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Introduction: Artificial intelligence (AI) has the potential to transform clinical decision-making as we know it. Powered by sophisticated machine learning algorithms, clinical decision support systems (CDSS) can generate unprecedented amounts of predictive information about individuals' health. Yet, despite the potential of these systems to promote proactive decision-making and improve health outcomes, their utility and impact remain poorly understood due to their still rare application in clinical practice. Taking the example of AI-powered CDSS in stroke medicine as a case in point, this paper provides a nuanced account of stroke survivors', family members', and healthcare professionals' expectations and attitudes towards medical AI. Methods: We followed a qualitative research design informed by the sociology of expectations, which recognizes the generative role of individuals' expectations in shaping scientific and technological change. Semi-structured interviews were conducted with stroke survivors, family members, and healthcare professionals specialized in stroke based in Germany and Switzerland. Data was analyzed using a combination of inductive and deductive thematic analysis. Results: Based on the participants' deliberations, we identified four presumed roles that medical AI could play in stroke medicine, including an administrative, assistive, advisory, and autonomous role AI. While most participants held positive attitudes towards medical AI and its potential to increase accuracy, speed, and efficiency in medical decision making, they also cautioned that it is not a stand-alone solution and may even lead to new problems. Participants particularly emphasized the importance of relational aspects and raised questions regarding the impact of AI on roles and responsibilities and patients' rights to information and decision-making. These findings shed light on the potential impact of medical AI on professional identities, role perceptions, and the doctor-patient relationship. Conclusion: Our findings highlight the need for a more differentiated approach to identifying and tackling pertinent ethical and legal issues in the context of medical AI. We advocate for stakeholder and public involvement in the development of AI and AI governance to ensure that medical AI offers solutions to the most pressing challenges patients and clinicians face in clinical care. [ABSTRACT FROM AUTHOR]

The article presents the discussion on Machine learning (ML) having highly transformative approaches to the automation of numerous clinical tasks. Topics include computer scientists being most concerned with demonstrating the superiority of ML-driven systems at performing classificatory or predictive tasks; and focusing on ensuring the safety and effectiveness of medical devices, software, and drugs before receiving market authorization.

This Viewpoint discusses how regulators across the world should approach the legal and ethical challenges, including privacy, device regulation, competition, intellectual property rights, cybersecurity, and liability, raised by the medical use of large language models. [ABSTRACT FROM AUTHOR]

The past few years have witnessed several media-covered cases involving citizens actively engaging in the pursuit of experimental treatments for their medical conditions—or those of their loved ones—in the absence of established standards of therapy. This phenomenon is particularly observable in patients with rare genetic diseases, as the development of effective therapies for these disorders is hindered by the limited profitability and market value of pharmaceutical research. Sociotechnical trends at the cross-section of medicine and society are facilitating the involvement of patients and creating the digital infrastructure necessary to its sustainment. Such participant-led research (PLR) has the potential to promote the autonomy of research participants as drivers of discovery and to open novel non-canonical avenues of scientific research. At the same time, however, the extra-institutional, self-appointed, and, often, oversight-free nature of PLR raises ethical concern. This paper explores the complex ethical entanglement of PLR by critically appraising case studies and discussing the conditions for its moral justification. Furthermore, we propose a path forward to ensure the safe and effective implementation of PLR within the current research ecosystem in a manner that maximizes the benefits for both individual participants and society at large, while minimizing the risks. [ABSTRACT FROM AUTHOR]

Effy Vayena and colleagues argue that machine learning in medicine must offer data protection, algorithmic transparency, and accountability to earn the trust of patients and clinicians. [ABSTRACT FROM AUTHOR]

Effy Vayena and colleagues argue that machine learning in medicine must offer data protection, algorithmic transparency, and accountability to earn the trust of patients and clinicians. [ABSTRACT FROM AUTHOR]

Massive amounts of data are collected and stored on a routine basis in virtually all domains of human activities. Such data are potentially useful to biomedicine. Yet, access to data for research purposes is hindered by the fact that different kinds of individual-patient data reside in disparate, unlinked silos. We propose that data cooperatives can promote much needed data aggregation and consequently accelerate research and its clinical translation. Data cooperatives enable direct control over personal data, as well as more democratic governance of data pools. This model can realize a specific kind of data economy whereby citizens and communities are empowered to steer data use according to their motivations, preferences, and concerns. Policy makers can promote this model by recognizing citizens’ rights to access and to obtain a copy of their own data, and by funding distributed data infrastructures piloting new data aggregation models. [ABSTRACT FROM AUTHOR]

The article focuses on the challenges in deploying digital contact tracing (DCT) apps to tackle coronavirus disease 2019. It mentions the number of uncertainties attributed to the general awareness of DCT apps, which include privacy risks, as well as public attitudes toward a potentially pervasive form of digital surveillance. The author suggests the need for policy-makers to set up mechanisms to test effectiveness, oversee the use of DCT apps and also monitor public attitudes.

