Wearable devices are increasingly present in the health context, as tools for biomedical research and clinical care. In this context, wearables are considered key tools for a more digital, personalised, preventive medicine. At the same time, wearables have also been associated with issues and risks, such as those connected to privacy and data sharing. Yet, discussions in the literature have mostly focused on either technical or ethical considerations, framing these as largely separate areas of discussion, and the contribution of wearables (...) to the collection, development, application of biomedical knowledge has only partially been discussed. To fill in these gaps, in this article we provide an epistemic (knowledgerelated) overview of the main functions of wearable technology for health: monitoring, screening, detection, and prediction. On this basis, we identify 4 areas of concern in the application of wearables for these functions: data quality, balanced estimations, health equity, and fairness. To move the field forward in an effective and beneficial direction, we present recommendations for the 4 areas: local standards of quality, interoperability, access, and representativity. (shrink)

Growing social inequalities represent a major concern associated with the Digital Revolution. The article tackles this issue by exploring how welfare regulations and redistribution policies can be rethought in the age of digital capitalism. It focuses on the history and enduring crisis of social citizenship rights in their connection with technological changes, in order to draw a comparison between the industrial and the digital scenario. The first section addresses the link between the Industrial Revolution and the genesis of social rights. (...) It describes the latter as a legal ‘machine’ designed to offset the imbalances produced by the technological movement of industrialization. The second and third sections introduce the notion of ‘industrial citizenship’ to describe the architecture of social rights in mature industrial societies and to contend that European systems of welfare are still largely modeled on an industrial standard. The fourth part investigates the impact of the Digital Revolution on this model of social citizenship. It identifies debates on basic income as a major trajectory for redesigning welfare regulations in a post-industrial era, and the digital user as a crucial emerging subject of rights. The final part explores how digital users could be entitled to social rights as data suppliers. To this end, it introduces the idea of ‘digital-social rights’ resulting from the incorporation of welfare and redistribution principles into emerging digital rights. Hence, it proposes a legal-political framework for the redistribution of the revenues generated by data in the form of a ‘digital basic income’ for citizens of cyberspace. (shrink)

The debate surrounding ‘big tech’ and antitrust has dominated public policy discourses over the past few years in many parts of the world. Noteworthy is that several countries and regions, including China, the European Union, and the United States, have launched investigations into the allegedly anticompetitive and exclusionary business practices of companies such as Amazon, Apple, Facebook, and Google and their Chinese counterparts, Alibaba and Tencent. This paper builds on the renewed interest in the topic and discusses in detail – (...) and from an ordoliberal perspective – the key characteristics of the digital economy, the business conduct of tech platforms, and the corresponding antitrust concerns, as well as possible reform steps which could help to strengthen modern-day competition law and policy (and antitrust enforcement). (shrink)

Digital Twins are conceptualised in the academic technical discourse as real-time realistic digital representations of physical entities. Originating from product engineering, the Digital Twin quickly advanced into other fields, including the life sciences and earth sciences. Digital Twins are seen by the tech sector as the new promising tool for efficiency and optimisation, while governmental agencies see it as a fruitful means for improving decision-making to meet sustainability goals. A striking example of the latter is the European Commission who wishes (...) to delegate a significant role to Digital Twins in addressing climate change and supporting Green Deal policy. As Digital Twins give rise to high expectations, ambitions, and are being entrusted important societal roles, it is crucial to critically reflect on the nature of Digital Twins. In this article, we therefore philosophically reflect on Digital Twins by critically analysing dominant conceptualisations, the assumptions underlying them, and their normative implications. We dissect the concept and argue that a Digital Twin does not merely fulfil the role of being a representation, but is in fact a steering technique used to direct a physical entity towards certain goals by means of multiple representations. Currently, this steering seems mainly fuelled by a reductionist approach focused on efficiency and optimisation. However, this is not the only direction from which a Digital Twin can be thought and, consequently, designed and deployed. We therefore set an agenda based on a critical understanding of Digital Twins that helps to draw out their beneficial potential, while addressing their potential issues. (shrink)

