Purpose: The method of diagnosing diabetic retinopathy (DR) through artificial intelligence (AI)-based systems has been commercially available since 2018. This introduces new ethical challenges with regard to obtaining informed consent from patients. The purpose of this work is to develop a checklist of items to be disclosed when diagnosing DR with AI systems in a primary care setting. -/- Methods: Two systematic literature searches were conducted in PubMed and Web of Science databases: a narrow search focusing on DR and a (...) broad search on general issues of AI-based diagnosis. An ethics content analysis was conducted inductively to extract two features of included publications: (1) novel information content for AI-aided diagnosis and (2) the ethical justification for its disclosure. -/- Results: The narrow search yielded n = 537 records of which n = 4 met the inclusion criteria. The information process was scarcely addressed for primary care setting. The broad search yielded n = 60 records of which n = 11 were included. In total, eight novel elements were identified to be included in the information process for ethical reasons, all of which stem from the technical specifics of medical AI. -/- Conclusions: Implications for the general practitioner are two-fold: First, doctors need to be better informed about the ethical implications of novel technologies and must understand them to properly inform patients. Second, patient's overconfidence or fears can be countered by communicating the risks, limitations, and potential benefits of diagnostic AI systems. If patients accept and are aware of the limitations of AI-aided diagnosis, they increase their chances of being diagnosed and treated in time. (shrink)

Artificial intelligence (AI) systems have demonstrated impressive performance across a variety of clinical tasks. However, notoriously, sometimes these systems are 'black boxes'. The initial response in the literature was a demand for 'explainable AI'. However, recently, several authors have suggested that making AI more explainable or 'interpretable' is likely to be at the cost of the accuracy of these systems and that prioritising interpretability in medical AI may constitute a 'lethal prejudice'. In this paper, we defend the value of interpretability (...) in the context of the use of AI in medicine. Clinicians may prefer interpretable systems over more accurate black boxes, which in turn is sufficient to give designers of AI reason to prefer more interpretable systems in order to ensure that AI is adopted and its benefits realised. Moreover, clinicians may be justified in this preference. Achieving the downstream benefits from AI is critically dependent on how the outputs of these systems are interpreted by physicians and patients. A preference for the use of highly accurate black box AI systems, over less accurate but more interpretable systems , may itself constitute a form of lethal prejudice that may diminish the benefits of AI to - and perhaps even harm - patients. (shrink)

The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...

Should decision-making algorithms be held to higher standards of transparency than human beings? The way we answer this question directly impacts what we demand from explainable algorithms, how we govern them via regulatory proposals, and how explainable algorithms may help resolve the social problems associated with decision making supported by artificial intelligence. Some argue that algorithms and humans should be held to the same standards of transparency and that a double standard of transparency is hardly justified. We give two arguments (...) to the contrary and specify two kinds of situations for which higher standards of transparency are required from algorithmic decisions as compared to humans. Our arguments have direct implications on the demands from explainable algorithms in decision-making contexts such as automated transportation. (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 rapid adoption and implementation of artificial intelligence in medicine creates an ontologically distinct situation from prior care models. There are both potential advantages and disadvantages with such technology in advancing the interests of patients, with resultant ontological and epistemic concerns for physicians and patients relating to the instatiation of AI as a dependent, semi- or fully-autonomous agent in the encounter. The concept of libertarian paternalism potentially exercised by AI (and those who control it) has created challenges to conventional assessments (...) of patient and physician autonomy. The unclear legal relationship between AI and its users cannot be settled presently, an progress in AI and its implementation in patient care will necessitate an iterative discourse to preserve humanitarian concerns in future models of care. This paper proposes that physicians should neither uncritically accept nor unreasonably resist developments in AI but must actively engage and contribute to the discourse, since AI will affect their roles and the nature of their work. One’s moral imaginative capacity must be engaged in the questions of beneficence, autonomy, and justice of AI and whether its integration in healthcare has the potential to augment or interfere with the ends of medical practice. (shrink)

Artificial intelligence (AI) is expected to revolutionise the practice of medicine. Recent advancements in the field of deep learning have demonstrated success in variety of clinical tasks: detecting diabetic retinopathy from images, predicting hospital readmissions, aiding in the discovery of new drugs, etc. AI’s progress in medicine, however, has led to concerns regarding the potential effects of this technology on relationships of trust in clinical practice. In this paper, I will argue that there is merit to these concerns, since AI (...) systems can be relied on, and are capable of reliability, but cannot be trusted, and are not capable of trustworthiness. Insofar as patients are required to rely on AI systems for their medical decision-making, there is potential for this to produce a deficit of trust in relationships in clinical practice. (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)

