It is commonly accepted that clinicians are ethically obligated to disclose their use of medical machine learning systems to patients, and that failure to do so would amount to a moral fault for which clinicians ought to be held accountable. Call this ‘the disclosure thesis.’ Four main arguments have been, or could be, given to support the disclosure thesis in the ethics literature: the risk-based argument, the rights-based argument, the materiality argument and the autonomy argument. In this article, I argue (...) that each of these four arguments are unconvincing, and therefore, that the disclosure thesis ought to be rejected. I suggest that mandating disclosure may also even risk harming patients by providing stakeholders with a way to avoid accountability for harm that results from improper applications or uses of these systems. (shrink)

The increasing integration of artificial intelligence (AI) in healthcare presents a host of ethical, legal, social, and political challenges involving various stakeholders. These challenges prompt various studies proposing frameworks and guidelines to tackle these issues, emphasizing distinct phases of AI development, deployment, and oversight. As a result, the notion of responsible AI has become widespread, incorporating ethical principles such as transparency, fairness, responsibility, and privacy. This paper explores the existing literature on AI use in healthcare to examine how it addresses, (...) defines, and discusses the concept of responsibility. We conducted a scoping review of literature related to AI responsibility in healthcare, searching databases and reference lists between January 2017 and January 2022 for terms related to “responsibility” and “AI in healthcare”, and their derivatives. Following screening, 136 articles were included. Data were grouped into four thematic categories: (1) the variety of terminology used to describe and address responsibility; (2) principles and concepts associated with responsibility; (3) stakeholders’ responsibilities in AI clinical development, use, and deployment; and (4) recommendations for addressing responsibility concerns. The results show the lack of a clear definition of AI responsibility in healthcare and highlight the importance of ensuring responsible development and implementation of AI in healthcare. Further research is necessary to clarify this notion to contribute to developing frameworks regarding the type of responsibility (ethical/moral/professional, legal, and causal) of various stakeholders involved in the AI lifecycle. (shrink)

The use of artificial intelligence in healthcare contexts is highly controversial for the (bio)ethical conundrums it creates. One of the main problems arising from its implementation is the lack of transparency of machine learning algorithms, which is thought to impede the patient’s autonomous choice regarding their medical decisions. If the patient is unable to clearly understand why and how an AI algorithm reached certain medical decision, their autonomy is being hovered. However, there are alternatives to prevent the negative impact of (...) AI opacity in shared (healthcare professional–patient) decision-making processes, and benefit from the high accuracy of such systems. Despite these ethical issues, this paper advocates for its usage and also defends the positive role that it could have in enhancing patients’ autonomy. I advocate for a system where the implementation of AI is only partial, and humans will remain in control of oversighting algorithm interpretation of medical images and patients’ data. (shrink)

This paper argues that one problem that besets black-box AI is that it lacks algorithmic justifiability. We argue that the norm of shared decision making in medical care presupposes that treatment decisions ought to be justifiable to the patient. Medical decisions are justifiable to the patient only if they are compatible with the patient’s values and preferences and the patient is able to see that this is so. Patient-directed justifiability is threatened by black-box AIs because the lack of rationale provided (...) for the decision makes it difficult for patients to ascertain whether there is adequate fit between the decision and the patient’s values. This paper argues that achieving algorithmic transparency does not help patients bridge the gap between their medical decisions and values. We introduce a hypothetical model we call Justifiable AI to illustrate this argument. Justifiable AI aims at modelling normative and evaluative considerations in an explicit way so as to provide a stepping stone for patient and physician to jointly decide on a course of treatment. If our argument succeeds, we should prefer these justifiable models over alternatives if the former are available and aim to develop said models if not. (shrink)

Without doctors being able to explain medical decisions to patients, I argue their use of black box AIs would erode the effective and respectful care they provide patients. In addition, I argue that physicians should use AI black boxes only for patients in dire straits, or when physicians use AI as a “co-pilot” (analogous to a spellchecker) but can independently confirm its accuracy. I respond to A.J. London’s objection that physicians already prescribe some drugs without knowing why they work.

Artificial intelligence (AI) and its introduction into clinical pathways presents an array of ethical issues that are being discussed in the JME. 1–7 The development of AI technologies that can produce text that will pass plagiarism detectors 8 and are capable of appearing to be written by a human author 9 present new issues for medical ethics. One set of worries concerns authorship and whether it will now be possible to know that an author or student in fact produced submitted (...) work. That seems likely to be a general worry for secondary and higher education, as well as for all academic journals. Thus far generative AI chatbots do not seem to be able to produce a fully referenced and well-argued ethics article, but they probably could generate a blog or student essay that would... (shrink)

The use of machine learning systems for decision-support in healthcare may exacerbate health inequalities. However, recent work suggests that algorithms trained on sufficiently diverse datasets could in principle combat health inequalities. One concern about these algorithms is that their performance for patients in traditionally disadvantaged groups exceeds their performance for patients in traditionally advantaged groups. This renders the algorithmic decisions unfair relative to the standard fairness metrics in machine learning. In this paper, we defend the permissible use of affirmative algorithms; (...) that is, algorithms trained on diverse datasets that perform better for traditionally disadvantaged groups. Whilst such algorithmic decisions may be unfair, the fairness of algorithmic decisions is not the appropriate locus of moral evaluation. What matters is the fairness of final decisions, such as diagnoses, resulting from collaboration between clinicians and algorithms. We argue that affirmative algorithms can permissibly be deployed provided the resultant final decisions are fair. (shrink)

