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‘Compliance is a journey’: how femtech companies could navigate privacy and clinical safety requirements

Most femtech companies understand the importance of privacy, but experts say they often fail to address it at the development stage

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Women’s health has never seen more prominence. Since 2016, when the term “femtech” was coined, the health sector serving half of the world’s population has been on an upward trajectory.

In the course of just a few years, more than 2,000 femtech companies and apps have sprung up to address women’s needs, including tracking apps, fertility solutions and menopause platforms.

In 2022, VCs invested US$1bn of funding into femtech start-ups, the second best year on record after the US$2bn raised in 2021.

Dealroom reported that in 2023 femtech companies were worth upwards of US$28bn, while current forecasts predicted that this rapidly growing industry would be worth US$103bn by the end of 2030.

However, the “taboo” nature of women’s health and gender imbalances in investment are providing obstacles to the industry – femtech attracted only one per cent of health tech investments in 2022.

On top of that, the sector also faces significant challenges around regulatory compliance.

“Femtech companies often struggle with the secure and lawful processing of personal data and access to data,” said Amy Ford, data privacy specialist and managing director at Kaleidoscope.

“Start-ups simply don’t have the guidance and regulatory support they need when they are developing and bringing products to market.”

This is especially a problem considering that femtech apps and products are collecting and processing a wide range of sensitive personal information, said Ford.

“Not processing personal and sensitive health data in a safe and lawful way could lead to an infringement on the rights and freedoms of women. These could be loss of control over their personal data, discrimination and profiling, reputational damage, loss of privacy, limited access to services, loss of anonymity, exclusion and bias and even surveillance by authorities.

“Failure to protect users’ data could cause irrevocable damage and life-altering changes to women and their families.”

The other challenge, the data privacy specialist said, is around lack of access to data.

“Not having enough data causes a detrimental impact to the development of products and services in the femtech industry,” she explained.

“The data may be inaccurate, and companies may not have the interoperability to link it with health records, leading to an awful lot of problems and stifling innovation.”

While most femtech companies understand the importance of privacy, they often lack the knowledge and experience to address it at the development stage.

“When femtech start-ups come to me, they don’t have the time or experience to handle compliance, they have many plates spinning, – they are unsure, nervous about privacy controls going wrong and just don’t know what to do,” said Ford.

“I think the hope and want is there, but they just need a little bit of help.”

There are ways, however, in which companies can access support and equip themselves with the knowledge they need to navigate privacy and clinical requirements.

London-based Kaleidoscope has data privacy and clinical safety experts who specialise in health, health tech and life sciences and is one of the few consulting firms specifically helping femtech companies optimise data protection, clinical safety and risk management.

The organisation, led by Ford, supports start-ups in achieving their strategic objectives, while lawfully and ethically processing personal data, assuring their digital products are clinically safe for deployment and ensuring compliance with legislation.

The team have in-depth knowledge of all aspects of the lawful utilisation and sharing of personal and sensitive data, experienced clinicians with a passion for digital safety, and have created robust governance approaches and systems that provide effective technical and organisational controls for organisations.

“Compliance is a journey and it is an ambition of mine to help and support femtech companies go through the ever-changing and complex regulatory area,” said Ford.

“By working with femtech organisations, we are sharing and transferring our knowledge and we are able to set up an effective privacy programme to help them understand what they need to do and eventually run their own privacy operations.”

Kaleidoscope’s mission, she said, is to ensure that the products that are brought to market are lawful and safe.

“The key is to build trust and provide much needed support to women going through their personal journeys at every stage of life. And that’s why we are here for start-ups.”

To help businesses navigate the complexities of privacy and clinical safety, Kaleidoscope is providing free webinars tailored to femtech companies. To find out more, visit femtechworld.co.uk/events.

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Could this app change the way we live and work?

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Imagine a tool that could help women align their daily schedules around their menstrual cycle – it exists thanks to two passionate tech entrepreneurs and start-up co-founders.

Elina Vale, chief executive officer and Rustam Galiev, chief product officer, are on a mission to dismantle society’s 24/7 work culture and replace it with an “evidence-based” approach where women can thrive – regardless of the menstrual phase they are in.

The concept, also known as cycle syncing, is a way by which women adapt their health and lifestyle habits to fit the four phases of their menstrual cycle, namely menstruation, the follicular phase, ovulation and the luteal phase. During these phases, it is thought, women experience changes in key hormone levels that can affect their mood, energy and productivity.

The idea isn’t new. In fact, the practice was introduced by nutritionist Alisa Vitti in her book WomanCode in 2014.

