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

Forthcoming in Medical Law International 

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.


‘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.


‘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).