One of the great dangers of our time is that the cumulative long-term action of smart socio-technical environments engineered to control thought and behavior results in an excessive loss of freedom. In response to this challenge, that we shall call humanity’s socio-technical dilemma, we outline here some fundamental ideas of a political program to control these environments, which is similar to the one proposed by Brett Frischmann and Evan Selinger. It is similar insofar as we share their paternalistic and humanistic (...) approach. But it is different insofar as we claim, first, the duty to admit that it is a version of Sloterdijk’s controversial human zoo; second, the theoretical and practical convenience of identifying the human capabilities to be promoted by these environments with the capabilities necessary for the democratic electorate to comply with the competence principle; and third, the awareness of the probable long-term unsustainability of the program in a context of competition between countries and companies, in spite of which it must be implemented because of its moral superiority. (shrink)

In recent years, there has been a surge of high-profile publications on applications of artificial intelligence (AI) systems for medical diagnosis and prognosis. While AI provides various opportunities for medical practice, there is an emerging consensus that the existing studies show considerable deficits and are unable to establish the clinical benefit of AI systems. Hence, the view that the clinical benefit of AI systems needs to be studied in clinical trials—particularly randomised controlled trials (RCTs)—is gaining ground. However, an issue that (...) has been overlooked so far in the debate is that, compared with drug RCTs, AI RCTs require methodological adjustments, which entail ethical challenges. This paper sets out to develop a systematic account of the ethics of AI RCTs by focusing on the moral principles of clinical equipoise, informed consent and fairness. This way, the objective is to animate further debate on the (research) ethics of medical AI. (shrink)

To integrate social robots in real-life contexts, it is crucial that they are accepted by the users. Acceptance is not only related to the functionality of the robot but also strongly depends on how the user experiences the interaction. Established design principles from usability and user experience research can be applied to the realm of human–robot interaction, to design robot behavior for the comfort and well-being of the user. Focusing the design on these aspects alone, however, comes with certain ethical (...) challenges, especially regarding the user’s privacy and autonomy. Based on an example scenario of human–robot interaction in elder care, this paper discusses how established design principles can be used in social robotic design. It then juxtaposes these with ethical considerations such as privacy and user autonomy. Combining user experience and ethical perspectives, we propose adjustments to the original design principles and canvass our own design recommendations for a positive and ethically acceptable social human–robot interaction design. In doing so, we show that positive user experience and ethical design may be sometimes at odds, but can be reconciled in many cases, if designers are willing to adjust and amend time-tested design principles. (shrink)

In this article it will be concluded that systematic menstrual tracking in women’s sport has the potential to cause harm to athletes. Since the ruling of Dobbs v. Jackson Women’s Health Organization (2022) in the United States, concerns regarding menstrual health tracking have arisen. Research suggests that the menstrual tracking of female athletes presents potential risks to “women’s autonomy, privacy, and safety in sport” (Casto 2022, 1725). At present, the repercussions of systematic menstrual tracking are particularly under-scrutinized, and this paper (...) seeks to combine novel research in the sport sciences with present ethical debates in the philosophy of sports. Utilizing Beauvoir’s feminist philosophy (2011), this paper argues that systematic menstrual tracking may contribute to the wider system of women’s oppression by exploiting female athletes, as well as enabling the internalization of submissive behaviour in cultures where athletes are expected to comply unquestioningly. Five policy recommendations are made concerning autonomy, informed consent, education, safeguarding and data access. The overall findings of this paper propose that a more in-depth understanding of the links between data, privacy, and the menstrual cycle are required by sports organizations and governing bodies if athletes are to be protected in a future where systematic menstrual tracking is inevitable. (shrink)

