Both developing and developed countries face an increasing mismatch between what patients expect to receive from healthcare and what the public healthcare systems can afford to provide. Where there has been a growing recognition of the entitlement to receive healthcare, the frustrated expectations with regards to the level of provision has led to lawsuits challenging the denial of funding for health treatments by public health systems. This book analyses the impact of courts and litigation on the way (...) class='Hi'>health systems set priorities and make rationing decisions. In particular, it focuses on how the judicial protection of the right to healthcare can impact the institutionalization, functioning and centrality of Health Technology Assessment (HTA) for decisions about the funding of treatment. Based on the case study of three jurisdictions - Brazil, Colombia, and England - it shows that courts can be a key driver for the institutionalization of HTA. These case studies show the paradoxes of judicial control, which can promote accountability and impair it, demand administrative competence and undermine bureaucratic capacities. The case studies offer a nuanced and evidence-informed understanding of these paradoxes in the context of health care by showing how the judicial control of priority-setting decisions in health care can be used to require and control an explicit scheme for health technology assessment, but can also limit and circumvent it. (shrink)

“HTA is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused, and seek to achieve best value” (EUnetHTA 2007). Even though the assessment of ethical aspects of a health technology is listed as one of the objectives of a (...) HTA process, in practice, the integration of these dimensions into reports remains limited. The article is focused on four points: 1. the HTA concept; 2. the difficult HTA-ethics relationship; 3. the ethical issues in HTA; 4. the methods for integrating ethical analysis into HTA. (shrink)

The World Health Assembly has encouraged WHO member-states to establish capacity in health technology assessment (HTA) as a support for achieving universal health coverage (UHC). Simultaneously, the WHO has stated that UHC is “a practical expression of the concern for health equity and the right to health.” This has prompted questions about potential tensions between priority-setting efforts and the right to health on the road to UHC. South Africa (SA) is an ideal (...) setting in which to explore how the priority-setting work of an HTA body may be integrated with an existing rights framework. (shrink)

In this contribution, I wish to explore the potential of health technology assessment and ethics for increasing our capacity to pre-empt the shortcomings and undesired consequences of modern health care while maintaining its benefits. Central is the presumption that in case of some health problems this cannot be done unless we explicitly reconsider some features of the modern health care system, especially those related to its strong reliance on scientific rationality and the strong role (...) played by medical professionals.So as to both maintain the benefits of advanced health care and ensure that it produces less reason for concern, we need to reconsider our approach to rationality—and maybe even the way in which we build our health care system around that rationality. That is, we need to introduce an element of reflexivity. Two types of circumstances are being explored in which such reflexivity may prove worthwhile: controversies on side effects, and persistent problems encountered in optimising health care. Drawing on brief discussions of typical cases, we explore the potential of reflexive HTA and its methodical prerequisites.We conclude that ethicists may contribute to reflexive HTA, if they combine a hermeneutic—and often also participative—methodology with a solid understanding of the relation between the health problem under scrutiny and more general critique of the health care system. Insights from the areas of science and technology studies, as well as from social philosophy may be critical items in their tool kit. (shrink)

Health technology assessment (HTA) is often biased in the sense that it neglects relevant perspectives on the technology in question. To incorporate different perspectives in HTA, we should pursue agreement about what are relevant, plausible, and feasible research questions; interactive technology assessment (iTA) might be suitable for this goal. In this way a kind of procedural ethics is established. Currently, ethics too often is focussed on the application of general principles, which leaves a lot (...) of confusion as to what really is the matter in specific cases; in an iTA clashes of values should not be approached by use of such ethics. Instead, casuistry, as a tool used within the framework of iTA, should help to articulate and clarify what is the matter, as to make room for explication and consensus building. (shrink)

A comprehensive assessment of a health technology requires that a wide variety of questions are addressed. These range from whether the use of a technology results in achievement of its intended effects at acceptable costs and without incurring undue risks to the patient, to whether its use may challenge existing social arrangements and values. Clearly, this is a major challenge, since it requires the use of quite different methods of inquiry. In the past decades, we have (...) rarely witnessed assessments where both types of questions were addressed in a balanced way. Rather, a wide gap exists between inquiries with a strong empirical focus and an almost complete neglect of underlying normative issues, and inquiries which are largely discursive, but with a serious disregard of relevant empirical data. The complex interplay between normative frameworks and empirical data in the assessment of health technologies is illustrated in two case studies: the assessment of surgical management of children with glue ears, and the assessment of Extra Corporeal Membrane Oxygenation in neonates. (shrink)

