Rethinking the regulation of digital contraception under the medical devices regime

Abstract

Contraceptives are vital healthcare for women and people with wombs. Recently, there has been a rise in the use of ‘digital contraceptives’, a type of ‘femtech’ software available for download on app stores which require data input in order to make predictions about users’ fertility. Digital contraceptives, when marketed as such, fall within the definition of a ‘medical device’ and under the authority of the Medical Devices Regulations 2002 are a ‘medium-risk’ device. However, not all femtech which may be used as contraception is captured by this framework. In this article it is argued that the regulatory category into which digital contraceptives have been placed by the medical devices regime is (a) unduly limited in scope, (b) insufficiently stringent to protect users, considering the grave and life-changing effects this technology can have if things go wrong, and (c) ill-conceived as a regulatory response to a technology that affects large sections of the population. It is suggested here that the broader context in which software as a contraceptive sits (i.e. within the general contraceptive market) is key to understanding the regulatory blindness that is occurring when it comes to digital contraceptives and some other forms of fertility-related femtech. As such, software which can be used as a contraceptive is in fact ‘high risk’ and should be reclassified as such.