This paper attempts to address the general question whether information technologies, as applied in the area of medicine and health care, have or are likely to change fundamental concepts regarding disease and health. After a short excursion into the domain of medical informatics I provide a brief overview of some of the current theories of what a disease is from a more philosophical perspective, i.e., the "value free" and "value laden" view of disease. Next, I consider at some (...) length, whether health care informatics is currently modifying fundamental concepts of disease. To this question I will answer largely in the negative. (shrink)

The exponential digitization of medical data has led to a transformation of the practice of medicine. This change notably raises a new complexity of issues surrounding health IT. The proper use of these communication tools, such as telemedicine, e-health, m-health the big medical data, should improve the quality of monitoring and care of patients for an information system to "human face". Faced with these challenges, the author analyses in an ethical angle the patient-physician relationship, sharing, transmission and storage (...) of medical information, setting pins to an ethic for the digitization of medical information. Drawing on good practice recommendations closely associated with values, this model is developing tools for reflection and present the keys to understanding the decision-making issues that reflect both the technological constraints and the complex nature of human reality in medicine. (shrink)

Rising health insurance costs and the cost of living crisis are likely leading to an increase in unpaid health insurance bills in many countries. In Switzerland, a particularly drastic measure to sanction defaulting insurance payers is employed. Since 2012, Swiss cantons – who have to cover most of the bills of defaulting payers - are allowed by federal law to blacklist them and to restrict their access to medical care to emergencies.In our paper, we briefly describe blacklisting in the (...) context of the Swiss healthcare system before we examine the ethical issues involved in light of what is known about its social and health impacts. We found no evidence that blacklisting serves as an effective way of recovering unpaid health insurance contributions or of strengthening solidarity within the health insurance system. Furthermore, the ambiguous definitions of what constitutes an emergency treatment and the incompatibility of the denial of medical care with the obligation to provide professional assistance complicate the implementation of blacklists and expose care providers to enormous pressure.Therefore, we conclude that blacklists and the (partial) denial of medical care not only pose profound ethical problems but are also unsuitable for fulfilling the purpose for which they were introduced. (shrink)

Faced with the exponential development of Big Data and both its legal and economic repercussions, we are still slightly in the dark concerning the use of digital information. In the perpetual balance between confidentiality and transparency, this data will lead us to call into question how we understand certain paradigms, such as the Hippocratic Oath in medicine. As a consequence, a reflection on the study of the risks associated with the ethical issues surrounding the design and manipulation of this "massive (...) data" seems to be essential. This book provides a direction and ethical value to these significant volumes of data. It proposes an ethical analysis model and recommendations to better keep this data in check. This empirical and ethico-technical approach brings together the first aspects of a moral framework directed toward thought, conscience and the responsibility of citizens concerned by the use of data of a personal nature. Defines Big Data applications in health Presents the ethical value of the medical datasphere via the description of a model of an ethical analysis of Big Data Provides the recommendations and steps necessary for successful management and governance of personal health data Helps readers determine what conditions are essential for the development of the study of Big Data. (shrink)

The use of black box algorithms in medicine has raised scholarly concerns due to their opaqueness and lack of trustworthiness. Concerns about potential bias, accountability and responsibility, patient autonomy and compromised trust transpire with black box algorithms. These worries connect epistemic concerns with normative issues. In this paper, we outline that black box algorithms are less problematic for epistemic reasons than many scholars seem to believe. By outlining that more transparency in algorithms is not always necessary, and by explaining that (...) computational processes are indeed methodologically opaque to humans, we argue that the reliability of algorithms provides reasons for trusting the outcomes of medical artificial intelligence. To this end, we explain how computational reliabilism, which does not require transparency and supports the reliability of algorithms, justifies the belief that results of medical AI are to be trusted. We also argue that several ethical concerns remain with black box algorithms, even when the results are trustworthy. Having justified knowledge from reliable indicators is, therefore, necessary but not sufficient for normatively justifying physicians to act. This means that deliberation about the results of reliable algorithms is required to find out what is a desirable action. Thus understood, we argue that such challenges should not dismiss the use of black box algorithms altogether but should inform the way in which these algorithms are designed and implemented. When physicians are trained to acquire the necessary skills and expertise, and collaborate with medical informatics and data scientists, black box algorithms can contribute to improving medical care. (shrink)

Objective: There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective was to develop a structured ethics framework to accomplish this. -/- Methods: We reviewed existing literature on the ethical and policy issues, developed an ethics framework called a “Points to (...) Consider” (P2C) document, and convened a national expert panel to review and critique the P2C. -/- Results: We developed the P2C to aid informaticists designing an advanced query tool for an electronic health record (EHR) system in Indianapolis. The P2C consists of six questions (“Points”) that frame important ethical issues, apply accepted principles of bioethics and Fair Information Practices, comment on how questions might be answered, and address implications for patient care. -/- Discussion: The P2C is intended to clarify whatis at stake when designers try to accommodate potentially competing ethical commitments and logistical realities. The P2C was developed to guide informaticists who were designing a query tool in an existing EHR that would permit patient granular control. While consideration of ethical issues is coming to the forefront of medical informatics design and development practices, more reflection is needed to facilitate optimal collaboration between designers and ethicists. This report contributes to that discussion. (shrink)