AbstractBackgroundMethodsResultsConclusionsThere are intense discussions about the ethical and societal implications of biomedical engineering, but little data to suggest how scientists think about the ethics of their work. The aim of this study is to describe how scientists frame the ethics of their research, with a focus on the field of molecular systems engineering.Semi-structured qualitative interviews were conducted during 2021–2022, as part of a larger study. This analysis includes a broad question about how participants view ethics as related to their work, with follow up probes about the topics they consider most important. Interviews were transcribed, inductively coded by two researchers to consensus, and analyzed thematically.Twenty-four scientists participated in the study. Interviewees hold positions as professors, principal investigators, and senior staff researchers in universities or research institutes in the United States and Europe. Among those scientists who reported reflecting on ethical considerations in their work, many equated ethics with research ethics topics (e.g., safety, replicability), or with regulation and guidelines. Participants expressed the view that ethical issues are primarily relevant for clinical trials of bioengineered products, or for those working with animal or human subjects. Scientists described their research as “too early” or “not examining anything living” with regard to ethical reflection. Finally, many felt that ethics is seen as territory for experts and therefore beyond scientists’ competencies.Molecular systems engineering scientists currently focus on regulatory aspects as the framework for their ethical analyses. They describe using a framework to define when life arises, as a means to determine when further ethical engagement is warranted. Further research is needed to investigate how scientists relate to the ethics of their scientific work, and build consensus around concepts of life, autonomous behavior, and physiological relevance of bioengineered systems. [ABSTRACT FROM AUTHOR]

To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features (adaptivity, flexibility, monitoring, responsiveness, reflexivity, and inclusiveness) and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless oversight activities by different stakeholders acquire a common substantive orientation. [ABSTRACT FROM AUTHOR]

Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals. However, with medicine becoming a data-intense enterprise, informed consent and medical confidentiality, as mechanisms of control, are put under pressure. In this paper we explore emerging models of informational control in data-intense healthcare and clinical research, which can compensate for the limitations of currently available instruments. More specifically, we discuss three approaches that hold promise in increasing individual control: the emergence of data portability rights as means to control data access, new mechanisms of informed consent as tools to control data use, and finally, new participatory governance schemes that allow individuals to control their data through direct involvement in data governance. We conclude by suggesting that, despite the impression that biomedical big data diminish individual control, the synergistic effect of new data management models can in fact improve it. [ABSTRACT FROM AUTHOR]

With the launch of the Precision Medicine Initiative (PMI) in January 2015, the White House granted a high degree of federal support to an emerging biomedical paradigm. What explains this level of political recognition? Based on literature and policy analysis, we reconstruct the scientific and the legislative paths that led to the political endorsement of precision medicine. First, we describe the proliferation of personalized approaches to therapy ignited by the discovery of hemoprotein cytochrome P450 polymorphism in 1988. Then, we analyze the legislative history of precision medicine, from the unsuccessful introduction of Genomics and Personalized Medicine Acts in the second half of the last decade, to the highly acclaimed PMI. However, scientific progress and political contingency alone do not explain the upheaval of precision medicine as an institutionally supported initiative. On examination, the launch of a Precision Medicine Research Cohort and the incorporation of a participatory ethos into the fabric of the PMI proved to be crucial determinants of the political support for precision medicine. Weaving together the scientific and legislative antecedents of precision medicine, we illuminate how the mutual constitution of science and social order generates political recognition for innovative biomedical paradigms. [ABSTRACT FROM AUTHOR]

In this paper, we address the complex relationship between big data and human rights. Because this is a vast terrain, we restrict our focus in two main ways. First, we concentrate on big data applications in scientific research, mostly health-related research. And, second, we concentrate on two human rights: the familiar right to privacy and the less well-known right to science. Our contention is that human rights interact in potentially complex ways with big data, not only constraining it, but also enabling it in various ways; and that such rights are dynamic in character, rather than fixed once and for all, changing in their implications over time in line with changes in the context we inhabit, and also as they interact among themselves in jointly responding to the opportunities and risks thrown up by a changing world. Understanding this dynamic interaction of human rights is crucial for formulating an ethic tailored to the realities—the new capabilities and risks—of the rapidly evolving digital environment. [ABSTRACT FROM AUTHOR]

The article discusses digital medicine's definition as a device technology and medication combination in the article by Klugman et al. in 2018. Topics covered include questions on the digital medicine and digital health difference, digital medicine's alternative definition as the subset of digital products, and the quest for solid evidence on the effectivity of digital medicine solutions. Also noted is the ethical significance of the semantic ambiguity of digital health and digital medicine.