This master thesis studies to what degree Responsible Research & Innovation can be applied to the concept of the Digital Self. In order to examine this properly, it focuses on aspects of privacy, ownership and democracy. This work is inspired by the digital health domain, where a growing number of patients become enabled to benefit from AI-powered clinical decision sup port. Aim of this study is to provide insight into what cases can be considered for exploring new design requirements for (...) digital health applications. Increasingly, we use technology to manage our daily digital selves. Our smartphones, being examples of extensions of ourselves, are able to empower us as citizens within a democracy. The decision-making process belongs more and more to the realm of artificial intelligence, powering our extended selves with algorithms. Although the era of the DS has already begun, it remains unnoticed by the paradigm of RRI. Instead of empowering informational self-determination, RRI tends to be overprotective of an outdated concept of what it is like to act as a human within a democracy which is obviously reshaped by digitization. In order to maintain our general understanding of a democracy, there is a need for a concept of the DS in the near future. Not only will the DS-concept have the capacity to empower a democratic citizen, it will also be able to empower patients within a digital health environment. Due to the data hunger of large technology companies and governments, it has already become clear that the rise of digitization comes with a price for our society and our health. Therefore, it is the DS concept that can make a difference in contributing to ethical and social standards. If the future of digital health offers us – additional to human medical stakeholders – AI-powered digital health apps to increase the quality of healthcare, we have the duty to take our values into account when designing such apps. (shrink)

The essay proposes to use alienation as a heuristic and conceptual tool for the analysis of the impact of digital information and communication technologies (ICTs) on users. It follows a historical materialist understanding, according to which data can be considered as things produced in an industrial fashion. A representational interpretation, according to which data would merely reflect a given reality, is untenable. It will be argued instead to understand data as an additional layer which has a transformative impact on reality (...) as a whole. The analysis follows the early Marx in thinking of alienation as a structural condition which holds even if it is not experienced psychologically by users. Alienation means that the desire to express oneself and achieve social recognition, self-realization, and participation through the use of ICTs is incongruent to the inherent purposes and functions of these technologies. Digital platforms create the ideological illusion that users contribute to the production of data solely for their own gratification. Users, in turn, react to structural alienation either by internalizing it, in which case they may become enthusiastic data producers, or by imposing alienating conditions on other users. Finally, it will be shown that a strong notion of privacy is less suited to articulate concerns about the impact of ICTs because it expresses a desire for privilege and individual control which has become unfulfillable in the environment of data industries. The essay closes by showing some of the changes in institutional structures and behavior that could follow from the focus on alienation. (shrink)

This paper serves a dual function: (1) it is intended to proffer a stable understanding of our digital engagement on the Internet as a form of labor that is co-opted by digital firms for private profit; (2) it extends the concept of participatory democracy to our digital world, arguing that our collective or common production of value for digital firms (in the form of what I call“knowledge goods”) requires the implementation of participatory democratic governance mechanisms over these digital firms and (...) the experimentation with democratic digital alternatives.Whereas others have argued in favor of democratic control over digital platforms on the basis of the power that digital firms have over user's lives (Engelmann et al.,2020), this paper adds to this discussion by arguing in favor of digital platform democratization based on the value-generating labor contributed by digital users. (shrink)

Personal information is key to informational privacy and the algorithmically generated profiles of individuals. However, the concept of personal information and its nature is rarely discussed. The concept of personal information thus seems to be based on an idea of information as objective and truthful—as natural information—that is depicted as digital footprints in the online and digital realm. I argue that the concept of personal information should exit the realm of natural information and enter the realm of nonnatural information—grounded in (...) meaning, intention, and convention—as this will provide us with a concept that can account for potential misleadingness, inaccuracies, and mistakes. (shrink)

