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)

The contention that medical artificial intelligence (AI) should be ‘explainable’ is widespread in contemporary philosophy and in legal and best practice documents. Yet critics argue that ‘explainability’ is not a stable concept; non-explainable AI is often more accurate; mechanisms intended to improve explainability do not improve understanding and introduce new epistemic concerns; and explainability requirements are ad hoc where human medical decision-making is often opaque. A recent ‘political response’ to these issues contends that AI used in high-stakes scenarios, including medical (...) AI, must be explainable to meet basic standards of legitimacy: People are owed reasons for decisions that impact their vital interests, and this requires explainable AI. This article demonstrates why the political response fails. Attending to systemic considerations, as its proponents desire, suggests that the political response is subject to the same criticisms as other arguments for explainable AI and presents new issues. It also suggests that decision-making about non-explainable medical AI can meet public reason standards. The most plausible version of the response amounts to a simple claim that public reason demands reasons why AI is permitted. But that does not actually support explainable AI or respond to criticisms of strong requirements for explainable medical AI. (shrink)

Medical artificial intelligence (AI) is considered to be one of the most important assets for the future of innovative individual and public health care. To develop innovative medical AI, it is necessary to repurpose data that are primarily generated in and for the health care context. Usually, health data can only be put to a secondary use if data subjects provide their informed consent (IC). This regulation, however, is believed to slow down or even prevent vital medical research, including AI (...) development. For this reason, a number of scholars advocate a moral civic duty to share electronic health records (EHRs) that overrides IC requirements in certain contexts. In the medical AI context, the common arguments for such a duty have not been subjected to a comprehensive challenge. This article sheds light on the correlation between two normative discourses concerning informed consent for secondary health record use and the development and use of medical AI. There are three main arguments in favour of a civic duty to support certain developments in medical AI by sharing EHRs: the ‘rule to rescue argument’, the ‘low risks, high benefits argument’, and the ‘property rights argument’. This article critiques all three arguments because they either derive a civic duty from premises that do not apply to the medical AI context, or they rely on inappropriate analogies, or they ignore significant risks entailed by the EHR sharing process and the use of medical AI. Given this result, the article proposes an alternative civic responsibility approach that can attribute different responsibilities to different social groups and individuals and that can contextualise those responsibilities for the purpose of medical AI development. (shrink)

Artificial intelligence increasingly executes tasks that previously only humans could do, such as drive a car, fight in war, or perform a medical operation. However, as the very best AI systems tend to be the least controllable and the least transparent, some scholars argued that humans can no longer be morally responsible for some of the AI-caused outcomes, which would then result in a responsibility gap. In this paper, I assume, for the sake of argument, that at least some of (...) the most sophisticated AI systems do indeed create responsibility gaps, and I ask whether we can bridge these gaps at will, viz. whether certain people could take responsibility for AI-caused harm simply by performing a certain speech act, just as people can give permission for something simply by performing the act of consent. So understood, taking responsibility would be a genuine normative power. I first discuss and reject the view of Champagne and Tonkens, who advocate a view of taking liability. According to this view, a military commander can and must, ahead of time, accept liability to blame and punishment for any harm caused by autonomous weapon systems under her command. I then defend my own proposal of taking answerability, viz. the view that people can makes themselves morally answerable for the harm caused by AI systems, not only ahead of time but also when harm has already been caused. (shrink)

The impact of machine learning in healthcare on patient informed consent is now the subject of significant inquiry in bioethics. However, the topic has predominantly been considered in the context of black box diagnostic or treatment recommendation algorithms. The impact of machine learning involved in healthcare resource allocation on patient consent remains undertheorized. This paper will establish where patient consent is relevant in healthcare resource allocation, before exploring the impact on informed consent from the introduction of black box machine learning (...) into resource allocation. It will then consider the arguments for informing patients about the use of machine learning in resource allocation, before exploring the challenge of whether individual patients could principally contest algorithmic prioritization decisions involving black box machine learning. Finally, this paper will examine how different forms of opacity in machine learning involved in resource allocation could be a barrier to patient consent to clinical decision-making in different healthcare contexts. (shrink)