What is new, however, is the way Vale and Galiev adjusted the method to suit women’s needs in the workplace. The founders developed an employee benefits platform that claims to combine science, coaching and artificial intelligence to help female employees improve their productivity and performance by working with their menstrual cycle. 

The app, they say, combines a to-do list, habit tracker, period tracker and mindfulness app in one tool.

“The way women’s menstrual cycle works is very different from the common nine to five routine that we, as a society, tend to prioritise. That’s what we are challenging at Essence,” says Vale.

“We aim to provide women with a tool that allows them to think [of what they could do] based on the phases of their cycle and not just in the traditional work routine.

“We are looking at things such as the type of activity that you do, the intensity, your workload and what your needs are to balance your performance and wellbeing.”

While there aren’t many scientific studies to support cycle syncing, evidence does show that hormone fluctuations affect energy, mood, appetite and sleep.

Vale says there is some research on how each phase of the menstrual cycle affects the types of activities women do. “We know, for example, that in the follicular phase it’s better to start new projects and in the luteal phase it’s better to wrap them up.”

She also says there is evidence to suggest that cultivating an inclusive workplace and actively supporting employees could improve their wellbeing and unlock their full potential.

“An inclusive workplace has been shown to improve motivation and engagement. The problem is that currently, everything in the workplace is structured in a ‘gender neutral way’, which is, by default, very male-focused. From our research, we know that most women don’t know much about their menstrual cycle, so they don’t look at the month through the four phases of the cycle.

“However, we are trying to change this perception and help women think differently.”

The end goal, the founder says, is to make employers prioritise menstrual health in the workplace and take women’s needs seriously.

“Most companies have mental health and wellbeing programmes in place – we think menstrual wellbeing should be a part of that too.”

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What Iceland can teach the world about gender equality in tech

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Áslaug Arna Sigurbjörnsdóttir speaking at the Nordic Women in Tech Awards in Reykjavík

The recent surge in artificial intelligence (AI) is reviving the tech industry, but gender bias is preventing women from joining the sector. Sorina Mihaila travelled to Reykjavík to find out what needs to change.

When, as a 24-year-old lawyer, Áslaug Arna Sigurbjörnsdóttir ran as the secretary of the Independence Party in Iceland she had one goal: to make an impact.

Eight years later, in a packed conference hall in her native Reykjavík, Sigurbjörnsdóttir, now Iceland’s Minister of Higher Education, Science and Innovation, maintained she has the same mission.

“I was lucky to be born in a world where a female was president of Iceland,” she told a crowd of 200+ delegates at the Nordic Women in Tech Awards, referring to Iceland’s former president, Vigdís Finnbogadóttir, the first elected female head of state in the world.

“Icelandic women have changed the world and I believe we can do it again.”

In the light of October’s “kvennafrí”, the country’s first full-day women’s strike since 1975 when women stopped work in protest at gender inequality, Sigurbjörnsdóttir echoed many Icelandic women’s view when she said equality is still far from being achieved. 

“Iceland has been ranked the best country in the world for gender equality by the World Economic Forum for 14 years in a row. But we need to do more,” she explained.

Touching on the role models that helped her become the person that she is today, Sigurbjörnsdóttir told the audience that she believes in innovation and she believes progress in innovation means recognising women for their contributions.

It was truly an empowering atmosphere – a beautiful way of celebrating women in the world’s most gender-equal country.

As I’ve come to realise during my time in Iceland, Icelanders are receptive to innovation and therefore adoption of new technology in this small island nation happens quickly. Focusing on women in tech feels, in this context, not only necessary but essential.

One organisation that caught my eye in this sense was WomenTechIceland, the non-profit behind this year’s Nordic Women in Tech Awards.

Started as a Facebook group, WomenTechIceland was officially registered as a non-profit organisation in 2021 by founders Paula Gould and Valenttina Griffin and dedicated its work towards encouraging equality in the tech industry.

Since 2017, the organisation has been working with visiting businesses, dignitaries, personas and influential voices in tech to host special events, panel discussions and online events to connect Iceland’s tech ecosystem with the global tech community.

Sigurbjörnsdóttir echoed many Icelandic women’s view when she said equality is still far from being achieved

Reykjavík-based venture capital firm Crowberry Capital is too on a mission to support women building businesses around technology advances.

As the only major Nordic venture fund headed by an all-female team, the firm has achieved recognition for focusing on backing founders who have traditionally not had access to capital.