This paper explores the role and resolution of disagreements between physicians and their diagnostic AI-based decision support systems. With an ever-growing number of applications for these independently operating diagnostic tools, it becomes less and less clear what a physician ought to do in case their diagnosis is in faultless conflict with the results of the DSS. The consequences of such uncertainty can ultimately lead to effects detrimental to the intended purpose of such machines, e.g. by shifting the burden of proof (...) towards a physician. Thus, we require normative clarity for integrating these machines without affecting established, trusted, and relied upon workflows. In reconstructing different causes of conflicts between physicians and their AI-based tools—inspired by the approach of “meaningful human control” over autonomous systems and the challenges to resolve them—we will delineate normative conditions for “meaningful disagreements”. These incorporate the potential of DSS to take on more tasks and outline how the moral responsibility of a physician can be preserved in an increasingly automated clinical work environment. (shrink)

The emergence of ethical concerns surrounding artificial intelligence (AI) has led to an explosion of high-level ethical principles being published by a wide range of public and private organizations. However, there is a need to consider how AI developers can be practically assisted to anticipate, identify and address ethical issues regarding AI technologies. This is particularly important in the development of AI intended for healthcare settings, where applications will often interact directly with patients in various states of vulnerability. In this (...) paper, we propose that an ‘embedded ethics’ approach, in which ethicists and developers together address ethical issues via an iterative and continuous process from the outset of development, could be an effective means of integrating robust ethical considerations into the practical development of medical AI. (shrink)

Artificial Intelligence (AI) is a diverse technology. It is already having significant effects on many jobs and sectors of the economy and over the next ten to twenty years it will drive profound changes in the way New Zealanders live and work. Within the workplace AI will have three dominant effects. This report (funded by the New Zealand Law Foundation) addresses: Chapter 1 Defining the Technology of Interest; Chapter 2 The changing nature and value of work; Chapter 3 AI and (...) the employment relationship; Chapter 4 Consumers, professions and society. The report includes recommendations to the New Zealand Government. (shrink)

The use of black box algorithms in medicine has raised scholarly concerns due to their opaqueness and lack of trustworthiness. Concerns about potential bias, accountability and responsibility, patient autonomy and compromised trust transpire with black box algorithms. These worries connect epistemic concerns with normative issues. In this paper, we outline that black box algorithms are less problematic for epistemic reasons than many scholars seem to believe. By outlining that more transparency in algorithms is not always necessary, and by explaining that (...) computational processes are indeed methodologically opaque to humans, we argue that the reliability of algorithms provides reasons for trusting the outcomes of medical artificial intelligence. To this end, we explain how computational reliabilism, which does not require transparency and supports the reliability of algorithms, justifies the belief that results of medical AI are to be trusted. We also argue that several ethical concerns remain with black box algorithms, even when the results are trustworthy. Having justified knowledge from reliable indicators is, therefore, necessary but not sufficient for normatively justifying physicians to act. This means that deliberation about the results of reliable algorithms is required to find out what is a desirable action. Thus understood, we argue that such challenges should not dismiss the use of black box algorithms altogether but should inform the way in which these algorithms are designed and implemented. When physicians are trained to acquire the necessary skills and expertise, and collaborate with medical informatics and data scientists, black box algorithms can contribute to improving medical care. (shrink)

The Journal of Medical Ethics can sometimes read part Men Like Gods and part A Brave New World. At times, we learn how all controversies can resolved with reference to four principles. At other times, we learn how “every discovery in pure science is potentially subversive”.1 This issue is no exception. Here, we can read about the utopia of gene editing, manufactured organs, and machine learnt algorithmic decision-making. We can also read about the dystopia of inherited disorders from edited germlines, (...) the testing of xenotransplants on braindead patients, and misdiagnosis by artificial intelligence. What we see in the three papers that I will foreground here is the application of medical ethics to avoid the dystopia while preserving the promises of medical science. But as I seek to explain here, our ability to address the controversies that we anticipate in medical science depend on our ability to refine our understanding of what medical ethics requires of us now. From the diagnosis of eye diseases from fungus images to predicting the risk of imminent risk of suicide attempts, machine learnt medical decision making has, in some high profile instances, outperformed clinicians in medical diagnosis and treatment recommendations. While clinician and machine learnt diagnoses will both involve degrees of uncertainty and fallibility, Thomas Grote2 asks us to consider is how much weight a clinician ought to give an algorithmic diagnosis which she disagreements with. Since a clinician is held to account for …. (shrink)

Advanced AI systems are rapidly making their way into medical research and practice, and, arguably, it is only a matter of time before they will surpass human practitioners in terms of accuracy, reliability, and knowledge. If this is true, practitioners will have a prima facie epistemic and professional obligation to align their medical verdicts with those of advanced AI systems. However, in light of their complexity, these AI systems will often function as black boxes: the details of their contents, calculations, (...) and procedures cannot be meaningfully understood by human practitioners. When AI systems reach this level of complexity, we can also speak of black-box medicine. In this paper, we want to argue that black-box medicine conflicts with core ideals of patient-centered medicine. In particular, we claim, black-box medicine is not conducive for supporting informed decision-making based on shared information, shared deliberation, and shared mind between practitioner and patient. (shrink)

In recent years, a plethora of high-profile scientific publications has been reporting about machine learning algorithms outperforming clinicians in medical diagnosis or treatment recommendations. This has spiked interest in deploying relevant algorithms with the aim of enhancing decision-making in healthcare. In this paper, we argue that instead of straightforwardly enhancing the decision-making capabilities of clinicians and healthcare institutions, deploying machines learning algorithms entails trade-offs at the epistemic and the normative level. Whereas involving machine learning might improve the accuracy of medical (...) diagnosis, it comes at the expense of opacity when trying to assess the reliability of given diagnosis. Drawing on literature in social epistemology and moral responsibility, we argue that the uncertainty in question potentially undermines the epistemic authority of clinicians. Furthermore, we elucidate potential pitfalls of involving machine learning in healthcare with respect to paternalism, moral responsibility and fairness. At last, we discuss how the deployment of machine learning algorithms might shift the evidentiary norms of medical diagnosis. In this regard, we hope to lay the grounds for further ethical reflection of the opportunities and pitfalls of machine learning for enhancing decision-making in healthcare. (shrink)