Zusammenfassung Hintergrund Die exponentiell wachsende Verfügbarkeit von Gesundheitsdaten bietet Forschenden ungeahnte Potenziale für Innovationen. Gleichzeitig gehen mit der Verwertung von Big Data auch große ethische Herausforderungen einher, die es zu bewältigen gilt, um den Anforderungen an verantwortungsvolle Forschung und Innovation gerecht zu werden (Gerke et al. 2020; Howe III und Elenberg 2020). Datensouveränität und die damit verbundenen Grundsätze der Selbstbestimmung und der informierten Zustimmung sind dabei zentrale Ziele. Allerdings hat deren konsistente Umsetzung enorme Konsequenzen für die Datenerhebung und -verarbeitung in (...) der Praxis. Dies trifft insbesondere angesichts einer Zunahme an Quantität und Komplexität von Daten im Gesundheitswesen zu. Denn aufgrund des Potenzials, relevante aber bisher verborgene Informationen aus der Datenmenge zu erschließen, ist eine zunehmende Anwendung von künstlicher Intelligenz (KI) in diesem Bereich zu erwarten (Jiang et al. 2017). Folglich besteht ein Bedarf an ethisch fundierten Handlungsanweisungen, die helfen, Datensouveränität und informierte Zustimmung in der klinischen Forschung umzusetzen. Material und Methoden Durch Anwendung einer narrativen Literaturrecherche in Kombination mit einem Design-Thinking-Ansatz soll das vorliegende Papier einen Beitrag zur Literatur leisten, indem die folgende Forschungsfrage beantwortet wird: Welche praktischen Anforderungen gibt es für eine konsequente Umsetzung von Datensouveränität und informierter Einwilligung im Gesundheitswesen? Ergebnisse Es wird gezeigt, dass Privatsphäre wahrende Technologien, menschenzentriert entwickelte Nutzungs- und Interaktionslösungen, erklärbare und vertrauenswürdige KI, Nutzerakzeptanz und -vertrauen, Patientenbeteiligung und eine wirksame Gesetzgebung zentrale Voraussetzungen für Datensouveränität und Selbstbestimmung in der klinischen Forschung sind. Die Bedeutung für die Entwicklung von IT-Lösungen im deutschen Gesundheitssystem wird dargelegt. (shrink)

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as (...) a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss. (shrink)

Zusammenfassung Problemhintergrund Biomedizinische Forschung auf Grundlage von Big Data bietet immense Vorteile. Groß angelegte multizentrische Forschung, die große Mengen persönlicher Gesundheitsdaten einbezieht, v. a. genetische und genomische Daten, könnte zu einer stärker personalisierten Medizin beitragen. Dieser Typ Forschung erfordert den Transfer und die Speicherung hochsensibler Daten, wodurch sich die Frage ergibt, wie Datensubjekte vor „data harm“ geschützt werden können, etwa vor Verletzungen der Privatsphäre, Disempowerment, Verlust von Rechten und Ausbeutung. Hier ergibt sich das Dilemma, wie die Vorteile der auf Big (...) Data basierenden biomedizinischen Forschung zu nutzen sind und zugleich das Recht von Datensubjekten auf informationelle Selbstbestimmung zu schützen ist. Argumentation Blockchain-Technologien werden aufgrund ihrer Features häufig als technische Lösung des genannten Dilemmas diskutiert. Dazu gehören die Herkunftsbestimmung von Daten, Dezentralisierung, Unveränderbarkeit sowie Zugang und das Governance-System. Allerdings wirft die Implementierung von Blockchain-Technologien in der biomedizinischen Forschung auch Fragen auf, besonders hinsichtlich Consent, rechtlicher Rahmenbedingungen und Integration in den Workflow. Somit bedarf es begleitender Maßnahmen, die ich als „enabler“ bezeichne, um das Potenzial von Blockchain-Technologien aktualisieren zu können. Zu diesen gehören innovative Consent-Modelle, Modelle zum Datenbesitzrecht und regulatorische Modelle. Schlussfolgerung Blockchain-Technologien als bloß technische Lösung sind unzureichend hinsichtlich des beschriebenen Dilemmas. Die Kombination aus dieser technischen Lösung und den genannten „enablers“ könnte der richtige Weg sein, um auf Big Data fußende biomedizinische Forschung zu ermöglichen und zugleich die informationelle Selbstbestimmung von Datensubjekten zu schützen. (shrink)

Definition of the problem Biomedical research based on big data offers immense benefits. Large multisite research that integrates large amounts of personal health data, especially genomic and genetic data, might contribute to a more personalized medicine. This type of research requires the transfer and storage of highly sensitive data, which raises the question of how to protect data subjects against data harm, such as privacy breach, disempowerment, disenfranchisement, and exploitation. As a result, there is a trade-off between reaping the benefits (...) of big-data-based biomedical research and protecting data subjects’ right to informational privacy. Arguments Blockchain technologies are often discussed as a technical fix for the abovementioned trade-off due to their specific features, namely data provenance, decentralization, immutability, and access and governance system. However, implementing blockchain technologies in biomedical research also raises questions regarding consent, legal frameworks, and workflow integration. Hence, accompanying measures, which I call enablers, are necessary to unleash the potential of blockchain technologies. These enablers are innovative models of consent, data ownership models, and regulatory models. Conclusion Blockchain technologies as a technical fix alone is insufficient to resolve the aforementioned trade-off. Combining this technical fix with the enablers outlined above might be the best way to perform biomedical research based on big data and at the same time protect the informational privacy of data subjects. (shrink)