Health technology assessment (HTA) is often biased in the sense that it neglects relevant perspectives on the technology in question. To incorporate different perspectives in HTA, we should pursue agreement about what are relevant, plausible, and feasible research questions; interactive technology assessment (iTA) might be suitable for this goal. In this way a kind of procedural ethics is established. Currently, ethics too often is focussed on the application of general principles, which leaves a lot (...) of confusion as to what really is the matter in specific cases; in an iTA clashes of values should not be approached by use of such ethics. Instead, casuistry, as a tool used within the framework of iTA, should help to articulate and clarify what is the matter, as to make room for explication and consensus building. (shrink)

The UK’s National Institute for Health and Care Excellence is responsible for conducting health technology assessment on behalf of the National Health Service. In seeking to justify its recommendations to the NHS about which technologies to fund, NICE claims to adopt two complementary ethical frameworks, one procedural—accountability for reasonableness —and one substantive—an ‘ethics of opportunity costs’ that rests primarily on the notion of allocative efficiency. This study is the first to empirically examine normative changes to (...) NICE’s approach and to analyse whether these enhance or diminish the fairness of its decision-making, as judged against these frameworks. It finds that increasing formalisation of NICE’s approach and a weakening of the burden of proof laid on technologies undergoing HTA have together undermined its commitment to EOC. This implies a loss of allocative efficiency and a shift in the balance of how the interests of different NHS users are served, in favour of those who benefit directly from NICE’s recommendations. These changes also weaken NICE’s commitment to AfR by diminishing the publicity of its decision-making and by encouraging the adoption of rationales that cannot easily be shown to meet the relevance condition. This signals a need for either substantial reform of NICE’s approach, or more accurate communication of the ethical reasoning on which it is based. The study also highlights the need for further empirical work to explore the impact of these policy changes on NICE’s practice of HTA and to better understand how and why they have come about. (shrink)

Consumer engagement in decisions about the funding of medicines is often framed as a good in and of itself and as an activity that should be universally encouraged. A common justification for calls for consumer engagement is that it enhances equity. In this paper we systematically critique this assumption. We show that consumer engagement may undermine equity as well as enhance it and show that a simple relationship cannot be assumed but must be justified and demonstrated. In concluding, we present (...) a number of challenges that need to be overcome in order for consumer engagement to contribute to health technology assessment in a morally and politically sound manner. (shrink)

In many countries, health technology assessment organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in the methodologies HTA (...) organizations use to conduct their evaluations and considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy. (shrink)

The role of normative reflection and the possibilities of ethical inquiry in technology assessment have been under discussion in the TA community for several years. As an outcome of this discussion the necessity of explicitly dealing with normativity in TA has widely been acknowledged. However, it is still quite unclear in which way this should be done. This paper is dedicated to the role (and limitations) of ethical expertise in this field, especially in HTA. By methodological analysis an (...) approach is developed to show how entry points for ethical expertise could be identified. The result is that ethical expertise can inform moral debates by uncovering underlying assumptions, by making the normative structure of argumentation transparent, and by weighing the strength of the arguments. In this way moral debates in HTA can become more transparent and opened to argumentative reasoning instead of consisting of bargaining processes determined by power distributions. Ethical reflection, however, does not replace decision-making. (shrink)

The worldwide COVID-19 pandemic has shed more light on the difficulty of making health care decisions integrating scientific knowledge and values associated to life and death issues, human suffering, quality of life, economic losses, liberty of movement, etc. But the difficulties related to health care decisions and the use of innovative drugs or technologies are not new, and many countries have created agencies that have the mandate to evaluate new technologies in health care. Health Technological (...) class='Hi'>Assessment (HTA) reports’ aim is to guide the decision makers in these difficult matters. There are two ethical components in HTA. The first is the report’s presentation of an ethical evaluation of the technology. The second is the value-ladenness of the HTA decision-making process itself. When implicit value judgments are not elicited, the justification of the final decision cannot be transparent. The present paper aims to identify and elicit the implicit value-judgments related to each step of the HTA process. This research is grounded on an applied ethics decision-making paradigm based on the role of value judgments in the decision-making process. The first part discusses two different approaches to values and value judgments in HTA. In the second part, citations mentioning value judgments extracted from a systematic review on the integration of ethics into HTA were categorized to elicit the value judgments and their criteria for each different HTA decision-making steps. The results show that there are 18 decision-making steps in the HTA process where 23 implicit value-judgments can be recognized. The range of these value judgments encompasses the whole HTA process: from the initial request, the presenting of the principal issues, to the final report’s dissemination. Since stakeholders need to understand which value judgments the conclusion of a report relies on, eliciting the implicit value judgments in the HTA decision-making process should yield more transparency. (shrink)