In 2021 the company, led by founders Hekla Arnardottir, Helga Valfells and Jenny Ruth Hrafnsdottir, launched a US$90m fund to invest in technology start-ups in the Nordics, with a focus on supporting businesses in emerging tech sectors, with a particular emphasis on encouraging inclusivity.

Their reason? “To demonstrate that the region can also show the way in terms of inventive venture support.”

Whether it’s IT, sustainability, femtech or digital health, the tech industry unarguably needs more gender diversity to continue thriving.

For starters, gender diversity encourages divergent ways of thinking, which can improve quality in the ideas output. This, in turn, drives innovation and growth.

Countries like Iceland have shown us that improving gender equality is a great place to start, but there’s still some way to go.

Women must be able to see that they can have an exciting career in technology and succeed. That means fostering an inclusive work culture, advocating for better representation and introducing more family-friendly policies.

As minister Sigurbjörnsdóttir rightly put it on stage: “If we want to make an impact, we need to engage, participate, campaign and put words into action.”

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‘I went undiagnosed for 15 years’ – the researcher leading the fight against endometriosis

The lack of research in endometriosis and her experience of the disease have prompted Dora Koller to study the condition herself

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Dora Koller, postdoctoral fellow at the University of Barcelona and Yale University School of Medicine

When Dora Koller noticed her first endometriosis symptoms, she was 14, but it wasn’t until she turned 29 that she got a diagnosis.

“They say diagnosis time is between four and 11 years. In my case, it was 15,” she explains.

One might have thought her background would have made a difference – Dora is a postdoctoral researcher in computational genomics at Yale University and the University of Barcelona. However, it didn’t.

“I had to keep insisting because I knew something was wrong,” she says.

“I understand biology, but I can’t imagine how it must be for someone who doesn’t have my background.”

One in 10 women of reproductive age has endometriosis, yet often their primary care doctors do not know what it is and the specialists to whom they are sent are ill-informed.

Vast numbers of women go undiagnosed or under-treated, with some scientists arguing endometriosis is an example of “undone science”. However, Koller thinks the issue goes beyond research.

“Often patients with endometriosis get diagnosed when they present with infertility and the fact that women are not properly represented in the medical profession is partly responsible for that,” she says.

“Gynaecology has been a very male-dominated field and [conditions like endometriosis] have not been a priority. The priority was for us to procreate. When that didn’t happen, they may have started thinking about what’s happening to us. Otherwise, pain wasn’t important.”

The under-representation of women, the lack of research in endometriosis and her experience of the disease have prompted Koller to study the condition herself.

“I work in the field of psychiatry, but having endometriosis made me interested in knowing as much as possible about it,” she says.

“I wanted to connect the two and understand the link between endometriosis and mental health.”

Her latest research – the largest epidemiological study to date on the psychiatric factors that can accompany endometriosis – has demonstrated that depression, anxiety, and eating disorders are not only a result of the chronic pain endometriosis generates, but also have their own underlying genetic mechanisms.

“It’s a great result, because now we can say that it’s not women’s fault.

“For a long time, researchers thought endometriosis was just a gynaecological disease — that it didn’t affect anything but female reproduction, and so women were often only treated when they presented with infertility.

“Now, we have to acknowledge that the effects of endometriosis extend far beyond reproduction.”

Although she thinks understanding the impact of endometriosis is important, Koller says diagnosis and treatment should remain a priority.

“The fact that it’s 2023 and the only available diagnostic method for endometriosis is surgery is unacceptable.”

‘This is not just a conversation between scientists’

There is still a long way to go to address the challenges in diagnosing and managing endometriosis, but by raising awareness the researcher believes we can open up the conversation.

“I always like to talk about this based on what happened 10 years ago with breast cancer,” she says.

“We saw women and campaigners talking about breast cancer and now everyone is aware how common it is. I think something similar is happening with endometriosis.”

However, not all countries are involved in this discussion. According to the World Health Organization, in many places, the general public and healthcare providers are not aware that life-altering pelvic pain is not normal, leading to a normalisation and stigmatisation of endometriosis.

“The change is happening mostly in the West, but we need to make more efforts to bring it everywhere and raise awareness everywhere,” Koller agrees.

“Most of the things [we are seeing] appear in English or Spanish which makes it harder to reach people who don’t speak those languages. We need to translate that information to other languages to reach as many people as possible.

“Scientists, myself included, also need to work on translating the information to the public, because often we’re using difficult language that people can’t understand.

“This is not just a conversation between scientists. This is a conversation that needs to involve patients and the general public.”

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