Cancer registries are an important part of the public health infrastructure, since they allow to monitor the temporal trends of this illness as well as facilitate epidemiological research. In order to effectively set up such registries, it is necessary to create a system of data collection that permits to record health-related information from patients who are diagnosed with cancer. Given the sensitive nature of such data, it is debated whether their recording should be based on consent or whether alternative arrangements (...) are possible (eg, opt-out systems where information is automatically collected but patients can later withdraw). In the recent reform of the Swiss cancer registration legislation, the lawmaker set out to implement rules about the recording of data in cancer registries that would allegedly go beyond a consent-based model, in order to balance accurate registration with respect of patient rights. However, by analysing the operational norms of the new legislation and comparing them with those of other systems, it emerges that the Swiss rules de facto closely resemble a system of registration based on informed consent—in partial contradiction with the objective pursued by the lawmaker. In this paper, we show how the details of a policy are crucial to determine its true nature and we highlight some critical elements—from an ethical standpoint—of the recently reformed Swiss policy on cancer registration. (shrink)

In various official documents, the European Union has declared its goal to pursue a citizen-centric governance of digital transformation. Through a critical review of several of these documents, here we show how “citizen-centric” is more a glamouring than a driving concept. De facto, the EU is enabling a federated data system that is corporate-driven, economic-oriented, and GDPR-compliant; in other words, a Digital Single Market (DSM). This leaves out societal and collective-level dimensions of digital transformation—such as social inclusion, digital sovereignty, and (...) environmental sustainability—which are acknowledged, but not operationalized, by the EU as pillars of a citizen-centric governance. Hence, the door is open to a complementary approach to the governance of digital transformation. We argue that, while a federated data model can constitute the tech-legal backbone of the emerging DSM, a commoning of data, as an ecosystemic approach that maintains a societal and collective outlook by default, can represent a complement to enact a truly citizen-centric governance. (shrink)

Background The field of personal health monitoring (PHM) develops rapidly in different contexts, including the armed forces. Understanding the ethical dimension of this type of monitoring is key to a morally responsible development, implementation and usage of PHM within the armed forces. Research on the ethics of PHM has primarily been carried out in civilian settings, while the ethical dimension of PHM in the armed forces remains understudied. Yet, PHM of military personnel by design takes place in a different setting (...) than PHM of civilians, because of their tasks and the context in which they operate. This case study therefore focusses on obtaining insights into the experiences and related values of different stakeholders regarding an existing form of PHM, the Covid-19 Radar app, in the Netherlands Armed Forces. Methods We carried out an exploratory qualitative study, using semi-structured interviews with twelve stakeholders in the Netherlands Armed Forces. We focussed on participation in the use of PHM, reflections on the practical use and use of data, moral dilemmas and the need for ethics support, all in regard to PHM. The data was analysed using an inductive thematic approach. Results Three interlinking categories reflecting ethical dimensions of PHM emerged: (1) values, (2) moral dilemmas, and (3) external norms. The main values identified were: security (in relation to data), trust and hierarchy. Multiple related values were found. Some, but no broadly shared, moral dilemmas were identified and no strong need for ethics support was expressed. Conclusion This study shed light on key values, provide insights in the experienced and presumed moral dilemmas and bring to mind ethics support considerations when looking at PHM in the armed forces. Some values bring a certain vulnerability to military users when personal and organisational interests are not aligned. Furthermore, some identified values may hinder a careful consideration of PHM because they potentially conceal parts of ethical dimensions of PHM. Ethics support can assist in uncovering and addressing these concealed parts. The findings highlight a moral responsibility for the armed forces to devote attention to the ethical dimensions of PHM. (shrink)