Background Despite continuous performance improvements, especially in clinical contexts, a major challenge of Artificial Intelligence based Decision Support Systems (AI-DSS) remains their degree of epistemic opacity. The conditions of and the solutions for the justified use of the occasionally unexplainable technology in healthcare are an active field of research. In March 2024, the European Union agreed upon the Artificial Intelligence Act (AIA), requiring medical AI-DSS to be ad-hoc explainable or to use post-hoc explainability methods. The ethical debate does not seem (...) to settle on this requirement yet. This systematic review aims to outline and categorize the positions and arguments in the ethical debate. Methods We conducted a literature search on PubMed, BASE, and Scopus for English-speaking scientific peer-reviewed publications from 2016 to 2024. The inclusion criterion was to give explicit requirements of explainability for AI-DSS in healthcare and reason for it. Non-domain-specific documents, as well as surveys, reviews, and meta-analyses were excluded. The ethical requirements for explainability outlined in the documents were qualitatively analyzed with respect to arguments for the requirement of explainability and the required level of explainability. Results The literature search resulted in 1662 documents; 44 documents were included in the review after eligibility screening of the remaining full texts. Our analysis showed that 17 records argue in favor of the requirement of explainable AI methods (xAI) or ad-hoc explainable models, providing 9 categories of arguments. The other 27 records argued against a general requirement, providing 11 categories of arguments. Also, we found that 14 works advocate the need for context-dependent levels of explainability, as opposed to 30 documents, arguing for context-independent, absolute standards. Conclusions The systematic review of reasons shows no clear agreement on the requirement of post-hoc explainability methods or ad-hoc explainable models for AI-DSS in healthcare. The arguments found in the debate were referenced and responded to from different perspectives, demonstrating an interactive discourse. Policymakers and researchers should watch the development of the debate closely. Conversely, ethicists should be well informed by empirical and technical research, given the frequency of advancements in the field. (shrink)

Developments in Machine Learning (ML) have attracted attention in a wide range of healthcare fields to improve medical practice and the benefit of patients. Particularly, this should be achieved by providing more or less automated decision recommendations to the treating physician. However, some hopes placed in ML for healthcare seem to be disappointed, at least in part, by a lack of transparency or traceability. Skepticism exists primarily in the fact that the physician, as the person responsible for diagnosis, therapy, and (...) care, has no or insufficient insight into how such recommendations are reached. The following paper aims to make understandable the specificity of the deliberative model of a physician-patient relationship that has been achieved over decades. By outlining the (social-)epistemic and inherently normative relationship between physicians and patients, I want to show how this relationship might be altered by non-traceable ML recommendations. With respect to some healthcare decisions, such changes in deliberative practice may create normatively far-reaching challenges. Therefore, in the future, a differentiation of decision-making situations in healthcare with respect to the necessary depth of insight into the process of outcome generation seems essential. (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)

In recent years, there has been a surge of high-profile publications on applications of artificial intelligence (AI) systems for medical diagnosis and prognosis. While AI provides various opportunities for medical practice, there is an emerging consensus that the existing studies show considerable deficits and are unable to establish the clinical benefit of AI systems. Hence, the view that the clinical benefit of AI systems needs to be studied in clinical trials—particularly randomised controlled trials (RCTs)—is gaining ground. However, an issue that (...) has been overlooked so far in the debate is that, compared with drug RCTs, AI RCTs require methodological adjustments, which entail ethical challenges. This paper sets out to develop a systematic account of the ethics of AI RCTs by focusing on the moral principles of clinical equipoise, informed consent and fairness. This way, the objective is to animate further debate on the (research) ethics of medical AI. (shrink)