In a time marked by the development of innovative treatments in healthcare and the need for health professionals to deal with resulting ethical dilemmas in clinical practice, this study was developed to determine the influence of the bioethics teaching on the moral competence of medical and nursing students. The authors conduct a longitudinal study using the Moral Competence Test extended version before and after attending the ethics curricular unit, in three nursing schools and three medical schools of Portugal. (...) In this questionnaire the participant is confronted with three ethical dilemmas and asked to evaluate arguments for and against the attitude of the main character. For both nursing and medical students, C-score was lower after the attendance of the ethics curricular units, with a statistically significant decrease in the total score for nursing students and a decrease not statistically significant for medical students. A multivariate analysis did not find any association between this decrease and gender, course, or age. The phenomenon of moral segmentation was observed, with better performance in the worker and judge dilemma, than in the doctor dilemma. These results highlight the need to reflect on the curricular strategies that can be implemented for health professionals to better develop moral competence and decision-making, allowing for the provision of humanized health care. (shrink)

In this article, consultation via the Internet and the use of the Internet as a source of medical information is examined from an ethical point of view. It is argued that important ethical aspects of the clinical interaction, such as dialogue and trust will be difficult to realise in an Internet-consultation. Further, it is doubtful whether an Internet doctor will accept responsibility. However, medical information via the Internet can be a valuable resource for patients wanting to know more (...) about their disease and, thus, it is a means to enhancing their autonomy. (shrink)

“Wicked” problems are characterized by intractable complexity, uncertainty, and conflict between individuals or institutions, and they inhabit almost every corner of medical ethics. Despite wide acceptance of the same ethical principles, we nevertheless disagree about how to formulate such problems, how to solve them, what would _count_ as solving them, or even what the possible solutions _are_. That is, we don’t always know how best to implement ethical ideals in messy real-world contexts. I sketch an implementation framework for (...) class='Hi'>medical ethics that can help clarify wicked problems and organize further ethics research toward their resolutions. This framework describes the procedural variables that work alongside substantive ethical ideals to deliver ethical decisions in complex real-world situations. Using controversial GM mosquito research as an example, I illustrate how the generalizable relationships between the variables clarify emerging ethical guidelines of research governance and provide a pathway to extend these guidelines in a way consistent with our ethical intuitions across a wide range of research and public health ethics. (shrink)

BackgroundThe globalization of medical science carries for doctors worldwide a correlative duty to deepen their understanding of patients' cultural contexts and religious backgrounds, in order to satisfy each as a unique individual. To become better informed, practitioners may turn to MedLine, but it is unclear whether the information found there is an accurate representation of culture and religion. To test MedLine's representation of this field, we chose the topic of death and dying in the three major monotheistic religions.MethodsWe searched (...) MedLine using PubMed in order to retrieve and thematically analyze full-length scholarly journal papers or case reports dealing with religious traditions and end-of-life care. Our search consisted of a string of words that included the most common denominations of the three religions, the standard heading terms used by the National Reference Center for Bioethics Literature (NRCBL), and the Medical Subject Headings (MeSH) used by the National Library of Medicine. Eligible articles were limited to English-language papers with an abstract.ResultsWe found that while a bibliographic search in MedLine on this topic produced instant results and some valuable literature, the aggregate reflected a selection bias. American writers were over-represented given the global prevalence of these religious traditions. Denominationally affiliated authors predominated in representing the Christian traditions. The Islamic tradition was under-represented.ConclusionMedLine's capability to identify the most current, reliable and accurate information about purely scientific topics should not be assumed to be the same case when considering the interface of religion, culture and end-of-life care. (shrink)

Objectives: Machine learning (ML) has the potential to facilitate “continual learning” in medicine, in which an ML system continues to evolve in response to exposure to new data over time, even after being deployed in a clinical setting. In this article, we provide a tutorial on the range of ethical issues raised by the use of such “adaptive” ML systems in medicine that have, thus far, been neglected in the literature. -/- Target audience: The target audiences for this tutorial are (...) the developers of ML AI systems, healthcare regulators, the broader medical informatics community, and practicing clinicians. -/- Scope: Discussions of adaptive ML systems to date have overlooked the distinction between 2 sorts of variance that such systems may exhibit—diachronic evolution (change over time) and synchronic variation (difference between cotemporaneous instantiations of the algorithm at different sites)—and underestimated the significance of the latter. We highlight the challenges that diachronic evolution and synchronic variation present for the quality of patient care, informed consent, and equity, and discuss the complex ethical trade-offs involved in the design of such systems. (shrink)