This paper aims at discussing some contributions, limitations and opportunities that efficiency and equity studies could make to form a better understanding of ethical issues involved in health technology assessment (HTA). Prenatal detection of Down syndrome is used as a case study for further discussions regarding efficiency and equity, as well as other ethical principles including beneficence, non-maleficence and autonomy. The development and use of adequate methods and the need for context appraisal are two imperative issues in (...) this field of knowledge. The analysis of ethical implications in HTA should account for both. Economic evaluation methodologies have great potential in the assessment of some key ethical principles such as efficiency and equity but are of limited use concerning other fundamental principles. Social and individual values play a prominent role in this respect. (shrink)

A comprehensive assessment of a health technology requires that a wide variety of questions are addressed. These range from whether the use of a technology results in achievement of its intended effects (e.g., better tumour control, pain relief, improved mobility, etc.) at acceptable costs and without incurring undue risks to the patient, to whether its use may challenge existing social arrangements and values (e.g., individual responsibility for preserving good health, the value of human life, etc.). (...) Clearly, this is a major challenge, since it requires the use of quite different methods of inquiry. In the past decades, we have rarely witnessed assessments where both types of questions were addressed in a balanced way. Rather, a wide gap exists between inquiries with a strong empirical focus and an almost complete neglect of underlying normative issues, and inquiries which are largely discursive, but with a serious disregard of relevant empirical data. The complex interplay between normative frameworks and empirical data in the assessment of health technologies is illustrated in two case studies: the assessment of surgical management of children with glue ears, and the assessment of Extra Corporeal Membrane Oxygenation in neonates. (shrink)

The widespread application of technology in health care has imposed a broad range of challenges. The field of health technology assessment (HTA) is developed in order to face some of these challenges. However, this strategy has not been as successful as one could hope. One of the reasons for this is that social and ethical considerations have not been integrated in the HTA process. Nowadays however, such considerations have been included in many HTAs. Still, the (...) conclusions and recommendations of the HTAs are not followed. The reason for this may be that the methods for integrating ethics for HTA are not sufficiently developed, or that they are not adequate. This article presents a supplementary approach to the ethical inquiry in HTA. It is argued that a value analysis is crucial in order to address the ethical issues of health care technology in a fruitful way and to make viable decisions about such technology. (shrink)

Healthcare expenditures account for approximately 9% of GDP in OECD countries and are on an upward trajectory (OECD, 2017). This significant financial burden, combined with an aging global population and increasing demand, emphasizes the imperative for sustained research and innovation to enhance health system efficacy. Key to this transformation are technological advancements, including digital health, which presents novel opportunities for improvement. Emerging digital health technologies, such as virtual consultations, complex imaging procedures, and electronic medical records, are fundamental (...) to modern healthcare infrastructures. However, significant gaps remain in the evaluation and understanding of these innovations, especially for nascent technological areas. This thesis addresses this subject, aiming to delineate how individuals and institutions can bolster their evaluative capabilities, strategic decision-making, and planning for the deployment of emerging digital healthcare technologies. The research methodology amalgamates theoretical exploration, literature scrutiny, and empirical examinations, presenting an integrated perspective that intersects the disciplines of Management & Decision Science, Technology & Innovation, and Health Economics & Outcomes Research. From an applied perspective, this research focuses on developing evidence within the context of pediatric healthcare in Canada — a context notably underrepresented in healthcare management research, despite its disproportionate per capita expenditure. Technologically, the predominant focus is on applications in virtual reality (VR) and three-dimensional (3D) printing and virtualization, though with the aspiration of ensuring the generalizability of results. The current thesis is structured to parallel the progression of the research itself, as three distinct phases; this begins with a comprehensive Background that contextualizes the initial intent, exploring the relationship between technology, innovation, and health outcomes. In this phase, each academic discipline is analyzed to identify base theoretical underpinnings for the research. The second phase of this work includes five empirical studies, each preceded by context-specific literature reviews for the respective technological domain, providing insight into the current state of evidence related to value-based assessment and economic evaluation in that area. Empirical studies included a randomized controlled trial and a cost consequences assessment of VR for pre-procedural preparation for medical imaging. Additionally, novel applications of 3D printing and virtualization are critically analyzed, accompanied by a multi-case study on the implementation of 3D printing in pediatrics, a cost-consequences study of applications for thoracoabdominal surgeries, and an outcomes study on the use of 3D virtualization in medical education during the COVID-19 pandemic. The final phase of this research includes the critical analysis and synthesis of findings into a proposal for a novel value-based assessment and decision-making framework specific to emerging health innovations; this framework integrates insights and resources for clinicians, administrators, and policymakers. The outcomes of this research are skewed toward Knowledge Users, but also aims to advance the theoretical basis for health technology assessment (HTA). (shrink)

