Health Canada Approves Natural Cycles as First Licensed Birth-Control App
In January 2024, Health Canada approved the Natural Cycles app as a Class II medical device for contraceptive use, making it the only licensed birth-control app in the country. While the app uses algorithms based on body temperature and menstrual data to estimate fertility windows, critics highlight concerns about real-world accuracy, privacy, and regulatory clarity.
In January 2024, Health Canada approved the Natural Cycles app, granting it a medical device licence and making it the first and only app licensed for contraceptive use in Canada. The Swedish digital health company's product was granted a Class II “moderate-risk” licence under Canadian medical device regulations.
The app functions by using basal body temperature (BBT) and menstrual cycle information processed through an algorithm to estimate a user’s fertility window. Users may rely on these predictions when deciding whether to use protection during sex, which can lead to potential unintended pregnancies if the prediction is wrong.
Figures reviewed by the Society of Obstetricians and Gynaecologists of Canada (SOGC) indicate that seven out of 100 users may become pregnant with typical app use over one year. With perfect use—defined as consistent and accurate temperature testing and avoiding unprotected sex on fertile days—the pregnancy rate is closer to two out of 100.
However, several factors can affect body temperature or menstrual cycles, impacting the app's accuracy. These include stress, illness, disrupted sleep, some medical conditions, weight changes, and irregular work schedules. Disparities in access to abortion care and financial stability mean that the consequences of app failure vary significantly among different socioeconomic groups.
Critics argue that current regulatory oversight does not adequately address real-world performance variations or privacy concerns regarding reproductive data. Regulatory ambiguity causes confusion among users regarding what aspects of the app, such as privacy and software updates, are covered by the medical device licence versus other consumer protection and privacy laws.
Since January, the health minister has been able to impose or change terms and conditions on Class II, III, and IV licences at any point. This development has prompted calls for clearer public communication about what the approval covers and ongoing monitoring of the app's effectiveness across diverse user groups.