I analyse an argument according to which medical artificial intelligence represents a threat to patient autonomy—recently put forward by Rosalind McDougall in the Journal of Medical Ethics. The argument takes the case of IBM Watson for Oncology to argue that such technologies risk disregarding the individual values and wishes of patients. I find three problems with this argument: it confuses AI with machine learning; it misses machine learning’s potential for personalised medicine through big data; it fails to distinguish between evidence-based (...) advice and decision-making within healthcare. I conclude that how much and which tasks we should delegate to machine learning and other technologies within healthcare and beyond is indeed a crucial question of our time, but in order to answer it, we must be careful in analysing and properly distinguish between the different systems and different delegated tasks. (shrink)

Background Artificial intelligence-driven Clinical Decision Support Systems (AI-CDSS) are increasingly being integrated into healthcare for various purposes, including resource allocation. While these systems promise improved efficiency and decision-making, they also raise significant ethical concerns. This study aims to explore healthcare professionals’ perspectives on the ethical implications of using AI-CDSS for healthcare resource allocation. Methods We conducted semi-structured qualitative interviews with 23 healthcare professionals, including physicians, nurses, administrators, and medical ethicists in Turkey. Interviews focused on participants’ views regarding the use of (...) AI-CDSS in resource allocation, potential ethical challenges, and recommendations for responsible implementation. Data were analyzed using thematic analysis. Results Participant responses are clustered around five pre-determined thematic areas: (1) balancing efficiency and equity in resource allocation, (2) the importance of transparency and explicability in AI-CDSS, (3) shifting roles and responsibilities in clinical decision-making, (4) ethical considerations in data usage and algorithm development, and (5) balancing cost-effectiveness and patient-centered care. Participants acknowledged the potential of AI-CDSS to optimize resource allocation but expressed concerns about exacerbating healthcare disparities, the need for interpretable AI models, changing professional roles, data privacy, and maintaining individualized care. Conclusions The integration of AI-CDSS into healthcare resource allocation presents both opportunities and significant ethical challenges. Our findings underscore the need for robust ethical frameworks, enhanced AI literacy among healthcare professionals, interdisciplinary collaboration, and rigorous monitoring and evaluation processes. Addressing these challenges proactively is crucial for harnessing the potential of AI-CDSS while preserving the fundamental values of equity, transparency, and patient-centered care in healthcare delivery. (shrink)

BackgroundIt is increasingly recognised that the success of artificial intelligence-based clinical decision support (AI/CDS) tools will depend on physician and patient trust, but factors impacting patients’ views on clinical care reliant on AI have been less explored.ObjectiveThis pilot study explores whether, and in what contexts, detail of explanation provided about AI/CDS tools impacts patients’ attitudes toward the tools and their clinical care.MethodsWe designed a Sequential Multiple Assignment Randomized Trial vignette web-based survey. Participants recruited through Amazon Mechanical Turk were presented with (...) hypothetical vignettes describing health concerns and were sequentially randomised along three factors: (1) the level of detail of explanation regarding an AI/CDS tool; (2) the AI/CDS result; and (3) the physician’s level of agreement with the AI/CDS result. We compared mean ratings of comfort and confidence by the level of detail of explanation using t-tests. Regression models were fit to confirm conditional effects of detail of explanation.ResultsThe detail of explanation provided regarding the AI/CDS tools was positively related to respondents’ comfort and confidence in the usage of the tools and their perception of the physician’s final decision. The effects of detail of explanation on their perception of the physician’s final decision were different given the AI/CDS result and the physician’s agreement or disagreement with the result.ConclusionsMore information provided by physicians regarding the use of AI/CDS tools may improve patient attitudes toward healthcare involving AI/CDS tools in general and in certain contexts of the AI/CDS result and physician agreement. (shrink)

Artificial intelligence (AI) has long been recognised as a challenge to responsibility. Much of this discourse has been framed around robots, such as autonomous weapons or self-driving cars, where we arguably lack control over a machine’s behaviour and therefore struggle to identify an agent that can be held accountable. However, most of today’s AI is based on machine-learning technology that does not act on its own, but rather serves as a decision-support tool, automatically analysing data to help human agents make (...) better decisions. I argue that decision-support tools pose a challenge to responsibility that goes beyond the familiar problem of finding someone to blame or punish for the behaviour of agent-like systems. Namely, they pose a problem for what we might call “decision ownership”: they make it difficult to identify human agents to whom we can attribute value-judgements that are reflected in decisions. Drawing on recent philosophical literature on responsibility and its various facets, I argue that this is primarily a problem of attributability rather than of accountability. This particular responsibility problem comes in different forms and degrees, most obviously when an AI provides direct recommendations for actions, but also, less obviously, when it provides mere descriptive information on the basis of which a decision is made. (shrink)

In the ethics of algorithms, a specifically epistemological analysis is rarely undertaken in order to gain a critique (or a defense) of the handling of or trust in medical black box algorithms (BBAs). This article aims to begin to fill this research gap. Specifically, the thesis is examined according to which such algorithms are regarded as epistemic authorities (EAs) and that the results of a medical algorithm must completely replace other convictions that patients have (preemptionism). If this were true, it (...) would be a reason to distrust medical BBAs. First, the author describes what EAs are and why BBAs can be considered EAs. Then, preemptionism will be outlined and criticized as an answer to the question of how to deal with an EA. The discussion leads to some requirements for dealing with a BBA as an EA. (shrink)