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish. [ABSTRACT FROM AUTHOR]

With the prospect of genomic data becoming ever more easily available, Effy Vayena and Urs Gasser discuss how we could balance making the most of its benefits with reducing its risks to privacy. [ABSTRACT FROM AUTHOR]

The flourishing of citizen science is an exciting phenomenon with the potential to contribute significantly to scientific progress. However, we lack a framework for addressing in a principled and effective manner the pressing ethical questions it raises. We argue that at the core of any such framework must be the human right to science. Moreover, we stress an almost entirely neglected dimension of this right-the entitlement it confers on all human beings to participate in the scientific process in all of its aspects. We then explore three of its key implications for the ethical regulation of citizen science: (a) the positive obligations imposed by the right on the state and other agents to recognize and promote citizen science, (b) the convective nature of the participation in science facilitated by the right and (c) the potential to mobilize the right in rolling back the unprecedented expansion of intellectual property regimes. [ABSTRACT FROM AUTHOR]

Background: As digital technology presents the potential to enhance the accessibility and effectiveness of health promotion campaigns, adolescents and young adults are an important target population. Young people are establishing behaviors that will contribute to the quality of their health later in life, and thus understanding their particular perspectives and receptivity to digital technologies for health promotion is crucial. With this review we aimed to synthesize the published literature reporting perspectives on digital health promotion (DHP) from adolescents and young adults worldwide. Methods: We conducted a scoping review of the literature on five research databases. We included papers which defined a target population of young people, and encompassed qualitative, quantitative, and mixed methods studies. Two independent reviewers thematically analyzed the included publications and provided both a quantitative and a narrative synthesis of the views of youth (namely opportunities and concerns) on digital health promotion. Results: We retrieved and analyzed 50 studies which met our inclusion and exclusion criteria. The large majority of these studies were conducted in high-income countries, while only a few collected the perspectives of youth in low- or middle-income countries. Findings revealed the importance of certain technology features, such as user interface design, as well as the significance of lack of personalization or user experience friction, for example, as deterrents to engagement with DHP tools. Ethically relevant aspects, such as those related to privacy or scientific reliability of the tools, did not receive much attention from youth. Yet, DHP for particularly sensitive areas of health elicited more frequent concerns about data security and evidence of effectiveness. Conclusions: Young people express distinct opinions and preferences concerning the use of digital technologies for health promotion. Our review identified a general appreciation and receptivity on the part of adolescents and young adults towards these technologies, even when taking potential risks into account. [ABSTRACT FROM AUTHOR]

The article analyzes the implications of big data for policies in the health care industry. It explores the use of big data to transform personal care, clinical care and public health, and related research. The role of big data in the development of models of disease progression and in the provision of personalized medicine is discussed, as well as the need to establish accountability and transparency due to the increasing complexity and sophistication of data-linkage methods.

Direct-to-consumer (DTC) genetic services have generated enormous controversy from their first emergence. A dramatic recent manifestation of this is the Food and Drug Administration's (FDA) cease and desist order against 23andMe, the leading provider in the market. Critics have argued for the restrictive regulation of such services, and even their prohibition, on the grounds of the harm they pose to consumers. Their advocates, by contrast, defend them as a means of enhancing the autonomy of those same consumers. Autonomy emerges as a key battle-field in this debate, because many of the 'harm' arguments can be interpreted as identifying threats to autonomy. This paper assesses whether DTC genomic services are a threat to, or instead, an enhancement of, personal autonomy. It deploys Joseph Raz's account of personal autonomy, with its emphasis on choice from a range of valuable options. It then seeks to counter claims that DTC genomics threatens autonomy because it involves manipulation in contravention of consumers' independence or because it does not generate valuable options which can be meaningfully engaged with by consumers. It is stressed that the value of the options generated by DTC genomics should not be judged exclusively from the perspective of medical actionability, but should take into consideration plural utilities. Finally, the paper ends by broaching policy recommendations, suggesting that there is a strong autonomy-based argument for permitting DTC genomic services, and that the key question is the nature of the regulatory conditions under which they should be permitted. The discussion of autonomy in this paper helps illuminate some of these conditions. [ABSTRACT FROM AUTHOR]

The authors reflect on ethical challenges concerning the emergence of digital disease detection (DDD) or digital epidemiology, which promises tangible global public health benefits. They discuss the context in which DDD operates which covers the fields of personal information, public health, and information technology. They also explore the continued growth of digital media and ethical oversight and governance.

