Data driven or data informed? How general practitioners use data to evaluate their own and colleagues' clinical work in clusters.

In contemporary policy discourses, data are presented as key assets for improving health-care quality: policymakers want health care to become 'data driven'. In this article, we focus on a particular example of this ambition, namely a new Danish national quality development program for general practitioners (GPs) where doctors are placed in so-called 'clusters'. In these clusters, GPs are obliged to assess their own and colleagues' clinical quality with data derived from their own clinics-using comparisons, averages and benchmarks. Based on semi-structured interviews with Danish GPs and drawing on Science and Technology Studies, we explore how GPs understand these data, and what makes them trust-or question-a data analysis. The GPs describe how they change clinical practices based on these discussions of data. So, when and how do data for quality assurance come to influence their perceptions of quality? By exploring these issues, we carve out a role for a sociological engagement with evidence in everyday medical practices. In conclusion, we suggest a need to move from the aim of being data driven to one of being data informed.

The practical ethics of repurposing health data: how to acknowledge invisible data work and the need for prioritization.

Throughout the Global North, policymakers invest in large-scale integration of health-data infrastructures to facilitate the reuse of clinical data for administration, research, and innovation. Debates about the ethical implications of data repurposing have focused extensively on issues of patient autonomy and privacy. We suggest that it is time to scrutinize also how the everyday work of healthcare staff is affected by political ambitions of data reuse for an increasing number of purposes, and how different purposes are prioritized. Our analysis builds on ethnographic studies within the Danish healthcare system, which is internationally known for its high degree of digitalization and well-connected data infrastructures. Although data repurposing ought to be relatively seamless in this context, we demonstrate how it involves costs and trade-offs for those who produce and use health data. Even when IT systems and automation strategies are introduced to enhance efficiency and reduce data work, they can end up generating new forms of data work and fragmentation of clinically relevant information. We identify five types of data work related to the production, completion, validation, sorting, and recontextualization of health data. Each of these requires medical expertise and clinical resources. We propose that the implications for these forms of data work should be considered early in the planning stages of initiatives for large-scale data sharing and reuse, such as the European Health Data Space. We believe that political awareness of clinical costs and trade-offs related to such data work can provide better and more informed decisions about data repurposing.

'You should see a doctor', said the robot: Reflections on a digital diagnostic device in a pandemic age.

AIMS: In three days at the beginning of the COVID-19 pandemic, the Copenhagen Emergency Medical Services developed a digital diagnostic device. The purpose was to assess and triage potential COVID-19 symptoms and to reduce the number of calls to public health-care helplines. The device was used almost 150,000 times in a few weeks and was described by politicians and administrators as a solution and success. However, high usage cannot serve as the sole criterion of success. What might be adequate criteria? And should digital triage for citizens by default be considered low risk? METHODS: This paper reflects on the uncertain aspects of the performance, risks and issues of accountability pertaining to the digital diagnostic device in order to draw lessons for future improvements. The analysis is based on the principles of evidence-based medicine (EBM), the EU and US regulations of medical devices and the taxonomy of uncertainty in health care by Han et al. RESULTS: Lessons for future digital devices are (a) the need for clear criteria of success, (b) the importance of awareness of other severe diseases when triaging, (c) the priority of designing the device to collect data for evaluation and (d) clear allocation of responsibilities. CONCLUSIONS: A device meant to substitute triage for citizens according to its own criteria of success should not by default be considered as low risk. In a pandemic age dependent on digitalisation, it is therefore important not to abandon the ethos of EBM, but instead to prepare the ground for new ways of building evidence of effect.

'Standing together - at a distance': Documenting changes in mental-health indicators in Denmark during the COVID-19 pandemic.

