Catálogo de publicaciones - libros

While donation schemes with dedicated regulatory frameworks have made it relatively easy to donate blood, organs or tissue, it is virtually impossible to donate one’s own medical data. The lack of appropriate framework to govern such data donation makes it practically difficult to give away one’s data, even when this would be within the current limits of the law. Arguments for facilitation of such a process have been advanced but so far have not been implemented. Discussions on the ethics of using medical data tend to take a system-centric perspective and focus on what researchers and the health service may or may not do with data that are placed within their trust. Rarely, if ever, is the question of the data subjects preferences addressed beyond practical matters of obtaining valid consent. This constitutes an important omission in the ethical debate, which this volume seeks to address.

Large corporations are attracting criticism for their quasi-monopolist role in the digital data domain. It has been argued that they are no longer regular market participants but have become market regulators against whom public and civil society actors are powerless even when faced with stark ethical misconduct. Companies such as , , , and (GAFA) have become a new Leviathan: a monster for which people give up freedoms in exchange for other goods that they consider essential. Data donation is a strategy that could, if certain conditions are met, help tackle the overarching power of multinational enterprises. I will propose that data donation, understood as a specific type of transaction, has three distinctive characteristics: relationality, indirect reciprocity and multiplicity. I suggest ways in which ethical and regulatory frameworks for data donation should consider these characteristics to ensure that data donations respond to the institutional and power relationships that digital data use is embedded in, that data donations contribute to the public good, and that they and protect the personal needs and interests of people involved in it.

We propose that the notion of individual sovereignty encompasses more than having the power to exclude others from one’s personal space. Instead, sovereignty is realized at least in part along outward-reaching, interactive and participatory dimensions. On the basis of reflections from gift theory, we argue that donations can generate social bonds, convey recognition and open up new options in social space. By virtue of these features, donations offer the potential to advance individual sovereignty. We go on to highlight distinctive benefits of donations, before articulating several difficulties and puzzles: data donors are bound to have a limited grip on future uses of their data and the people affected by their decision to share. Further characteristic traits of data donations come from the invasive and comprehensive character of state-of-the-art data gathering and processing tools, and the fact that the relevant sense of data ownership is far from straightforward. In order to minimize tensions with negative, protective aspects of sovereignty, we argue that thoughtful mechanisms at the level of consent procedures, the representation of data subjects in governance structures, and organizational-level constraints are necessary. Along the way, we will devote particular attention to challenges and opportunities within big data contexts.

Modern health data practices come with many practical uncertainties. In this paper, I argue that data subjects’ trust in the institutions and organizations that control their data, and their ability to know their own moral obligations in relation to their data, are undermined by significant uncertainties regarding the what, how, and who of mass data collection and analysis. I conclude by considering how proposals for managing situations of high uncertainty might be applied to this problem. These emphasize increasing organizational flexibility, knowledge, and capacity, and reducing hazard.

The creation of vast, complex datasets made possible by technological advances over recent decades, has resulted in data becoming big business across many sectors and disciplines world-wide. Everyday life is increasingly networked via a growing array of digital devices to which individuals provide data, passively and actively. The pace of development has led to questions about the role of such ‘data donors’ and how individuals can be safeguarded when they might not be fully cognisant of the extent or destinations of data provided. We show that the many ways in which individuals provide data about themselves can result in incongruities and dilemmas in apparent decision making. We argue that it is not ethical for the vast swathes of data provided by individuals not to be used for public good. We explore whether we can make truly informed choices with the panoply of issues that may influence our decisions. We conclude without a straightforward yes or no, but propose that if we provide the best available information and engage with information presented, we stand a more reasonable chance. Do that, there is a need for demonstrable trustworthiness and clarity, greater awareness so that trust can be placed wisely, and for us to hone our juggling skills.

This article explores the options for establishing a legal framework for posthumous medical data donation (PMDD). This concept has not been discussed in legal scholarship to date at all. The paper is, therefore, a first legal study of PMDD, aiming to address the gap and shed light on the most significant legal issues that could affect this concept. The paper starts by looking at the protection of the deceased’s health records and medical data, finding that this protection in law is more extensive than the general protection of the deceased’s personal data, or the protection of post-mortem privacy as a concept. The paper then investigates key issues around ownership and succession of personal data, including medical and health-related data, and how these could affect PMDD and its legal framework.

The author then goes on to explore some parallels with organ donation to determine whether there are some lessons to be learned from this comparable regulatory framework. The paper concludes with the discussion around the need for a Code for posthumous medical data donation developed by the Digital Ethics Lab at the Oxford Internet Institute, and a more formal regime that would enable and facilitate this practice. Here, the author proposes key law reforms in the area of data protection and governance related to PMDD. These reforms would include amendments to the general data protection ideally, to ensure harmonisation and consistency across the EU, as well as between the general and sector-specific data protection laws and policies. These changes would contribute to legal and regulatory clarity and would help implement this important and valuable practice, which aims to facilitate research and advances in medical treatments and care.

Posthumous medical data donation (PMDD) could deliver a longitudinal dataset that facilitates significant advances in health research. This chapter focuses on a central challenge of PMDD, namely what good governance looks like in circumstances where consent does not provide a ‘single magic bullet’. The central argument is that consent in PMDD must be properly understood as merely one aspect of a holistic governance regime, and that more emphasis ought to be placed on the role of authorisation. This brings to the fore the potential role of the public interest in navigating the various interests in play. As will be demonstrated, this proposed re-orientation of governance could deliver tangible benefits in PMDD and enhance three key elements of good governance: transparency, accountability and engagement with evidence of the views of actual publics. Part I outlines the impetus for the examination of PMDD in the context of the (non)delivery of the ‘data sharing revolution’. Part II considers the pressure that temporal aspects of PMDD exert on traditional notions of consent, and the interests this brings into play. Finally, Part III suggests that authorisation should have a role to play alongside consent.

The success of personalized medicine does not only rely on methodological advances but also on the availability of data to learn from. While the generation and sharing of large data sets is becoming increasingly easier, there is a remarkable lack of diversity within shared datasets, rendering any novel scientific findings directly applicable only to a small portion of the human population. Here, we are investigating two fields that have been majorly impacted by data sharing initiatives, neuroscience and genetics. Exploring the limitations that are a result of a lack of participant diversity, we propose that data sharing in itself is not enough to enable a global personalized medicine.

Personalized health research depends on aggregated sets of personal data from millions of people. Given that personal data can be copied, individuals are entitled to copies of their data and individuals are the ultimate aggregators of all their personal data, citizens are elevated to new roles at the center of health research and a novel personal data economy. There, citizens, not some multinational company, control the use of and benefit from the intellectual and economic value of these data. Here, I show that democratically controlled nonprofit personal data cooperatives provide a governance and trust framework for data sharing and data donation. They also provide a means of attaining improved precision health and a digital society in which socio-economic asymmetries can be balanced.

This chapter explores what we actually mean by data donation after death, and what different types of data donation metadata are involved in the process. It then provides an analysis of the ethical ramifications of each of these different types of data, outlines the concepts of data advance directives and data donation guardians as one way of dealing with these issues, and considers alternative governance mechanisms. The degree of control given to the first data donors may need to be high in order to maintain trust, but over time attitudes may evolve towards everyone giving “big consent” to data donation.