Innovations in digital health are expected to transform health care, health research, and public health in the years ahead. Health data governance should ensure the ethical use of data and development of trustworthy digital health applications, yet it has received comparably little attention. [Extracted from the article]

Aims: This study examined the attitudes of 1,146 Swiss University students to direct-to-consumer (DTC) genomic testing and to genomic research participation. Methods: Data were collected through a self-completion online questionnaire by students from 2 higher education institutions in Zurich, Switzerland. The survey aimed to capture motivation for undergoing or refraining from genomic testing, reactions to mock genetic risk results, and views about contributing data to scientific research. Descriptive and inferential statistics were used for the analysis. Results: A total of 1.5% of the students had undergone testing. Most respondents were studying natural sciences and were interested in undergoing DTC genomic testing. The main motive was to contribute their data to scientific research, followed closely by their interest to find out disease risks and personal traits. Overall, 41% of the respondents were not interested in DTC tests. The primary reasons were concerns about receiving potentially worrying results. There was a significant correlation between studying natural sciences, as opposed to the humanities, and interest in undergoing testing. Male respondents were more interested in testing compared to females. There was a strong interest in genetic research participation and notably limited privacy concerns. Conclusion: Although 59% of the respondents were interested in DTC genomic testing, they were not likely to be affected by them or act upon them. This raises questions about concerns relating to potential risks of DTC genomics users and users' understanding of genetic information including their awareness of privacy risks. Furthermore, the strong interest in genetic research participation signals an underexplored personal utility of genomic testing which needs to be both better understood and better harnessed. © 2014 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Introduction The management of disorders or differences of sex development ( DSD) remains complex, especially with respect to parents' decision for or against early genitoplasty. Most parents still tend to disfavor postponing surgery until the child is old enough to provide consent. Aim To identify the determinants of parental decisions for or against early sex assignment surgery in DSD children, and in particular to assess the influence of contrasting behavior of health-care professionals and the information they dispense. Methods Preliminary data analysis from a focus group identified two broad approaches to counseling information. Two six-minute counseling videos were produced on this basis: one medicalized, by an endocrinologist, the other demedicalized, by a psychologist. Third-year medical students (N = 89) were randomized to watch either video as prospective parents and report its impact on their decision in a self-administered questionnaire. Main Outcome Measures Statistical analysis of questionnaire responses regarding decisions for or against surgery, including self-assessed impact of potential determinants. Results Thirty-eight of eighty-nine 'parents' (43%) chose early surgery for 'their' child, including 27/41 'parents' (66%) shown the medicalized video vs. 11/48 (23%) shown the demedicalized video ( P < 0.001). Desired aims for 'their' child also differed significantly depending on the counseling approach viewed. Yet 'parents' perceived their personal attitudes on a four-point Likert scale as the main influence on their decision although their 'attitude' was significantly shaped by the video. Conclusions Parental decisions concerning early sex assignment surgery for DSD children depend on the health professional counseling received, to a degree of which neither parents nor professionals appear fully aware. In the absence of conclusive data for or against early surgery, there is a danger of medicalized or demedicalized parentalism resulting in irreversible and inadequately grounded decisions, regardless of the consensus statement of 2005 and the subsequent call for multidisciplinary management. Streuli JC, Vayena E, Cavicchia-Balmer Y, and Huber J. Shaping parents: Impact of contrasting professional counseling on parents' decision making for children with disorders of sex development. J Sex Med 2013;10:1953-1960. [ABSTRACT FROM AUTHOR]

The authors examine whether adequate ethical oversight of participant-led research (PLR) must involve standard ethics review. The protection of study participants is the principal justification for ethical oversight in research with humans. The authors describe a proposal for adapting current ethical oversight standards to address the distinctive concerns raised by PLR.

