, which matches women to the contraceptive treatment appropriate to their particular hormonal profile.

Innovations like these will be an essential part of women’s healthcare in the age of “pharmacy first”, driving efficiencies in high-street pharmacies and expanding women’s access to treatment.

The future of health tech will empower women

Other health technologies will help amplify the impact of femtech. Apps, such as Charac, offer a dashboard for both pharmacists and their customers, allowing customers to book pharmacy appointments and get their prescriptions delivered to their door.

These kinds of accessible, integrated health tech systems that will prove so valuable in the age of “pharmacy first” will also help improve patient outcomes for women. One of the primary hindrances to better healthcare for women is a lack of information and access.

Research by the Department of Health and Social Care revealed that around 85 per cent of British women did not feel comfortable talking to their GPs about their physical health, and a similar percentage can remember an occasion where they did not feel listened to by medical professionals.

Similarly, knowledge of women’s health issues is often low: less than one in five UK women felt that they had enough information on menstrual health, and less than one in 10 felt they knew enough about gynaecological conditions.

What’s clear is that a lack of information and access is leading to worse health outcomes for women than men, but health tech can make a valuable contribution – streamlining appointments and prescriptions, raising public awareness of health conditions and the treatment services that women can access and making patient outcomes and healthcare more equal.

As “pharmacy first” becomes policy, we have a chance to use the latest developments in femtech and health tech to both make a dent in the NHS backlog, and to put women’s healthcare on a surer foundation.

Katherine Bridges is head of brand and clinical lead at the pharmacy app Charac.

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