I. Introductory Comments   The Human Genome Project will be completed within 2 years, and “targeted†sequence data from the most promising sections of the genome will be released even sooner. Based on this wealth of information, at least 400 new genetic tests will become available within the next decade. The blending of microelectronic and genetic technology will make the “genetic report card†an affordable and routine part of medical care. The implicit assumption driving much of this push (...) for genetic testing is that information is inherently good and patients should have the right to any information about themselves they desire. However, the informational content of genetic tests for most conditions is not known and may in fact be very low. Under such circumstances, it seems prudent to treat access to genetic testing the same way we currently treat access to other new medical procedures and drugs – that is, access is afforded only 1) in the context of a clinical trial or  2) after the safety and effectiveness of the treatment has been established. The fact is, genetic “information†of uncertain quality is not innocous. II. The Difficulty with Genetic Testing   Everyone is familiar with one difficulty posed by genetic testing: the possibility that a test may show either a “false positive†or a “false negativeâ€.  This is the problem of the analytic accuracy of testing. However, as our analytic techniques become more sophisticated, the incidence of such errors will steadily decline. If nothing else, administration of multiple tests is often (though not always) a simple and effective way of boosting analytic accuracy.   There is, however, a much more serious accuracy problem which has been largely overlooked in the literature.. (shrink)

The General Medical Council (GMC) instructs doctors to act ‘reasonably’ in obtaining consent from patients. However, the GMC does not explain what it means to be reasonable: it is left to doctors to figure out the substance of this instruction. The GMC relies on the Supreme Court’s judgment in Montgomery v Lanarkshire Health Board; and it can be assumed that the judges’ idea of reasonability is adopted. The aim of this paper is to flesh out this idea of reasonability. (...) This idea is commonly personified as the audience that has to be satisfied by the doctor’s justification for offering, or withholding, certain treatments and related information. In case law, this audience shifted from a reasonable doctor to a ‘reasonable person in the patient’s position’; and Montgomery expands the audience to include ‘particular’ patients, too. Senior judges have clarified that the reasonable person is a normative ideal, and not a sociological construct; but they do not set out the characteristics of this ideal. John Rawls has conceived the reasonable person-ideal as one that pursues fair terms of co-operation with other members of society. An alternative ideal can be inferred from the feminist ethic of care. However, the reasonable patient from Montgomery does not align with either theoretical ideal; but, instead, is an entirely rational being. Such a conception conflicts with both real-life constraints on rationality and the doctor’s duty to care for the patient, and it challenges the practice of medicine. (shrink)

This article provides a critical comparative analysis of the substantive and procedural values and ethical concepts articulated in guidelines for allocating scarce resources in the COVID-19 pandemic. We identified 21 local and national guidelines written in English, Spanish, German and French; applicable to specific and identifiable jurisdictions; and providing guidance to clinicians for decision making when allocating critical care resources during the COVID-19 pandemic. US guidelines were not included, as these had recently been reviewed elsewhere. Information was extracted from each (...) guideline on: 1) the development process; 2) the presence and nature of ethical, medical and social criteria for allocating critical care resources; and 3) the membership of and decision-making procedure of any triage committees. Results of our analysis show the majority appealed primarily to consequentialist reasoning in making allocation decisions, tempered by a largely pluralistic approach to other substantive and procedural values and ethical concepts. Medical and social criteria included medical need, co-morbidities, prognosis, age, disability and other factors, with a focus on seemingly objective medical criteria. There was little or no guidance on how to reconcile competing criteria, and little attention to internal contradictions within individual guidelines. Our analysis reveals the challenges in developing sound ethical guidance for allocating scarce medical resources, highlighting problems in operationalising ethical concepts and principles, divergence between guidelines, unresolved contradictions within the same guideline, and use of naïve objectivism in employing widely used medical criteria for allocating ICU resources. (shrink)

The use of platelet rich plasma as a novel treatment is discussed in the context of a qualitative research study comprising 38 interviews with sports medicine practitioners and other stakeholders working within the English Premier League during the 2013–16 seasons. Analysis of the data produced several overarching themes: conservatism versus experimentalism in medical attitudes; therapy perspectives divergence; conflicting versions of appropriate evidence; subcultures; community beliefs/practices; and negotiation of medical decision-making. The contested evidence base for the efficacy of PRP (...) is presented in the context of a broader professional shift towards evidence based medicine within sports medicine. Many of the participants while accepting this shift are still committed to casuistic practices where clinical judgment is flexible and does not recognize a context-free hierarchy of evidentiary standards to ethically justifiable practice. We also discuss a tendency in the data collected to consider the use of deceptive, placebo-like, practices among the clinician participants that challenge dominant understandings of informed consent in medical ethics. We conclude that the complex relation between evidence and ethics requires greater critical scrutiny for this emerging specialism within the medical community. (shrink)

Background The globalization of medical science carries for doctors worldwide a correlative duty to deepen their understanding of patients' cultural contexts and religious backgrounds, in order to satisfy each as a unique individual. To become better informed, practitioners may turn to MedLine, but it is unclear whether the information found there is an accurate representation of culture and religion. To test MedLine's representation of this field, we chose the topic of death and dying in the three major monotheistic religions. (...) Methods We searched MedLine using PubMed in order to retrieve and thematically analyze full-length scholarly journal papers or case reports dealing with religious traditions and end-of-life care. Our search consisted of a string of words that included the most common denominations of the three religions, the standard heading terms used by the National Reference Center for Bioethics Literature (NRCBL), and the Medical Subject Headings (MeSH) used by the National Library of Medicine. Eligible articles were limited to English-language papers with an abstract. Results We found that while a bibliographic search in MedLine on this topic produced instant results and some valuable literature, the aggregate reflected a selection bias. American writers were over-represented given the global prevalence of these religious traditions. Denominationally affiliated authors predominated in representing the Christian traditions. The Islamic tradition was under-represented. Conclusion MedLine's capability to identify the most current, reliable and accurate information about purely scientific topics should not be assumed to be the same case when considering the interface of religion, culture and end-of-life care. (shrink)

