The difficulty of explaining the outputs of artificial intelligence (AI) models and what has led to them is a notorious ethical problem wherever these technologies are applied, including in the medical domain, and one that has no obvious solution. This paper examines the proposal, made by Luciano Floridi and colleagues, to include a new ‘principle of explicability’ alongside the traditional four principles of bioethics that make up the theory of ‘principlism’. It specifically responds to a recent set of criticisms that (...) challenge the supposed need for such a principle to perform an enabling role in relation to the traditional four principles and therefore suggest that these four are sufficient without the addition of explicability. The paper challenges the critics’ premise that explicability cannot be an ethical principle like the classic four because it is explicitly subordinate to them. It argues instead that principlism in its original formulation locates the justification for ethical principles in a midlevel position such that they mediate between the most general moral norms and the contextual requirements of medicine. This conception of an ethical principle then provides a mold for an approach to explicability on which it functions as an enabling principle that unifies technical/epistemic demands on AI and the requirements of high-level ethical theories. The paper finishes by anticipating an objection that decision-making by clinicians and AI fall equally, but implausibly, under the principle of explicability’s scope, which it rejects on the grounds that human decisions, unlike AI’s, can be explained by their social environments. (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)

Background Artificial intelligence-driven Clinical Decision Support Systems (AI-CDSS) are being increasingly introduced into various domains of health care for diagnostic, prognostic, therapeutic and other purposes. A significant part of the discourse on ethically appropriate conditions relate to the levels of understanding and explicability needed for ensuring responsible clinical decision-making when using AI-CDSS. Empirical evidence on stakeholders’ viewpoints on these issues is scarce so far. The present study complements the empirical-ethical body of research by, on the one hand, investigating the requirements (...) for understanding and explicability in depth with regard to the rationale behind them. On the other hand, it surveys medical students at the end of their studies as stakeholders, of whom little data is available so far, but for whom AI-CDSS will be an important part of their medical practice. Methods Fifteen semi-structured qualitative interviews (each lasting an average of 56 min) were conducted with German medical students to investigate their perspectives and attitudes on the use of AI-CDSS. The problem-centred interviews draw on two hypothetical case vignettes of AI-CDSS employed in nephrology and surgery. Interviewees’ perceptions and convictions of their own clinical role and responsibilities in dealing with AI-CDSS were elicited as well as viewpoints on explicability as well as the necessary level of understanding and competencies needed on the clinicians’ side. The qualitative data were analysed according to key principles of qualitative content analysis (Kuckartz). Results In response to the central question about the necessary understanding of AI-CDSS tools and the emergence of their outputs as well as the reasons for the requirements placed on them, two types of argumentation could be differentiated inductively from the interviewees’ statements: the first type, the clinician as a systemic trustee (or “the one relying”), highlights that there needs to be empirical evidence and adequate approval processes that guarantee minimised harm and a clinical benefit from the employment of an AI-CDSS. Based on proof of these requirements, the use of an AI-CDSS would be appropriate, as according to “the one relying”, clinicians should choose those measures that statistically cause the least harm. The second type, the clinician as an individual expert (or “the one controlling”), sets higher prerequisites that go beyond ensuring empirical evidence and adequate approval processes. These higher prerequisites relate to the clinician’s necessary level of competence and understanding of how a specific AI-CDSS works and how to use it properly in order to evaluate its outputs and to mitigate potential risks for the individual patient. Both types are unified in their high esteem of evidence-based clinical practice and the need to communicate with the patient on the use of medical AI. However, the interviewees’ different conceptions of the clinician’s role and responsibilities cause them to have different requirements regarding the clinician’s understanding and explicability of an AI-CDSS beyond the proof of benefit. Conclusions The study results highlight two different types among (future) clinicians regarding their view of the necessary levels of understanding and competence. These findings should inform the debate on appropriate training programmes and professional standards (e.g. clinical practice guidelines) that enable the safe and effective clinical employment of AI-CDSS in various clinical fields. While current approaches search for appropriate minimum requirements of the necessary understanding and competence, the differences between (future) clinicians in terms of their information and understanding needs described here can lead to more differentiated approaches to solutions. (shrink)