Aims: There is a need to document the mental-health effects of the COVID-19 pandemic and its associated societal lockdowns. We initiated a large mixed-methods data collection, focusing on crisis-specific worries and mental-health indicators during the lockdown in Denmark. Methods: The study incorporated five data sources, including quantitative surveys and qualitative interviews. The surveys included a time series of cross-sectional online questionnaires starting on 20 March 2020, in which 300 (3×100) Danish residents were drawn every three days from three population groups: the general population (N=1046), families with children (N=1032) and older people (N=1059). These data were analysed by trend analysis. Semi-structured interviews were conducted with 32 people aged 24-83 throughout Denmark to provide context to the survey results and to gain insight into people's experiences of the lockdown. Results: Absolute level of worries, quality of life and social isolation were relatively stable across all population groups during the lockdown, although there was a slight deterioration in older people's overall mental health. Many respondents were worried about their loved ones' health (74-76%) and the potential long-term economic consequences of the pandemic (61-66%). The qualitative interviews documented significant variation in people's experiences, suggesting that the lockdown's effect on everyday life had not been altogether negative. Conclusions: People in Denmark seem to have managed the lockdown without alarming changes in their mental health. However, it is important to continue investigating the effects of the pandemic and various public-health measures on mental health over time and across national contexts.

The rise and fall of an opt-out system.

Introduction: In Denmark, citizens participate in register-based research without the possibility of opting out. However, in 1995 it was made possible for Danish citizens to register an opt-out called 'researcher protection' [forskerbeskyttelse], which implied that researchers could not contact people to invite them to participate in research projects, such as clinical trials or questionnaries, based on their registrations in national registers. Data already registered could still be used for research. In 2014, this possibility of opt-out was revoked by law. Aims: The aims of this paper are to understand how the Danish researcher protection system came about, why it was terminated and what we can we learn from this example. Methods: We conducted a descriptive analysis of a copy of the former researcher protection register along with policies and media debate surrounding the rise and revocation of the researcher protection system. Results: Our results show how both the inception and the abolishment of researcher protection appear to be ad hoc and without specified criteria of success. An examination of the recorded entries in the researcher protection registry could have led to changes in its administration as an alternative to its total abolition. Conclusions: In future opt-out systems, there should be focus on monitoring register practices and the purpose and criteria for evaluation must be defined prior to implementation.

Weak Data: The Social Biography of a Measurement Instrument and How It Failed to Ensure Accountability in Home Care.

Contemporary health and social care is saturated by processes of datafication. In many cases, these processes are nested within an ostensibly simple logic of accountability: Define a politically and morally desirable goal, then measure the level of achievement. This logic has come to permeate public health initiatives globally and today it operates in most health care systems in various ways. We explore here a particular instantiation of the logic associated with the introduction of a measurement instrument used in Danish home care. Building on ethnographic fieldwork, interviews, and analysis of policy documents, we show how the instigated processes of datafication-despite hopeful political claims-erode care levels and disempower older people. We believe that these findings can be of relevance for other settings that subscribe to the same accountability logic and to similar forms of measurement instruments.

"That is why I have trust": unpacking what 'trust' means to participants in international genetic research in Pakistan and Denmark.

Trust features prominently in a number of policy documents that have been issued in recent years to facilitate data sharing and international collaboration in medical research. However, it often remains unclear what is meant by 'trust'. By exploring a concrete international collaboration between Denmark and Pakistan, we develop a way of unpacking trust that shifts focus from what trust 'is' to what people invest in relationships and what references to trust do for them in these relationships. Based on interviews in both Pakistan and Denmark with people who provide blood samples and health data for the same laboratory, we find that when participants discuss trust they are trying to shape their relationship to researchers while simultaneously communicating important hopes, fears and expectations. The types of trust people talk about are never unconditional, but involve awareness of uncertainties and risks. There are different things at stake for people in different contexts, and therefore it is not the same to trust researchers in Pakistan as it is in Denmark, even when participants donate to the same laboratory. We conclude that casual references to 'trust' in policy documents risk glossing over important local differences and contribute to a de-politicization of basic inequalities in access to healthcare.

Transplantation as an abstract good: practising deliberate ignorance in deceased organ donation in Denmark.

