A European regulatory pathway for Tidepool loop following clearance in the United States?

The recent clearance by the United States Food and Drug Administration of Tidepool Loop sets an important precedent within the medical device landscape. For the first time, an automated insulin delivery mobile application-based on an algorithm initially designed and developed by users -has been recognised as safe and effective by a regulatory body. The aim of this paper is twofold: firstly, we map out the regulatory pathways and processes that were navigated by Tidepool, the non-profit behind Tidepool Loop, in order to make this landmark moment possible. Secondly, we set out potential approvals processes in the European Union and United Kingdom with a view to examining the challenges to obtaining regulatory clearance for Tidepool Loop in these jurisdictions. In so doing, we highlight the significant differences, not only between the United States and European systems but also between the European Union and Great Britain systems. We conclude by arguing that the complexity encountered when seeking to introduce an innovative solution in different regulatory systems has the potential to act as a disincentive to open source developers from seeking regulatory approvals for such technologies in the future.

#WeAreNotWaiting DIY artificial pancreas systems and challenges for the law.

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 processes, 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 uncertainty, 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.

In response to slow progress regarding technological innovations to manage type 1 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 article, 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.

Exacerbating Inequalities? Health Policy and the Behavioural Sciences.

There have been calls for some time for a new approach to public health in the United Kingdom and beyond. This is consequent on the recognition and acceptance that health problems often have a complex and multi-faceted aetiology. At the same time, policies which utilise insights from research in behavioural economics and psychology ('behavioural science') have gained prominence on the political agenda. The relationship between the social determinants of health (SDoH) and behavioural science in health policy has not hitherto been explored. Given the on-going presence of strategies based on findings from behavioural science in policy-making on the political agenda, an examination of this is warranted. This paper begins by looking at the place of the SDoH within public health, before outlining, in brief, the recent drive towards utilising behavioural science to formulate law and public policy. We then examine the relationship between this and the SDoH. We argue that behavioural public health policy is, to a certain extent, blind to the social and other determinants of health. In section three, we examine ways in which such policies may perpetuate and/or exacerbate health inequities and social injustices. We argue that problems in this respect may be compounded by assumptions and practices which are built into some behavioural science methodologies. We also argue that incremental individual gains may not be enough. As such, population-level measures are sometimes necessary. In section four we defend this contention, arguing that an equitable and justifiable public health requires such measures.

Everyday Cyborgs: On Integrated Persons and Integrated Goods.

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.

Are health nudges coercive?

Governments and policy-makers have of late displayed renewed attention to behavioural research in an attempt to achieve a range of policy goals, including health promotion. In particular, approaches which could be labelled as 'nudges' have gained traction with policy-makers. A range of objections to nudging have been raised in the literature. These include claims that nudges undermine autonomy and liberty, may lead to a decrease in responsibility in decision-making, lack transparency, involve deception, and involve manipulation, potentially occasioning coercion. In this article I focus on claims of coercion, examining nudges within two of the main approaches to coercion-the pressure approach and the more recent enforcement approach. I argue that coercion entails an element of control over the behaviour of agents which is not plausibly displayed by the kinds of serious examples of nudges posited in the literature.

Nudging for health: on public policy and designing choice architecture.

There have been recent policy moves aimed at encouraging individuals to lead healthier lives. The Cabinet Office has set up a 'nudge unit' with health as one of its priorities and behavioural approaches have started to be integrated into health-related domestic policy in a number of areas. Behavioural research has shown that that the way the environment is constructed can shape a person's choices within it. Thus, it is hoped that, by using insights from such research, people can be nudged towards making decisions which are better for their health. This article outlines how nudges can be conceived of as part of an expanding arsenal of health-affecting regulatory tools being used by the Government and addresses some concerns which have been expressed regarding behavioural research-driven regulation and policy. In particular, it makes the case that, regardless of new regulatory and policy strategies, we cannot escape the myriad of influences which surround us. As such, we can view our health-affecting decisions as already being in some sense shaped and constructed. Further, it argues we may in fact have reason to prefer sets of health-affecting options which have been intentionally designed by the state, rather than those that stem from other sources or result from random processes. Even so, in closing, this article draws attention to the largely unanswered questions about how behavioural research translates into policy and regulatory initiatives.

Organ donation and priority points in Israel: an ethical analysis.

Israel's rates of organ donation have been one of the lowest among developed countries. An attempt to change this has led to the introduction of a pioneering new law, the Organ Transplant Act 2008, which came into effect in January 2010 and sets out principles underlying a new policy in relation to the allocation of organs for transplantation. According to this policy, a person can gain priority points by signing a donor card, making a nondirected organ donation during their lifetime, or as a result of a first-degree relative signing a donor card, or consenting to procurement of organs after death. In this opinion piece, we argue that although this approach merits attention for its innovative aspects and its potential benefits, it raises some ethical difficulties. In particular, we discuss some problems of justice and fairness inherent in the system, focusing on inequalities because of the (a) number of relatives one might have, (b) the type of living donation one makes, (c) the potential for strategic behavior, and (d) problems regarding the consent of family members.