Health-related research is increasingly drawing on novel sources of online data, such as crowdsourced information about disease outbreaks, consumer-supplied information provided to health or wellness Web sites, Internet search queries about personal health, and social network postings that identify health behaviors. We offer examples of online sources and their uses, identify ethical and policy issues they generate, and formulate key questions for future discussion and investigation. Further work in this area will require cross-disciplinary collaboration to develop ethics and policy guidance for the ethical use of these novel data sources in health-related research. (Am J Public Health. 2012; 102: 2225-2230.) [ABSTRACT FROM AUTHOR]

An attitude shift toward ART in developing countries has resulted in attempts exploring low-cost ART suitable to limited resource settings. This is a positive and needed development. Future steps should consider national infertility needs, position of infertility services within comprehensive reproductive health programs, ART surveillance, and equitable access. [Copyright &y& Elsevier]

Background The widespread increase in the use of contraception, due to multiple factors including improved access to modern contraception, is one of the most dramatic social transformations of the past fifty years. This study explores whether the global progress in the use of modern contraceptives has also benefited the poorest. Methods and Findings Demographic and Health Surveys from 55 developing countries were analyzed using wealth indices that allow the identification of the absolute poor within each country. This article explores the macro level determinants of the differences in the use of modern contraceptives between the poor and the national averages of several countries. Despite increases in national averages, use of modern contraception by the absolute poor remains low. South and Southeast Asia have relatively high rates of modern contraception in the absolute poor, on average 17% higher than in Latin America. Over time the gaps in use persist and are increasing. Latin America exhibits significantly larger gaps in use between the poor and the averages, while gaps in sub-Saharan Africa are on average smaller by 15.8% and in Southeast Asia by 11.6%. Conclusions The secular trend of increasing rates of modern contraceptive use has not resulted in a decrease of the gap in use for those living in absolute poverty. Countries with large economic inequalities also exhibit large inequalities in modern contraceptive use. In addition to macro level factors that influence contraceptive use, such as economic development and provision of reproductive health services, there are strong regional variations, with sub-Saharan Africa exhibiting the lowest national rates of use, South and Southeast Asia the highest use among the poor, and Latin America the largest inequalities in use. [ABSTRACT FROM AUTHOR]

The authors the lessons from the social-computing research conducted by online social networking site Facebook researchers working with Cornell University scholars and offer recommendations from ethical perspectives. It notes the challenge for investigators of research in identifying the treatment of data collection and analysis. It mentions that social-computing research made or funded by private entities does not require to undergo review and protections of the U.S. federal research policies.

Effy Vayena and colleagues argue that machine learning in medicine must offer data protection, algorithmic transparency, and accountability to earn the trust of patients and clinicians. [ABSTRACT FROM AUTHOR]

Governments around the globe have started to develop and deploy digital contact tracing apps to gain control over the spread of the novel coronavirus (Covid-19). The appropriateness and usefulness of these technologies as a containment measure have since sparked political and academic discussions globally. The present paper contributes to this debate through an exploration of how the national daily newspapers in Germany, Austria, and Switzerland reported on the development and adoption of digital contact-tracing apps during early and after stages of the lockdown. These countries were among the first in Europe to develop apps and were critical voices in the debate of decentralized vs. centralized data processing. We conducted thematic analysis on news coverage published between January and May 2020 in high-circulation national daily newspapers from Germany, Austria, and Switzerland. A total of 148 articles from nine newspaper companies were included in the final analysis. From our analysis emerged six core themes of the development and adoption of digital contact tracing apps: 1) data governance; 2) role of IT giants; 3) scientific rigor; 4) voluntariness; 5) functional efficacy; 6) role of the app. These results shed light on the different facets of discussion regarding digital contact tracing as portrayed in German-speaking media. This study complements emerging survey data on public perceptions of digital contact tracing apps by providing a better understanding of the ideas circulating in the media ecosystem. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Aspirations and Strategies for Public Health" in the 2016 issue of the periodical.

Despite the bourgeoning of digital tools for bioethics research, education, and engagement, little research has empirically investigated the impact of interactive visualizations as a way to translate ethical frameworks and guidelines. To date, most frameworks take the format of text-only documents that outline and offer ethical guidance on specific contexts. This study's goal was to determine whether an interactive-visual format supports frameworks in transferring ethical knowledge by improving learning, deliberation, and user experience. An experimental comparative study was conducted with a pre-, mid-, and post-test design using the online survey platform Qualtrics. Participants were university based early-stage health researchers who were randomly assigned to either the control condition (text-only document) or the experimental condition (interactive-visual). The primary outcome variables were learning, (measured using a questionnaire), deliberation (using cases studies) and user experience (measured using the SED/UD Scale). Analysis was conducted using descriptive statistics and mixed-effects linear regression. Of the 80 participants, 44 (55%) used the text-only document and 36 (45%) used the interactive-visual. Results of the knowledge-test scores showed a statistically significant difference between participants' post-test scores, indicating that the interactive-visual format better supported understanding, acquisition, and application of the framework's knowledge. Findings from the case studies showed both formats supported ethical deliberation. Results further indicated the interactive-visual provided an overall better episodic and remembered user experience compared with the text-only document. Our findings show that ethical frameworks formatted with interactive and visual qualities provide a more pleasing user experience and are effective formats for ethics learning and deliberation. These findings have implications for practitioners developing and deploying ethical frameworks and guidelines (e.g., in educational or employee-onboarding settings), in that the knowledge generated can lead to more effective dissemination practices of normative guidelines and health data ethics concepts. [ABSTRACT FROM AUTHOR]

