Powered by ‘big health data’ and enormous gains in computing power, artificial intelligence and related technologies are already changing the healthcare landscape. Harnessing the potential of these technologies will necessitate partnerships between health institutions and commercial companies, particularly as it relates to sharing health data. The need for commercial companies to be trustworthy users of data has been argued to be critical to the success of this endeavour. I argue that this approach is mistaken. Our interactions with commercial companies need (...) not, and should not, be based on trust. Rather, they should be based on confidence. I begin by elucidating the differences between trust, reliability, and confidence, and argue that trust is not the appropriate attitude to adopt when it comes to sharing data with commercial companies. I argue that what we really should want is confidence in a system of data sharing. I then provide an outline of what a confidence-worthy system of data sharing with commercial companies might look like, and conclude with some remarks about the role of trust within this system. (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)

The concept of ‘ownership’ is increasingly central to debates, in the media, health policy and bioethics, about the appropriate management of clinical data. I argue that the language of ownership acts as a metaphor and reflects multiple concerns about current data use and the disenfranchisement of citizens and collectives in the existing data ecosystem. But exactly which core interests and concerns ownership claims allude to remains opaque. Too often, we jump straight from ‘ownership’ to ‘private property’ and conclude ‘the data (...) belongs to the patient’. I will argue here that private property is only one type of relevant relationship between people, communities and data. There are several reasons to doubt that conceptualising data as private property presents a compelling response to concerns about clinical data ownership. In particular I argue that clinical data are co-constructed, so a property account would fail to confer exclusive rights to the patient. A non-property account of ownership acknowledges that the data are ‘about the patient’, and therefore the patient has relevant interests, without jumping to the conclusion that the data ‘belongs to the patient’. On this broader account of ownership, the relevant harm is the severing of the connection between the patient and their data, and the solution is to re-engage and re-connect patients to the data research enterprise. (shrink)

Many corporations are large, powerful, and wealthy. There are massive shortfalls of global justice, with hundreds of millions of people in the world living below the threshold of extreme poverty, and billions more living not far above that threshold. Where injustice and needs shortfalls must be remediated, we often look towards agents’ capabilities to determine who ought to bear the costs of rectifying the situation. The combination of these three claims grounds what I call a ‘linkage-based’ account of why corporations (...) have demanding positive duties to the global poor. In this paper, I put forward a distinctive linkage-based account of corporations’ positive duties centred on the idea of dependence and the importance of meeting agents’ core needs. In addition to outlining and defending this account, I will show that we can utilise its basic conceptual components to make headway on questions that have received insufficient attention in the business ethics literature; specifically, we can say something substantive about the weighting of needy agents’ competing claims to assistance, and about the limits to the demands that can be lodged against corporations on the basis of others' unmet needs. Having integrated considerations of duties' grounding, their comparative weight, and the limits of their demandingness into a single account of corporate positive duty, I conclude by discussing a challenge to attributing to corporations duties owed to the worst-off amongst the global poor. (shrink)

Background In the UK, the solidaristic character of the NHS makes it one of the most trusted public institutions. In recent years, the introduction of data-driven technologies in healthcare has opened up the space for collaborations with private digital companies seeking access to patient data. However, these collaborations appear to challenge the public’s trust in the. Main text In this paper we explore how the opening of the healthcare sector to private digital companies challenges the existing social contract and the (...) NHS’s solidaristic character, and impacts on public trust. We start by critically discussing different examples of partnerships between the NHS and private companies that collect and use data. We then analyse the relationship between trust and solidarity, and investigate how this relationship changes in the context of digital companies entering the healthcare system. Finally, we show ways for the NHS to maintain public trust by putting in place a solidarity grounded partnership model with companies seeking to access patient data. Such a model would need to serve collective interests through, for example, securing preferential access to goods and services, providing health benefits, and monitoring data access. Conclusion A solidarity grounded partnership model will help establish a social contract or licence that responds to the public’s expectations and to principles of a solidaristic healthcare system. (shrink)

BackgroundThe SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research.MethodsWe therefore (...) conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process.ResultsWe observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies.ConclusionsIn conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law. (shrink)

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; in a second (...) step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. (shrink)

Holt argues that Rawls’s first principle of justice requires democratic control of the economy and that property owning democracy fails to satisfy this requirement; only liberal socialism is fully democratic. However, the notion of democratic control is ambiguous, and Holt has to choose between the weaker notion of democratic control that Rawls is committed to and the stronger notion that property owning democracy fails to satisfy. It may be that there is a tension between capitalism and democracy, so that only (...) liberal socialism can be fully democratic, but if so, we should reject, rather than argue from, the theory of democracy we find in justice as fairness. (shrink)