Publications


2022

‘Open-Source automated insulin delivery: international consensus statement and practical guidance for health-care professionals’ 

Lancet Diabetes Endocrinology (2022) 10 (1): 58-74

Authors: Katarina Braune, Rayhan A Lal, Lenka Petruželková, Gary Scheiner, Per Winterdijk, Signe Schmidt, Linda Raimond, Korey K Hood, Michael C Riddell, Timothy C Skinner, Klemens Raile, Sufyan Hussain on behalf of the OPEN International Healthcare Professional Network OPEN Legal Advisory Group.

A full list of members of the advisory group, including Muireann Quigley, is available in the appendix of the article.

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Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven innovations that were co-created and supported by an online community who were directly affected by diabetes. Their uptake continues to increase globally, with current estimates suggesting several thousand active users worldwide. Real-world user-driven evidence is growing and provides insights into safety and effectiveness of these systems. The aim of this consensus statement is two-fold. Firstly, it provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective. Secondly, it provides a much-needed international health-care consensus supporting the implementation of open-source systems in clinical settings, with detailed clinical guidance. This consensus also provides important recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.

 

‘Integrating the Biological and the Technological: Time to Move Beyond Law’s Binaries?’

In Dove, E.S. & Nic Shuibhne, N. (Eds) Law and Legacy in Medical Jurisprudence: Essays in Honour of Graeme Laurie (Cambridge University Press 2022)

Authors: Muireann Quigley and Laura Downey

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The common law takes a bounded approach to persons and objects: something is either a person (subject) or a thing (object), but not both. This conceptualisation of persons as bounded selves and objects as separate from persons represents an encumbrance that goes to the very heart of law. The person–thing binary is so fundamental that it both structures the law conceptually and dictates its practical applications. This chapter explores the consequences of this legacy in relation to ‘everyday cyborgs’ – that is, persons with attached and implanted medical devices. Drawing on Graeme Laurie’s work, it argues that recognising the inherent liminality of everyday cyborgs (and everyday cyborg technologies) allows us to look beyond law’s binaries more fully to account for the ‘spaces in-between’. The chapter finds that Laurie’s liminal analysis of law and his framework for processual regulation give us much needed analytical tools to begin to look beyond boundaries, beyond binaries and beyond bodies.


2021 

‘#WeAreNotWaiting DIY artificial pancreas systems and challenges for the law’

Diabetic Medicine, DOI: 10.1111/dme.14715

Authors: Rachael Dickson, Jessica Bell, Amber Dar, Laura Downey, Victoria Moore & Muireann Quigley

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Commercial hybrid closed- loop systems are becoming more readily available, yet the number of DIY artificial pancreas system (DIY APS) users continues to rise. These DIY systems have not gone through the usual regulatory approvals pro-cesses, and, thus, present a number of legal difficulties for a number of actors, including clinicians, parents who build DIY APS for their children, and users themselves. These issues have so far received insufficient attention. Due to the complex constellation of actors involved in both development of DIY APSs and in its deployment, it is not currently clear who, and to what extent, different parties might (successfully) be held liable if something goes wrong. Despite this uncer-tainty, unless and until clearer guidance is issued by relevant bodies, or a case appears before the courts which clarifies the situation, existing legal principles apply. In this article, we examine some of these to shed light on how the law would likely be applied if harm were to result from the use of a DIY APS.

‘Prescribing Unapproved Medical Devices? The case of DIY Artificial Pancreas Systems’

Medical Law International (2021) 21(1): 42-68

Authors: Joseph T.F. Roberts, Victoria Moore, Muireann Quigley 

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In response to slow progress regarding technological innovations to manage type one diabetes, some patients have created unregulated Do-It- Yourself Artificial Pancreas Systems (DIY APS). Yet both in the United Kingdom (UK) and internationally, there is an almost complete lack of specific guidance – legal, regulatory, or ethical – for clinicians caring for DIY APS users. Uncertainty regarding their professional obligations has led to them being cautious about discussing DIY APS with patients, let alone recommending or prescribing them. In this paper we argue that this approach threatens to undermine trust and transparency. Analysing the professional guidance from the UK regulator – the General Medical Council – we demonstrate that nothing within it ought to be interpreted as precluding clinicians from initiating discussions about DIY APS. Moreover, in some circumstances it may require that clinicians do so. We also argue that the guidance does not preclude clinicians from prescribing such
unapproved medical devices.

 

Publication of this paper was covered by a number of online publications: Pharmacy Times, Medscape, MedicalXpress, childrenwithdiabetes.com, Patient Safety Learning’s online platform The Hub, and the American Association for the Advancement of Science’s EurekAlert!


2020

‘User and Healthcare Professional Perspectives on Do-It-Yourself Artificial Pancreas Systems: A Need for Guidelines’ 

Journal of Diabetes Science and Technology

Authors: Jacyln A Shepard, Marc Breton, Revital Nimri, Joseph T F Roberts, Timothy Street, David Klonoff, and Katherine Barnard Kelly

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A growing number of individuals with type 1 diabetes are choosing to use “do-it-yourself” artificial pancreas systems (DIY APS) to support their diabetes self-management. Observational and self-report data of glycemic benefits of DIY APS are promising; however, without rigorous clinical trials or regulation from governing bodies, liability and user safety continue to be central concerns for stakeholders. Despite DIY APS having been used for several years now, there are no guidelines to assist users and healthcare professionals in addressing DIY APS use in routine clinical care. This commentary reports key stakeholders’ perspectives presented at the annual Advanced Technologies and Treatments in Diabetes conference in February 2020. Important considerations to inform the development of clinical care guidelines are also presented to generate further debate.


2018

‘Everyday Cyborgs: On Integrated Persons and Integrated Goods’ 

Medical Law Review

Authors: Muireann Quigley and Semande Ayihongbe

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Using the metaphor and actuality of the ‘everyday cyborg’, this article makes the case that the law is ill-equipped to deal with challenges raised by the linking of the organic, biological person with synthetic, inorganic parts and devices. For instance, should internal medical devices that keep the person alive be viewed as part of the person or mere objects (or something else)? Is damage to neuro-prostheses (eg nervous system integrated limb prostheses) personal injury or damage to property? Who ought to control/own the software in implanted medical devices? And how should the law deal with risks around third-party device access (including that of unauthorised access and hacking)? We argue that satisfactorily answering such questions will likely require a re-analysis of the conceptual and philosophical underpinnings of the law, as well as the law itself. To demonstrate this, we examine the uncharted terrain which everyday cyborgs pose for the law, looking in particular at five areas: (i) medical device regulation, safety, and product liability; (ii) damage to devices and liability; (iii) data and privacy; (iv) security and biohacking; and (v) intellectual property rights. The article highlights how advancing biotechnology continues to reveal, and prompts us to confront, lacunae within the law. Our analysis calls particular attention to law’s boundary-work (how the law utilises and incorporates supposed ontological and moral boundaries) and the challenges which everyday cyborgs pose to this.

Work on this paper was supported by a Wellcome Trust Seed Award in Humanities and Social Science 2016 (Grant No: 201675/Z/16/Z).