Medical devices are often referred to as being invasive or non-invasive. Though invasiveness is relevant, and central, to how devices are understood and regarded in medicine and bioethics, a consensus concept or definition of invasiveness is lacking. To begin to address this problem, this essay explores four possible descriptive meanings of invasiveness: how devices are introduced to the body, where they are located in the body, whether they are foreign to the body, and how they change the body. An argument (...) is offered that invasiveness is not purely descriptive, but implicates normative concepts of danger, intrusion, and disruption. In light of this, a proposal is offered for how to understand use of the concept of invasiveness in discussions of medical devices. (shrink)

Authors De Marco and colleagues have presented a new model on the concept of invasiveness, redefining both its technical definition and practical implementation.1 While the authors raise valid critiques regarding the discrepancy in definitions, I cannot help but wonder about the purpose of redefining terms for which little confusion, if any, exists? This commentary seeks to scrutinise the rationale supporting the new model in the absence of significant clinical confusion and to explore the implications for clinical practice. Initially, one may (...) notice there is no mention of clinical relevancy, confusion among patients or whether the discrepancy in terms is causing miscommunication. It seems reasonable that some clinical confusion may exist, but so too does a similar imbalance of terms when speaking technically across the specialties; take depression and its definition as a primary example. While I certainly agree with the illustration of non-invasive prenatal testing being compared with venous blood draws as a disparity in terminology, little evidence suggests confusion concerning the nosology.2 The medical community, including both physicians and patients, recognises that the terminology is specifically used within the …. (shrink)

Advances in neurotechnologies, artificial intelligence (AI) and Big Data analytics are allowing interpretation of patterns from brain data to identify and even predict and manipulate mental states. Furthermore, there are avenues through which brain data can move into the consumer sphere, be reidentified and brokered. In response to these developments, there have been a number of approaches proposed to strengthen protections of brain data. To better understand the landscape of brain data protection discussions, we conducted a scoping review to identify (...) the rationales for establishing brain data protections and the proposals for protecting brain data offered in the ethics and neuroscience literature. To draw comparisons, we also surveyed the rationales given in the literature for the protection of sensitive behavioral inferences drawn from other types of personal data and associated approaches to achieving protection. This systematic examination of the rationale behind heightened protection for brain data should be useful to clarify the functional and conceptual bases given for brain data protection and to provide a better grounding for evaluating how the different approaches to brain data protection address these concerns. (shrink)

Invasive neurotechnologies are a frequent subject of discussion in neuroethics. Technologies, like deep brain stimulation and implantable brain-computer interfaces, are thought to hold significant promise for human health and well-being, but they also raise important ethical questions about autonomy, safety, stigma, privacy, and agency, among others. The terms ‘invasive’ and ‘invasiveness’ are commonly applied to these and other neurotechnologies, yet the concept of invasiveness itself is rarely defined or delimited. Some have suggested that invasiveness may have multiple meanings – physical, (...) emotional, or lifestyle – and that confusion about how people use the terms may lead to harm, especially for users of invasive devices. It is uncertain if debates in neuroethics contribute to this confusion. To investigate this, we conducted a study of how the term ‘invasiveness’ is used in neuroethics. We found that neuroethicists almost always use ‘invasiveness’ to refer to the physical features of interventions, and rarely to refer to other senses of invasiveness. We also found that referencing invasiveness does not determine which ethical issues are prioritized for a given type of neurotechnology. Overall, this study affirms the importance of understanding the meaning and use of the concept of invasiveness in ethical discussion of neurotechnology while also suggesting the need for further work in the area and consideration for rethinking what forms of technology we consider to be invasive. (shrink)

While the various therapeutic neurotechnologies currently in development—TMS, tDCS, and related treatment modalities—have the potential to greatly augment the treatment of a spectrum of diseases an...

There is growing interest in the use of neurointerventions to reduce the risk that criminal offenders will reoffend. Commentators have raised several ethical concerns regarding this practice. One prominent concern is that, when imposed without the offender’s valid consent, neurointerventions might infringe offenders’ right to bodily integrity. While it is commonly held that we possess a moral right to bodily integrity, the extent to which this right would protect against such neurointerventions is as-yet unclear. In this paper, we will assess (...) whether, why, and how severely three forms of neurointervention might infringe the right to bodily integrity. We show that the severity of the infringement of the right to bodily integrity differs across different forms of neurointervention. Moreover, we argue that mental and behavioral effects of neurointerventions could in some cases be relevant to determining the severity of infringements of the right to bodily integrity. (shrink)

