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.

#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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Best interests and potential organ donors.

Many potential donor organs are currently lost because of misunderstanding of the law. clarify what is permissible in non-heart-beating donation

Non-human primates: the appropriate subjects of biomedical research?

Following the publication of the Weatherall report on the use of non-human primates in research, this paper reflects on how to provide appropriate and ethical models for research beneficial to humankind. Two of the main justifications for the use of non-human primates in biomedical research are analysed. These are the "least-harm/greatest-good" argument and the "capacity" argument.

Property and the body: applying Honore.

This paper argues that the new commercial and quasi-commercial activities of medicine, scientists, pharmaceutical companies and industry with regard to human tissue has given rise to a whole new way of valuing our bodies. It is argued that a property framework may be an effective and constructive method of exploring issues arising from this. The paper refers to A M Honoré's theory of ownership and aims to show that we have full liberal ownership of our own bodies and as such can be considered to be self-owners.

Frozen embryos, genetic information and reproductive rights.

Recent ethical and legal challenges have arisen concerning the rights of individuals over their IVF embryos, leading to questions about how, when the wishes of parents regarding their embryos conflict, such situations ought to be resolved. A notion commonly invoked in relation to frozen embryo disputes is that of reproductive rights: a right to have (or not to have) children. This has sometimes been interpreted to mean a right to have, or not to have, one's own genetic children.

A NICE fallacy.

A response is given to the claim by Claxton and Culyer, who stated that the policies of the National Institute for Health and Clinical Excellence (NICE) do not evaluate patients rather than treatments. The argument is made that the use of values such as quality of life and life-years is ethically dubious when used to choose which patients ought to receive treatments in the National Health Service (NHS).