This article investigates valuations of organ transfers that are currently seen as legitimising increasingly aggressive procurement methods in Denmark. Based on interviews with registered donors and the intensive care unit staff responsible for managing organ donor patients we identify three types of valuation: the needs of recipients, respect for donors' autonomy and support of donors' relatives in their grieving process. Sometimes these modes of valuation conflict with each other, and we show how our informants then respond with a form of deliberate ignorance. We suggest that deliberate ignorance has a more general salience in the organ transplant field by way of facilitating a perception of organ transplantation as an abstract moral good rather than a specific good for specific people. Furthermore, we suggest that multiple forms of ignorance sustain each other: a desire for ignorance with respect to the prioritisation of recipients sustains pressure for more organs; this pressure necessitates more aggressive measures in organ procurement and these measures increase the need for ignorance in relation to the actual procedures as well as the actual recipients. These attempts to avoid knowledge are in remarkable contrast to the otherwise widespread policy emphasis on education and information in this medical domain.

Regulatory Anatomy: How "Safety Logics" Structure European Transplant Medicine.

This article proposes the term "safety logics" to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of "safety" produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape.

Speed, accuracy, and efficiency: The promises and practices of digitization in pathology.

Digitization is often presented in policy discourse as a panacea to a multitude of contemporary problems, not least in healthcare. How can policy promises relating to digitization be assessed and potentially countered in particular local contexts? Based on a study in Denmark, we suggest scrutinizing the politics of digitization by comparing policy promises about the future with practitioners' experience in the present. While Denmark is one of the most digitalized countries in the world, digitization of pathology has only recently been given full policy attention. As pathology departments are faced with an increased demand for pathology analysis and a shortage of pathologists, Danish policymakers have put forward digitization as a way to address these challenges. Who is it that wants to digitize pathology, why, and how does digitization unfold in routine work practices? Using online search and document analysis, we identify actors and analyze the policy promises describing expectations associated with digitization. We then use interviews and observations to juxtapose these expectations with observations of everyday pathology practices as experienced by pathologists. We show that policymakers expect digitization to improve speed, patient safety, and diagnostic accuracy, as well as efficiency. In everyday practice, however, digitization does not deliver on these expectations. Fulfillment of policy expectations instead hinges on the types of artificial intelligence (AI) applications that are still to be developed and implemented. Some pathologists remark that AI might work in the easy cases, but this would leave them with only the difficult cases, which they consider too burdensome. Our particular mode of juxtaposing policy and practice throws new light on the political work done by policy promises and helps to explain why the discipline of pathology does not seem to easily lend itself to the digital embrace.

Searching for information about stem cells online in an age of artificial intelligence: How should the stem cell community respond?

Patients and their families routinely use the Internet to learn about stem cell research. What they find, is increasingly influenced by ongoing changes in how information is filtered and presented online. This article reflects on recent developments in generative artificial intelligence and how the stem cell community should respond.

Public attitudes to financial incentive models for organs: a literature review suggests that it is time to shift the focus from 'financial incentives' to 'reciprocity'.

Waiting lists for organs have stimulated interest in the use of financial incentives for organ donation (FIs), but the literature does not contain an adequate overview of studies of public attitudes toward this mode of procurement. We conducted a literature review of international peer-reviewed research published between 2002 and 2012 on how members of the public position themselves toward FIs. We identified and analyzed 23 studies using MEDLINE, PsycINFO, Sociological Abstracts and cross-reference search. The search included whole organs, donation, quantitative and empirical qualitative social scientific studies on, public attitudes (excluding professionals and medical students). The review reveals a broad divergence of public opinions on financial incentives. However, quantitative studies showed a low overall level of acceptance of payment for organs in living donation (LD); only a slightly higher one for deceased donation (DD); and a general preference for alternative forms, such as removal of disincentives or expressions of social reciprocity. Across different national and methodological settings we observed a considerable preference of noncommercial forms. This does not preclude the opportunity to consider various types of acknowledgement of economic value given in return for the organ. This provides reason to shift the focus from incentives to reciprocity.

The life and death of confidentiality: a historical analysis of the flows of patient information.

