Health innovation is mainly envisioned in direct connection to medical research institutions or pharmaceutical and technology companies. Yet, these types of innovation often do not meet the needs and expectations of individuals affected by health conditions. With the emergence of digital health technologies and social media, we can observe a shift, which involves people living with illness modifying and improving medical and health devices outside of the formal research and development sector, figuring both as users and innovators. This patient-led innovation has been celebrated in innovation studies and economics as a "bottom-up" type of innovation. In this article, we take a closer look at open-source patient-led innovation in the context of type 1 diabetes care. In our inquiry, we pay particular attention to the social and ethical dimensions of this innovation, building on empirical material. Upon exploring the notion of patient-led innovation and its socio-political context through the lens of intersectional and global health justice, we argue that a proactive strategy is needed to ensure that open-source patient-led innovation will be more globally accessible, center the health needs of the most underserved populations, as well as facilitate equitable and just health benefits. To support this aim, we provide a range of examples of different initiatives addressing the persistent inequalities that have so far inhibited patient-led innovation from more fully materializing its innovative potential.

Vaccine mandates can take many forms, and different kinds of mandates can implicate an array of values in diverse ways. It follows that good ethics arguments about particular vaccine mandates will attend to the details of individual policies. Furthermore, attention to particular mandate policies-and to attributes of the communities they aim to govern-can also illuminate which ethics arguments may be more salient in particular contexts. If ethicists want their arguments to make a difference in policy, they should attend to these kinds of empirical considerations. This paper focuses on the most common and contentious vaccine mandate reform in the contemporary United States: the elimination of nonmedical exemptions (NMEs) to school and daycare vaccine mandates. It highlights, in particular, debates about California's Senate Bill 277 (SB277), which was the first successful recent effort to eliminate NMEs in that country. We use media, secondary sources, and original interviews with policymakers and activists to identify and evaluate three ethics arguments offered by critics of SB277: parental freedom, informed consent, and children's rights to care and education. We then turn to one ethics argument often offered by advocates of SB277: harm prevention. We note, however, that three arguments for mandates that are common in the immunization ethics literature-fairness/free-riding, children's rights to vaccination, and utilitarianism-did not play a role in debates about SB277.

A number of authors criticise opt-out (or 'deemed consent') systems for failing to secure valid consent to organ donation. Further, several suggest that mandated choice offers a more ethical alternative. This article responds to criticisms that opt-out does not secure informed consent. If we assume current (low) levels of public awareness, then the explicit consent secured under mandated choice will not be informed either. Conversely, a mandated choice policy might be justifiable if accompanied by a significant public education campaign. However, if this entitles us to assume that members of the public are informed, then an opt-out system would also be justified in the same circumstances. The alleged advantages of mandated choice seem to rest on an unfair comparison, between mandated choice with a public education campaign and an opt-out system without one. While it may be that some countries with opt-out systems should do more to inform their publics, I see no reason to assume that this cannot be done. Indeed, advocates of mandated choice seem committed to thinking it possible to raise awareness. If opt-out systems adopt the same methods, such as writing to every individual, this should also address concerns about whether consent is informed.

The typical outcome measure in infertility treatment is the (cumulative) healthy live birth rate per patient or per cycle. This means that those who end the treatment trajectory with a healthy baby in their arms are considered to be successful and those who do not are considered to have failed. In this article, we argue that by adopting the healthy live birth standard as the outcome measure that defines a successful fertility treatment, it becomes an interpretative self-fulfilling prophecy: those who achieve the goal consider themselves successful and those who do not consider themselves failures. This is regardless of the fact that having children is only one out of many ways to alleviate the suffering related to infertility and that stopping fertility treatment can also be a positive decision to move on to other goals, rather than a form of "giving up," "dropping out," "nonadherence," or failure. We suggest that those seeking fertility treatment would be served better by an alternative outcome measure, which can be equally self-fulfilling, according to which a successful treatment is one in which people leave the clinic released from the suffering that accompanied their status as infertile when they first entered the clinic. This new outcome measure still implies that walking out with a healthy baby is a positive outcome. What changes is that walking out without a baby can also be a positive outcome, rather than being marked exclusively as a failure.

