The computer says no: AI, health law, ethics and patient safety.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recent reports on artificial intelligence (AI) and machine learning in the context of law, ethics and patient safety.

Social Prescribing in National Health Service Primary Care: What Are the Ethical Considerations?

Policy Points Social prescribing is proposed as a way of improving patients' health and well-being by attending to their non-clinical needs. This is done by connecting patients with community assets (typically voluntary or charitable organizations) that provide social and personal support. In the United Kingdom, social prescribing is used to improve patient well-being and reduce use of National Health Service resources. Although social prescribing schemes hold promise, evidence of their effects and effectiveness is sparse. As more information on social prescribing is gathered, it will be important to consider the associated ethical issues for patients, clinicians, link workers, and community assets.

Fairness, Ethnicity, and COVID-19 Ethics : A Discussion of How the Focus on Fairness in Ethical Guidance During the Pandemic Discriminates Against People From Ethnic Minority Backgrounds.

Recent weeks have seen an increased focus on the ethical response to the COVID-19 pandemic. Ethics guidance has proliferated across Britain, with ethicists and those with a keen interest in ethics in their professions working to produce advice and support for the National Health Service. The guiding principles of the pandemic have emerged, in one form or another, to favour fairness, especially with regard to allocating resources and prioritizing care. However, fairness is not equivalent to equity when it comes to healthcare, and the focus on fairness means that existing guidance inadvertently discriminates against people from ethnic minority backgrounds. Drawing on early criticisms of existing clinical guidance (for example, the frailty decision tool) and ethical guidance in Britain, this essay will discuss the importance of including sociology, specifically the relationship between ethnicity and health, in any ethical and clinical guidance for care during the pandemic in the United Kingdom. To do otherwise, I will argue, would be actively choosing to allow a proportion of the British population to die for no other reason than their ethnic background. Finally, I will end by arguing why sociology must be a key component in any guidance, outlining how sociology was incorporated into the cross-college guidance produced by the Royal College of Physicians.

Ethical framework for adult social care in COVID-19.

In March 2020, the Government produced a document entitled "Responding to COVID-19: The Ethical Framework for Adult Social Care" ('The Ethical Framework'). In this article, we summarise the key features of the proposed ethical framework and subject it to critical analysis. We highlight three primary issues. First, the emphasis placed on autonomy as the primary ethical principle. We argue if ever there was a context in which autonomy should dominate the ethical analysis, this is not it. Second, we examine the interface between ethics and law which is largely overlooked in the document. Finally, we explore the surprising lack of attention paid to the concept of responsibility and communal obligations within the framework.

The cost of consent: why healthcare providers must be compliant with the Montgomery principles.

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of "failure to warn", i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on "failure to warn" and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550-555.

Best interests versus resource allocation: could COVID-19 cloud decision-making for the cognitively impaired?

The COVID-19 pandemic is putting the NHS under unprecedented pressure, requiring clinicians to make uncomfortable decisions they would not ordinarily face. These decisions revolve primarily around intensive care and whether a patient should undergo invasive ventilation. Certain vulnerable populations have featured in the media as falling victim to an increasingly utilitarian response to the pandemic-primarily those of advanced years or with serious existing health conditions. Another vulnerable population potentially at risk is those who lack the capacity to make their own care decisions. Owing to the pandemic, there are increased practical and normative challenges to following the requirements of the Mental Capacity Act 2005. Both capacity assessments and best interests decisions may prove more difficult in the current situation. This may create a more paternalistic situation in decisions about the care of the cognitively impaired which is at risk of taking on a utilitarian focus. We look to these issues and consider whether there is a risk of patients who lack capacity to make their own care decisions being short-changed.

Putting the NHS England on trial: uncertainty-as-power, evidence and the controversy of PrEP in England.

Pre-exposure prophylaxis (PrEP) (Truvada) is a medication which if taken correctly is almost entirely effective in preventing HIV infection. In regions and countries where it has been widely taken up, HIV seroconversion rates have significantly decreased. Alongside testing and treatment, it offers the very real prospect of ending HIV infections. However, in England, commissioning it has (and still is) a controversial process, where NHS England has repeatedly raised supposed 'uncertainties', first legal and then scientific. The same has not happened in Scotland, where PrEP was commissioned to anyone who needed it in April 2017. This article presents a close reading of the IMPACT trial protocol, which we conclude cannot answer the questions it sets out to answer. We then suggest that the uncertainties the trial claims to address are in fact a tool of power which is deployed to strategically ration healthcare; introduce uncertainty about commissioning PrEP; and shift the boundary between individual responsibilities and state responsibilities for public health and HIV prevention. We conclude that all the above constitute an unethical use of clinical trial rhetoric, systematically discriminate against minority and vulnerable groups, and ration healthcare for those who most need it. As such, we call on all academics, clinicians and activists to resist further unethical misuses of clinical trial rhetoric.

An Ethical Analysis of Coverage With Evidence Development.