We are sceptical of concerns over the opacity of algorithmic decision tools. While transparency and explainability are certainly important desiderata in algorithmic governance, we worry that automated decision-making is being held to an unrealistically high standard, possibly owing to an unrealistically high estimate of the degree of transparency attainable from human decision-makers. In this paper, we review evidence demonstrating that much human decision-making is fraught with transparency problems, show in what respects AI fares little worse or better and argue that (...) at least some regulatory proposals for explainable AI could end up setting the bar higher than is necessary or indeed helpful. The demands of practical reason require the justification of action to be pitched at the level of practical reason. Decision tools that support or supplant practical reasoning should not be expected to aim higher than this. We cast this desideratum in terms of Daniel Dennett’s theory of the “intentional stance” and argue that since the justification of action for human purposes takes the form of intentional stance explanation, the justification of algorithmic decisions should take the same form. In practice, this means that the sorts of explanations for algorithmic decisions that are analogous to intentional stance explanations should be preferred over ones that aim at the architectural innards of a decision tool. (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)

Artificial intelligence is increasingly being developed for use in medicine, including for diagnosis and in treatment decision making. The use of AI in medical treatment raises many ethical issues that are yet to be explored in depth by bioethicists. In this paper, I focus specifically on the relationship between the ethical ideal of shared decision making and AI systems that generate treatment recommendations, using the example of IBM’s Watson for Oncology. I argue that use of this type of system creates (...) both important risks and significant opportunities for promoting shared decision making. If value judgements are fixed and covert in AI systems, then we risk a shift back to more paternalistic medical care. However, if designed and used in an ethically informed way, AI could offer a potentially powerful way of supporting shared decision making. It could be used to incorporate explicit value reflection, promoting patient autonomy. In the context of medical treatment, we need value-flexible AI that can both respond to the values and treatment goals of individual patients and support clinicians to engage in shared decision making. (shrink)

Implicit biases involve associations outside conscious awareness that lead to a negative evaluation of a person on the basis of irrelevant characteristics such as race or gender. This review examines the evidence that healthcare professionals display implicit biases towards patients. PubMed, PsychINFO, PsychARTICLE and CINAHL were searched for peer-reviewed articles published between 1st March 2003 and 31st March 2013. Two reviewers assessed the eligibility of the identified papers based on precise content and quality criteria. The references of eligible papers were (...) examined to identify further eligible studies. Forty two articles were identified as eligible. Seventeen used an implicit measure, to test the biases of healthcare professionals. Twenty five articles employed a between-subjects design, using vignettes to examine the influence of patient characteristics on healthcare professionals’ attitudes, diagnoses, and treatment decisions. The second method was included although it does not isolate implicit attitudes because it is recognised by psychologists who specialise in implicit cognition as a way of detecting the possible presence of implicit bias. Twenty seven studies examined racial/ethnic biases; ten other biases were investigated, including gender, age and weight. Thirty five articles found evidence of implicit bias in healthcare professionals; all the studies that investigated correlations found a significant positive relationship between level of implicit bias and lower quality of care. The evidence indicates that healthcare professionals exhibit the same levels of implicit bias as the wider population. The interactions between multiple patient characteristics and between healthcare professional and patient characteristics reveal the complexity of the phenomenon of implicit bias and its influence on clinician-patient interaction. The most convincing studies from our review are those that combine the IAT and a method measuring the quality of treatment in the actual world. Correlational evidence indicates that biases are likely to influence diagnosis and treatment decisions and levels of care in some circumstances and need to be further investigated. Our review also indicates that there may sometimes be a gap between the norm of impartiality and the extent to which it is embraced by healthcare professionals for some of the tested characteristics. Our findings highlight the need for the healthcare profession to address the role of implicit biases in disparities in healthcare. More research in actual care settings and a greater homogeneity in methods employed to test implicit biases in healthcare is needed. (shrink)

A novel advantage of the use of machine learning (ML) systems in medicine is their potential to continue learning from new data after implementation in clinical practice. To date, considerations of the ethical questions raised by the design and use of adaptive machine learning systems in medicine have, for the most part, been confined to discussion of the so-called “update problem,” which concerns how regulators should approach systems whose performance and parameters continue to change even after they have received regulatory (...) approval. In this paper, we draw attention to a prior ethical question: whether the continuous learning that will occur in such systems after their initial deployment should be classified, and regulated, as medical research? We argue that there is a strong prima facie case that the use of continuous learning in medical ML systems should be categorized, and regulated, as research and that individuals whose treatment involves such systems should be treated as research subjects. (shrink)

This paper focuses on the use of ‘black box’ AI in medicine and asks whether the physician needs to disclose to patients that even the best AI comes with the risks of cyberattacks, systematic bias, and a particular type of mismatch between AI’s implicit assumptions and an individual patient’s background situation.Pacecurrent clinical practice, I argue that, under certain circumstances, these risks do need to be disclosed. Otherwise, the physician either vitiates a patient’s informed consent or violates a more general obligation (...) to warn him about potentially harmful consequences. To support this view, I argue, first, that the already widely accepted conditions in the evaluation of risks, i.e. the ‘nature’ and ‘likelihood’ of risks, speak in favour of disclosure and, second, that principled objections against the disclosure of these risks do not withstand scrutiny. Moreover, I also explain that these risks are exacerbated by pandemics like the COVID-19 crisis, which further emphasises their significance. (shrink)

