IViR Lecture Series: Regulating Femtech: Addressing Regulatory Gaps in Women’s Health Technologies

The proliferation of femtech—technologies designed to monitor, manage, or enhance aspects of women’s health— poses novel challenges for contemporary regulatory and legal frameworks. Operating at the boundaries of medical devices, consumer products, and digital platforms, many femtech innovations fall into the gaps between existing law and regulation. Using contraception and fertility-focused femtech by way of example, this talk examines how regulatory systems in the UK (drawn from EU frameworks such as the GDPR and EU MDR) regulate, or fail to regulate, femtech products and the sensitive personal data they generate. It argues that prevailing approaches to classification, risk assessment, and consent are ill-suited to the hybrid and data-intensive nature of femtech, leaving both consumers and innovators exposed to uncertainty. The analysis highlights the need for reflexive and intersectional regulatory approaches to fill these gaps that prioritise, rather than ignore, risks femtech poses to women’s health and wellbeing.

Catriona (Katy) McMillan is a Reader in Medical Law and Ethics at the University of Edinburgh School of Law. Dr. McMillan holds an LLB from the University of Glasgow, an LLM from the London School of Economics and Political Science, and a PhD in Medical Law and Ethics from the University of Edinburgh. She joined the Law School in 2018 as a Senior Research Fellow, contributing to the Wellcome Trust-funded project ‘Confronting the Liminal Spaces of Health Research Regulation’. She subsequently secured a British Academy Postdoctoral Fellowship for her project entitled ‘Femtech: how should law and regulation respond?’.

Her research focuses on the legal and ethical regulation of human reproduction, with particular interests in femtech, including period-tracking applications and digital contraception, contraception, assisted reproduction, embryo research and termination of pregnancy.

She is the author of The Human Embryo in vitro: Breaking the Legal Stalemate (Cambridge University Press, 2021) and co-editor of The Cambridge Handbook of Health Research Regulation (Cambridge University Press, 2021). 

Dr. McMillan is also Deputy Director of the JK Mason Institute for Medicine, Life Sciences and the Law. From 2021 to 2023, she served as Convenor of the Law Society of Scotland’s Health and Medical Law Sub-Committee.