Femtech and women's health

How safe is it to use period tracking and digital contraception apps? Who is your data being shared with? What regulation actually exists in this area to protect app users?

Femtech offers women digital tools for tracking reproductive health. Gavin and Jessamy are joined by Dr. Catriona McMillan, Senior Research Fellow in Medical Law and Ethics at the University of Edinburgh, to talk about how accurate these apps actually are, significant concerns about data privacy, and what regulatory oversight exists and can be applied.

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Transcript

This transcript was automatically generated using speech recognition technology and may differ from the original audio. In citing or otherwise referring to the contents of this podcast, please ensure that you are quoting the recorded audio rather than this transcript.

Gavin: Hello, and welcome to The Lancet Voice. I'm Gavin Cleaver and I'm here with my co-host Jessamy Bagenal. It's June, 2025. Today we explore the rapidly evolving world of femtech, or the technologies designed to address women's health needs. We're joined by Dr. Katrina McMillan, an expert in medical law to discuss the critical legal, regulatory and data privacy challenges that this sector faces.

And we'll talk about things like how digital contraception and period tracking apps are affecting how women take charge of their health. And Katrina's gonna fill us in on what must be done to ensure safety, accuracy, and of course, adequate legal protections in this rapidly expanding field. We hope you enjoy the conversation.

Jessamy: So lovely to have you with us and we are gonna talk today a little bit about fem tech. You've written very thoughtfully about this and I wondered whether you could just give us a bit of a sort of definition for people who aren't really in the health tech world to understand what is FunTech.

Catriona: First of all, thank you so much for having me on. FinTech is a kind of growing, really popular category of new technologies that were made to address women's health and wellness needs. It's quite broad at the moment, I would say, and it encompasses all kinds of products and services that are aimed at either helping, facilitating, tracking, or giving information on things.

Like pregnancy planning, menstrual health, pregnancy and childbirth, menopause, and also things like sexual health and other kind of sex related health conditions as well. So it's a really broad category, basically aimed at improving and enhancing women's health. 

Jessamy: What's the sort of, what's the background of the field?

What's it trying to, what they trying to solve? The 

Catriona: term as far as we know, was coined back in 2016 by a wound called Ida Tin, who was one of the co-founders of quite a big FinTech company called Clue, which is a period tracker predominantly. And this kind of happened a short time after the more general boom quite a few years ago of.

Personal health tracking technologies in general, and these are things like fitness trackers and smart watches which today a lot of people have and use either just through their phones or by wearable devices as well. And so the EmTech industry grew in parallel to that shortly afterwards.

It certainly spurred on purely by the fact that a lot of health and wellness interests to do with women and their biology were pretty much ignored by this. Boom of personal health tracking. So for example, when Apple introduced their health app in 2014 into phones and it claimed to be a comprehensive tracker that could track most things, there was absolutely no capable to track periods back then.

So this industry expanded as a response to that. And also more broadly, I think, as a response to the general lack of attention to women's health needs and wellness interests. In broader sphere, not just in the technology industry. 

Jessamy: A hundred percent agree with you. And we know that for the most part, women's health issues are underfunded, under researched, and we've made very little progress on a lot of the issues that have a really high burden for women thinking about topics like endometriosis.

So there's clearly a need for women to have some kind of control over their health and to be able to inform the decisions that they're making and also. Hopefully this might stimulate research, but what's different between this and other parts of health tech or other types of digital interventions would you say?

Catriona: So I think there's two kind of key differences that I've noticed and I'm sure there's more, but its core really is the idea that women have this kind of distinct set of health needs and interests due to the fundamental difference in their biology. What's interesting is that the majority of this industry, which is all focused on personal health tracking, so things you can do for yourself it's.

Quite distinctly separate from the kinds of things that doctors and other healthcare practitioners might have access to and use is that it's really focused on people tracking and improving their reproductive potential in some shape or form. And so there are of course, which is great, some other technologies within the fem deck industry that focus on things like menopause and improving to the extent that they can, the kind of experience of that process.

The majority of this industry does focus on either preventing or aiding pregnancies. So there's an interesting theme that I think has emerged in this industry that is all to do with women's reproductive capacity in some shape or form. And then and interrelated other difference that I think has really come out in this.

Is this idea of self-regulation, which is of course a theme with all of this kind of tech in this industry. Of course, whether you're tracking how good your run's been through to how many calories even in a day. This is all about self-regulation. But what's really interesting about it when it comes to women and thinking about the reproductive processes is that it involves such a high level of involvement, not only in terms of giving apps very sensitive data, for example.

When you've had sex, maybe who you've had sex with, it can even track things like cervical mucus if you want it to through, to using the way that the app processes that data to make decisions about when you do or don't have sex and all sorts of other things. So there's a kind of difference in the degree of an both an intrusiveness and importance compared to something like tracking.

