The introduction of the General Data Protection Regulation (GDPR) in 2018 served as the cornerstone of the new data governance regime of the European Union. Informed by principles and values such as privacy, accountability, transparency, and fairness, the GDPR is premised on the objective to balance the protection of individual privacy and the promotion of a thriving European data economy. Still, shortcomings of this regulatory effort have been noted by recent ethical, socio-political, legal, and policy scholarship. Focusing on the deployment of digital health technologies and big data practices within the European digital health ecosystem, this article draws upon these bodies of literature to chart the main lines of tension emerging between the current GDPR-based data governance regime and the broader societal shifts coming along with the expansion of digital health. Central aspects of the GDPR-i.e. key underlying data protection principles and regulatory categories, the reliance on the "notice-and-consent" model, the (narrow) remit of the Regulation vis-a-vis possible harms and discriminations-are misaligned with the surge in digital health. This throws into doubt whether the Regulation is fully fit for the purpose of governing current developments in this field, while also calling for swift and adequate policy responses.

Vaccine uptake is essential to managing the ongoing COVID-19 pandemic, and vaccine hesitancy is a persistent concern. At the same time, both decision-makers and the general population have high hopes for COVID-19 vaccination. Drawing from qualitative interview data collected in October 2020 as part of the pan-European SolPan study, this study explores early and anticipatory expectations, hopes and fears regarding COVID-19 vaccination across seven European countries. We find that stances towards COVID-19 vaccines were shaped by personal lived experiences, but participants also aligned personal and communal interests in their considerations. Trust, particularly in expert institutions, was an important prerequisite for vaccine acceptance, but participants also expressed doubts about the rapid vaccine development process. Our findings emphasise the need to move beyond the study of factors driving vaccine hesitancy, and instead to focus on how people personally perceive vaccination in their particular social and political context.

Mobile applications for digital contact tracing have been developed and introduced around the world in response to the COVID-19 pandemic. Proposed as a tool to support 'traditional' forms of contact-tracing carried out to monitor contagion, these apps have triggered an intense debate with respect to their legal and ethical permissibility, social desirability and general feasibility. Based on a large-scale study including qualitative data from 349 interviews conducted in nine European countries

As digital health technologies (DHT) have been embraced as a ‘panacea’ for health care systems, they have evolved from a buzzword into a high priority objective for health policy across the globe. In the realm of quality and safety standards for medical devices, the US Food and Drug Administration (FDA) has been a frontrunner in adapting its regulatory framework to DHT. However, despite the utmost relevance of quality and safety standards and their role for sustaining the innovation pathway of DHT, their actual making has not yet been subjected to in-depth social-science scrutiny. Drawing on the conceptual repertoires of Science and Technology Studies (STS), this article investigates how digital health evolved from a buzzword into an ‘object of government’, or gained material meaning and transformed into a regulatable object, by charting the standard-making process of FDA’s medical digital health policy between 2008 and 2018. From this, we reflect on the mutually sustaining dynamics between technological and organizational innovation, as the FDA’s attempts to standardize medical DHT not only shaped the lifestyle/medical boundary for DHT. It also led to significant reconfigurations within the FDA itself, while fostering a broader shift toward the uptake of alternative forms of evidence in regulatory science.

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Calls for solidarity have been an ubiquitous feature in the response to the COVID-19 pandemic. However, we know little about how people have thought of and practised solidarity in their everyday lives since the beginning of the pandemic. What role does solidarity play in people’s lives, how does it relate to COVID-19 public health measures and how has it changed in different phases of the pandemic? Situated within the medical humanities at the intersection of philosophy, bioethics, social sciences and policy studies, this article explores how the practice-based understanding of solidarity formulated by Prainsack and Buyx helps shed light on these questions. Drawing on 643 qualitative interviews carried out in two phases (April–May 2020 and October 2020) in nine European countries (Austria, Belgium, France, Germany, Ireland, Italy, The Netherlands, German-speaking Switzerland and the UK), the data show that interpersonal acts of solidarity are important, but that they are not sustainable without consistent support at the institutional level. As the pandemic progressed, respondents expressed a longing for more institutionalised forms of solidarity. We argue that the medical humanities have much to gain from directing their attention to individual health issues, and to collective experiences of health or illness. The analysis of experiences through a collective lens such as solidarity offers unique insights to understandings of the individual and the collective. We propose three essential advances for research in the medical humanities that can help uncover collective experiences of disease and health crises: (1) an empirical and practice-oriented approach alongside more normative approaches; (2) the confidence to make recommendations for practice and policymaking and (3) the pursuit of cross-national and multidisciplinary research collaborations.

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