Weaving EU digital health policy into national healthcare practices. The making of a reimbursement standard for digital health technologies in Belgium.

Along the hopes and fears around the recent rise of Digital Health Technologies (DHT), EU and Member State (MS) policymakers have sought to find ways to translate these innovations into tangible trustworthy and reliable tools for health and care practices. While these translation-efforts have been developed across different healthcare contexts with their own histories, practices, and values, their increasing entanglement has over the years raised several implementation issues between EU and MS policy initiatives. While policymakers have struggled to understand the reasons behind this, this article proposes to 'move focus' towards a socio-technical understanding of DHT by investigating how these alignment attempts come about in practice. For this we focus on Belgium's frontrunning attempt to develop a reimbursement framework for DHT. Drawing on a document analysis of EU and Belgian policy, media, and industry publications (2016-2022), field observations, and interviews, we demonstrate how Belgian policymakers have tried to align their attempt to improve trust in DHT with existing EU efforts in this regard through the development of their 'mhealthBelgium validation pyramid'. With this, we show that rather than overcoming translation difficulties, the pyramid is in fact enacting frictions around 'trust', 'medical' devices, the 'empowered' patient, and 'valuable' data. Beyond mere technical accounts of the translation challenges at hand, this article therefore points to the way this pyramid is "locking-in" these frictions, and with this has hindered the implementation of DHT. Despite the Belgian government's announcement of a renewed reimbursement framework two years later, its emphasis on overcoming technical translation issues risks re-enacting these very same entrenched frictions.

Solidarity during the COVID-19 pandemic: evidence from a nine-country interview study in Europe.

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.

Democratic research: Setting up a research commons for a qualitative, comparative, longitudinal interview study during the COVID-19 pandemic.

The sudden and dramatic advent of the COVID-19 pandemic led to urgent demands for timely, relevant, yet rigorous research. This paper discusses the origin, design, and execution of the SolPan research commons, a large-scale, international, comparative, qualitative research project that sought to respond to the need for knowledge among researchers and policymakers in times of crisis. The form of organization as a research commons is characterized by an underlying solidaristic attitude of its members and its intrinsic organizational features in which research data and knowledge in the study is shared and jointly owned. As such, the project is peer-governed, rooted in (idealist) social values of academia, and aims at providing tools and benefits for its members. In this paper, we discuss challenges and solutions for qualitative studies that seek to operate as research commons.

Anticipating hopes, fears and expectations towards COVID-19 vaccines: A qualitative interview study in seven European countries.

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.

Normative positions towards COVID-19 contact-tracing apps: findings from a large-scale qualitative study in nine European countries.

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 (Austria, Belgium, France, Germany, Ireland, Italy, the Netherlands, German-speaking Switzerland, the United Kingdom), this paper shows that the binary framing often found in surveys and polls, which contrasts privacy concerns with the usefulness of these interventions for public health, does not capture the depth, breadth, and nuances of people's positions towards COVID-19 contact-tracing apps. The paper provides a detailed account of how people arrive at certain normative positions by analysing the argumentative patterns, tropes and (moral) repertoires underpinning people's perspectives on digital contact-tracing. Specifically, we identified a spectrum comprising five normative positions towards the use of COVID-19 contact-tracing apps: opposition, scepticism of feasibility, pondered deliberation, resignation, and support. We describe these stances and analyse the diversity of assumptions and values that underlie the normative orientations of our interviewees. We conclude by arguing that policy attempts to develop and implement these and other digital responses to the pandemic should move beyond the reiteration of binary framings, and instead cater to the variety of values, concerns and expectations that citizens voice in discussions about these types of public health interventions.

The FDA's standard-making process for medical digital health technologies: co-producing technological and organizational innovation.

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.