The law of informed consent to medical treatment has recently been extensively overhauled in England. The 2015 Montgomery judgment has done away with the long-held position that the information to be disclosed by doctors when obtaining valid consent from patients should be determined on the basis of what a reasonable body of medical opinion agree ought to be disclosed in the circumstances. The UK Supreme Court concluded that the information that is material to a patient’s decision should instead (...) be judged by reference to a new two-limbed test founded on the notions of the ‘reasonable person’ and the ‘particular patient’. The rationale outlined in Montgomery for this new test of materiality, and academic comment on the ruling’s significance, has focused on the central ethical importance that the law now accords to respect for patient autonomy in the process of obtaining consent from patients. In this paper, we dispute the claim that the new test of materiality articulated in Montgomery equates with respect for autonomy being given primacy in re-shaping the development of the law in this area. We also defend this position, arguing that our revised interpretation of Montgomery’s significance does not equate with a failure by the courts to give due legal consideration to what is owed to patients as autonomous decision-makers in the consent process. Instead, Montgomery correctly implies that doctors are ethically obliged to attend to a number of relevant ethical considerations in framing decisions about consent to treatment, which include subtle interpretations of the values of autonomy and well-being. Doctors should give appropriate consideration to how these values are fleshed out and balanced in context in order to specify precisely what information ought to be disclosed to a patient as a requirement of obtaining consent, and as a core component of shared decision-making within medical encounters more generally. (shrink)

The first ethics casebook that integrates clinical ethics (medical, nursing, and dental) and research ethics with public health and informatics. The book opens with five chapters on ethics, the development of interprofessional ethics, and brief instructional materials for students on how to analyze ethical cases and for teachers on how to teach ethics. In today's rapidly evolving healthcare system, the cases in this book are far more realistic than previous efforts that isolate the decision-making process by professions as (...) if each is not embedded in a larger context that involves healthcare teams, hospital policies, and technology. The central claim of this book is that ethics is an important common ground for all of the health professions. Furthermore, when we recognize that our professions converge upon a common goal we will find less conflict and more pleasure in working together. (shrink)

Clinical ethics can be viewed as a practical discipline that provides a structured approach to assist healthcare practitioners in identifying, analysing and resolving ethical issues that arise in practice. Clinical ethics can therefore promote ethically sound clinical and organisational practices and decision-making, thereby contributing to health organisation and system quality improvement. In order to develop students’ decision-making skills, as well as prepare them for practice, we decided to introduce a clinical ethics strand within an undergraduate medical curriculum. We designed (...) a programme of clinical ethics activities for teaching and assessment purposes that involved using ethical frameworks to analyse hypothetical and real-life cases in uni- and inter- professional groups. In this paper, we draw on medical student feedback collected over 6 years to illustrate the appeal to students of learning clinical ethics. We also outline the range of benefits for students, healthcare organisations, and the field of clinical ethics arising from tomorrow’s doctors experiencing clinical ethics early in their training. We conclude by briefly reflecting on how including clinical ethics within tomorrow’s doctors curricular can secure and continue future engagement in clinical ethics support services in the UK, alongside the dangers of preparing students for organisational cultures that might not exist. We anticipate the findings presented in the paper will contribute to wider debates examining the impact of ethics teaching, and its ability to inform future doctors’ practice. (shrink)

Access to abortion care has been hugely affected by the COVID-19 pandemic. This has prompted several governments to permit the use of telemedicine for fully remote care pathways, thereby ensuring pregnant people are still able to access services. One such government is that of England, where these new care pathways have been publicly scrutinised. Those opposed to telemedical early medical abortion care have raised myriad concerns, though they largely centre on matters of patient safeguarding. It is argued that healthcare (...) professionals cannot adequately carry out their safeguarding duties if the patient is not in the room with them. These concerns lack empirical support. Emerging evidence suggests that safeguarding processes may, in fact, be more effective within telemedical abortion care pathways. In this article, we address two specific safeguarding concerns: (1) that a remote consultation prevents a healthcare professional from identifying instances of abuse, and (2) that healthcare professionals cannot reliably confirm the absence of coercion during a remote consultation. We demonstrate that such concerns are misplaced, and that safeguarding may actually be improved in telemedical care pathways as victims of abuse may find it easier to engage with services. It is inevitable that some individuals will fall through the net, but this is unavoidable even with in-person care and thus does not constitute a strong critique of the use of telemedicine in abortion care. These safeguarding concerns set aside, then, we argue that the current approval that enables telemedical early medical abortion should be afforded permanence. (shrink)

Telemedicine encompasses medical practice, teaching, and research with real-time interactions over distances too great for unaided communication. It includes audio and video transmissions, either separately or combined, and can be done through mechanical or electronic means. In many ways, telemedicine is a subset of medical informatics, itself a rapidly developing field. Prior definitions have been broader, including not only medical practice over distance, but also simple information transfer.