BackgroundWhile evaluation of ethical aspects in health technology assessment has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA.MethodsThe framework was developed through the following (...) phases: 1) a systematic review and content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework.ResultsThe proposed framework consists of three main components: an algorithmic flowchart, which exhibits the different steps of an ethical inquiry throughout the HTA process, including: defining the objectives and scope of the evaluation, stakeholder analysis, assessing organizational capacity, framing ethical evaluation questions, ethical analysis, deliberation, and knowledge translation; a stepwise guide, which focuses on the task objectives and potential questions that are required to be addressed at each step; and a list of some commonly recommended or used tools to help facilitate the evaluation process.ConclusionsThe proposed framework can be used to support and promote good practice in integration of ethics into HTA. However, further validation of the framework through case studies and expert consultation is required to establish its utility for HTA practice. (shrink)

Innovative healthcare technologies may raise ethical concerns which prevent their implementation for fear of unexpected or undesirable outcomes, even before they are introduced into usual clinical practice. Essential to innovation is therefore to analyze benefits and drawbacks from a multidisciplinary point of view (i.e., biomedical, social, financial). Value-based healthcare is currently the most comprehensive theoretical framework to evaluate the benefits of healthcare technologies on patients and society in the longer term. Technically, “the systematic evaluation of properties, effects and/or impacts of (...) health technologies” must be performed by validated procedures of Health Technology Assessment (HTA), supported by early HTA procedures to retrieve preliminary evidence and expert opinions. The aim of this study is to perform an early HTA of germline editing technologies in order to estimate their impact on patients and society, in light of the recent, controversial debate which followed the germline gene editing of human embryos. (shrink)

Health technology assessment consists of thesystematic study of the consequences of theintroduction or continued use of the technology in aparticular context, with the explicit objective toarrive at a judgment of the value or merit of thetechnology. Ideally, it is aimed at assessing allaspects of a given technology or group oftechnologies, including non-technical, e.g.socio-ethical, aspects. However, methods for assessingsocio-ethical implications of health technology arerelatively undeveloped and few mechanisms exist totake action based on the results (...) of such evaluations.Still, the examples of cochlear inplants and other cases illustratethat HTA is not a matter of merely collecting thefacts about a technology. The facts must beplausible and relevant from a particular framework,which is not always shared by different groups. It ishere that socio-ethical aspects are encountered. Ifhealth technology assessment aims to enhance theaccountability of the decision making processregarding funding and use of health technology, it isa major challenge to assessors of health technologiesto deal adequately with existing value pluralism. Inthis respect interactive evaluation may have somethingto offer. (shrink)

While evaluation of ethical aspects in health technology assessment has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response...

ML-HCAs have the potential to significantly change an entire healthcare system. It is not even necessary to presume that this will be disruptive but sufficient to assume that the mere adaptation of...

With a growing number of genetic tests becoming available to the health and consumer markets, genetic health care providers in Canada are faced with the challenge of developing robust decision rules or guidelines to allocate a finite number of public resources. The objective of this study was to gain Canadian genetic health providers' perspectives on factors and criteria that influence and shape resource allocation decisions for publically funded predictive genetic testing in Canada. The authors conducted semi-structured interviews (...) with 16 senior lab directors and clinicians at publically funded Canadian predictive genetic testing facilities. Participants were drawn from British Columbia, Alberta, Manitoba, Ontario, Quebec and Nova Scotia. Given the community sampled was identified as being relatively small and challenging to access, purposive sampling coupled with snowball sampling methodologies were utilized. Surveyed lab directors and clinicians indicated that predictive genetic tests were funded provincially by one of two predominant funding models, but they themselves played a significant role in how these funds were allocated for specific tests and services. They also rated and identified several factors that influenced allocation decisions and patients' decisions regarding testing. Lastly, participants provided recommendations regarding changes to existing allocation models and showed support for a national evaluation process for predictive testing. Our findings suggest that largely local and relatively ad hoc decision making processes are being made in relation to resource allocations for predictive genetic tests and that a more coordinated and, potentially, national approach to allocation decisions in this context may be appropriate. (shrink)