BackgroundDespite the recognition that developing artificial intelligence (AI) that is trustworthy is necessary for public acceptability and the successful implementation of AI in healthcare contexts, perspectives from key stakeholders are often absent from discourse on the ethical design, development, and deployment of AI. This study explores the perspectives of birth parents and mothers on the introduction of AI-based cardiotocography (CTG) in the context of intrapartum care, focusing on issues pertaining to trust and trustworthiness.MethodsSeventeen semi-structured interviews were conducted with birth parents (...) and mothers based on a speculative case study. Interviewees were based in England and were pregnant and/or had given birth in the last two years. Thematic analysis was used to analyze transcribed interviews with the use of NVivo. Major recurring themes acted as the basis for identifying the values most important to this population group for evaluating the trustworthiness of AI.ResultsThree themes pertaining to the perceived trustworthiness of AI emerged from interviews: (1) trustworthy AI-developing institutions, (2) trustworthy data from which AI is built, and (3) trustworthy decisions made with the assistance of AI. We found that birth parents and mothers trusted public institutions over private companies to develop AI, that they evaluated the trustworthiness of data by how representative it is of all population groups, and that they perceived trustworthy decisions as being mediated by humans even when supported by AI.ConclusionsThe ethical values that underscore birth parents and mothers’ perceptions of trustworthy AI include fairness and reliability, as well as practices like patient-centered care, the promotion of publicly funded healthcare, holistic care, and personalized medicine. Ultimately, these are also the ethical values that people want to protect in the healthcare system. Therefore, trustworthy AI is best understood not as a list of design features but in relation to how it undermines or promotes the ethical values that matter most to its end users. An ethical commitment to these values when creating AI in healthcare contexts opens up new challenges and possibilities for the design and deployment of AI. (shrink)

In their proof-of-concept study, Meier et al. built an algorithm to aid ethical decision making. In the limitations section of their paper, the authors state a frequently cited ax...

The application of machine-learning technologies to medical practice promises to enhance the capabilities of healthcare professionals in the assessment, diagnosis, and treatment, of medical conditions. However, there is growing concern that algorithmic bias may perpetuate or exacerbate existing health inequalities. Hence, it matters that we make precise the different respects in which algorithmic bias can arise in medicine, and also make clear the normative relevance of these different kinds of algorithmic bias for broader questions about justice and fairness in healthcare. (...) In this paper, we provide the building blocks for an account of algorithmic bias and its normative relevance in medicine. (shrink)

Bioethics has developed approaches to address ethical issues in health care, similar to how technology ethics provides guidelines for ethical research on artificial intelligence, big data, and robotic applications. As these digital technologies are increasingly used in medicine, health care and public health, thus, it is plausible that the approaches of technology ethics have influenced bioethical research. Similar to the “empirical turn” in bioethics, which led to intense debates about appropriate moral theories, ethical frameworks and meta-ethics due to the increased (...) use of empirical methodologies from social sciences, the proliferation of health-related subtypes of technology ethics might have a comparable impact on current bioethical research. This systematic journal review analyses the reporting of ethical frameworks and non-empirical methods in argument-based research articles on digital technologies in medicine, health care and public health that have been published in high-impact bioethics journals. We focus on articles reporting non-empirical research in original contributions. Our aim is to describe currently used methods for the ethical analysis of ethical issues regarding the application of digital technologies in medicine, health care and public health. We confine our analysis to non-empirical methods because empirical methods have been well-researched elsewhere. Finally, we discuss our findings against the background of established methods for health technology assessment, the lack of a typology for non-empirical methods as well as conceptual and methodical change in bioethics. Our descriptive results may serve as a starting point for reflecting on whether current ethical frameworks and non-empirical methods are appropriate to research ethical issues deriving from the application of digital technologies in medicine, health care and public health. (shrink)

Autonomy is a core value that is deeply entrenched in the moral, legal, and political practices of many societies. The development and deployment of artificial intelligence (AI) have raised new questions about AI’s impacts on human autonomy. However, systematic assessments of these impacts are still rare and often held on a case-by-case basis. In this article, I provide a conceptual framework that both ties together seemingly disjoint issues about human autonomy, as well as highlights differences between them. In the first (...) part, I distinguish between distinct concerns that are currently addressed under the umbrella term ‘human autonomy’. In particular, I show how differentiating between autonomy-as-authenticity and autonomy-as-agency helps us to pinpoint separate challenges from AI deployment. Some of these challenges are already well-known (e.g. online manipulation or limitation of freedom), whereas others have received much less attention (e.g. adaptive preference formation). In the second part, I address the different roles AI systems can assume in the context of autonomy. In particular, I differentiate between AI systems taking on agential roles and AI systems being used as tools. I conclude that while there is no ‘silver bullet’ to address concerns about human autonomy, considering its various dimensions can help us to systematically address the associated risks. (shrink)

This article discusses the application of artificially intelligent robots within eldercare and explores a series of ethical considerations, including the challenges that AI (Artificial Intelligence) technology poses to traditional Chinese Confucian filial piety. From the perspective of Confucian ethics, the paper argues that robots cannot adequately fulfill duties of care. Due to their detachment from personal relationships and interactions, the “emotions” of AI robots are merely performative reactions in different situations, rather than actual emotional abilities. No matter how “humanized” robots (...) become, it is difficult to establish genuine empathy and a meaningful relationship with them for this reason. Even so, we acknowledge that AI robots are a significant tool in managing the demands of elder care and the growth of care poverty, and as such, we attempt to outline some parameters within which care robotics could be acceptable within a Confucian ethical system. Finally, the paper discusses the social impact and ethical considerations brought on by the interaction between humans and machines. It is observed that the relationship between humans and technology has always had both utopian and dystopian aspects, and robotic elder care is no exception. AI caregiver robots will likely become a part of elder care, and the transformation of these robots from “service providers” to “companions” seems inevitable. In light of this, the application of AI-augmented robotic elder care will also eventually change our understanding of interpersonal relationships and traditional requirements of filial piety. (shrink)