The case of Charlie Gard sparked an ongoing public and academic debate whether in court decisions about medical treatment for children in England & Wales the best interests test should be replaced by a harm threshold. However, the literature has scantly considered (1) what the impact of such a replacement would be on future litigation and (2) how a harm threshold should be introduced: for triage or as standard for decision-making. This article directly addresses these gaps, by first analysing (...) reported cases in England & Wales about medical treatment in the context of a S31 order, thus using a harm threshold for triage and second comparing court decisions about medical treatment for children in England & Wales based on the best interest test with Dutch and German case law using a harm threshold. The investigation found that whilst no substantial increase of parental discretion can be expected an introduction of a harm threshold for triage would change litigation. In particular, cases in which harm is limited, currently only heard when there are concerns about parental decision-making, may be denied a court hearing as might cases in which the child has lost their capacity to suffer. Applying a harm threshold for triage in decisions about withholding or withdrawing life-sustaining treatment might lead to a continuation of medical treatment that could be considered futile. (shrink)

Evidence shows that during birth women frequently experience unconsented care, coercion, and a loss of autonomy. For many countries, this contradicts both the law and medical ethics guidelines, which emphasize that competent and fully informed women’s autonomy must always be respected. To better understand this discordance, we empirically describe perinatal maternity care providers’ and women’s moral deliberation surrounding coercive measures during birth. Data were obtained from 1-on-1 interviews with providers (N = 15) and women (N = 14), and a (...) survey of women (N = 118). Analyses focused on an in-depth exploration of responses to a question on the permissibility of coercion in birth whose wording was borrowed from a Swiss medical-ethical guideline. Reasons for and against a principle permissibility of coercive measures in birth were grouped into clusters of reasons to build a coherent explanatory framework. Factors considered morally relevant when deliberating on coercion included women’s decisional capacity, beneficence/non-maleficence, authority through knowledge on the part of providers, flaws of the medical system, or the imperative to protect the most vulnerable. Also, we identified various misconceptions, such as the conviction that a pathological birth can justify coercion or that fetal rights can justifiably infringe on women’s autonomy. Information and education on the issue of coercion in birth are urgently needed to enable women to fully exercise their reproductive autonomy, to prevent long-term adverse health outcomes of women and children, and to reconcile the medical vigilance which has lead to a reduction of perinatal morbidity and mortality with women’s enfranchisement in their own care. (shrink)

As healthcare institutions expand and vertically integrate, healthcare delivery is less constrained by geography, nationality, or even by institutional boundaries. As part of this trend, some aspects of the healthcare process are shifted from medical centers back into the home and communities. Telehealth applications intended for health promotion, social services, and other activitiesprovide services outside clinical settings in homes, schools, libraries, and other governmental and community sites. Such developments include health information web sites, on-line support groups, automated telephone counseling, (...) interactive health promotion programs, and electronic mail exchanges. Concomitant with these developments is the growth of consumer health informatics, in which individuals seeking medical care or information are able to find various health information resources that take advantage of new information technologies. (shrink)

This paper attempts to address the general questionwhether information technologies, as applied in thearea of medicine and health care, have or are likelyto change fundamental concepts regarding disease andhealth. After a short excursion into the domain ofmedical informatics I provide a brief overview of someof the current theories of what a disease is from amore philosophical perspective, i.e. the ``valuefree'' and ``value laden'' view of disease. Next, Iconsider at some length, whether health careinformatics is currently modifying fundamentalconcepts of disease. (...) To this question I will answerlargely in the negative, and I will provide the sketchof some arguments from current research programs inmedical informatics why I think this is the case. Thisargumentation is supported by a detailed account ofhow the disease profile for beriberi heart disease,used in one of the major medical informaticsdiagnostic programs, QMR (and its ancestorINTERNIST-1), was developed, and why at least thisprogram essentially follows received views oftraditional medicine.The one main exception to theconformity of this program to ``received'' views of adisease occurs when the program's designers need tofine-tune a disease definition. This fine-tuning is tocomport with the expert's perspective on the disease,including his or her epistemic values, as well as theprogram's other resources for diagnosing components ofa disease. (shrink)

