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Here we consider two ways that nanomedicine might be disruptive. First, low-end disruptions that are intrinsically unpredictable but limited in scope, and second, high end disruptions that involve broader societal issues but can be anticipated, allowing opportunity for ethical reflection. [ABSTRACT FROM AUTHOR]

Many physicians assert that new cost-control mechanisms inappropriately interfere with clinical decision-making. They claim that high costs arise from poorly practiced medicine, and argue that effective utilization of resources is best promoted by advancing the scientific and ethical ideals of medicine. However, the claim is not warranted by empirical evidence. In this essay, I show how it rests upon aesthetic considerations associated with diagnostic elegance. I first consider scientific rationality generally. After a review of analytical empiricist and socio-historical approaches in the philosophy of science, a form of Kant's aesthetic is used to explain how scientific discovery and justification are linked, and to show how meta-theoretical considerations associated with the goals and method of science work together with exemplars of practice. This analysis enables us to understand how the ideals of medicine as a science guide the initial patient history and physical exam in such a way that a parsimonious use of tests is indicated. Aesthetic considerations unite the basic scientific and ethical commitments of the modern medical paradigm and are central for rightly understanding clinical judgment. [ABSTRACT FROM AUTHOR]

Introduction: The emergence of Big Data health research has exponentially advanced the fields of medicine and public health but has also faced many ethical challenges. One of most worrying but still under-researched aspects of the ethical issues is the risk of potential biases in data sets (eg, electronic health records (EHR) data) as well as in the data curation and acquisition cycles. This study aims to develop, refine and pilot test an ethical framework-guided instrument for assessing bias in Big Data research using EHR data sets., Methods and Analysis: Ethical analysis and instrument development (ie, the EHR bias assessment guideline) will be implemented through an iterative process composed of literature/policy review, content analysis and interdisciplinary dialogues and discussion. The ethical framework and EHR bias assessment guideline will be iteratively refined and integrated with preliminary summaries of results in a way that informs subsequent research. We will engage data curators, end-user researchers, healthcare workers and patient representatives throughout all iterative cycles using various formats including in-depth interviews of key stakeholders, panel discussions and charrette workshops. The developed EHR bias assessment guideline will be pilot tested in an existing National Institutes of Health (NIH) funded Big Data HIV project (R01AI164947)., Ethics and Dissemination: The study was approved by Institutional Review Boards at the University of South Carolina (Pro00122501). Informed consent will be provided by the participants in the in-depth interviews. Study findings will be disseminated with key stakeholders, presented at relevant workshops and academic conferences, and published in peer-reviewed journals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

There is a curious asymmetry in cases where the use of religious language involves a breakdown in communication and leads to a seemingly intractable dispute. Why does the use of religious language in such cases almost always arise on the side of patients and their families, rather than on the side of clinicians or others who work in healthcare settings? I suggest that the intractable disputes arise when patients and their families use religious language to frame their problem and the possibilities of solution. Unlike clinicians, they are not bilingual and thus lack the capacity to understand and negotiate differences in terms that are responsive to those who work in healthcare settings. After considering a representative case, I explore whether an ethics consultant or chaplain can function as a translator and suggest that, at best, such efforts at mediation depend on contingent aspects of a case and will only be partially successful. To appreciate limits on the role for bilingual translators, I consider a futility dispute where a parent using religious language demands that everything be done for a permanently unconscious child. I challenge the traditional interpretation that says the parent values "mere duration of biological life irrespective of quality." From a religious perspective, human life is never "merely biological." This effort to slot the dispute into standard philosophical schemas misses what is crucial in the dispute. I suggest that a better interpretation views the dispute at a meta-level as one about whether withholding and withdrawing care is morally distinguishable from killing. Curiously, this interpretation makes the advocate of futile care into an ally of those "quality of life" advocates who also challenge this distinction. The crux of their dispute now rests on the normative ethics of killing. While I think my interpretation comes much closer to the views of many who demand 'futile care,' I suggest that it still falls short because of the way it reconstructs the religious concerns in nonreligious terms. I close by considering an analogy between the language of suffering and the language of faith, suggesting that both require a much richer understanding of the narratives that orient the lives of patients and their families.

