Challenging the Femtech regulatory gap: the need for clearer laws and regulations

Dr Catriona McMillian, lecturer in Medical Law and Ethics, and Ruby Reed-Berendt, PhD candidate and research associate, have published a new policy document titled ‘Empowerment, Responsibility and Risk: Rethinking the Regulation of Digital Contraception’. The Faculty of Sexual and Reproductive Health have endorsed the publication.

The document explores how despite the rise in ‘femtech’, personal health tracking technologies aimed at women, the law and regulation of femtech has not kept pace with the multimillion-pound industry. This lack of regulation can result in significant risks to women and people with wombs when they are making decisions about their health and wellbeing. 

The femtech industry includes the development and widespread use of smartphone apps for tracking menstrual cycles which may be used for contraceptive purposes (digital contraceptives). There is no single legal or regulatory framework governing femtech, however, there are three relevant frameworks where questions of regulatory adequacy arise: the Medical Devices Regulations 2002 (MDR), Advertising Standards and Codes (ASA) and UK General Protection Regulations (GDPR). 

Many of the devices and apps are shared as health and wellbeing products, so they aren’t subject to the MDR and, in many cases, rely on a high degree of user accuracy. Femtech also fails to account for the huge diversity of the people using it and can, therefore, provide users with inaccurate information. In cases where there have been poor outcomes, the responsibility can be shifted from the femtech app onto the user. 

There is evidence to suggest that not all femtech apps are GDPR compliant and that many users may not be aware of all of the data that is gathered by the apps, how it is used and how it is shared.

Although the ASA can act upon complaints of false and misleading advertising, it can only act when a complaint has been made. They do provide clear guidance to influencers about labelling content as an advert when partnering with companies; however, there are gaps around the veracity of the claims made by companies and influencers.

The brief proposes that femtech should be: subject to the MDR, have more guidance available to femtech companies around the obligation of data protection, have clearer labelling around the purpose of apps, and address claims made by companies and online influencers.

Read the full policy brief

Empowerment, Responsibility and Risk: Rethinking the Regulation of Digital Contraception (updated Dec 2024)