BackgroundSystems medicine is the name for an assemblage of scientific strategies and practices that include bioinformatics approaches to human biology ; “big data” statistical analysis; and medical informatics tools. Whereas personalized and precision medicine involve similar analytical methods applied to genomic and medical record data, systems medicine draws on these as well as other sources of data. Given this distinction, the clinical translation of systems medicine poses a number of important ethical and epistemological challenges for researchers working (...) to generate systems medicine knowledge and clinicians working to apply it.DiscussionThis article focuses on three key challenges: First, we will discuss the conflicts in decision-making that can arise when healthcare providers committed to principles of experimental medicine or evidence-based medicine encounter individualized recommendations derived from computer algorithms. We will explore in particular whether controlled experiments, such as comparative effectiveness trials, should mediate the translation of systems medicine, or if instead individualized findings generated through “big data” approaches can be applied directly in clinical decision-making. Second, we will examine the case of the Riyadh Intensive Care Program Mortality Prediction Algorithm, pejoratively referred to as the “death computer,” to demonstrate the ethical challenges that can arise when big-data-driven scoring systems are applied in clinical contexts. We argue that the uncritical use of predictive clinical algorithms, including those envisioned for systems medicine, challenge basic understandings of the doctor-patient relationship. Third, we will build on the recent discourse on secondary findings in genomics and imaging to draw attention to the important implications of secondary findings derived from the joint analysis of data from diverse sources, including data recorded by patients in an attempt to realize their “quantified self.”SummaryThis paper examines possible ethical challenges that are likely to be raised as systems medicine to be translated into clinical medicine. These include the epistemological challenges for clinical decision-making, the use of scoring systems optimized by big data techniques and the risk that incidental and secondary findings will significantly increase. While some ethical implications remain still hypothetical we should use the opportunity to prospectively identify challenges to avoid making foreseeable mistakes when systems medicine inevitably arrives in routine care. (shrink)

This textbook introduces the reader to basic problems in the philosophy of science and ethics, mainly by means of examples from medicine. It is based on the conviction that philosophy, medical science, medical informatics, and medical ethics are overlapping disciplines. It claims that the philosophical lessons to learn from the twentieth century are not that nature is a 'social construction' and that 'anything goes' with respect to methodological and moral rules. Instead, it claims that there is (...) scientific knowledge, but that it is never completely secure; that there are norms, but that they are situation-bound; and that, therefore, it makes good sense to search for scientific truths and try to act in a morally decent way. Using philosophical catchwords, the authors advocate 'fallibilism' and 'particularism'; a combination that might be called 'pragmatic realism'. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This paper proposes a new definition of vocation that honors the concept’s ancient roots, is consistent with how the term is used in modern contexts, and also expands the concept for greater versatility. We discuss the centrality of service in the concept of vocation locating it as part of the bridge between a student’s core values and their embodiment in community life. The commitment to one’s profession begins before independent status as a practitioner of that profession. It begins in training (...) during which service-learning is a laudable and increasingly popular way to connect to the charitable aspects of professionalism. We further discuss how the concept of vocation is especially appropriate in the context of citizenship. Citizenship is a way of belonging to a community. It is a relationship that requires giving and taking. Service-learning is an ideal way to practice good citizenship on a local scale, and prepare future professionals for understanding their communities and commitments morebroadly. We discuss how these concepts are being emphasized in the medical informatics master’s degree program at Saint Louis University through the incorporation of a service-learning module. We describe the module, discussing how it can be applied to curricula at other institutions and modified for inclusion in other types of courses. (shrink)

This paper proposes a new definition of vocation that honors the concept’s ancient roots, is consistent with how the term is used in modern contexts, and also expands the concept for greater versatility. We discuss the centrality of service in the concept of vocation locating it as part of the bridge between a student’s core values and their embodiment in community life. The commitment to one’s profession begins before independent status as a practitioner of that profession. It begins in training (...) during which service-learning is a laudable and increasingly popular way to connect to the charitable aspects of professionalism. We further discuss how the concept of vocation is especially appropriate in the context of citizenship. Citizenship is a way of belonging to a community. It is a relationship that requires giving and taking. Service-learning is an ideal way to practice good citizenship on a local scale, and prepare future professionals for understanding their communities and commitments morebroadly. We discuss how these concepts are being emphasized in the medical informatics master’s degree program at Saint Louis University through the incorporation of a service-learning module. We describe the module, discussing how it can be applied to curricula at other institutions and modified for inclusion in other types of courses. (shrink)

Philosophers should be wary of using the methods they use in philosophy when engaging in discussions about policy makingThe beginning of November last year was a busy time in the bioethics calendar with four conferences taking place in New Zealand and Australia. The Fifth International Conference on Priorities in Health Care took place in Wellington; the Fifth Feminist Approaches to Bioethics congress, the Seventh World Congress of Bioethics, and the meeting of the Australasian Bioethics Association were all in Sydney.One of (...) the interesting features of these meetings was a move to a deeper exploration of the relations between ethics and political theory and political philosophy. The factors that drive this exploration are manifold but the four most important seem to be: 1) that ethicists often comment on, or propose political action and regulation; 2) that there is a growing awareness that the basic national and international societal and legal structures profoundly influences ethical issues; 3) the growing interest in global and third world issues, and 4) the move in many countries toward greater public participation in decision making concerning ethically contentious issues. All of these developments move the focus from the traditional subject matter of medical ethics—that is, the individual ethically charged action, to the question of how ethics should influence political action and regulation.To …. (shrink)