The article discusses the study regarding the effects of lithium on amyotrophic lateral sclerosis patients. It highlights the use of online community PatientsLikeMe for matching controls and publications. It also notes that the larger standard clinical trials support that the lithium had no positive effects on patients that suffered with amyotrophic lateral sclerosis.

The author discuses several challenges of personal genomics in Germany which shows the need to revisit regulation related to genomics testing. It discuses genomics testing service which are offered by several companies including 23andMe Inc. and deCODEme. It also informs about the organization, bio.logis, which has launched an online genomics testing service using selected targets of direct to-consumer (DTC) diagnostic genetics analyses.

Trust is a ubiquitous term used in emerging technology (e.g., Big Data, precision medicine), innovation policy, and governance literatures in particular. But what exactly is trust? Even though trust is considered a critical requirement for the successful deployment of precision medicine initiatives, nonetheless, there is a need for further conceptualization with regard to what qualifies as trust, and what factors might establish and sustain trust in precision medicine, predictive analytics, and large-scale biology. These new fields of 21st century medicine and health often deal with the 'futures' and hence, trust gains a temporal and ever-present quality for both the present and the futures anticipated by new technologies and predictive analytics. We address these conceptual gaps that have important practical implications in the way we govern risk and unknowns associated with emerging technologies in biology, medicine, and health broadly. We provide an in-depth conceptual analysis and an operative definition of trust dynamics in precision medicine. In addition, we identify three main types of 'trust facilitators': (1) technical, (2) ethical, and (3) institutional. This three-dimensional framework on trust is necessary to building and maintaining trust in 21st century knowledge-based innovations that governments and publics invest for progressive societal change, development, and sustainable prosperity. Importantly, we analyze, identify, and deliberate on the dimensions of precision medicine and large-scale biology that have carved out trust as a pertinent tool to its success. Moving forward, we propose a 'points to consider' on how best to enhance trust in precision medicine and predictive analytics. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to an editorial by T. Richards and F. Godless regarding patient participation in conducting health research.

This paper describes the results of a multi-country survey of governance approaches for the use of digital contact tracing (DCT) in response to the COVID-19 pandemic. We argue that the countries in our survey represent two distinct models of DCT governance, both of which are flawed. The "data protection model" emphasizes privacy protections at the expense of public health benefit, while the "emergency response model" sacrifices transparency and accountability, prompting concerns about excessive governance surveillance. The ethical and effective use of DCT in the future requires a new governance approach that is better suited to this novel use of mobile phone data to promote public health." [ABSTRACT FROM AUTHOR]

Big data trends in health research challenge the oversight mechanism of the Research Ethics Committees (RECs). The traditional standards of research quality and the mandate of RECs illuminate deficits in facing the computational complexity, methodological novelty, and limited auditability of these approaches. To better understand the challenges facing RECs, we explored the perspectives and attitudes of the members of the seven Swiss Cantonal RECs via semi-structured qualitative interviews. Our interviews reveal limited experience among REC members with the review of big data research, insufficient expertise in data science, and uncertainty about how to mitigate big data research risks. Nonetheless, RECs could strengthen their oversight by training in data science and big data ethics, complementing their role with external experts and ad hoc boards, and introducing precise shared practices. [ABSTRACT FROM AUTHOR]

The United Nations Convention of Children's Rights (UNCRC) introduced in 1989 has generated a global movement for the protection of children's rights and has brought about a paradigm change in how children are perceived. Pediatric healthcare professionals are interacting with children and therefore with children's rights on a daily basis. However, although at least 18 of the 54 articles are relevant for pediatric practice, there is limited systematic training on how pediatricians can support children's rights in the clinical setting. This article discusses the principles and aims of the UNCRC and proposes a comprehensive checklist of rights vis-à-vis issues that arise in clinical practice. [ABSTRACT FROM AUTHOR]