HTA and TA institutions at national parliaments (PTA) both share the same origin and of course have objectives and some of their methods in common. Nevertheless both TA branches developed in some distance during the 1970s and 1980s. Drawing on the case of biomedicine this paper outlines the differences between HTA and PTA, highlighting the “clinical perspective” of HTA and the “societal perspective” of PTA. It is shown that biomedicine which has developed rapidly during the last decade has hardly been (...) dealt with by HTA, whereas it ranked quite prominent on the agendas of PTA institutions. Biomedical technologies became a subject of policy making beyond the boundaries of health care politics since biomedicine is perceived as an ethical challenge to society and not only as a medical innovation that has to be assessed by clinical experts. It is argued that there may however be good reasons to integrate the HTA and the PTA perspective in future TA on biomedical technologies. (shrink)

Interactive technology assessment is a novel approach to evaluating (health) technology, which philosophically draws from the works of Rawls and Habermas. That is, it seeks to organise a practical setting for discursive ethics in order to find a legitimate basis for policy to be pursued when the technology under scrutiny features a moral controversy. Interactive technology assessment involves a cycle of interviews with all stakeholders, who are explicitly asked to respond (anonymously) to the (...) concerns and issues raised by other participants. This cycle is completed repeatedly, so that a process of vicarious learning develops. This process aims at identifying issues agreed and disagreed upon, on the basis of which widely endorsed policy recommendations can be formulated. This chapter involves an interactive technology assessment of paediatric cochlear implantation. The rationale, the design, and the results are explained, as well as the main ethical aspects of the procedure. (shrink)

This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S. have resulted in exceptionally thin protection for the users of consumer-facing devices and products that rely on or that facilitate consumer collection or aggregation of health and wellness data. It also examines some appealing legislative alternatives to the current thin model used in the U.S. (...) and suggests a framework for prioritizing ameliorative regulation. To better understand existing regulatory models, their deficiencies, and how they should be reformed, the article employs an analytical model describing these regulatory systems across two axes. The vertical axis describes the quantity or depth of regulation, such as, for example, the strictness of the rules imposed by the regulatory model. The horizontal axis describes the reach of the regulation, the behaviors, products, or industries to which the regulation applies. (shrink)

This article adopts a population-level bioethics approach to analyzing the ethical implications of novel deep-brain stimulation (DBS) technologies. I claim that a microlevel focus on costs and benefits is necessary but insufficient to address the concerns of social justice and health equity that attend the potential utilization of DBS technologies. A macrosocial, population-based analysis notes two ethically significant trends regarding novel health technologies: (1) that they are the prime mover of hyperinflationary health cost trajectories, and (2) that (...) even where they improve overall population health such technologies may expand health inequalities. Such an expansion could exacerbate what Powers and Faden have identified as “densely-woven patterns of disadvantage,” and therein could contravene mandates of social justice. Such concerns of justice and equity are sharpened by the fact that those populations that bear the highest risk of suffering the injuries and illnesses for which DBS technologies might be warranted are among the most disadvantaged groups in American society. Accordingly, ethical analysis of DBS technologies must include an assessment of the evidence suggesting that in their capacity to improve health and compress health inequalities, whole-population approaches that address the upstream factors that shape distributions of neuropsychiatric injuries and illness may be preferable to acute health interventions. However, the article warns against the false-choice fallacy, and notes that whole-population policies and acute care interventions can be simultaneously endorsed. The article concludes by suggesting that the ethical issue of relative priority between these approaches is best framed via a population-level analysis. (shrink)

Technology Assessment (TA) is a problem oriented endeavour dealing with political, societal, ecological, etc. problems. Only in rare cases is one individual scientific discipline sufficient to assess these problems. Usually the perspectives of different scientific disciplines have to be combined in order to develop interdisciplinary based recommendations to act. In this paper a quality controlled interdisciplinary discussion process is described which encourages an expert group to generate argumentation chains cross-cutting the disciplinary boundaries. The role of ethical reflection in (...) this procedure depends on the problem situation. Whenever a technical application is on the agenda which cannot be allocated to a so-called “business-as-usual” case, one would ask for ethical reflection. This contribution argues that this ethical reflection has to take place together with the interdisciplinary discussion due to two reasons. Firstly, the technical, economical, legal and social aspects are deeply cross-correlated with the ethical reflection. And secondly, participating in such interdisciplinary discussions enables an ethical reflection which keeps in touch with the real world. Two case studies dealing with robotics applications in health care are mentioned as examples for problem settings, in which interdisciplinary TA succeed in developing discipline-crossing argumentation chains. (shrink)

Medical technology assessment deals with the evaluation of novel or existing health care procedures. This paper addresses the interdependence between factual and normative issues, using the controversies about acceptability and desirability of reduced-size liver transplantations with living donors as example.