Tax needn't be taxing, but in the case of organ donation it might be.

Petersen and Lippert-Rasmussen argue that, while a tax credit scheme to encourage organ donation would be costly, the increased number of organs for transplantation would lead to other savings in the healthcare system. In the present work some calculations are provided and it is suggested that, even given optimistic assumptions, the cost to the state of implementing the system as proposed would be high and unlikely to garner the support of politicians and policymakers.

The assessment of the quality of reporting of meta-analyses in diagnostic research: a systematic review.

BACKGROUND: Over the last decade there have been a number of guidelines published, aimed at improving the quality of reporting in published studies and reviews. In systematic reviews this may be measured by their compliance with the PRISMA statement. This review aims to evaluate the quality of reporting in published meta-analyses of diagnostic tests, using the PRISMA statement and establish whether there has been a measurable improvement over time. METHODS: Eight databases were searched for reviews published prior to 31(st) December 2008. Studies were selected if they evaluated a diagnostic test, measured performance, searched two or more databases, stated the search terms and inclusion criteria, and used a statistical method to summarise a test's performance. Data were extracted on the review characteristics and items of the PRISMA statement. To measure the change in the quality of reporting over time, PRISMA items for two periods of equal duration were compared. RESULTS: Compliance with the PRISMA statement was generally poor: none of the reviews completely adhered to all 27 checklist items. Of the 236 meta-analyses included following selection: only 2(1%) reported the study protocol; 59(25%) reported the searches used; 76(32%) reported the results of a risk of bias assessment; and 82(35%) reported the abstract as a structured summary. Only 11 studies were published before 2000. Thus, the impact of QUOROM on the quality of reporting was not evaluated. However, the periods 2001-2004 and 2005-2008 (covering 93% of studies) were compared using relative risks (RR). There was an increase in the proportion of reviews reporting on five PRISMA items: eligibility criteria (RR 1.13, 95% CI 1.00 - 1.27); risk of bias across studies (methods) (RR 1.81, 95% CI 1.34 - 2.44); study selection results (RR 1.48, 95% CI 1.05 - 2.09); results of individual studies (RR 1.37, 95% CI 1.09 - 1.72); risk of bias across studies (results) (RR 1.65, 95% CI 1.20 - 2.25). CONCLUSION: Although there has been an improvement in the quality of meta-analyses in diagnostic research, there are still many deficiencies in the reporting which future reviewers need to address if readers are to trust the validity of the reported findings.

Uptake of newer methodological developments and the deployment of meta-analysis in diagnostic test research: a systematic review.

BACKGROUND: The last decade has seen a number of methodological developments in meta-analysis of diagnostic test studies. However, it is unclear whether such developments have permeated the wider research community and on which applications they are being deployed. The objective was to assess the uptake and deployment of the main methodological developments in the meta-analysis of diagnostic tests, and identify the tests and target disorders most commonly evaluated by meta-analysis. METHODS: Design--systematic review. Data Sources--Medline, EMBASE, CINAHL, Cochrane, PsychInfo, Global health, HMIC, and AMED were searched for studies published before 31st December 2008. Selection criteria--studies were included if they satisfied all of the following: evaluated a diagnostic test; measured test performance; searched two or more databases; stated search terms and inclusion criteria; used a statistical method to summarise performance. Data extraction--included the following data items: year; test; reference standard; target disorder; setting; statistical and quality methods. RESULTS: 236 studies were included. Over the last 5 years the number of meta-analyses published has increased, but the uptake of new statistical methods lags behind. Pooling the sensitivity and specificity and using the SROC remain the preferred methods for analysis in 70% of studies, with the bivariate random effects and HSROC model being used in only 22% and 5% of studies respectively. In contrast, between 2006 and 2008 the QUADAS tool was used in 40% of studies. Broadly, radiological imaging was the most frequent category of tests analysed (36%), with cancer (22%) and infection (21%) being the most common categories of target disorder. Nearly 80% of tests analysed were those normally used in specialist settings. CONCLUSION: Although quality assessment in meta-analyses has improved with the introduction of QUADAS, uptake of the newer statistical methods is still lagging behind. Furthermore, the focus of secondary research seems to be in evaluating specialist tests in specialist settings, in contrast to the more routine tests and settings encountered in the majority of clinical practice.

A right to reproduce?

How should we conceive of a right to reproduce? And, morally speaking, what might be said to justify such a right? These are just two questions of interest that are raised by the technologies of assisted reproduction. This paper analyses the possible legitimate grounds for a right to reproduce within the two main theories of rights; interest theory and choice theory.

Best interests, the power of the medical profession, and the power of the judiciary.

This paper is a response to a paper by John Coggon 'Best Interests, Public Interest, and the Power of the Medical Profession'. It argues that certain legal judgements in relation to best interests seek to change and curtail the role of the medical profession in this arena while simultaneously extending the jurisdiction of the courts. It also argues that we must guard against replacing one professional standard, that of the medical profession, with another, that of the judiciary in this area.