This paper develops an account of how the implementation of ML models into healthcare settings requires revising the methodological apparatus of philosophical bioethics. On this account, ML models are cognitive interventions that provide decision-support to physicians and patients. Due to reliability issues, opaque reasoning processes, and information asymmetries, ML models pose inferential problems for them. These inferential problems lay the grounds for many ethical problems that currently claim centre-stage in the bioethical debate. Accordingly, this paper argues that the best way (...) to make progress in remedying these ethical problems is to distil their epistemic core and to identify appropriate epistemic norms as guardrails. The viability of this approach will be highlighted based on four key issues: trust, responsibility, paternalism, and fairness. In that respect, the paper also contributes to a more pronounced view of the specific methodological challenges for ethical theorizing, when the point of reference are complex statistical models that make predictions, rather than individual agents, acting for reasons. (shrink)

Many ethical concerns have been voiced about Clinical Decision Support Systems (CDSSs). Special attention has been paid to the effect of CDSSs on autonomy, responsibility, fairness and transparency. This journal has featured a discussion between Rosalind McDougall and Ezio Di Nucci that focused on the impact of IBM’s Watson for Oncology (Watson) on autonomy. The present article elaborates on this discussion in three ways. First, using Jonathan Pugh’s account of rational autonomy we show that how Watson presents its results might (...) impact decisional autonomy, while how Watson produces knowledge might affect practical autonomy. Second, by drawing an analogy with patient decision aids we identify an empirical way of estimating Watson’s impact on autonomy (ie, value-congruence). Lastly, McDougall introduced the notion of value-flexible design as a way to account for the diverging preferences patients hold. We will clarify its relation with the established domain of value-sensitive design. In terms of the tripartite methodology of value-sensitive design, we offer aconceptualclarification using Pugh’s account of rational autonomy, anempiricaltool to evaluate Watson’s impact on autonomy and situate a group oftechnicaloptions to incorporate autonomy in Watson’s design. (shrink)

Informed consent is at the core of the clinical relationship. With the introduction of machine learning (ML) in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. Bridging this gap and considering the (...) whole picture is essential for advancing the debate. In the light of the possible future developments of the situation and the technologies, as well as the benefits that informed consent for ML can bring to shared decision-making, the present analysis concludes that it is necessary to prepare the ground for a possible future requirement of informed consent for medical ML. (shrink)

This article examines the role of medical doctors, AI designers, and other stakeholders in making applied AI and machine learning ethically acceptable on the general premises of shared decision-making in medicine. Recent policy documents such as the EU strategy on trustworthy AI and the research literature have often suggested that AI could be made ethically acceptable by increased collaboration between developers and other stakeholders. The article articulates and examines four central alternative models of how AI can be designed and applied (...) in patient care, which we call the ordinary evidence model, the ethical design model, the collaborative model, and the public deliberation model. We argue that the collaborative model is the most promising for covering most AI technology, while the public deliberation model is called for when the technology is recognized as fundamentally transforming the conditions for ethical shared decision-making. (shrink)

BackgroundOur human societies and certainly also (bio) medicine are more and more permeated with technology. There seems to be an increasing awareness among bioethicists that an effective and comprehensive approach to ethically guide these emerging biomedical innovations into society is needed. Such an approach has not been spelled out yet for bioethics, while there are frequent calls for ethical guidance of biomedical innovation, also by biomedical researchers themselves. New and emerging biotechnologies require anticipation of possible effects and implications, meaning the (...) scope is not evaluative after a technology has been fully developed or about hypothetical technologies, but real-time for a real biotechnology.Main textIn this paper we aim to substantiate and discuss six ingredients that we increasingly see adopted by ethicists and that together constitute “ethics parallel research”. This approach allows to fulfil two aims: guiding the development process of technologies in biomedicine and providing input for the normative evaluation of such technologies. The six ingredients of ethics parallel research are: (1) disentangling wicked problems, (2) upstream or midstream ethical analysis, (3) ethics from within, (4) inclusion of empirical research, (5) public participation and (6) mapping societal impacts, including hard and soft impacts. We will draw on gene editing, organoid technology and artificial intelligence as examples to illustrate these six ingredients.ConclusionEthics parallel research brings together these ingredients to ethically analyse and proactively or parallel guide technological development. It widens the roles and judgements from the ethicist to a more anticipatory and constructively guiding role. Ethics parallel research is characterised by a constructive, rather than a purely critical perspective, it focusses on developing best-practices rather than outlining worst practice, and draws on insights from social sciences and philosophy of technology. (shrink)

BackgroundHealthcare providers have to make ethically complex clinical decisions which may be a source of stress. Researchers have recently introduced Artificial Intelligence (AI)-based applications to assist in clinical ethical decision-making. However, the use of such tools is controversial. This review aims to provide a comprehensive overview of the reasons given in the academic literature for and against their use.MethodsPubMed, Web of Science, Philpapers.org and Google Scholar were searched for all relevant publications. The resulting set of publications was title and abstract (...) screened according to defined inclusion and exclusion criteria, resulting in 44 papers whose full texts were analysed using the Kuckartz method of qualitative text analysis.ResultsArtificial Intelligence might increase patient autonomy by improving the accuracy of predictions and allowing patients to receive their preferred treatment. It is thought to increase beneficence by providing reliable information, thereby, supporting surrogate decision-making. Some authors fear that reducing ethical decision-making to statistical correlations may limit autonomy. Others argue that AI may not be able to replicate the process of ethical deliberation because it lacks human characteristics. Concerns have been raised about issues of justice, as AI may replicate existing biases in the decision-making process.ConclusionsThe prospective benefits of using AI in clinical ethical decision-making are manifold, but its development and use should be undertaken carefully to avoid ethical pitfalls. Several issues that are central to the discussion of Clinical Decision Support Systems, such as justice, explicability or human–machine interaction, have been neglected in the debate on AI for clinical ethics so far.Trial registrationThis review is registered at Open Science Framework (https://osf.io/wvcs9). (shrink)