This paper presents work in progress on artificial intelligence in medicine (AIM) within the larger context of cognitive science. It introduces and develops the notion ofemergence both as an inevitable evolution of artificial intelligence towards machine learning programs and as the result of a synergistic co-operation between the physician and the computer. From this perspective, the emergence of knowledge takes placein fine in the expert's mind and is enhanced both by computerised strategies of induction and deduction, and by software abilities (...) to dialogue, co-operate and function as a cognitive extension of the physician's intellectual capabilities. The proposed methodology gives the expert a prominent role which consists, first, of faithfully enunciating the descriptive features of his medical knowledge, thus giving the computer a precise description of his own perception of basic medicine, and secondly, of painstakingly gathering patients into computerised case bases which simulate exhaustive long-term memory. The AI capacities for knowledge elaboration are then triggered, giving rise to mathematically optimal diagnoses, prognoses, or treatment protocols which the physician may then evaluate, accept, reject, or adapt at his convenience, and finally append to a knowledge base. The idea of emergence embraces many issues concerning the purpose and intent of artificial intelligence in medical practice. Particularly, we address the representation problem as it is raised by classical decisional knowledge-based systems, and develop the notions of classifiers and hybrid systems as possible answers to this problem. Finally, since the whole methodology touches the problem of technological investment in health care, now inherent in modern medical practice, some ethical considerations accompany the exposé. (shrink)

In the ethics of algorithms, a specifically epistemological analysis is rarely undertaken in order to gain a critique (or a defense) of the handling of or trust in medical black box algorithms (BBAs). This article aims to begin to fill this research gap. Specifically, the thesis is examined according to which such algorithms are regarded as epistemic authorities (EAs) and that the results of a medical algorithm must completely replace other convictions that patients have (preemptionism). If this were (...) true, it would be a reason to distrust medical BBAs. First, the author describes what EAs are and why BBAs can be considered EAs. Then, preemptionism will be outlined and criticized as an answer to the question of how to deal with an EA. The discussion leads to some requirements for dealing with a BBA as an EA. (shrink)

In a recent paper, Mpofu, Sen Gupta, and Hays attempt to outline the obligations of recruiting high-income countries and would-be emigrant health workers to tackle the effects of mass exodus of health workers from underserved regions. They reconstruct Rawlsian and Kantian global justice approaches to argue for moral obligations of HICs and an individual justice approach to point to non-enforceable social responsibilities of HWs to assist their compatriots. This critical commentary demonstrates that the argumentation within their individual justice approach is (...) problematic on the basis of three reasons: their discussion under-theorizes and undervalues individual rights and more specifically the right to exit, their argumentation in the latter part, even if problematically, does rather point to moral obligations in lieu of social responsibilities of HWs, and they overlook many other important freedoms, interests, and values pertinent to the issue of retention. (shrink)

In response to national trends calling for increasing accountability and an emerging dialogue within bioethics, we describe an effort to credential clinical ethicists at a major academic medical center. This effort is placed within the historical context of prior calls for credentialing and certification and efforts currently underway within organized bioethics to engage this issue. The specific details, and conceptual rationale, behind the New York-Presbyterian Hospital’s graduated credentialing plan are shared as is their evolution and ratification within the context (...) of institutional policy. While other programs will design their credentialing schema consistent with their local context and demographics, the description of one such effort is offered to be instructive to others who want to bring additional standardization to the assessment of the readiness and credentials of those who will engage in the practice of clinical ethics case consultation. (shrink)

Ethics and the Clinical Encounter explores the moral dimensions of clinical medicine and the phenomenon of illness, to determine what ethics must be in order to be fully responsive to clinical encounters. Written in a lively and conversational style with minimal technical terminology, and enhanced by actual experience or real clinical situations, this volume lays out a clinical ethics methodology both in practical and theoretical terms. Here's what the experts had to say: Professor Zaner has provided us with a remarkably (...) lucid and trenchant discussion of the interface of philosophy and the field of medicine. He brings into play an extraordinary range of historial knowledge, extensive observations based on firsthand experience with medical practices, and an acute sense of philosophical argumentation. This is a work that will be an exemplary and indispensable text in the philosophy of medicine for years to come. -- Calvin Schrag... it is a highly original contribution usable in a number of fields.... It really has no competition.... The genius of Zaner's approach is to ground ethics from the 'bottom up' and to direct us to the concrete particulars of therapeutic encounters wherein lie moral and ethical matters... meaty, challenging, and ultimately rewarding.... -- Paul R. Dokecki Richard M. Zaner founded the Center for Clinical and Research Ethics at Vanderbilt University Medical Center. Having established Vanderbilt's first Hospital Ethics Committee (1985), he served as co-chair of VUMC's Ethics Committee since its inception in 1990. Zaner has published five original books, edited ten, and translated four more, and has published more than 100 sections of books and professional journals. (shrink)

We write in response to the original article by Rennie and Rudland published in the April 2003 edition of this journal.1 Current and former Dundee Medical School students are concerned at the media misinterpretation of the study and the consequences that this branding of “dishonesty” will have on Dundee Medical School’s reputation and also on individuals embarking on their ….