Your latest run. Yeah, 

Jessamy: it's interesting, isn't it? And I think that theme is so important because it's a recurring one when we think about women's health and that for the most part, when people and governments or bodies do investigations or reports on women's health, it always centers that health around a woman's reproductive role in society.

And we often forget that non-communicable diseases are in fact the leading cause of women's mortality and morbidity. It's not their reproductive issues, but that's always where the focus is for women's health. 

Catriona: Yeah, absolutely. I think this is part of a kind of broader structural problem that we do have in society as you've noted there, that quite often women are depicted.

Their social role, despite the advancements that we've had recently, is predominantly to do with their capacity to have children. And that's come, comes into all sorts of topics and discussion, not just this particular industry, but to do with the way that we define gender and sex and roles in general.

While there is a degree of kind of biology and truth to that, in that sense that the trouble with that is that it causes all sorts of other kinds of harms, including the ignorance of other enormous. Really serious issues that can arise with regards to women's health. Let the example you use non-communicable diseases, so there's other harms that can come out outta this perpetuation of this idea that our biggest concern should always be our reproductive health.

It is. A very big concern. Something that's important to many people, but it's not, it's certainly not the only thing, and it's not everybody's biggest concern. User. 

Jessamy: Yeah. 

Catriona: Thanks. 

Jessamy: Just going back to the risks of this, this type of sensitive data, can you just lay them out for us or how you conceptualize the risks around EmTech and your thoughts on them?

I'd be really interested to hear. 

Catriona: Yeah, so I'll try to be as brief as I can, as I could possibly go on all day about this. But in my research, quite a lot of various categories of risk have come up and, I'll start with data first, as we've touched on that a little bit already. In using these technologies like when you use any kind of technology, particularly any new technology as associated with your smartphone, but even when you go online.

You're enrolling yourself really into what's called the data economy. So you're in some way exchanging your data for use of a service or product or whatever. And sometimes in the world of EmTech, you are also paying for that product. But either way, there's an exchange going on in here and. A big part of that valuable exchange for the person that's created that app or product is your personal data.

And of course the heightened issue with that when it comes to FinTech is that kind of personal data is a very special, quite sensitive category of data. And it's actually a mix of categories of data. I have to say. It's not just sex. It can be all sorts of things like your sexuality. Whether or not you've had an abortion, all sorts of things.

And that is becoming a bit of an issue when it comes to the fact that more often than not all of these companies operate to make profit. The concern here isn't that companies are making profit. That's a separate concern, rather, that when the collection of data is driven by profit motives.

Sometimes the way that data is stored and processed and sold on can be used in rather concerning ways. We've seen that of course in, in really obvious examples. For example, in the US where data from EmTech, either from period tracking apps or from similar kinds of apps have been used to prosecute women that have sought abortion across state lines.

The kind of new post Roe v Wade era in the us. The other big problem at risk when it comes to data is that in theory, anyone could make an app, put it on the app store, make any kind of particular claim. Of course, they may get caught, get to trouble for making false claims, but the problem that arises with that is that because the app stores, whichever one you use.

Such a wild West. There's thousands and thousands of apps uploaded by all sorts of creators from across the world. There's a real potential for misc categorization of apps and app tourism. And the problem that leads to is that sometimes the data protection laws that we have in the uk, that now we have the UK General Data Protection Regulation, which has come down from the eu one that we.

That we had before. It means that people can categorize their apps however they like, and often that means they slip through the kind of safety nets that are in place. So normally if you're a health app, you would categorize yourself as a health app, and it means that you're more likely to receive more kind of stringent oversight.

But if you're a peer tracking app and you'd categorize yourself as a game, you're much less likely to receive the same kind of oversight. So that's just one example of the kinds of risks that I've highlighted in my work. 

Gavin: Katrina, you lecture in medical law. What are some of the kind of legal implications of this area?

I know that the law can often be quite slow to catch up to sort of digital spaces, right? I think you touched on that a little bit there, talking about the sort of regulation of health apps versus, say, a gaming app for example, but what are some of the, what are some of the kind of legal issues that present themselves in the, in these spaces?

Catriona: Yeah, that, that's a great question and the massive question always for medical lawyers in particular, but any kind of technology lawyers, how can law keep up with technology as it advances and something that keeps us in business, that's for sure. Apart from the protection of data, the big thing that's come up for me in my work with regards to what law can do in this space is with regards to using fertility tracking apps as medical devices.

To break that down a little bit because the medical devices world is quite a convoluted and opaque world. I have to say, the most popular kinds of apps in the EmTech world are broadly period trackers. So thing you, you enter your data. The app, it usually looks a bit like a calendar when you're bleeding, when you stop bleeding, how heavy your bleeding might be, and what comes out of that.