This essay considers implications of formal mereologies and ontologies for medical metaphysics. Edward Fried's extensional mereological account of the human body is taken as representative of a prominent strand in analytic metaphysics that has close affinities with medical positivism. I show why such accounts fail. First, I consider how Fried attempts to make sense of the medical case of Barney Clark, the first recipient of an artificial heart, and show that his analytic metaphysical categories do not have the right kind of fit with the case. A proper medical metaphysic should involve a richer two way dialogue with medicine, and it should not just "apply" formal accounts worked out in other settings. Second, I argue that any effort to account for real wholes with extensional mereological sums requires all sorts of ad hoc, supplementary mechanisms that do the real work, and the full repertoire of these mechanisms involves inconsistencies and semantic shifts. Finally, I consider an alternative strand of work on non-extensional whole/part relations that is closer to medicine and that can deepen reflection on some core problems in bioethics, for example, associated with the determination of death when an organism ceases to function as a whole. In addition to the utility such formal ontologies have for addressing traditional problems such as the determination of death, philosophers of medicine should appreciate the increasingly influential role such formal tools are playing in the development of data system ontologies. Assumptions integral to these ontologies have far reaching implications for the way future research and practice in medicine will be conducted, and much greater critical reflection is needed on the full range of issues associated with the development and use of such medical ontologies.

Unlike drugs and medical devices, for which long standing and continuously improving quality assurance/quality control infrastructures exist, many nano-based products lack well-defined standards that are useful to manufacturers and regulators. Inherent variabilities in nanoparticle sizes and shapes, their large surface-to-volume ratios, and their mesoscale interactions with subcellular structures, suggest new complexities and challenges that must be met before widespread application of nanomedicines can be expected., (© 2012 American Society of Law, Medicine & Ethics, Inc.)

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern., (© 2012 American Society of Law, Medicine & Ethics, Inc.)

In current research on systems biology and nanomedicine, we often find an ideal of a new science-based preventive medicine. I consider how disease, cause, explanation, diagnosis, and treatment are understood within this ideal, with special attention to the role of nanoscience and technology in elucidating the "circuit diagram" of a healthy system. I argue that the developmental systems theory that informed George Engel's biopsychosocial model addresses some deficiencies in the current systems ideal, but it needs to be integrated with an ethical analysis that is more attentive to the socioeconomic, cultural, and institutional factors that condition how we understand and manage disease. We also need a richer account of top-down causal paths if we are to appropriately understand diseases as disruptions of inter- and intra-systemic integrity.

Insufficient attention has been given to ethical and social issues integral to nanomedicine. Part of this deficiency arises from some mistaken assumptions about ethics. I consider five of these: that ethics is only important when a technology is mature (reactionary ethics); that there are no new ethical issues in nanomedicine; that ethics involves a kind of risk assessment that is already being conducted; that ethics is a hindrance to science; and that ethics is a luxury for an ideal world. After critically assessing these assumptions, I consider two types of nanomedicine and the kinds of ethical issues they raise. Type 1 nanomedicine is of an incremental kind, and proper ethical assessment of the issues must involve a fine grained study of the specific application. Type 2 nanomedicine is of a more foundational, programmatic kind. Ethical issues raised by these more programmatic developments include challenges integral to formation of interdisciplinary teams; issues related to intellectual property, authorship and publication; development of informed consent and confidentiality protections associated with new data sets; future challenges to the clinician-patient relation and personalized medicine. Ethical analysis should also consider some of the reductionistic implications of engineering models and metaphors integral to nanomedicine, as well as uses of nanomedicine for non-medical purposes, such as human enhancement. Many of these challenges concern rate-limiting steps in nanomedical research, and they should be prominently featured in developing nanomedicine initiatives.

After historically situating NBIC Convergence in the context of earlier bioethical debate on genetics, ten questions are raised in areas related to the ethics of Convergence, indicating where future research is needed.

The traditional contrast between naturalist and normativist disease concepts fails to capture the most salient features of the health concepts debate. By using health concepts as a window on background notions of medical science and ethics, I show how Christopher Boorse (an influential naturalist) and Lennart Nordenfelt (an influential normativist) actually share deep assumptions about the character of medicine. Their disease concepts attempt, in different ways, to shore up the same medical model. For both, health concepts function like demarcation criteria in the philosophy of science: they mark off the jurisdiction of medical science, and protect it from an inappropriate intrusion of socioeconomic factors, which threaten the integrity of modern medicine. These views are challenged by new developments in healthcare such as managed care and total quality review. To frame the health concepts debate in a way that better captures the issues integral to these new developments, I advance a new way of reading the distinction between weak and strong normativists. Strong normativists are skeptical of the demarcation project, think facts and values cannot be disentangled, and hold that socioeconomic conditions unavoidably influence how pathology is understood. The new health concepts debate should be framed as one between weak and strong normativists, and it concerns how we should respond to the current developments in health care.

There is a consensus emerging on the importance of upstream ethical engagement in nanobiotechnology. Such a preventive ethic would anticipate downstream concerns that might arise and mitigate them as part of the research and development process. However, there is an unappreciated tension between the time horizon of upstream ethics and that assumed by most bioethical research. Current standards of high-quality research on ethical issues biases the research in favor of near-term, science-based, results-oriented work. A near-term focus would miss many of the important ethical issues integral to nanobiotechnology and undermine the goals integral to upstream ethical engagement. However, if we move to a far-term time horizon, the ethical debates tend to get too speculative and are no longer disciplined by existing research trajectories. This paper addresses the link between the midterm time horizon necessary for upstream ethics and the form, content, and style of ethical reflection. New paradigm cases, standards, and criteria will be needed for high-quality upstream ethics work in the area of nanobiotechnology.

