‘Being Novel? Regulating Emerging Technologies Under Conditions of Uncertainty’
Presented by Joseph TF Roberts and Muireann Quigley at:
If we accept that at some point novel beings – be they synthetic, biological, or biohybrid in nature – will be brought into existence, then we need to consider how the law should take account of (the emergence of) such beings. This is a sticky problem, because any attempt to engage in preparatory regulation with respect to novel beings is mired in uncertainty. Principally, this uncertainty relates to the fact that there is a large – perhaps insurmountable -epistemic gap when it comes to all manner of (legally and morally) significant facts about novel beings. Put simply, we do not know what type of beings they will be, either in terms of their physical nature/embodiment or mental/cognitive characteristics. Neither do we know, as McKeown has put it, ‘how their corporeality shapes their options, preferences, values, and is constitutive of their moral universe’ (McKeown 2020, p. 1). Essentially this means that, as these beings do not yet exist, we do not have access to the relevant context-dependent information needed to propose a detailed regulatory regime.
In light of these epistemic difficulties and uncertainties, in this presentation we do not propose a detailed account of law and regulation for novel beings. Instead we outline a range of normative principles which could help guide the regulation of precursor technologies without undermining our ability to appropriately regulate emerging novel beings in the future. By precursor technologies, we mean those technologies which exist now, but which are likely to serve as important stepping stones to the eventual emergence of particular novel beings. In this respect, we focus on digital-based task-specific expert systems as potential precursors to the kinds of advanced artificial general intelligences (AGIs) which would qualify as novel beings possessing moral status.
‘DIY APS: The Future & the Law’
Presented by Rachael Dickson at:
Recent years have seen commercial manufacturers of medical devices take their first steps into manufacturing hybrid-closed loop artificial pancreas systems. Whereas once this technology was the preserve of the #WeAreNotWaiting movement, there are now multiple commercial systems on the market.
One of the problems with DIY APS systems is that they are mired in legal uncertainty. Unlike DIY alternatives, commercial systems have been through the approval process required to receive market authorisation. As there is less legal uncertainty surrounding commercial systems, we might expect to see a shift away from DIY APS. In this presentation I explore four reasons why the presence of commercial systems will not necessarily resolve these legal uncertainties.
First, just because commercial systems have been granted market authorisation, that does not mean everyone who wishes to use them will be able to do so. This can occur because not all NHS trusts will fund commercial artificial pancreas systems and they are expensive to purchase privately. Secondly, as commercial manufacturers have to get approval for their devices, innovations can take longer to get to market than DIY alternatives which developed on an open-source model. In that time DIY APS systems may have incorporated new features; making them a more attractive option for some users.
Thirdly, DIY APS users are now experts on artificial pancreas systems. Without training for clinicians on how to support people using commercial systems individuals who are currently using DIY APS may be reluctant to move to a commercial system. Finally, many DIY APS users value the community surrounding the technology. The DIY APS community is a space where users can ask for advice from peers who are also using the system. The community’s assistance is not purely technical but also includes lifestyle advice and empathetic emotional support for people living with diabetes. If this support is not forthcoming from clinicians, DIY APS users may be reluctant to move on to a commercial system.
‘DIY Artificial Pancreas Systems: Ethical Issues‘
Presented by Joseph TF Roberts at:
The increasing use of DIY APS raises a series of ethical and legal problems including: ensuring patient safety, protecting privacy and preventing unauthorised access, determining liability for harms should the system fail and maintaining trust in the doctor patient relationship.
At the moment in the UK clinicians adopt a precautionary approach to discussing DIY APS with their patients in the clinic. Clinicians are currently advised not to initiate conversations about DIY APS. However, if the patient raises the issue, clinicians should inform their patients it is an unregulated medical device, the known risks of using it, and inform them that they use the device at their own risk.
In this talk I argued that this policy has the potential to undermine trust in the doctor patient relationship. Relationships of trust are built on honest and open communication. If clinicians fail to discuss potentially beneficial technologies and patients find out about them through alternative means (such as internet searches or patient support groups), they may come to distrust their clinicians for withholding information from them. If we want to maintain trust in the doctor patient relationship it is imperative that clinicians can have honest and open conversations with their patients. To do that, they may need to be able to initiate conversations about DIY APS in some instances.
‘Citizen Science and DIY Diabetes – Ethical and Regulatory Challenges of Patient-led Innovation’
Presented by Rachael Dickson and Muireann Quigley at:
- Centre for Health Law Science and Policy, University of Birmingham, 11th February 2020
- School of Law, Queens University Belfast, 19th February 2020
Healthcare technology innovation in diabetes management is a slow process, resulting in a community of ‘loopers’ emerging. Tired of waiting for commercial companies to produce effective, accessible products, loopers are constructing DIY ‘artificial pancreas’ systems (APS) to better manage their diabetes by connecting their insulin pumps to their glucose monitors using either a small computer or their smartphones.
In this paper we problematize and analyse the DIY diabetes movement as an aspect of ‘citizen science’. Citizen science is “understood broadly as the participation of non-professionals at any phase of scientific research” (Fiske et al. 2019). The types of activities captured by citizen science include “include volunteer monitoring, community science, and participatory research . . . [as well as] technology-supported projects where crowdsourcing techniques [which] are applied to scientific data or analysis” (Wiggins & Willbanks 2015).
Up until now, most discussions regarding citizen science have often focused on areas such as genomics, where citizen scientists are involved in genetic sequencing or working towards creating biomarker-based tests for rare diseases, or data collection, where the patients are leading projects to improve understanding of particular health conditions. In a number of respects DIY APS represents a much more complex, treatment-oriented (and potentially problematic) example of citizen science. Using citizen science as a lens for enquiry, in this paper we explore some potential ethical and regulatory challenges of patient-led innovation. We argue that while DIY APS generally represents a welcome democratisation of diabetes management, there are a number of pressing concerns which need to be addressed regarding the growing use of an essentially unregulated medical technology.