This paper inquiries into the complex issue of informed consent applying artificial intelligence in medical diagnostic consultations. The aim is to expose the main ethical and legal concerns of the New Health phenomenon, powered by intelligent machines. To achieve this objective, the first part of the paper analyzes ethical aspects of the alleged right to explanation, privacy, and informed consent, applying artificial intelligence in medical diagnostic consultations. This analysis is followed by a legal analysis of the limits and requirements for (...) the explainability of artificial intelligence. Followed by this analysis, recommendations for action are given in the concluding remarks of the paper. (shrink)

The escalating integration of Artificial Intelligence (AI) in clinical settings carries profound implications for the doctrine of informed consent, presenting challenges that necessitate immediate attention. China, in its advancement in the deployment of medical AI, is proactively engaging in the formulation of legal and ethical regulations. This paper takes China as an example to undertake a theoretical examination rooted in the principles of medical ethics and legal norms, analyzing informed consent and medical AI through relevant literature data. The study reveals (...) that medical AI poses fundamental challenges to the accuracy, adequacy, and objectivity of information disclosed by doctors, alongside impacting patient competency and willingness to give consent. To enhance adherence to informed consent rules in the context of medical AI, this paper advocates for a shift towards a patient‐centric information disclosure standard, the restructuring of medical liability rules, the augmentation of professional training, and the advancement of public understanding through educational initiatives. (shrink)

In an analysis of artificially intelligent systems for medical diagnostics and treatment planning we argue that patients should be able to exercise a right to withdraw from AI diagnostics and treatment planning for reasons related to (1) the physician’s role in the patients’ formation of and acting on personal preferences and values, (2) the bias and opacity problem of AI systems, and (3) rational concerns about the future societal effects of introducing AI systems in the health care sector.

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)

Bioethics, Volume 36, Issue 2, Page 162-169, February 2022.

When is it justified to use opaque artificial intelligence (AI) output in medical decision-making? Consideration of this question is of central importance for the responsible use of opaque machine learning (ML) models, which have been shown to produce accurate and reliable diagnoses, prognoses, and treatment suggestions in medicine. In this article, I discuss the merits of two answers to the question. According to the Explanation View, clinicians must have access to an explanation of why an output was produced. According to (...) the Validation View, it is sufficient that the AI system has been validated using established standards for safety and reliability. I defend the Explanation View against two lines of criticism, and I argue that within the framework of evidence-based medicine mere validation seems insufficient for the use of AI output. I end by characterizing the epistemic responsibility of clinicians and point out how a mere AI output cannot in itself ground a practical conclusion about what to do. (shrink)

In light of recent advances in machine learning for medical applications, the automation of medical diagnostics is imminent. That said, before machine learning algorithms find their way into clinical practice, various problems at the epistemic level need to be overcome. In this paper, we discuss different sources of uncertainty arising for clinicians trying to evaluate the trustworthiness of algorithmic evidence when making diagnostic judgments. Thereby, we examine many of the limitations of current machine learning algorithms (with deep learning in particular) (...) and highlight their relevance for medical diagnostics. Among the problems we inspect are the theoretical foundations of deep learning (which are not yet adequately understood), the opacity of algorithmic decisions, and the vulnerabilities of machine learning models, as well as concerns regarding the quality of medical data used to train the models. Building on this, we discuss different desiderata for an uncertainty amelioration strategy that ensures that the integration of machine learning into clinical settings proves to be medically beneficial in a meaningful way. (shrink)

Bioethics, Volume 36, Issue 2, Page 134-142, February 2022.

The term robustness is ubiquitous in modern Machine Learning (ML). However, its meaning varies depending on context and community. Researchers either focus on narrow technical definitions, such as adversarial robustness, natural distribution shifts, and performativity, or they simply leave open what exactly they mean by robustness. In this paper, we provide a conceptual analysis of the term robustness, with the aim to develop a common language, that allows us to weave together different strands of robustness research. We define robustness as (...) the relative stability of a robustness target with respect to specific interventions on a modifier. Our account captures the various sub-types of robustness that are discussed in the research literature, including robustness to distribution shifts, prediction robustness, or the robustness of algorithmic explanations. Finally, we delineate robustness from adjacent key concepts in ML, such as extrapolation, generalization, and uncertainty, and establish it as an independent epistemic concept. (shrink)

Char et al. aspire to provide “a systematic approach to identifying … ethical concerns” around machine learning healthcare applications, which includes artificial intelligence and...