Health data can contain sensitive information. People who consult a doctor seek help on issues that matter to them: they typically expect some form of confidentiality. However, the notion and practices of confidentiality have changed dramatically over time. In this article, we trace the history of confidentiality in the Danish healthcare system, which has one of the world's most integrated patient information infrastructures. Building on an analysis of legal and political documents dating back to the late seventeenth century, we show that confidentiality originated as a social phenomenon that helped build trust in healthcare professionals and gradually developed into an idiom of citizens rights. Lately, confidentiality has given way to more technocratic forms of data protection. As the political, legal and technological reality, which the idea of confidentiality once referred to, has radically changed, we argue that confidentiality has become what Ulrik Beck has called a 'zombie category'-a notion that lives on even if its content has passed away. If confidentiality has become a zombie concept, we suggest it is time to discuss what may take its place so that patient interests are protected in the current political economy of health data.

A Data-Political Spectacle: How COVID-19 Became A Source of Societal Division in Denmark.

The COVID-19 pandemic has been a data-political spectacle. Data are omnipresent in prediction and surveillance, and even in resistance to governmental measures. How have citizens, whose lives were suddenly governed by pandemic data, understood and reacted to the pandemic as a data-political phenomenon? Based on a study carried out in Denmark, we show how society became divided into those viewing themselves as supporters of the governmental approach to the COVID-19 pandemic, and those who oppose it. These groups seem to subscribe to very different truths. We argue, however, that both sides share a positivist ideal and think that data and facts ought to rule. Both sides have also come to acknowledge that data are not unambiguous, and both cast increasing doubts on political uses of data. Though the people agreeing with, and the people opposing, the government strategy are in many ways surprisingly similar with respect to epistemic norms, they differ in what they perceive as dangerous or desirable, and in who they believe are telling the "truth" about the pandemic. These different perceptions result in different types of pandemic-related activism. Resistance against restrictions is often understood as inspired by conspiracy theories and in some countries anti-restrictions activism has turned violent. In our case, however, we suggest that when looking at similarities and differences across both groups, the gap between those opposing and those agreeing with the government approach is not as unbridgeable as might be suggested by their beliefs in differing truths and the emerging societal division.

Data as symptom: Doctors' responses to patient-provided data in general practice.

People are increasingly able to generate their own health data through new technologies such as wearables and online symptom checkers. However, generating data is one thing, interpreting them another. General practitioners (GPs) are likely to be the first to help with interpretations. Policymakers in the European Union are investing heavily in infrastructures to provide GPs access to patient measurements. But there may be a disconnect between policy ambitions and the everyday practices of GPs. To investigate this, we conducted semi-structured interviews with 23 Danish GPs. According to the GPs, patients relatively rarely bring data to them. GPs mostly remember three types of patient-generated data that patients bring to them for interpretation: heart and sleep measurements from wearables and results from online symptom checkers. However, they also spoke extensively about data work with patient queries concerning measurements from the GPs' own online Patient Reported Outcome system and online access to laboratory results. We juxtapose GP reflections on these five data types and between policy ambitions and everyday practices. These data require substantial recontextualization work before the GPs ascribe them evidential value and act on them. Even when they perceived as actionable, patient-provided data are not approached as measurements, as suggested by policy frameworks. Rather, GPs treat them as analogous to symptoms-that is to say, GPs treat patient-provided data as subjective evidence rather than authoritative measures. Drawing on Science and Technology Studies (STS) literature,we suggest that GPs must be part of the conversation with policy makers and digital entrepreneurs around when and how to integrate patient-generated data into healthcare infrastructures.

The European health data space: Too big to succeed?