Organizational ethics—defined as the alignment of an institution’s practices with its mission, vision, and values—is a growing field in health care not well characterized in empirical literature. To capture the scope and context of organizational ethics work in United States healthcare institutions, we conducted a nationwide convenience survey of ethicists regarding the scope of organizational ethics work, common challenges faced, and the organizational context in which this work is done. In this article, we report substantial variability in the structure of (...) organizational ethics programs and the settings in which it is conducted. Notable findings included disagreement about the activities that comprise organizational ethics and a lack of common metrics used to assess organizational ethics activities. A frequently cited barrier to full engagement in these activities was poor institution-wide understanding about the role and function of organizational ethics resources. These data suggest a tension in the trajectory of organizational ethics’ professionalization: while some variability is appropriate to the field’s relative youth, inadequate attention to definitions of organizational ethics practice and metrics for success can impede discussions about appropriate institutional support, leadership context, and training for practitioners. (shrink)

The Council on Ethical and Judicial Affairs of the American Medical Association examines physicians’ professional ethical responsibility in the event that the security of patients’ electronic records is breached.

The field of medicine is generally greeted with great enthusiasm. This can be witnessed in the immense support for medical progress, which is widely hoped to lead to a realization of idealized goals. Indeed, with the help of medicine the human body would be controllable and constructible, human nature perfectible. However, enthusiasm in favor of medical progress is first and foremost a sentiment and, like all sentiments, not necessarily a product of rational contemplation. People are capable of enthusing (...) about the realization of utopian notions, such as life without disease or with the perfect body, without requiring any concrete arguments to back them up. Enthusiasm alone is not a guarantee of ethical desirability, however. Hence, this book takes a closer look at four research fields often referred to in medical utopian literature: 'tissue engineering', 'bioelectronics', 'germ line genome modification' and 'interventions in the biological aging process'. They serve as a basis for analyzing whether ethical arguments can be found to support the euphoric advocacy of the further development of these fields. (shrink)

The unprecedented development of medical informatics is constantly transforming the concept of expertise in medical sciences in a way that has far-reaching consequences for both the theory of knowledge and the philosophy of informatics. Deep medicine is based on the assumption that medical diagnosis should take into account the wide array of possible health factors involved in the diagnostic process, such as not only genome analysis alone, but also the metabolome (analysis of all body metabolites (...) important for e.g. drug-drug interactions), microbiome (i.e. analysis of all bodily microorganisms interacting with host cells) or exposome (analysis of all environmental factors triggering potentially harmful cell mutations, such as UV radiation, heavy metals, various carcinogens, etc.). Deep data analysis is of tantamount importance for personalized diagnosis but, at the same time, hardly achievable by a regular human being. However, adequately designed artificial intelligence (e.g. a deep neural network) can undeniably be of great help for finding correlations between symptoms and underlying diseases. Nowadays AI applies to nearly every aspect of medicine, starting from the data analysis of scientific literature, through the diagnostic process, to the act of communication between physicians and their patients. Medical image processing algorithms greatly enhance the chances of successful recognition of melanoma or intestinal polyps. Communication tools designed for physicians use techniques known from social media to provide users with an opportunity to consult the case with colleagues from the same discipline. Natural language processing tools significantly improve doctor-patient communication by the automation of note-taking. Is this enough to support the claim that the non-epistemic competences in medicine are becoming more and more important? Can we attribute expertise only to a person? How is medical informatics changing the way most people usually understand human-computer interactions? (shrink)

This baseline study was conducted to find out the knowledge, attitudes and practices of medical ethics among the undergraduate medical interns who did not have structured ethics curriculum in their course. A descriptive, cross-sectional study was carried out using a self-administered structured questionnaire among the medical undergraduate interns of Maharajgunj Medical Campus, the pioneer medical college of Nepal which enrols 60 students in a year. A total of 46 interns participated in the study. The most (...) common source of knowledge on ethics was lectures/seminars (35.7%) followed by experience at work (24.5%), training (21.4%) and own reading (17.3%). The main contents of Hippocratic Oath were known to 98.8% while 60.9% knew the main contents of Nepal Medical Council (NMC) code of ethics. Great majority (91.3%) regard ethics as very important in medical profession. “Doctors know the best irrespective of patients’ opinion” was disagreed by only 39.1% indicating the paternalistic attitude. However, 78.3% were in favour of adhering to the patient’s wish. None of the participant agreed to abandon confidentiality. Only about one-fourth (26.1%) claim to encounter ethical dilemma every day while the highest number (43.5%) had once in a month. To deal with the situation of ethical dilemma, majority approached to immediate supervisor followed by head of the department and colleagues. Eighty-seven percent of participating interns were involved in research activities involving human subjects. Only one of the participants had encountered the ethical issue on end-of-life and it was do-not-resuscitate consent in a terminally ill patient. On implementation of the curriculum on medical ethics focus should be - principles of biomedical ethics, sensitive ethical dilemmas like end-of-life care and practical experiences with participation in deliberations of the ethics committee. (shrink)

INTRODUCTION The Questions of Medical Ethics Call him Andrew. His face is gaunt and unshaven but peaceful. His eyelids are gently closed. ...