The algorithm will intent tell you when your next period is due. What often happens as well with those apps is they also tell you when you're going to ovulate and when you're ovulation window is, so women of course, cannot get pregnant for the whole month only during a particular window in their cycle, and so these period tracking apps will tell people about their old ation window.

There's another similar kind of app called either digital contraception, some people call it, or fertility tracking app. And these are apps that are specifically intended to act as a form of contraception or sometimes to help inform people about their fertility. But the more kind of dangerous one, I would say, is one that is intended to act as contraception.

And so it would do a very similar thing to a period tracking app, but it would also tell you when. Not to have sex in order to avoid getting pregnant. And these apps became quite famous not long ago after a scandal with a particular company where there was a major hospital in Sweden that reported that a lot, kind of high proportion of women who were seeking abortions had been using this specific app instead of their birth control.

And this specific app had been claiming we are birth control. So you don't need to use condoms, the pill, anything else, you can just use our app as breath control and you'll be fine. And obviously that wasn't really working out. And since then, the app has added some safeguards to make their predictions more reliable.

For example, the kind of main one has added a digital thermometer to make their predictions more accurate because as your fertility changes throughout your cycle, so does your body temperature. Still what's come out through that really is that to speak firstly to digital contraception and fertility tracking apps, ones that are really marketed and aimed at preventing people from getting pregnant compared to things like the pill.

They require obviously, quite a lot of user interventions. So to be using popular contraceptive app, for example, you would be taking your body temperature at the same time every day and during data probably at the same time every day. So that requires quite a high degree of involvement, and this is what we call perfect use.

So that in an ideal world, if you use it perfectly, there's not many companies that offer this kind of digital contraception, but of the ones that do they, they say that it's 93% reliable when it, when used like this, which is pretty good compared to other kinds of contraception. But here's the thing, the pill, for example, one of the most popular forms of contraception for women is about 99 per effective with perfect use, and about more like 91% effective when there's some flaws like you might.

Not take it the same time every day or something, but for digital contraception, that drops right down to 76%. It is much less effective if you are perfect with the way that you use it. And that's one of the big dangers that for law and regulation, I think we need to be more aware of. At the moment, this kind of contraception, digital contraception is classified as a medical device.

But in my research, what I think has come out is that it's maybe not classified as a high enough risk of medical device medical devices. I. Regulated by the A-M-H-R-A, which of course became quite famous through the pandemic have different kind of categories of risk and, but the lowest being not very heavily regulated, right up to the highest.

Being very heavily regulated. And what I've argued in the past is that we really need to increase its category of risk to make sure that we're accounting for the fact that these user errors are. Quite probable given the way that the amount of kind of user intervention required to make it work properly.

The other kind of big area that's an issue for law and regulation that's come up for me is going back to period trackers. So these are apps that are specifically well marketed as for tracking your period. But like I said earlier they reveal all sorts of other things about your cycle. The biggest thing.

Relevant to this being your ovulation window. Something that myself and other colleagues have argued is that when someone uses that app and sees an indication of their ovulation window, they might reasonably foreseeably think if I have sex unprotected outside of that window, I won't get pregnant.

I know how natural family planning works, which a lot of people do now. And what we're seeing is that is exactly what's happening. And a study actually just published this year, I. Has found that there's been a distinct rise in the uk of women seeking abortions because they've been using quote unquote, natural methods to, to prevent pregnancy.

And this has included fertility tracking apps. And we think part of the reason for that is that these apps don't actually aren't always necessarily using the most rigorous literature so on and so forth to create algorithms that make these predictions. So I. One review of 73 menstrual cycle tracking apps found that in fact none could accurately predict ovulation.

And this is backed up by kind of other facts. For example, another recent review found that only 5% of these kinds of EmTech apps actually site medical literature. The studies that go into creating these algorithms. So this is the other big problem, I think, for law and regulation. So at the moment, any period tracking app, whether or not people are using them to prevent pregnancy and evidence suggests they clearly are.

It's not caught by law and regulation at all when it comes to medical devices, which is the kind of thing it would be. Considering that digital contraception, things that are marketed as contraception are caught by medical device regulation. So the other big thing that I've argued is that we need to take period tracking apps and the fact that they could be foreseeably used as a form of contraception.

Whether or not companies want people to or not, they should be caught by this kind of regulation so that we can protect users more. I think there's a difficulty in this area sometimes with people saying people shouldn't be so silly. They shouldn't be so silly. It's obviously a period tracking up.

Why on earth would you make such a silly decision? But that's not how life works. It's not silly. There's an increased awareness of natural fertility planning. There's also a growing kind of resistance to the fact that the contraceptive burden falls primarily on women. I think this awareness is rising a lot in the younger generation and there's also whether or not it's.