Interdisciplinary research calls together different scientific disciplines in order to answer a research question which cannot be answered by an individual discipline alone. Technology Assessment (TA) is a problem-oriented approach (Bechmann and Frederichs 1996) dealing with the non-technical aspects of technology development, in order to gain knowledge about the (un-)intended consequences, the (un-)desired impacts, the main and side-effects and the chances and risks of (new) technologies. Moreover, by applying TA, scientists can develop potential solutions to solve societal (...) or political problems related to, for example, the “grand challenges” such as “feeding 10 billion people,” demographic change, global health. These societal problems need to be reframed or transformed into research questions to be dealt with by interdisciplinary research. Which scientific disciplines are invited to participate in an interdisciplinary research project is defined with respect to these research questi. (shrink)

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 293-302.

In this mixed methods study we identify and assess ethical and pragmatic issues and dilemmas surrounding e-health technologies in the context of primary care, including what is already in the literature. We describe how primary healthcare professionals can access reliable and accurate data, improve the quality of care for patients, and lower costs while following institutional guidelines to protect patients. Using qualitative and quantitative methodologies we identify several underlying ethical and pragmatic burdens and benefits of e-health technologies. The (...) 41 study participants reported more burdens than benefits, and were generally ambivalent about their level of satisfaction with their institutions’ ehealth technologies, their general knowledge about the technologies, and whether e-health can improve team-based communication and collaboration. Participants provided recommendations to improve e-health technologies in primary care settings. (shrink)

Innovations permeate healthcare settings on an ever-increasing scale. Health technology innovations impact our perceptions and experiences of health, care, disease, etc. Because of the fast pace these HTIs are being introduced in different healthcare settings, there is a growing societal consensus that these HTIs need to be governed by ethical reflection. This paper reports a systematic review of argument-based literature which focused on articles reporting on ethical frameworks to screen or evaluate HTIs. To do this a four (...) step methodology was followed: Literature search conducted in five electronic literature databases; Identification of relevant articles; Development of data-extraction tool to analyze the included articles; Analysis, synthesis of data and reporting of results. Fifty-seven articles were included, each reporting on a specific ethical framework. These ethical frameworks existed out of characteristics which were grouped into five common ones: Motivations for development and use of frameworks; Objectives of using frameworks; Specific characteristics of frameworks ; Ethical approaches and concepts used in the frameworks; Methods to use the frameworks. Although this multiplicity of ethical frameworks shows an increasing importance of ethically analyzing HTIs, it remains unclear what the specific role is of these analyses. An ethics of caution, on which ethical frameworks rely, guides HTIs in their design, development, implementation, without questioning their technological paradigm. An ethics of desirability questions this paradigm, without guiding HTIs. In the end, a place needs to be found in-between, to critically assess HTIs. (shrink)

COVID-19 has created additional challenges in mental health services, including the impact of social distancing measures on care and treatment. For situations where a detention under mental health legislation is required to keep an individual safe, psychiatrists may consider whether to conduct an assessment in person or using video technology. The Mental Health Act 2003 does not stipulate that an assessment has to be conducted in person. Yet, the Code of Practice envisions that detention (...) assessments would be conducted face to face in all circumstances. During the pandemic, the Mental Welfare Commission for Scotland, a statutory body with a duty to promote best practice of the Act, has been asked whether it may be acceptable and indeed preferable for some assessments to be conducted via video technology. Where an assessment is needed to determine if a patient needs to be detained, and where there is a need for social distancing or the need for ‘shielding’, remote assessments may in some circumstances be preferable. In this article, we outline the modification of the Mental Welfare Commission’s previous outright rejection of virtual assessments as the pandemic progressed and discuss the ethical and legal issues the possibility of remote assessments has exposed. We also discuss the limits and when a virtual assessment is not considered ethical. As the pandemic moves from a state of emergency into a ‘new normal’ in psychiatric services during second, or subsequent, waves, the use and place of remote assessments for detention needs to be considered. (shrink)