Sometimes a government or other payer is called on to fund a new health technology even when the evidence leaves a lot of uncertainty. One option is for the payer to provisionally fund the technology and reduce uncertainty by developing evidence. This is called coverage with evidence development (CED). Only-in-research CED, when the payer funds the technology only for patients who participate in the evidence development, raises the sharpest ethical questions. Is the patient coerced or induced into participating? If so, under what circumstances, if any, is this ethically justified? Building on work by Miller and Pearson, we argue that patients have a right to funding for a technology only when the payer can be confident that the technology provides reasonable value for money. Technologies are candidates for CED precisely because serious questions remain about value for money, and therefore patients have no right to technologies under a CED arrangement. This is why CED induces rather than coerces. The separate question of whether the inducement is ethically justified remains. We argue that CED does pose risks to patients, and the worse these risks are, the harder it is to justify the inducement. Finally, we propose conditions under which the inducement could be ethically justified and means of avoiding inducement altogether. We draw on the Australian context, and so our conclusions apply most directly to comparable contexts, where the payer is a government that provides universal coverage with a regard for cost-effectiveness that is prominent and fairly clearly defined.

Moral ambivalence towards the Cancer Drugs Fund.

The UK's Cancer Drugs Fund (CDF) was introduced in 2010 following the Conservative Party's promise to address the fact that numerous efficacious cancer drugs were not available because of their cost ineffectiveness, as deduced by the National Institute of Health and Care Excellence. While, at face value, this policy appears only to promote the UK's public welfare, a deeper analysis reveals the ethically unjustifiable inconsistencies that the CDF introduces; where is the analogous fund for other equally severe diseases? Have the patients without cancer been neglected simply due to the fear-inducing advertising and particularly ferocious speech which surrounds cancer? The CDF is unjustifiable when challenged by such questions. However, it is troubling to think that the CDF might be repealed in order to abolish these ethical concerns. Intuitively, one feels uncomfortable stripping the cancer patient of their benefits just so that they might be on an equally pessimistic footing with others. In the present essay, I argue that, although there are no ethically justifiable grounds for the CDF's introduction, its removal would be inappropriate. Following this realisation, I investigate whether the procedural steps of the CDF itself-theoretically removed from the context of resource distribution for all disease types-represent an ethically justifiable system. I believe that the answer is yes, given the CDF's conformity to accountability for reasonableness, a robust framework of procedural justice, which continuously improves the ethical and epistemological standards of the policies to which it is applied.

'Inglan is a bitch': hostile NHS charging regulations contravene the ethical principles of the medical profession.

Following the recent condemnation of the National Health Service charging regulations by medical colleges and the UK Faculty of Public Health, we demonstrate that through enactment of this policy, the medical profession is betraying its core ethical principles. Through dissection of the policy using Beauchamp and Childress' framework, a disrespect for autonomy becomes evident in the operationalisation of the charging regulations, just as a disregard for confidentiality was apparent in the data sharing Memorandum of Understanding. Negative consequences of the regulations are documented to highlight their importance for clinical decision makers under the principles of beneficence and non-maleficence. Exploration of the principle of justice illuminates the core differentiation between the border-bound duties of the State and borderless duties of the clinician, exposing a fundamental tension.

Co-payment for Unfunded Additional Care in Publicly Funded Healthcare Systems: Ethical Issues.

The burdens of resource constraints in publicly funded healthcare systems urge decision makers in countries like Sweden, Norway and the UK to find new financial solutions. One proposal that has been put forward is co-payment-a financial model where some treatment or care is made available to patients who are willing and able to pay the costs that exceed the available alternatives fully covered by public means. Co-payment of this sort has been associated with various ethical concerns. These range from worries that it has a negative impact on patients' wellbeing and on health care institutions, to fears that co-payment is in conflict with core values of publicly funded health care systems. This article provides an overview of the main ethical issues associated with co-payment, and ethical arguments both in support of and against it will be presented and analyzed.

Conflicting demands on a modern healthcare service: Can Rawlsian justice provide a guiding philosophy for the NHS and other socialized health services?

We explore whether a Rawlsian approach might provide a guiding philosophy for the development of a healthcare system, in particular with regard to resolving tensions between different groups within it. We argue that an approach developed from some of Rawls' principles - using his 'veil of ignorance' and both the 'difference' and 'just savings' principles which it generates - provides a compelling basis for policy making around certain areas of conflict. We ask what policies might be made if those making them did not know if one was patient, doctor, nurse or manager - in this generation or the next. We first offer a brief summary of Rawls' approach and how we intend to extrapolate from it. We examine how this adapted Rawlsian framework could be applied to specific examples of conflict within healthcare; we demonstrate how this framework can be used to develop a healthcare service which is both sustainable (in its training and treatment of staff, and in encouraging research and innovation) and open (to protect the powers and opportunities of those using the health service). We conclude that while Rawls' approach has previously been rejected as a means to address specific healthcare decisions, an adapted veil of ignorance can be a useful tool for the consideration of how a just health service should be constructed and sustained. Turning the theoretical into the practical (and combining Rawls' thought experiment with Scanlonian contractarianism), managers, doctors, patients, carers and nurses could come together and debate conflicting issues behind a hypothetical veil.