Background: The Covid-19 pandemic is characterized by uncertainty and constant change, forcing governments and health authorities to ramp up risk communication efforts. Consequently, visuality and social media platforms like Twitter have come to play a vital role in disseminating prevention messages widely. Yet to date, only little is known about what characterizes visual risk communication during the Covid-19 pandemic. To address this gap in the literature, this study's objective was to determine how visual risk communication was used on Twitter to promote the World Health Organisations (WHO) recommended preventative behaviours and how this communication changed over time.Methods: We sourced Twitter's 500 most retweeted Covid-19 messages for each month from January-October 2020 using Crowdbreaks. For inclusion, tweets had to have visuals, be in English, come from verified accounts, and contain one of the keywords 'covid19', 'coronavirus', 'corona', or 'covid'. Following a retrospective approach, we then performed a qualitative content analysis of the 616 tweets meeting inclusion criteria.Results: Our results show communication dynamics changed over the course of the pandemic. At the start, most retweeted preventative messages came from the media and health and government institutions, but overall, personal accounts with many followers (51.3%) predominated, and their tweets had the highest spread (10.0%, i.e., retweet count divided by followers). Messages used mostly photographs and images were found to be rich with information. 78.1% of Tweets contained 1-2 preventative messages, whereby 'stay home' and 'wear a mask' frequented most. Although more tweets used health loss framing, health gain messages spread more.Conclusion: Our findings can inform the didactics of future crisis communication. The results underscore the value of engaging individuals, particularly influencers, as advocates to spread health risk messages and promote solidarity. Further, our findings on the visual characteristic of the most retweeted tweets highlight factors that health and government organisations should consider when creating visual health messages for Twitter. However, that more tweets used the emotive medium of photographs often combined with health loss framing raises concerns about persuasive tactics. More research is needed to understand the implications of framing and its impact on public perceptions and behaviours. [ABSTRACT FROM AUTHOR]

This paper reports survey findings on the Swiss public's willingness, attitudes, and concerns regarding personalized health research participation by providing health information and biological material. The survey reached a sample of 15,106 Swiss residents, from which we received 5,156 responses (34.1% response rate). The majority of respondents were aware of research using human biological samples (71.0%) and held a positive opinion towards this type of research (62.4%). Of all respondents, 53.6% indicated that they would be willing to participate in a personalized health research project. Willingness to participate was higher in younger, higher educated, non-religious respondents with a background in the health sector. Respondents were more willing to provide 'traditional' types of health data, such as health questionnaires, blood or biological samples, as opposed to social media or app-related data. All respondents valued the return of individual research results, including risk for diseases for which no treatment is available. Our findings highlight that alongside general positive attitudes towards personalized health research using data and samples, respondents have concerns about data privacy and re-use. Concerns included potential discrimination, confidentiality breaches, and misuse of data for commercial or marketing purposes. The findings of this large-scale survey can inform Swiss research institutions and assist policymakers with adjusting practices and developing policies to better meet the needs and preferences of the public. Efforts in this direction could focus on research initiatives engaging in transparent communication, education, and engagement activities, to increase public understanding and insight into data sharing activities, and ultimately strengthen personalized health research efforts. [ABSTRACT FROM AUTHOR]

Paediatric decision-making is the art of respecting the interests of child and family with due regard for evidence, values and beliefs, reconciled using two important but potentially conflicting concepts: best interest standard (BIS) and shared decision-making (SD-M). We combine qualitative research, our own data and the normative framework of the United Nations Convention on the Rights of Children (UNCRC) to revisit current theoretical debate on the interrelationship of BIS and SD-M. Three cohorts of child, parent and health care professional interviewees (Ntotal = 47) from Switzerland and the United States considered SD-M an essential part of the BIS. Their responses combined with the UNCRC text to generate a coherent framework which we term the shared optimum approach (SOA) combining BIS and SD-M. The SOA separates different tasks (limiting harm, showing respect, defining choices and implementing plans) into distinct dimensions and steps, based on the principles of participation, provision and protection. The results of our empirical study call into question reductive approaches to the BIS, as well as other stand-alone decision-making concepts such as the harm principle or zone of parental discretion. Conclusion: Our empirical study shows that the BIS includes a well-founded harm threshold combined with contextual information based on SD-M. We propose reconciling BIS and SD-M within the SOA as we believe this will improve paediatric decision-making. What is Known: • Parents have wide discretion in deciding for their child in everyday life, while far-reaching treatment decisions should align with the child's best interest. • Shared decision-making harbours potential conflict between parental authority and a child's best interest. What is New: • The best interest standard should not be used narrowly as a way of saying "Yes" or "No" to a specific action, but rather in a coherent framework and process which we term the shared optimum approach. • By supporting this child-centred and family-oriented process, shared decision-making becomes crucial in implementing the best interest standard. [ABSTRACT FROM AUTHOR]

