Effective regulation of technology in women’s health and healthcare

Abstract

Carmel Schachar and colleagues argue that femtech requires robust and stringent privacy and security safeguards because of the sensitivity of the data The rise of direct-to-consumer technologies has produced rapid expansion of women’s health innovation in a sector popularly known as femtech. Femtech encompasses a “range of technology-enabled, consumer-centric products and solutions” targeted at female health needs,1 including maternal health, menstrual health, pelvic and sexual health, menopause, contraception, and many other health conditions that disproportionately affect women.2 One example highlighting the promise of femtech is an at-home cervical cancer screening tool that showed comparable effectiveness to traditional clinic based testing.3 Use of the tool could bridge screening gaps and improve health outcomes for women. Other examples of femtech include wearables and mobile applications such as period and fertility trackers that monitor menstrual cycles, biometric data, ovulation, and related reproductive and sexual health data.4 The femtech industry has grown tremendously, reaching an estimated value of $60bn (£44bn; €51bn) in 20245 and projected to reach $103bn by 2030.6 This expansion reflects both unmet health needs and rising awareness about female specific conditions, but it also shows the urgent need for thoughtful regulation to ensure transparency, safety, and accountability. Social undercurrents and the broader political climate can make women’s health data (particularly reproductive or sexual health information) more vulnerable than other health data. Although femtech may not require separate regulation from other digital health technologies, heightened privacy and security protections are urgently needed for femtech data as well as steps to mitigate bias. Femtech is used worldwide, but access and experience differ for women in the global north and south. This article, part of the BMJ Collection on Women’s Health Innovation (bmj.com/collections/womens-health-innovation), focuses on the global north, partly because these jurisdictions have been leaders in the regulation …