By Anna Nelson, Maria Tzanou and Tsachi Keren-Paz
Introduction
FemTech refers to apps and wearable devices (eg. smart breast pumps and bluetooth-enabled fertility monitors) purporting to empower women and non-binary users to manage their sexual, gynaecological and reproductive health. During their recent review of the data practices of period and fertility tracking apps, the Information Commissioner’s Office found that “some users are being recommended such apps by medical practitioners” (unpublished report, obtained through FoI request). Apps are part of everyday life; therefore, it is “logical” that doctors are increasingly encouraged to recommend apps to help patients as part of care pathways.” However, the use of privately-developed FemTech apps in healthcare gives rise to important legal and regulatory issues.
In this blog, the first of two, we introduce the issue and outline promises and pitfalls of using privately-developed FemTech apps in the healthcare setting. In the second blog, we consider the responsibilities of healthcare professionals (HCPs) who recommend such apps.
The Promise: FemTech Apps Addressing Healthcare Needs
There is a data gap regarding women’s health and a lack of knowledge about common menstrual and gynaecological health conditions. Alongside this, healthcare resources are increasingly stretched, and sexual, reproductive and gynaecological services are struggling to meet patients’ needs in a timely fashion. FemTech apps may be positioned as useful tools which can help fill such gaps on both a collective and individual level: helping to redress the paucity of data, and offering users an alternative means through which they can manage their own menstrual and reproductive health (which may seem like a useful interim measure in the face of long waiting lists for access to GP and gynaecology appointments). Additionally, many FemTech companies work hard to position their services as empowering for users, which may lead HCPs to view these as useful tools.
Furthermore, diagnosing certain menstrual health conditions (such as Premenstrual Syndrome) relies on patients keeping track of symptoms for a number of months. Thus, apps which are designed to facilitate just that may be seen as a particularly useful tool in this context. Some FemTech apps have specific functions designed to support healthcare and diagnosis in this way, enabling users to produce a ‘doctors’ report’ with information about symptoms across multiple cycles (eg. Flo).
The Pitfalls: FemTech Apps and Potential Harms
The potential for FemTech tracking data to be used in a harmful way garnered significant attention in 2022 when the US Supreme Court paved the way for the criminalisation of abortion in a number of US states. In England and Wales, abortion remains a criminal offence under the Offences Against the Person Act 1861, and there is evidence of police making requests to access data from menstruation tracking apps during investigations into ‘unexplained pregnancy loss’.
Beyond the criminal context, concerns have been raised about the privacy of data that users share with FemTech apps. A study carried out by the Organisation for the Review of Care and Health Apps highlighted “significant flaws” in the privacy policies of 25 period tracker apps. Similar research looking at period tracking apps and pregnancy apps has found that “most of these products collect vast amounts of personal data, and then share it widely.”
Reviewing FemTech apps privacy policies in the course of our project, we found similar issues – many of the policies provide insufficient clarity about what data (intimate or beyond) is shared with which third parties. In a world where the line between our digital and offline lives is increasingly blurred, loss of control of one’s personal, digital data (where this is used for purposes to which the user did not provide informed consent) can result in harm, not only to autonomy but also to bodily integrity (we explore this further in ongoing project work).
Another, broader concern can be raised about the epistemic impact of tracking tools. Those experiencing menstrual and gynaecological pain and other symptoms can face an ‘uphill battle’ to have their symptoms taken seriously by HCPs. There is a risk that the increased use of tracking apps will further devalue women’s qualitative and experiential testimony in the eyes of HCPs, making it even less likely that women will be granted legitimacy unless they ‘document’ or ‘track’ their symptoms in a quantifiable manner. A further question can be raised about whether the use of such apps really serves to empower patients, or whether this instead contributes to the responsibilisation of patients for their own care as part of a broader privatisation agenda.
Other work has highlighted the potential for FemTech to reinforce problematic gender stereotypes and that FemTech data could result in discrimination in the employment context and beyond. Finally, serious questions have also been raised about the accuracy of these apps, and of the science underpinning them.
Currently, there is a lack of clarity about which apps are being recommended to patients. While the NHS has developed a Digital Technology Assessment Criteria (DTAC), which must be met to allow for digital health technologies to be commissioned for formal use across NHS and social care services, there is no guarantee that all apps being recommended by HCPs during individual appointments have passed the DTAC assessment. Furthermore, the NHS Apps Library was decommissioned in December 2021 meaning there is no longer a ‘one stop shop’ for patients to check whether a particular app is DTAC-approved.
Conclusion
There are increasing moves to integrate digital health tools into NHS care. For example, the NHS Long Term Plan “envisages a move towards digitally enabled services” and one of the recommendations in the Women’s Health Strategy for England was that more should be done to “support the FemTech sector in delivering collaborative innovation within the NHS” . Therefore, to protect both patients and HCPs, it is important to understand the regulatory responsibilities that HCPs have when it comes to recommending the use of privately developed FemTech.
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About the Authors
Anna Nelson (she / her) is currently a Postdoctoral Research Associate on the Leverhulme-funded “FemTech Surveillance: Gendered Digital Harms and Regulatory Approaches” project at the University of Sheffield. She holds a PhD in Bioethics and Medical Jurisprudence from the University of Manchester, and has wider research interests in law and childbirth, reproductive technology and gendered experiences of healthcare.
Tsachi Keren-Paz is Professor of Private Law in the School of Law at the University of Sheffield. He is a Co-Investigator of the Leverhulme FemTech Surveillance Project, and the author of three monographs: Torts, Egalitarianism and Distributive Justice (Ashgate, 2007), Trafficking: A Private Law Response (Routledge, 2013) and Egalitarian Digital Privacy: Image Based Abuse and Beyond (BUP, 2023).
Maria Tzanou is a Senior Lecturer in Law at the University of Sheffield, UK. Her research focuses on privacy, data protection, AI, surveillance and the regulation of emerging technologies. She is the Principle Investigator of the Leverhulme FemTech Surveillance Project.
More information about the Femtech project can be found here: https://www.sheffield.ac.uk/law/research/centres-and-institutes/sciel/projects/femtech-surveillance-gendered-digital-harms-and-regulatory-approaches