Health policy is increasingly confronted with the demand for financing genetic testing on inherited susceptibility to disease. Tests on polymorphism/snp associated with multicausal and chronic conditions are already offered in private commercial institutions or in academic hospitals. The increasing pressure on public health services to offer SNP testing leads to first methodological approaches for a generally valid regulatory framework applicable for inclusion or refusal of genetic tests into the public health services. Systematic search in Medline, Embase and (...) the Web for methodological papers or guidelines for the assessment of polymorphism-screening. Since genetic testing has not only clinical and economic effects on health care, but also primarily ethical consequences by profiling our understanding of “health” and “disease”, this paper gives an overview of relevant aspects and background information to consider in the assessment of genetic tests. Although 2–3 million SNPs are identified and the journals are full of reported “significant” associations between disease and mutation, only a few can be replicated unequivocally. The ACCE -framework was developed by the Center of Disease Control for the assessment of genetic testing. This standardised appraisal approach proposes collecting and evaluating: Prevalence, genotype-/phenotype-relation. Clinical presentation: natural history; the different expressions of disease. Performance of the genetic test. Implications for therapy and prevention. Conclusion for clinical applications of risk-profiling of health on their susceptibility to disease and/or for clarification of disease for therapy planning. Since genetic testing is urging its way into the health care system, the actual danger is, that population screening starts before valid evidence from big prospective studies have been carried out and delivered proofs of direct causal associations. Before diffusing into the health care system we are suggesting to take a cautious and standardised approach. (shrink)

As the number of medical and health humanities degree programs in the United States rapidly increases, it is especially timely to consider the range of specific disciplinary perspectives that might benefit students enrolled in these programs. This paper discusses the inclusion of one such perspective from the field of Science and Technology Studies The author asserts that STS benefits students in the medical and health humanities in four particular ways, by: challenging the “progress narrative” around the advancement (...) of biomedicine as scientific practice, evaluating the meaning of technology, especially in how technology orients us towards sickness and how health technology is in turn shaped by social and cultural values, assessing the plurality of biomedical epistemologies, rather than assuming biomedicine is one, cohesive body of knowledge that does not differ across contexts, and critiquing bias in biomedical practice and science, especially in the marginalization of women’s voices and in the racial and postcolonial trajectories of contemporary biomedicine. The paper discusses the theoretical importance of these four trajectories to the medical and health humanities, as well as the venues for inclusion of STS within coursework and programming at Case Western Reserve University. The paper also comments on how programming at other institutions might be adapted to incorporate STS scholarship. By drawing on numerous examples of research in the anthropology, sociology, history, and the philosophy of science, this article seeks to open a conversation about the value of science and technology studies to health humanities pedagogy. (shrink)

In the field of health technology assessment, there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues in HTA in the field of complex health interventions. Complex health interventions have been the focus of methodological (...) attention in HTA. However, the potential methodological challenges for ethical analysis are as yet unknown.Six of the most frequently described and applied ethical approaches in HTA were critically assessed against a set of five characteristics of complex health interventions: multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes, and ethical complexity. The assessments are based on literature and the authors’ experiences of developing, applying and assessing the approaches.The Interactive, participatory HTA approach is by its nature and flexibility, applicable across most complexity characteristics. Wide Reflective Equilibrium is also flexible and its openness to different perspectives makes it better suited for complex health interventions than more rigid conventional approaches, such as Principlism and Casuistry. Approaches developed for HTA purposes are fairly applicable for complex health interventions, which one could expect because they include various ethical perspectives, such as the HTA Core Model® and the Socratic approach.This study shows how the applicability for addressing ethical issues in HTA of complex health interventions differs between the selected ethical approaches. Knowledge about these differences may be helpful when choosing and applying an approach for ethical analyses in HTA. We believe that the study contributes to increasing awareness and interest of the ethical aspects of complex health interventions in general. (shrink)

This paper challenges traditional views which oppose health economics and medical ethics by arguing that economic assessment is a necessary complement to medical ethics and can help to improve public participation and democratic processes in choices about resource allocation for health care technologies. In support of this argument, four points are emphasized: (1) Most current biomedical ethical debates implicitly deal with economic issues of resource allocation. (2) Clinical decisions, which usually respect the Hippocratic code of ethics, are (...) nevertheless influenced by economic incentives and constraints. (3) Economic assessment is concerned with both efficiency and equity and potential trade-offs between the two, which means that ethical judgements are always embedded in welfare economics. (4) The real debate is not between economics on the one side and medical ethics on the other. Rather it is between different ethical conceptions of social justice and the contrasting approaches they entail to reconciling individual interests and preferences with collective goods and welfare. (shrink)