Representatives from government and the private sector recommend a major, cooperative initiative directed toward using NBIC (nano-, bio-, info-, and cogno-) technologies for human enhancement. By appropriately seeding the convergence of NBIC domains, they believe that the rate of development can be both accelerated and simultaneously channeled to avoid adverse risk and advance human good. However, to accomplish these goals, leaders of the convergence efforts identified as a major intellectual barrier the "development of a hierarchical architecture for integrating science across many scales, disciplines, and data modalities." Such a holistic framework requires a radical rethinking of the nature of science and engineering, and, beyond this, is also necessary for addressing their normative ethical and societal implications. In the first part of this essay, I consider the claim that a new view of science and engineering is needed. After reviewing the central features of a classical view of science, I consider aspects of the nano-revolution, showing why the classical conception is inappropriate and how a systems-oriented perspective is responsive to the character of this new science. I then consider how both science and engineering are transformed, calling into question older dichotomies between pure and applied domains. With the reworking of this distinction comes opportunities for rethinking the relation between science and the humanities more generally, which is necessary if we are to more appropriately address normative ethical aspects of the convergence initiative. After providing this groundwork for the needed hierarchical architecture, I consider a useful example of how a systems perspective might guide NBIC convergence. In the 1960s-1990s George Engel advocated a systems-theoretic model as an alternative to a more reductionistic "biomedical model" in medicine, and he did it for the exact same reasons as those advocated by the leaders of the NBIC convergence; namely, it embodies a more appropriate notion of science and enables one to address ethical aspects of medicine that were insufficiently addressed in the older model. By reviewing Engel's "biopsychosocial model" we can learn important lessons for developing the needed NBIC framework. I close by extending Engel's model so that it addresses all areas of enhancement envisioned as a part of NBIC convergence, and then identify areas where future research is still needed.

The arguments against managed care can be divided into two general clusters. One cluster concerns the way managed care undermines the ethical ideals of medical professionalism. Since those ideals largely focus on the physician-patient relation, the first cluster comes under the rubric of micro-ethics; namely, the ethics of individual-individual relations. The second cluster of criticisms focuses on macro-ethical issues, primarily on issues of justice and policy. By reviewing these arguments, it becomes clear that managed care does not easily fit within traditional modes of ethical analysis. It poses a radical challenge to current medical and socio-political norms, and even resists the distinction between micro- and macro-ethical domains, a distinction that reflects the private/public distinction. Managed care organizations call for a third way, an inter-ethic for middle level organizations. The essays in this Journal provide a first step in this radical reassessment, laying the foundation for an organizational ethic that is responsive to the realities and promise of managed care.

Conflicts of interest serve as a cipher for a radical rupture in the Flexnerian paradigm of medicine, and they can only be addressed if we recognize that health care is now practiced by institutions, not just individual physicians. By showing how "appropriate utilization of services" or "that which is medically indicated" is a function of socioeconomic factors related to institutional responsibilities, I point toward an administrative and organizational ethic as a needed component for addressing conflicts of interest. The argument is developed by reviewing three important books. First, I consider Mark Rodwin's attempt to configure the economic structures of medicine so that classical fiduciary and scientific ideals can be fostered. Second, I consider E. Haavi Morreim's attempt to modify the classical ideals in order to account for new economic realities. Finally, by considering essays in a recent volume on conflicts of interest edited by Spece, Shimm, and Buchanan, I argue for a constructive dialectic between the approaches of Rodwin and Morreim. In order to properly address conflicts of interest, there must be a radical reassessment of medicine that accounts for the interrelation between scientific, ethical, and economic concerns. Until institutions come into view and professional ethics is developed to account for their role, legitimate interests and obligations of diverse parties cannot be harmonized.

Germund Hesslow has argued that concepts of health and disease serve no important scientific, clinical, or ethical function. However, this conclusion depends upon the particular concept of disease he espouses; namely, on Boorse's functional notion. The fact/value split embodied in the functional notion of disease leads to a sharp split between the "science" of medicine and bioethics, making the philosophy of medicine irrelevant for both. By placing this disease concept in the broader context of medical history, I shall show that it does capture an essential part of modern medical ideology. However, it is also a self-contradictory notion. By making explicit the value desiderate of medical nosologies, a reconfiguration of the relation between medicine, bioethics, and the philosophy of medicine is initiated. This, in turn, will involve a recovery of the caring dimensions of medicine, and thus a more humane practice.