In May 2022, the European Commission issued the Proposal for a Regulation on the European Health Data Space (EHDS), with the aims of granting citizens increased access to and control of their (electronic) health data across the EU, and facilitating health data re-use for research, innovation, and policymaking. As the first in a series of European domain-specific "data spaces", the EHDS is a high-stakes development that will transform health data governance in the EU region. As an international consortium of experts from health policy, law, ethics and the social sciences, we are concerned that the EHDS Proposal will detract from, rather than lead to the achievement of, its stated aims. We are in no doubt on the benefits of using health data for secondary purposes, and we appreciate attempts to facilitate such uses across borders in a carefully curated manner. Based on the current draft Regulation, however, the EHDS risks undermining rather than enhancing patient control over data; hindering rather than facilitating the work of health professionals and researchers; and eroding rather than increasing the public value generated through health data sharing. Therefore, significant adjustments are needed if the EHDS is to realize its promised benefits. Besides analyzing the implications for key groups and European societies at large who will be affected by the implementation of the EHDS, this contribution advances targeted policy recommendations to address the identified shortcomings of the EHDS Proposal.

Data authority: Public debate about personalized medicine in Denmark.

Personalized medicine has generated massive investments in data integration initiatives and stimulated new flows of health data among multiple actors. Such flows raise questions as to who should be able to access data, for which purposes, and how this access and use should be regulated. We suggest thinking of these questions as matters of 'data authority': who can legitimately do what with health data? In this article, we analyze a public debate developing in written media about personalized medicine to understand negotiations of data authority. We demonstrate how the debate creates no consensus and yet seems to stimulate selective regulatory changes. The changes are selective in the sense that they focus on the protection of autonomy but fail to address concerns about, for example, commercial interests. We argue that data authority rests on enduring conflict and that this conflict can be seen as constitutive for personalized medicine as a sociotechnical phenomenon.

Plastic diagnostics: The remaking of disease and evidence in personalized medicine.

Politically authorized reports on personalized and precision medicine stress an urgent need for finer-grained disease categories and faster taxonomic revision, through integration of genomic and phenotypic data. Developing a data-driven taxonomy is, however, not as simple as it sounds. It is often assumed that an integrated data infrastructure is relatively easy to implement in countries that already have highly centralized and digitalized health care systems. Our analysis of initiatives associated with the Danish National Genome Center, recently launched to bring Denmark to the forefront of personalized medicine, tells a different story. Through a "meta-taxonomy" of taxonomic revisions, we discuss what a genomics-based disease taxonomy entails, epistemically as well as organizationally. Whereas policy reports promote a vision of seamless data integration and standardization, we highlight how the envisioned strategy imposes significant changes on the organization of health care systems. Our analysis shows how persistent tensions in medicine between variation and standardization, and between change and continuity, remain obstacles for the production as well as the evaluation of genomics-based taxonomies of difference. We identify inherent conflicts between the ideal of dynamic revision and existing regulatory functions of disease categories in, for example, the organization and management of health care systems. Moreover, we raise concerns about shifts in the regulatory regime of evidence standards, where clinical care increasingly becomes a vehicle for biomedical research.

Subject in the Making: Technologies of the Self and Aspirations for a Good Life in Contemporary Denmark.

Coping with crisis is fundamental for human life, but so is the pursuit of everything good and fruitful. We revisit Foucault's technologies of the self as an analytical lens for what people do when pursuing a good life in contemporary Denmark. Comparing three emerging self-improvement domains; psychedelic micro-dosing, meditation and mindfulness, and fitness self-tracking, we explore processes though which individuals become subjects of their own actions. We argue that engaging in these transformational practices produces and reflects different notions of self, yet all involve attempts at managing vulnerabilities by accepting, controlling and balancing tensions between self-making and relation-making.

Organ donation and the ethics of muddling through.

Organ donation offers opportunities for people in critical care units to help save the lives of other patients. It is not always easy, however, to handle the transition from treating a patient to preserving a potential donor, and organ donation consistently provokes ethical questions in critical care units. What do we expect ethics to deliver? In light of a recent ethics conference in Denmark, we suggest that by acknowledging that decisions made in the clinic rarely abide to rational decision trees with clear ethical priorities, we can better learn from each other's experiences. We suggest embracing an 'ethics of muddling through' to enhance relevant reflections and stimulate a productive dialogue among health professionals.