Healthcare provision, like many other sectors of society, is undergoing major changes due to the increased use of data-driven methods and technologies. This increased reliance on big data in medicine can lead to shifts in the norms that guide healthcare providers and patients. Continuous critical normative reflection is called for to track such potential changes. This article presents the results of an interview-based study with 20 German and Swiss experts from the fields of medicine, life science research, informatics and humanities (...) of digitalisation. The aim of the study was to explore expert opinions regarding current challenges and opportunities related to data-driven medicine and medical research and to provide a methodological framework for empirically grounded, continuous normative reflection. To this end, we developed a heuristic tool to map and structure empirical findings for normative analysis. Using this tool, our interview material points to a polarisation between individualistic and collectivistic orientated argumentations among experts. The study shows that a multilevel analysis is required to deal with complex normative implications of data-driven approaches in medical research and healthcare. (shrink)

BackgroundMachine learning-based clinical decision support systems (ML_CDSS) are increasingly employed in various sectors of health care aiming at supporting clinicians’ practice by matching the characteristics of individual patients with a computerised clinical knowledge base. Some studies even indicate that ML_CDSS may surpass physicians’ competencies regarding specific isolated tasks. From an ethical perspective, however, the usage of ML_CDSS in medical practice touches on a range of fundamental normative issues. This article aims to add to the ethical discussion by using professionalisation theory (...) as an analytical lens for investigating how medical action at the micro level and the physician–patient relationship might be affected by the employment of ML_CDSS.Main textProfessionalisation theory, as a distinct sociological framework, provides an elaborated account of what constitutes client-related professional action, such as medical action, at its core and why it is more than pure expertise-based action. Professionalisation theory is introduced by presenting five general structural features of professionalised medical practice: (i) the patient has a concern; (ii) the physician deals with the patient’s concern; (iii) s/he gives assistance without patronising; (iv) s/he regards the patient in a holistic manner without building up a private relationship; and (v) s/he applies her/his general expertise to the particularities of the individual case. Each of these five key aspects are then analysed regarding the usage of ML_CDSS, thereby integrating the perspectives of professionalisation theory and medical ethics.ConclusionsUsing ML_CDSS in medical practice requires the physician to pay special attention to those facts of the individual case that cannot be comprehensively considered by ML_CDSS, for example, the patient’s personality, life situation or cultural background. Moreover, the more routinized the use of ML_CDSS becomes in clinical practice, the more that physicians need to focus on the patient’s concern and strengthen patient autonomy, for instance, by adequately integrating digital decision support in shared decision-making. (shrink)

Providing healthcare services frequently involves cognitively demanding tasks, including diagnoses and analyses as well as complex decisions about treatments and therapy. From a global perspective, ethically significant inequalities exist between regions where the expert knowledge required for these tasks is scarce or abundant. One possible strategy to diminish such inequalities and increase healthcare opportunities in expert-scarce settings is to provide healthcare solutions involving digital technologies that do not necessarily require the presence of a human expert, e.g., in the form of (...) artificial intelligent decision-support systems (AI-DSS). Such algorithmic decision-making, however, is mostly developed in resource- and expert-abundant settings to support healthcare experts in their work. As a practical consequence, the normative standards and requirements for such algorithmic decision-making in healthcare require the technology to be at least as explainable as the decisions made by the experts themselves. The goal of providing healthcare in settings where resources and expertise are scarce might come with a normative pull to lower the normative standards of using digital technologies in order to provide at least some healthcare in the first place. We scrutinize this tendency to lower standards in particular settings from a normative perspective, distinguish between different types of absolute and relative, local and global standards of explainability, and conclude by defending an ambitious and practicable standard of local relative explainability. (shrink)

Artificial intelligence (AI) systems are increasingly being used in healthcare, thanks to the high level of performance that these systems have proven to deliver. So far, clinical applications have focused on diagnosis and on prediction of outcomes. It is less clear in what way AI can or should support complex clinical decisions that crucially depend on patient preferences. In this paper, we focus on the ethical questions arising from the design, development and deployment of AI systems to support decision-making around (...) cardiopulmonary resuscitation and the determination of a patient’s Do Not Attempt to Resuscitate status (also known as code status). The COVID-19 pandemic has made us keenly aware of the difficulties physicians encounter when they have to act quickly in stressful situations without knowing what their patient would have wanted. We discuss the results of an interview study conducted with healthcare professionals in a university hospital aimed at understanding the status quo of resuscitation decision processes while exploring a potential role for AI systems in decision-making around code status. Our data suggest that (1) current practices are fraught with challenges such as insufficient knowledge regarding patient preferences, time pressure and personal bias guiding care considerations and (2) there is considerable openness among clinicians to consider the use of AI-based decision support. We suggest a model for how AI can contribute to improve decision-making around resuscitation and propose a set of ethically relevant preconditions—conceptual, methodological and procedural—that need to be considered in further development and implementation efforts. (shrink)

Artificial intelligence-based clinical decision support systems have a potential to improve clinical practice, but they may have a negative impact on the physician-patient dialogue, because of the control problem. Physician-patient dialogue depends on human qualities such as compassion, trust, and empathy, which are shared by both parties. These qualities are necessary for the parties to reach a shared understanding -the merging of horizons- about clinical decisions. The patient attends the clinical encounter not only with a malfunctioning body, but also with (...) an ‘unhomelike’ experience of illness that is related to a world of values and meanings, a life-world. Making wise individual decisions in accordance with the patient’s life-world requires not only scientific analysis of causal relationships, but also listening with empathy to the patient’s concerns. For a decision to be made, clinical information should be interpreted considering the patient’s life-world. This side of clinical practice is not a job for computers, and they cannot be final decision-makers. On the other hand, in the control problem users blindly accept system output because of over-reliance, rather than evaluating it with their own judgement. This means over-reliant parties leave their place in the dialogue to the system. In this case, the dialogue may be disrupted and mutual trust may be lost. Therefore, it is necessary to design decision support systems to avoid the control problem and to limit their use when this is not possible, in order to protect the physician-patient dialogue. (shrink)

Machine learning-driven decision support systems (ML_CDSS) are poised for increasing presence and influence in clinical contexts. Salloch and Eriksen (2024) make two key arguments, that together bu...

