A birth-control app can look straightforward. A user records body temperature and menstrual cycle data, and the app identifies days when pregnancy is more or less likely. The decision that follows can have serious consequences. Someone may rely on the app’s prediction when deciding whether to use protection during sex.

Health Canada approved Natural Cycles in January 2024 and granted a Swedish digital health company what is called a medical device licence. It was the first and remains the only app licensed for contraceptive use in Canada. For people who cannot or do not want to use hormonal birth control like the pill, the app offers another option. Its approval also reflects the growing place of software in health care.

When people see that a health product has been approved by the federal government, they are likely to take that as a sign that the product has been carefully assessed. Yet a licence approval may not tell the entire story. Few will know what Health Canada examined, which parts of an app may fall outside the review, or how the product will be monitored once it’s on the market. Those questions are especially important for an app that depends on software that can change through regular updates or intimate personal data like sexual activity.

Health Canada should make it easier for Canadians to understand what a medical device licence covers. It should also pay closer attention to how digital contraceptives perform in the lives of the people who use them.

The gap between perfect use and real life

Natural Cycles uses basal body temperature (BBT) and menstrual cycle information — processed through an algorithm — to estimate a user’s fertility window. Figures (p. 2) reviewed by the Society of Obstetricians and Gynaecologists of Canada (SOGC) show seven out of 100 users may become pregnant with typical app use over one year. With perfect use —........

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