Background Psychiatric electroceutical interventions (PEIs) use electrical or magnetic stimulation to treat mental disorders and may raise different ethical concerns than other therapies such as medications or talk therapy. Yet little is known about stakeholders’ perceptions of, and ethical concerns related to, these interventions. We aimed to better understand the ethical concerns of a variety of stakeholder groups (patients with depression, caregivers of patients, members of the public, and psychiatrists) regarding four PEIs: electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), (...) deep brain stimulation (DBS), and adaptive brain implants (ABI). Methods We conducted a national survey of these four stakeholder groups, using an embedded video vignette experiment depicting a patient with treatment-resistant depression and her psychiatrist discussing the possibility of treatment with one of the four PEIs. Results Participants’ ethical concerns varied by stakeholder group, by PEI, and by the interaction of the two. The three non-clinician groups tended to have similar ethical concerns, but to differ from psychiatrists. Similar concerns were raised with regard to the two implantable technologies, DBS and ABI. Overall, there was relatively little concern about the involuntary use of PEIs, though some expressed concern about the adequacy of information provided during the consent process. There was also significant concern that patients may not receive helpful therapies. Conclusions To our knowledge, this is the first national survey that includes multiple stakeholder groups and multiple PEI modalities. A better understanding of the ethical concerns of stakeholders can help to shape clinical practice and health care policy regarding PEIs. (shrink)

Bluhm et al.’s (2023) qualitative study on psychiatric electroceutical interventions describes several types and characteristics of invasiveness identified by psychiatrists and people living with a...

As the new Editor-in-Chief (EiC) of the AJOB Neuroscience, I am aware that I have some very large shoes to fill. Paul Root Wolpe, who established the quality of the journal and served in that posit...

Bluhm et al. (2023) identify invasiveness as a genus with multiple species: a treatment protocol or intervention can be invasive along physical, emotional, or lifestyle dimensions. They also identi...

Major depression is among the most common, challenging and disabling conditions. It is highly heterogeneous, affects patients throughout the lifespan and, in up to one-third of people affected, res...

Psychiatric electroceutical interventions (PEIs) use electrical or magnetic stimulation to treat psychiatric conditions. For depression therapy, PEIs include both approved treatment modalities, such as electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), and experimental neurotechnologies, such as deep brain stimulation (DBS) and adaptive brain implants (ABIs). We present results from a survey-based experiment in which members of four relevant stakeholder groups (psychiatrists, patients with depression, caregivers of adults with depression, and the general public) assessed whether treatment with one of (...) four PEIs (ECT, rTMS, DBS, or ABIs) was better or worse than living with treatment-resistant depression (TRD) and then provided a narrative explanation for their assessment. Overall, the prevalence of many narrative themes differed substantially by stakeholder group—with psychiatrists typically offering different reasons for their assessment than non-clinicians—but much less so by PEI modality. A large majority of all participants viewed their assigned PEI as better than living with TRD, with their reasons being a mix of positive views about the treatment and negative views about TRD. The minority of all participants who viewed their assigned PEI as worse than living with TRD tended to express negative affect toward it as well as emphasize its riskiness, negative side effects, and, to a lesser extent, its invasiveness. The richness of these narrative explanations enabled us to put in context and add depth to key patterns seen in recent survey-based research on PEIs. (shrink)

We are grateful to the commentators for their close reading of our article 1 and for their challenging and interesting responses to it. We do not have space to respond to all of the objections that they raise, so in this reply, we address only a selection of them. Some commentaries question the usefulness of developing an account of the sort we provide, 2 or of revising the Standard Account (SA) in doing so. 3–5 Our schema is intended to provide (...) a framework for developing a full account of invasiveness that captures existing uses of the term. On the assumption that the term is used somewhat reliably and consistently–and we are inclined to agree with some of our commentators 3 4 that people are not terribly confused or mistaken in how they employ the term–an account that captures these... (shrink)

Medical interventions are usually categorized as “invasive” when they involve piercing the skin or inserting an object into the body. However, the findings of Bluhm and collaborators (2023) (hencef...

Bluhm et al. (2023) interviewed psychiatrists, patients with depression, and members of the public and concluded that participants recognized multiple categories of invasiveness, including emotiona...

In their recent target article, Bluhm et al. (2023) discuss the construct of “invasiveness” as it relates to medical treatments, and in particular to treatments that affect brain function. Cruciall...

De Marco et al 1 argue that the standard account of medical ‘invasiveness’ (as ‘incision’ or ‘insertion’) fails to capture three aspects of its existing use, namely that invasiveness can come in degrees, often depends on features of alternative medical interventions and can be non-physical. They propose a new schematic account that suggests that medical interventions can possess ‘basic invasiveness’ (which can come in degrees and of which they suggest at least two types: physical and mental), and ‘threshold invasiveness’ which (...) can depend on the alternatives a specific intervention is being compared with. While we agree that the standard account of invasiveness fails to capture existing use and are supportive of their aim, here we express scepticism about the practical utility of De Marco et al ’s revised account. Our scepticism concerns the application of De Marco et al’s revised account in the narrow context of clinician–patient communication and deliberation about medical interventions within clinical practice, which we see as a crucial context for its use. While De Marco et al do not specify the contexts in which their revised account could be used, we assume from their discussion of treatment interventions (e.g. non-invasive prenatal testing, ventilation) and their comparison to ‘more or less invasive’ options, that at least one of the purposes in mind for …. (shrink)