Contraception, Fertility Tracking, and the Limits of Medical Devices Regulation

Abstract

Many technologies in mobile health (mHealth) available for private purchase and use are becoming available in smartphone app stores worldwide. Of key concern is the proliferation of fertility-related ‘femtech’ (FRF), a category of software that is increasingly being used by women, girls and people with wombs as their main contraceptive method. Contraceptives are an important part of women’s health, and like any other medicine, they are stringently regulated in the United Kingdom (UK). ‘Digital contraceptive’ software, when marketed as such, normally falls within the definition of a ‘medical device’ and is regulated by the UK’s medical devices regime. However, some apps that may be used as digital contraceptives through tracking users’ ‘fertile windows’ sit outwith this framework and thus leave their users at risk of unplanned pregnancy. Software as a medical device (SaMD) is rapidly growing beyond the vision of the current medical devices regime, even within the past few years. This paper explores, in depth, the urgent issue of regulatory inadequacy when it comes to femtech software that may be used for contraceptive purposes. Law and regulation in this field, as they are currently constituted, are ill equipped to capture the types of mHealth and personal health tracking technologies that, normatively speaking, ought to be caught by the medical devices regime. Therefore, it is posited that while FRF poses a distinct challenge for law and regulation in that FRF may cause unwanted pregnancies, the specific issue of regulatory inadequacy posed is symptomatic of a broader problem faced by the medical devices regime.