BackgroundIncreasingly, hospitals and research institutes are developing technical solutions for sharing patient data in a privacy preserving manner. Two of these technical solutions are homomorphic encryption and distributed ledger technology. Homomorphic encryption allows computations to be performed on data without this data ever being decrypted. Therefore, homomorphic encryption represents a potential solution for conducting feasibility studies on cohorts of sensitive patient data stored in distributed locations. Distributed ledger technology provides a permanent record on all transfers and processing of (...) patient data, allowing data custodians to audit access. A significant portion of the current literature has examined how these technologies might comply with data protection and research ethics frameworks. In the Swiss context, these instruments include the Federal Act on Data Protection and the Human Research Act. There are also institutional frameworks that govern the processing of health related and genetic data at different universities and hospitals. Given Switzerland’s geographical proximity to European Union (EU) member states, the General Data Protection Regulation (GDPR) may impose additional obligations.MethodsTo conduct this assessment, we carried out a series of qualitative interviews with key stakeholders at Swiss hospitals and research institutions. These included legal and clinical data management staff, as well as clinical and research ethics experts. These interviews were carried out with two series of vignettes that focused on data discovery using homomorphic encryption and data erasure from a distributed ledger platform.ResultsFor our first set of vignettes, interviewees were prepared to allow data discovery requests if patients had provided general consent or ethics committee approval, depending on the types of data made available. Our interviewees highlighted the importance of protecting against the risk of reidentification given different types of data. For our second set, there was disagreement amongst interviewees on whether they would delete patient data locally, or delete data linked to a ledger with cryptographic hashes. Our interviewees were also willing to delete data locally or on the ledger, subject to local legislation.ConclusionOur findings can help guide the deployment of these technologies, as well as determine ethics and legal requirements for such technologies. (shrink)

The concept of health is not only a specific criterion for evaluation of water quality delivered by a distribution system but also a suitable paradigm for overall functioning of the hydraulic and structural components of the system. This article views health, despite its complexities, as the only criterion with suitable depth and breadth to allow a holistic assessment of system performance. Although many decisions relating to the planning and design of water distribution systems do implicitly consider human (...) health, engineers and planners seldom explicitly adopt a “health mindset” overall and, thus, miss the richness and possibilities of a health framework for a wider range of system evaluations, considerations, and trade-offs. This article argues why a breakdown in a healthy system will so frequently result in stresses experienced by humans and briefly reviews the concepts of human health and system health and provides specific examples of a significant interaction between the two. (shrink)

Health technology assessment (HTA) was developed in the 1970s and 1980s to facilitate decision making on the desirability of new biomedical technologies. Since then, many of the standard tools and methods of HTA have been criticized for their implicit normativity. At the same time research into the character of technology in practice has motivated philosophers, sociologists and anthropologists to criticize the traditional view of technology as a neutral instrument designed to perform a specific function. Such (...) research suggests that the tools and methods of more traditional forms of HTA are often inspired by an ‘instrumentalist’ conception of technology that does not fit the way technology actually works. This paper explores this hypothesis for a specific case: the assessments and deliberations leading to the introduction of breast cancer screening in the Netherlands. After reconstructing this history of HTA ‘in the making’ the stepwise model of HTA that emerged during the process is discussed. This model was rooted indeed in an instrumentalist conception of technology. However, a more detailed reconstruction of several episodes from this history reveals how the actors already experienced the inadequacy of some of the instrumentalist presuppositions. The historical case thus shows how an instrumentalist conception of technology may result in implicit normative effects. The paper concludes that an instrumentalist view of technology is not a good starting point for HTA and briefly suggests how the fit between HTA methods and the actual character of technology in practice might be improved. (shrink)

The use of mobile technology, such as sports bracelets, is gaining popularity as it modifies the ways and processes of learning and teaching in college physical education. However, little empirical evidence can be seen in literature to demonstrate crucial factors that influence university students’ acceptance of sports bracelets. Guided by the technology acceptance model, this study hence aimed at explaining university students’ intention to use sports bracelets. In total, 445 university students in China responded to a 19-item survey (...) package. Results indicated that users’ attitudes toward technology and perceived usefulness were significant predictors of intention to use sports bracelets. Meanwhile, users’ intrinsic sports motivation significantly promoted users’ positive attitudes toward this technology and was significantly influenced by perceived ease of use and perceived usefulness. Overall, our findings highlighted the importance of stimulating young adults’ intrinsic sports motivation that facilitates their intention to use sports bracelets such that to develop a healthy lifestyle that benefits their physical health. (shrink)