Monitoring female fertility through ‘Femtech’:The need for a whole-system approach to regulation

Concurrent with the rise of digital health and personal health tracking technologies, a market has also emerged of products targeted specifically at women: ‘femtech’. This article is motivated by the concern that insufficient regulatory attention has been devoted to this growing market, and that extant ambiguity in the regulation of femtech leaves its users at risk of relying on technologies of as-yet unproven worth. It is posited that femtech profoundly disrupts well-established regulatory mechanisms of protection in ways that mean that these silos of protection will not be adequate. This is because regulation, as it is currently constructed, is insufficiently sensitive to feminist perspectives regarding what these technologies mean for women. As a result, the regulatory sphere in which femtech operates fundamentally fails to ensure that the health and safety of femtech users are protected as this market continues to expand. To counteract this, the argument is made that an appropriate regulatory response to femtech must respond to the distinctive unmet need in the regulation of this technological realm and the acute risk that femtech poses. This must include a multidimensional whole-system approach grounded in feminist perspectives on health, fertility, and technology

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

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

Human embryo in vitro: a processual entity in legal stasis

This doctoral research explores the ways in which UK law engages with embryonic processes, namely under the Human Fertilisation and Embryology Act 1990 (as amended). The research offers a fuller understanding of these elusive and evolving biological processes, and in particular, how they can, in turn, allow us to understand legal process and legal regulation more deeply. To do so, the thesis employs an anthropological concept - liminality - coined by Arnold van Gennep, which is itself concerned with revealing the dynamics of process. Liminality may be described as being concerned with the spaces in between distinct stages of human experience or with the process of transition between such stages. With this framing of liminality in mind - which is often characterised as a three-stage process of human experience - the research is divided into three parts, broadly reflecting the three parts of van Gennep’s liminal schema: into, through, and out of liminality. It is argued herein that in regulating the embryo – that is, a processual liminal entity in itself - the law is regulating for uncertainty. Tracing the legal governance of the early stages of human life, from its inception to today’s regulatory frameworks, the research diagnoses a ‘legal gap’ between the conceptual basis for regulation, and practical ‘realities’ of the 1990 Act (as amended). In particular, this ‘gap’ is typified by uncertainty surrounding embryos in vitro, and what this thesis diagnoses as ‘legal stasis’. In order to situate this novel liminal analysis within existing paradigms, however, the thesis first frames embryos in vitro as ‘gothic’, building upon emergent analytical responses to postmodern forms of categorisation. This framing helps to articulate the nature of, and the reasons for, the above-mentioned ‘legal gap.’ This framing is nonetheless incomplete without a liminal lens, as it draws our attention to the dynamics of the processes occurring within this ‘gap’. It is argued that considering the ‘problem’ in this manner enables us to move beyond conceptualisation, towards realisation. The gothic, and the liminal are thus used to critically assess legal representations of the embryo, and suggests that there are ways in which the law might better embrace the multiplicity of environments through which the embryo in vitro can travel, that is, either towards reproductive or research ends. It is argued that full recognition of these variable, relational liminal states of the embryo is important for the future of artificial reproduction and embryo research, and that this does not currently happen. In order for the law to reflect better the uncertain nature of embryonic processes, and the technologies that create them, the thesis posits a nuanced, contextual reframing of the embryo that captures the multiplicity of embryonic ‘pathways’ available within the 1990 Act (as amended). The overarching objective of this work is to consider a more coherent and robust intellectual defence of the ways in which we justify different treatments of in vitro embryos. It thus proposes a ‘context-based approach’ that embraces the variable, relational pathways already facilitated by the 1990 Act (as amended) in order to lead the embryo (and itself) into, through and out of liminality

Beyond categorisation:Refining the relationship between subjects and objects in health research regulation

In this article, we argue that the relationship between ‘subject’ and ‘object’ is poorly understood in health research regulation (HRR), and that it is a fallacy to suppose that they can operate in separate, fixed silos. By seeking to perpetuate this fallacy, HRR risks, among other things, objectifying persons by paying insufficient attention to human subjectivity, and the experiences and interests related to being involved in research. We deploy the anthropological concept of liminality – concerned with processes of transformation and change over time – to emphasise the enduring connectedness between subject and object in these contexts. By these means, we posit that regulatory frameworks based on processual regulation can better recognise and encompass the fluidity and significance of these relationships, and so ground more securely the moral legitimacy and social licence for human health research