Machine learning (ML) systems play an increasingly relevant role in medicine and healthcare. As their applications move ever closer to patient care and cure in clinical settings, ethical concerns about the responsibility of their use come to the fore. I analyse an aspect of responsible ML use that bears not only an ethical but also a significant epistemic dimension. I focus on ML systems’ role in mediating patient–physician relations. I thereby consider how ML systems may silence patients’ voices and relativise (...) the credibility of their opinions, which undermines their overall credibility status without valid moral and epistemic justification. More specifically, I argue that withholding credibilitydue tohow ML systems operate can be particularly harmful to patients and, apart from adverse outcomes, qualifies as a form of testimonial injustice. I make my case for testimonial injustice in medical ML by considering ML systems currently used in the USA to predict patients’ risk of misusing opioids (automated Prediction Drug Monitoring Programmes, PDMPs for short). I argue that the locus of testimonial injustice in ML-mediated medical encounters is found in the fact that these systems are treated asmarkers of trustworthinesson which patients’ credibility is assessed. I further show how ML-based PDMPs exacerbate and further propagate social inequalities at the expense of vulnerable social groups. (shrink)

In recent years, increasingly advanced artificial intelligence (AI), and in particular machine learning, has shown great promise as a tool in various healthcare contexts. Yet as machine learning in medicine has become more useful and more widely adopted, concerns have arisen about the “black-box” nature of some of these AI models, or the inability to understand—and explain—the inner workings of the technology. Some critics argue that AI algorithms must be explainable to be responsibly used in the clinical encounter, while supporters (...) of AI dismiss the importance of explainability and instead highlight the many benefits the application of this technology could have for medicine. However, this dichotomy fails to consider the particular ways in which machine learning technologies mediate relations in the clinical encounter, and in doing so, makes explainability more of a problem than it actually is. We argue that postphenomenology is a highly useful theoretical lens through which to examine black-box AI, because it helps us better understand the particular mediating effects this type of technology brings to clinical encounters and moves beyond the explainability stalemate. Using a postphenomenological approach, we argue that explainability is more of a concern for physicians than it is for patients, and that a lack of explainability does not introduce a novel concern to the physician–patient encounter. Explainability is just one feature of technological mediation and need not be the central concern on which the use of black-box AI hinges. (shrink)

Making good decisions in extremely complex and difficult processes and situations has always been both a key task as well as a challenge in the clinic and has led to a large amount of clinical, legal and ethical routines, protocols and reflections in order to guarantee fair, participatory and up-to-date pathways for clinical decision-making. Nevertheless, the complexity of processes and physical phenomena, time as well as economic constraints and not least further endeavours as well as achievements in medicine and healthcare (...) continuously raise the need to evaluate and to improve clinical decision-making. This article scrutinises if and how clinical decision-making processes are challenged by the rise of so-called artificial intelligence-driven decision support systems (AI-DSS). In a first step, this article analyses how the rise of AI-DSS will affect and transform the modes of interaction between different agents in the clinic. In a second step, we point out how these changing modes of interaction also imply shifts in the conditions of trustworthiness, epistemic challenges regarding transparency, the underlying normative concepts of agency and its embedding into concrete contexts of deployment and, finally, the consequences for (possible) ascriptions of responsibility. Third, we draw first conclusions for further steps regarding a ‘meaningful human control’ of clinical AI-DSS. (shrink)

Artificial intelligence-based (AI) technologies such as machine learning (ML) systems are playing an increasingly relevant role in medicine and healthcare, bringing about novel ethical and epistemological issues that need to be timely addressed. Even though ethical questions connected to epistemic concerns have been at the center of the debate, it is going unnoticed how epistemic forms of injustice can be ML-induced, specifically in healthcare. I analyze the shortcomings of an ML system currently deployed in the USA to predict patients’ likelihood (...) of opioid addiction and misuse (PDMP algorithmic platforms). Drawing on this analysis, I aim to show that the wrong inflicted on epistemic agents involved in and affected by these systems’ decision-making processes can be captured through the lenses of Miranda Fricker’s account of hermeneutical injustice. I further argue that ML-induced hermeneutical injustice is particularly harmful due to what I define as an automated hermeneutical appropriation from the side of the ML system. The latter occurs if the ML system establishes meanings and shared hermeneutical resources without allowing for human oversight, impairing understanding and communication practices among stakeholders involved in medical decision-making. Furthermore and very much crucially, an automated hermeneutical appropriation can be recognized if physicians are strongly limited in their possibilities to safeguard patients from ML-induced hermeneutical injustice. Overall, my paper should expand the analysis of ethical issues raised by ML systems that are to be considered epistemic in nature, thus contributing to bridging the gap between these two dimensions in the ongoing debate. (shrink)