With regard to current debates on the ethical implementation of AI, especially two demands are linked: the call for explainability and for ultimate human responsibility. In the medical field, both are condensed into the role of one person: It is the physician to whom AI output should be explainable and who should thus bear ultimate responsibility for diagnostic or treatment decisions that are based on such AI output. In this article, we argue that a black box AI indeed creates a (...) rationally irresolvable epistemic situation for the physician involved. Specifically, strange errors that are occasionally made by AI sometimes detach its output from human reasoning. Within this article it is further argued that such an epistemic situation is problematic in the context of ultimate human responsibility. Since said strange errors limit the promises of explainability and the concept of explainability frequently appears irrelevant or insignificant when applied to a diverse set of medical applications, we deem it worthwhile to reconsider the call for ultimate human responsibility. (shrink)

Intelligibility and interpretability related to artificial intelligence (AI) are crucial for enabling explicability, which is vital for establishing constructive communication and agreement among various stakeholders, including users and designers of AI. It is essential to overcome the challenges of sharing an understanding of the details of the various structures of diverse AI systems, to facilitate effective communication and collaboration. In this paper, we propose four fundamental terms: “I/O,” “Constraints,” “Objectives,” and “Architecture.” These terms help mitigate the challenges associated with intelligibility (...) and interpretability in AI by providing appropriate levels of abstraction to describe structure of AI systems generally, thereby facilitating the sharing of understanding among various stakeholders. The relationship between the Objective of AI designers and the Purpose of AI users is linked to the issues of AI alignment. (shrink)

Definition of the problem In medicine, as well as in other disciplines, computer science expertise is becoming increasingly important. This requires a culture of interdisciplinary assessment, for which medical ethics committees are not well prepared. The use of big data and artificial intelligence (AI) methods (whether developed in-house or in the form of “tools”) pose further challenges for research ethics reviews. Arguments This paper describes the problems and suggests solving them through procedural changes. Conclusion An assessment that is interdisciplinary from (...) the outset appears to be more suitable than having two commissions with different expertise. However, this would require that the composition of medical ethics committees be altered. In addition, the article recommends initial measures to be taken during research ethics reviews of big data and AI projects in order to consolidate the review process and ensure standardization of the criteria. (shrink)

Background Artificial intelligence (AI) has revolutionized various healthcare domains, where AI algorithms sometimes even outperform human specialists. However, the field of clinical ethics has remained largely untouched by AI advances. This study explores the attitudes of anesthesiologists and internists towards the use of AI-driven preference prediction tools to support ethical decision-making for incapacitated patients. Methods A questionnaire was developed and pretested among medical students. The questionnaire was distributed to 200 German anesthesiologists and 200 German internists, thereby focusing on physicians who (...) often encounter patients lacking decision-making capacity. The questionnaire covered attitudes toward AI-driven preference prediction, availability and utilization of Clinical Ethics Support Services (CESS), and experiences with ethically challenging situations. Descriptive statistics and bivariate analysis was performed. Qualitative responses were analyzed using content analysis in a mixed inductive-deductive approach. Results Participants were predominantly male (69.3%), with ages ranging from 27 to 77. Most worked in nonacademic hospitals (82%). Physicians generally showed hesitance toward AI-driven preference prediction, citing concerns about the loss of individuality and humanity, lack of explicability in AI results, and doubts about AI’s ability to encompass the ethical deliberation process. In contrast, physicians had a more positive opinion of CESS. Availability of CESS varied, with 81.8% of participants reporting access. Among those without access, 91.8% expressed a desire for CESS. Physicians' reluctance toward AI-driven preference prediction aligns with concerns about transparency, individuality, and human-machine interaction. While AI could enhance the accuracy of predictions and reduce surrogate burden, concerns about potential biases, de-humanisation, and lack of explicability persist. Conclusions German physicians frequently encountering incapacitated patients exhibit hesitance toward AI-driven preference prediction but hold a higher esteem for CESS. Addressing concerns about individuality, explicability, and human-machine roles may facilitate the acceptance of AI in clinical ethics. Further research into patient and surrogate perspectives is needed to ensure AI aligns with patient preferences and values in complex medical decisions. (shrink)