The widespread adoption of digital technologies raises important ethical issues in health care and public health. In our view, understanding these ethical issues demands a perspective that looks beyond the technology itself to include the sociotechnical system in which it is situated. In this sense, a sociotechnical system refers to the broader collection of material devices, interpersonal relationships, organizational policies, corporate contracts, and government regulations that shape the ways in which digital health technologies are adopted and used. Bioethical approaches to the assessment of digital health technologies are typically confined to ethical issues raised by features of the technology itself. We suggest that an ethical perspective confined to functions of the technology is insufficient to assess the broader impact of the adoption of technologies on the care environment and the broader health-related ecosystem of which it is a part. In this paper we review existing approaches to the bioethics of digital health, and draw on concepts from design ethics and science & technology studies (STS) to critique a narrow view of the bioethics of digital health. We then describe the sociotechnical system produced by digital health technologies when adopted in health care environments, and outline the various considerations that demand attention for a comprehensive ethical analysis of digital health technologies in this broad perspective. We conclude by outlining the importance of social justice for ethical analysis from a sociotechnical perspective.

Applications of artificial intelligence/machine learning (AI/ML) in health care are dynamic and rapidly growing. One strategy for anticipating and addressing ethical challenges related to AI/ML for health care is patient and public involvement in the design of those technologies – often referred to as ‘co-design’. Co-design has a diverse intellectual and practical history, however, and has been conceptualized in many different ways. Moreover, AI/ML introduces challenges to co-design that are often underappreciated. Informed by perspectives from critical data studies and critical digital health studies, we review the research literature on involvement in health care, and involvement in design, and examine the extent to which co-design as commonly conceptualized is capable of addressing the range of normative issues raised by AI/ML for health care. We suggest that AI/ML technologies have amplified and modified existing challenges related to patient and public involvement, and created entirely new challenges. We outline three pitfalls associated with co-design for ethical AI/ML for health care and conclude with suggestions for addressing these practical and conceptual challenges.

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A variety of approaches have appeared in academic literature and in design practice representing “ethics-first” methods. These approaches typically focus on clarifying the normative dimensions of design, or outlining strategies for explicitly incorporating values into design. While this body of literature has developed considerably over the last 20 years, two themes central to the endeavour of ethics and values in design (E + VID) have yet to be systematically discussed in relation to each other: (a) designer agency, and (b) the strength of normative claims informing the design process. To address this gap, we undertook a structured review of leading E + VID approaches and critiques, and classified them according to their positions on normative strength, and views regarding designer agency. We identified 18 distinct approaches and 13 critiques that met the inclusion criteria for our review. Included papers were distributed across the spectrum of views regarding normative strength, and we found that no approaches and only one critique represented a view characteristic of “low” designer agency. We suggest that the absence of “low” designer agency approaches results in the neglect of crucial influences on design as targets of intervention by designers. We conclude with suggestions for future research that might illuminate strategies to achieve ethical design in information mature societies, and argue that without attending to the tensions raised by balancing normatively “strong” visions of the future with limitations imposed on designer agency in corporate-driven design settings, “meaningful” ethical design will continue to encounter challenges in practice.