Natural Cycles Is the First FDA-Approved Contraception App. But It's Not for All Women

^{Image has been cropped and resized. Courtesy of PRNewsfoto/Natural Cycles.}

Digital health is rapidly changing our lives. Almost every day, new developments using data, artificial intelligence and smartphones to improve health, on individual and population levels, are entering the market. In 2015, there were more than 40,000 healthcare apps on Apple's U.S. App Store alone. And the number has kept growing.

But in the process of delivering the next revolutionary technology, health-tech innovators have often neglected to include usability in their apps so that they may also benefit people with disabilities, research suggests (PDF).

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“People with disabilities have a particularly hard time, as they are often overlooked in the design of new technology, both regarding tools and content,” noted a report titled, “Health Inequalities in eHealth Context,” by the European Commission. “Due to their impairment, the notion of them being proficient (information and communications technology) users is often sidelined.”

So, what does this issue look like in the real world?

In August, the U.S. Food and Drug Administration approved the marketing of the first mobile health (mHealth) app for contraception: Natural Cycles. The app allows women to avoid pregnancy by monitoring their resting body temperature — known as the basal body temperature — and recording their data so that an algorithm can determine their daily fertility.

With “perfect use,” the app’s creators say the failure rate is 1.8 percent, which means that 1.8 in 100 women annually will become pregnant despite using the technology.

But although the app meets the FDA’s guidelines governing mHealth apps, Natural Cycles poses problems for some nontraditional eHealth users, including women who have disabilities or irregular periods.

Natural Cycles told Healthcare Analytics News™ that while the algorithm had been “intricately designed” to account for a number of factors, including variation in cycle length, ovulation day and the length of the follicular and luteal phase, women with very irregular cycles could not benefit from it.

“They may find that Natural Cycles is not the most suitable method of contraception for them, but it may be helpful as a means to track and better understand their monthly cycles,” a Natural Cycles spokesperson said.

Similarly, for those with conditions that are not classified as disabilities but that could impair the menstrual cycle — such as polycystic ovary syndrome, thyroid disorders or eating disorders — Natural Cycles said the app “may be less suitable.”

Finally, for women with physical disabilities like cerebral palsy and multiple sclerosis or conditions such as down syndrome, the app doesn’t have the “data that investigates the effectiveness” in those patient groups, the company said.

Some industry observers expect that other birth control apps will be granted FDA approval soon by simply demonstrating that they work in a similar way to Natural Cycles. Critics say this could set a bad precedent for contraceptive mHealth apps, which may reach market without catering to women with disabilities.

“There is very little written about disability and menstruation generally, and what little there is (is) most often not written by disabled people,” writes Kim Sauder, a Ph.D. student in disability studies, in her blog, Crippled Scholar. “As a result, a lot of it is about control and often menstrual cessation in order to make the menstruating person more convenient for a care giver … Menstruation is still, unfortunately, a taboo subject.”

Therefore, in the process of eHealth development, companies might be smart to consider disability and the accessibility of alternative menstrual products. Otherwise, who will?

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