Machine learning platforms have emerged as a new promissory technology that some argue will revolutionize work practices across a broad range of professions, including medical care. During the past few years, IBM has been testing its Watson for Oncology platform at several oncology departments around the world. Published reports, news stories, as well as our own empirical research show that in some cases, the levels of concordance over recommended treatment protocols between the platform and human oncologists have been quite low. (...) Other studies supported by IBM claim concordance rates as high as 96%. We use the Watson for Oncology case to examine the practice of using concordance levels between tumor boards and a machine learning decision-support system as a form of evidence. We address a challenge related to the epistemic authority between oncologists on tumor boards and the Watson Oncology platform by arguing that the use of concordance levels as a form of evidence of quality or trustworthiness is problematic. Although the platform provides links to the literature from which it draws its conclusion, it obfuscates the scoring criteria that it uses to value some studies over others. In other words, the platform “black boxes” the values that are coded into its scoring system. (shrink)

Within the ethical debate on Machine Learning-driven decision support systems (ML_CDSS), notions such as “human in the loop” or “meaningful human control” are often cited as being necessary for ethical legitimacy. In addition, ethical principles usually serve as the major point of reference in ethical guidance documents, stating that conflicts between principles need to be weighed and balanced against each other. Starting from a neo-Kantian viewpoint inspired by Onora O'Neill, this article makes a concrete suggestion of how to interpret the (...) role of the “human in the loop” and to overcome the perspective of rivaling ethical principles in the evaluation of AI in health care. We argue that patients should be perceived as “fellow workers” and epistemic partners in the interpretation of ML_CDSS outputs. We further highlight that a meaningful process of integrating (rather than weighing and balancing) ethical principles is most appropriate in the evaluation of medical AI. (shrink)

The increased presence of medical AI in clinical use raises the ethical question which standard of explainability is required for an acceptable and responsible implementation of AI-based applications in medical contexts. In this paper, we elaborate on the emerging debate surrounding the standards of explainability for medical AI. For this, we first distinguish several goods explainability is usually considered to contribute to the use of AI in general, and medical AI in specific. Second, we propose to understand the value of (...) explainability relative to other available norms of explainable decision-making. Third, in pointing out that we usually accept heuristics and uses of bounded rationality for medical decision-making by physicians, we argue that the explainability of medical decisions should not be measured against an idealized diagnostic process, but according to practical considerations. We conclude, fourth, to resolve the issue of explainability-standards by relocating the issue to the AI’s certifiability and interpretability. (shrink)

In this article, we explore questions about the culture of trustworthy artificial intelligence (AI) through the lens of ecosystems. We draw on the European Commission’s Guidelines for Trustworthy AI and its philosophical underpinnings. Based on the latter, the trustworthiness of an AI ecosystem can be conceived of as being grounded by both the so-called rational-choice and motivation-attributing accounts—i.e., trusting is rational because solution providers deliver expected services reliably, while trust also involves resigning control by attributing one’s motivation, and hence, goals, (...) onto another entity. Our research question is: What aspects contribute to a responsible AI ecosystem that can promote justifiable trustworthiness in a healthcare environment? We argue that especially within devising governance and support aspects of a medical AI ecosystem, considering the so-called motivation-attributing account of trust provides fruitful pointers. There can and should be specific ways and governance structures supporting and nurturing trustworthiness beyond mere reliability. After compiling a list of preliminary requirements for this, we describe the emergence of one particular medical AI ecosystem and assess its compliance with and future ways of improving its functioning as a responsible AI ecosystem that promotes trustworthiness. (shrink)

This paper develops an account of the opacity problem in medical machine learning (ML). Guided by pragmatist assumptions, I argue that opacity in ML models is problematic insofar as it potentially undermines the achievement of two key purposes: ensuring generalizability and optimizing clinician–machine decision-making. Three opacity amelioration strategies are examined, with explainable artificial intelligence (XAI) as the predominant approach, challenged by two revisionary strategies in the form of reliabilism and the interpretability by design. Comparing the three strategies, I argue that (...) interpretability by design is most promising to overcome opacity in medical ML. Looking beyond the individual opacity amelioration strategies, the paper also contributes to a deeper understanding of the problem space and the solution space regarding opacity in medical ML. (shrink)

In this article, I will argue in favor of both the ethical and epistemological utility of explanations in artificial intelligence -based medical technology. I will build on the notion of “explicability” due to Floridi, which considers both the intelligibility and accountability of AI systems to be important for truly delivering AI-powered services that strengthen autonomy, beneficence, and fairness. I maintain that explicable algorithms do, in fact, strengthen these ethical principles in medicine, e.g., in terms of direct patient–physician contact, as well (...) as on a longer-term epistemological level by facilitating scientific progress that is informed through practice. With this article, I will therefore attempt to counter arguments against demands for explicable AI in medicine that are based on a notion of “whatever heals is right.” I will elucidate my elaboration on the positive aspects of explicable AI in medicine as well as by pointing out risks of non-explicable AI. (shrink)

Artificial intelligence is currently changing many areas of society. Especially in health, where critical decisions are made, questions of control must be renegotiated: who is in control when an automated system makes clinically relevant decisions? Increasingly, the concept of meaningful human control (MHC) is being invoked for this purpose. However, it is unclear exactly how this concept is to be understood in health. Through a systematic review, we present the current state of the concept of MHC in health. The results (...) show that there is not yet a robust MHC concept for health. We propose a broader understanding of MHC along three strands of action: enabling, exercising and evaluating control. Taking into account these strands of action and the established rules and processes in the different health sectors, the MHC concept needs to be further developed to avoid falling into two gaps, which we have described as theoretical and labelling gaps. (shrink)

In contrast to Di Nucci’s characterisation, my argument is not a technoapocalyptic one. The view I put forward is that systems like IBM’s Watson for Oncology create both risks and opportunities from the perspective of shared decision-making. In this response, I address the issues that Di Nucci raises and highlight the importance of bioethicists engaging critically with these developing technologies.