Background: Explainability is one of the most heavily debated topics when it comes to the application of artificial intelligence (AI) in healthcare. Even though AI-driven systems have been shown to outperform humans in certain analytical tasks, the lack of explainability continues to spark criticism. Yet, explainability is not a purely technological issue, instead it invokes a host of medical, legal, ethical, and societal questions that require thorough exploration. This paper provides a comprehensive assessment of the role of explainability in medical AI and makes an ethical evaluation of what explainability means for the adoption of AI-driven tools into clinical practice.Methods: Taking AI-based clinical decision support systems as a case in point, we adopted a multidisciplinary approach to analyze the relevance of explainability for medical AI from the technological, legal, medical, and patient perspectives. Drawing on the findings of this conceptual analysis, we then conducted an ethical assessment using the "Principles of Biomedical Ethics" by Beauchamp and Childress (autonomy, beneficence, nonmaleficence, and justice) as an analytical framework to determine the need for explainability in medical AI.Results: Each of the domains highlights a different set of core considerations and values that are relevant for understanding the role of explainability in clinical practice. From the technological point of view, explainability has to be considered both in terms how it can be achieved and what is beneficial from a development perspective. When looking at the legal perspective we identified informed consent, certification and approval as medical devices, and liability as core touchpoints for explainability. Both the medical and patient perspectives emphasize the importance of considering the interplay between human actors and medical AI. We conclude that omitting explainability in clinical decision support systems poses a threat to core ethical values in medicine and may have detrimental consequences for individual and public health.Conclusions: To ensure that medical AI lives up to its promises, there is a need to sensitize developers, healthcare professionals, and legislators to the challenges and limitations of opaque algorithms in medical AI and to foster multidisciplinary collaboration moving forward. [ABSTRACT FROM AUTHOR]

The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft‐law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics. [ABSTRACT FROM AUTHOR]

A growing number of individuals who are not professional scientists are working with professional scientists to contribute to scientific research through a broad spectrum of volunteer activities and roles. To guide the regulatory oversight of scientists carrying out citizen science projects, we draw distinctions among five categories of projects in which volunteer activities and roles vary based on the combination of setting (institutional or not), subject matter (human or not), and the norms and expectations of handling volunteers' personally identifiable information. Each category has potentially different ethical considerations and forms of institutional (or regulatory) oversight. We identify and assign numeric labels to these categories rather than names to avoid confusion and value-laden connotations regarding terminology. We hope the absence of terminology will initiate conversations and encourage rapid evolution of necessary vocabulary in this area. We focus on Type 4 research, projects led in academia and in which volunteers are not the subject of the research, but provide personally identifiable information with expectations of non- confidentiality. Our preliminary data show that current Type 4 projects generally lack informed consent, and most do not provide details about their handling of personally identifiable data. We identify areas where federal guidelines, as well as existing institutional ethics review protocols for protection of human subjects in research, might be applied to some forms of citizen science in ways that could either support, or inadvertently undermine, the Common Rule (the US regulation regarding protection of human subjects). We illustrate these areas with examples of projects from Cooper's lab. By highlighting the complex and distinct challenges of responsible conduct with each project type, we urge professional scientists, citizen scientists, regulators, and other stakeholders to jointly determine the type of institutional oversight that will best mitigate risks without stymying innovation and benefits. We hope that this essay will spark a lively discussion and refinement of concepts, research, and improved practices. [ABSTRACT FROM AUTHOR]

The European Medical Information Framework (EMIF) project, funded through the IMI programme (Innovative Medicines Initiative Joint Undertaking under Grant Agreement No. 115372), has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice (ECoP) to ensure the privacy protection of data subjects, protect the interests of data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board (EAB), to provide feedback on its approach, platform, and the EcoP. The most important challenges the ECoP team faced were: how to define, control and monitor the purposes (kinds of research) for which federated health data are used; the kinds of organisation that should be permitted to conduct permitted research; and how to monitor this. This manuscript explores those issues, offering the combined insights of the EAB and EMIF core ECoP team. For some issues, a consensus on how to approach them is proposed. For other issues, a singular approach may be premature but the challenges are summarised to help the community to debate the topic further. Arguably, the issues and their analyses have application beyond EMIF, to many research infrastructures connected to health data sources. [ABSTRACT FROM AUTHOR]

The authors report on the plan of the "Bulletin of the World Health Organization" (WHO) to publish a theme issue on new ethical challenges of digital technologies, machine learning, and artificial intelligence in public health. The aim is to show ethical and governance matters that artificial intelligence applications are raising in public health. The deadline for submission is May 15, 2019. WHO Member States are said to be adopting the use of digital technologies in the health sector.