True. And there's lots of fantastic contraceptive options available, of course. An increasing resistance amongst, particularly, again, amongst the younger generation to the kind of hormonal side effects of some form of contraception. So there's all these things working against the idea of you should not be so silly and just use a pill.

Just use a condom. So these are the two in some of these two big areas that I think need attention from the law. I 

Jessamy: think that's really interesting and I love the way that you've laid that out so clearly, I suppose there's clearly a desire for this and there's many good things about it in terms of education, information, empowerment.

So how do you envisage or what are the things that we need to do as a community of people involved in health to make sure that we get the benefits of this type of technology and really mitigate or minimize the risks? What would be the ideal scenario or the steps that our government or another government would take?

Absolutely, and I think 

Catriona: you raise a really important point There is. Which is that there's so much potential for these technologies. EmTech generally, or specifically these two examples I've been talking about, contraception and period tracking to have enormous benefit for people in society, not just here, but also in places rural areas where access to healthcare is maybe more difficult.

There's all sorts of situations in which this might be a really excellent thing and is excellent for a lot of people. You can't deny that it's just that there's enough concern being caused for us to raise this issue. And so there's a few things I think need done in order to help make this more positive for everybody.

First of all, I think we need to be more alive to the diversity of users of EmTech, so there's an issue. Generally with the fact that a lot of kind of fem tech, anything to do with cycle tracking or fertility doesn't really account for people that have endometriosis. For example, their studies don't include them and it often doesn't work for them.

And this is something that law and regulation, as much as lawyers would love to say that we can have the answer for everything. This is something that law and regulation might have a little bit more difficulty encompassing this as something that we need to do. I think partially. Not fully, but at least partially through things like lobbying and raising awareness.

This leads to my, the second thing that I think really needs to come outta this, which is clear information and guidance for healthcare practitioners. I think from either anecdotal evidence and conversations I've had with healthcare practitioners, what's come through is that there's not a lot of information exam, for example, for GPS working clinics about the kinds of apps that are available on the market.

Often now, if a woman goes into a clinic for a smear or anything else, they'll be asked, when was your last period? And almost always, people will get out their phone. And say, oh, I can tell you it was on this exact date. So there's an awareness of course, with GPS and other healthcare practitioners that these have been used, but not enough guidance on the kind of pitfalls and issues and perhaps.

Kind of context, specific things that might need to be raised with particular patients. For example, people with endometriosis. So I think issuing clearer guidance, and that would be very helpful considering that we know these things are being used in conversations in practice. And then the kind of goal a little bit higher.

I think two big things that law regulation can do. Tighten that medical devices regulation, so not necessarily have more regulation. I think that's something that we call for a lot and it's not always much helpful thing to say, but. Tighten up. So it actually has a considered account for the kind of unique challenges and risks and harms that these technologies pose to women.

The framework that we have at the moment is very much a kind of blanket framework originally created for medical devices like pacemakers and all sorts of other things. So we really do need a kind of, we need to continually update it and refresh it to account for these new kinds of technologies. And I think we also need to have a good look at data protection and the way in which it acts in practice to protect users when we have such sensitive data, particularly in light of ongoings in the US and the transference of the kind of issues going on over there to hear with the rise in investigations and prosecutions for women seeking abortions in England and Wales.

Gavin: I think we're just gonna ask you how you see everything in this area moving forward. Do you think that this technology is going to evolve faster than the law can keep up with it? What's your opinion on the future of it? 

Catriona: I think all technology will almost always evolve faster than the law can keep up.

So I think that's a really great point to raise. As I said, I think there's real potential for this to become a positive space, enables people to know more about their bodies and track periods effectively. Maybe have an alternative if hormonal and other kinds of contraception isn't working for them.

But if we don't really pay attention to the harms that are being caused the biggest and most urgent harm, in my view being causing unplanned pregnancy and the dangers that can cause either physically or mentally, or both then we can't really move forward in a way that protects women and often women's health and interests.

Are so unprotected structurally across the board, not accounted for. And research into contraception is really lagging behind for men, for example, despite clear evidence that men do want other forms of contraception to be available to 'em too, there needs to be a kind of broader whole system rethink about how we really properly account for and protect women's health and interests.

And elsewhere in, as a society in general, it's an enormous task. That is something I think it would be great to continue to work towards, and it's something that EmTech can certainly be a part of. We just need to get a few things right first. 

Gavin: I think that's probably a really good place to, to end. Dr.

Katrina McMillan, thanks so much for joining us on the podcast today. 

Catriona: Thank you so much for having me.

Gavin: Thanks so much for listening to this episode of The Lancet Voice. If you have the time, please do leave us a quick review wherever you usually get your podcasts and we'll see you next time. Until then, take care.