This article discusses an approach to translational bioethics (TB) that is concerned with the adaptation-or 'translation'-of concepts, theories and methods from bioethics to practical contexts, in order to support 'non-bioethicists', such as researchers and healthcare practitioners, in dealing with their ethical issues themselves. Specifically, it goes into the participatory development of clinical ethics support (CES) instruments that respond to the needs and wishes of healthcare practitioners and that are tailored to the specific care contexts in which they are to be used. The theoretical underpinnings of this participatory approach to TB are found in hermeneutic ethics and pragmatism. As an example, the development of CURA, a low-threshold CES instrument for healthcare professionals in palliative care, is discussed. From this example, it becomes clear that TB is a two-way street. Practice may be improved by means of CES that is effectively tailored to specific end users and care contexts. The other way around, ethical theory may be enriched by means of the insights gained from engaging with practice in developing CES in a process of co-creation. TB is also a two-way street in the sense that it requires collaboration and commitment of both bioethicists and practitioners, who engage in a process of mutual learning. However, substantial challenges remain. For instance, is there a limit to the extent to which a method of moral reasoning can be adapted in order to meet the constraints of a given healthcare setting? Who is to decide, the bioethicist or the practitioners?

Despite more than a century of research on sexual dysfunction, there has been limited attention to ethical concerns. This is problematic because sex research involves complex ethical questions that generate confusion for ethics review and have not been addressed by ethical guidelines. We analyze two questions. First, does sexual content raise the risk profile of a research protocol? We argue that there is nothing inherent in sexual content that makes a study high risk and that many sexual dysfunction studies involve no more than minimal risk. Second, we ask whether research interventions that involve seeing participants undressed or having physical contact with a research subject are permissible? We argue that these interventions raise an important ethical challenge-they often involve sexual dysfunction researchers engaging in interventions that would not be conducted in their standard practice. To resolve this, we propose an expertise-based account of the permissibility of sexual dysfunction research.

In-vitro fertilization clinics across the world currently use the body mass index (BMI) to assess risk for and determine access to in-vitro fertilization (IVF); however, clinics vary widely in both setting specific BMI limits for access to IVF and articulating the reasons for their policies. Given that scholars have begun to question the usefulness of BMI for individual health risk assessment, it is striking that ethicists have not yet systematically evaluated the reasons given for using BMI in assessing individuals' risk in IVF treatments. In this paper, I provide the first systematic analysis of the chief arguments currently offered by IVF programs for using BMI as a criterion for risk assessment. Specifically, I articulate empirical concerns about the success of IVF in high-BMI patients, practical concerns about the ability of high-BMI patients to safely undergo procedures associated with IVF, and ethical concerns about the risk-to-reward ratio for high-BMI patients and their potential children. I advance a series of objections to those arguments, using empirical data regarding IVF procedures and analogies with other high-risk conditions including systemic lupus erythematosus, and science regarding the diagnosis of BMI-correlated comorbidities such as high blood pressure or diabetes to argue that BMI alone is not a reasonable criterion for risk assessment in IVF; moreover, the usage of BMI may involve unacceptable violations of the bioethical principles of justice and respect for autonomy. Instead, I hold that IVF programs should rely on more precise laboratory and clinical measurements to evaluate risk in IVF.

Artificially intelligent systems (AISs) are being created by software developing companies (SDCs) to influence clinical decision-making. Historically, clinicians have led healthcare decision-making, and the introduction of AISs makes SDCs novel actors in the clinical decision-making space. Although these AISs are intended to influence a clinician's decision-making, SDCs have been clear that clinicians are in fact the final decision-makers in clinical care, and that AISs can only inform their decisions. As such, the default position is that clinicians should hold responsibility for the outcomes of the use of AISs. This is not the case when an AIS has influenced a clinician's judgement and their subsequent decision. In this paper, we argue that this is an imbalanced and unjust position, and that careful thought needs to go into how personal moral responsibility for the use of AISs in clinical decision-making should be attributed. This paper employs and examines the difference between prospective and retrospective responsibility and considers foreseeability as key in determining how personal moral responsibility can be justly attributed. This leads us to the view that moral responsibility for the outcomes of using AISs in healthcare ought to be shared by the clinical users and SDCs.

Sometimes, offering someone beneficial care is likely to thwart the similar or more serious medical needs of more people. For example, when acute shortage is strongly predicted to persist, providing the long period on scarce intensive care that a certain COVID-19 patient needs is sometimes projected to block several future COVID-19 patients from receiving the shorter periods on intensive care that they will need. Expected utility is typically higher if the former is denied intensive care. A tempting initial account of such cases is that consequentialism supports denying care to that patient and nonconsequentialism supports providing that care. This paper argues that the consequentialist case is more complicated than it may initially seem and that nonconsequentialism sides more readily with denial of the beneficial treatment. It also shows that when denying it would directly enhance public health by a lot, either ethical approach would normally recommend denying it. Practical implications are discussed, including how to address conscientious objection to this shared recommendation.