Stefano Canali

Exposomics has become a leading framework for examining how lifelong environmental exposures shape human health. We draw on historical and philosophical scholarship to situate its political epistemology and outline possible future paths. Historically, exposomics fits within a neo-Hippocratic tradition that links knowledge of environments and health to political priorities and interventions. Within this frame, two political epistemologies emerge: an internalist approach focused on biological tracking of environmental effects, and an integrative approach encompassing broader social and environmental layers. Both face notable epistemic and political limits. Drawing on analogical historical and contemporary cases, we identify three potential trajectories for exposomics – techno-solutionism, evidential pluralism, and fundamental-cause reasoning – each presenting distinct opportunities and challenges.

New approaches to biomedical evidence are emerging in relation to innovative technologies and data sources. These include digital health, which promises to revolutionise established paradigms such as Evidence-Based Medicine (EBM) and address longstanding criticism from philosophy and beyond. In this paper, we investigate the promises and show the limitations of digital health for the epistemology of medicine. Focusing on a paradigmatic type of digital health technologies – wearable devices – we specify the key epistemic assumptions at the basis of digital health and show their grounding on ideas of internal and external validity that come from EBM and promise to fix its limitations. Hence, digital health is expected to address longstanding issues of EBM and expand and reinforce its paradigm, and yet going in this direction exacerbates and creates concerns for the epistemology of medical evidence, with ethical and social implications too. In observational studies, we show that wearables are used with the assumption of extending EBM approaches to internal validity. Yet new and different issues emerge, leading to complicated trade-offs and concerns about overdetection and high false positive rates. In intervention studies, wearables are used with the assumption of creating a larger and more diverse evidential basis, potentially mitigating concerns about external validity. However, we argue that this can exacerbate and create new issues of representativity. Behind the hype, we thus paint a nuanced picture of the contribution of digital health to EBM and biomedical research and show the need to acknowledge limitations to avoid harmful applications.

The use of big data and machine learning has been discussed in an expanding literature, detailing concerns on ethical issues and societal implications. In this paper we focus on big data and machine learning in the context of health systems and with the specific purpose of personalization. Whilst personalization is considered very promising in this context, by focusing on concrete uses of personalized models for glucose monitoring and anomaly detection we identify issues that emerge with personalized models and show that personalization is not necessarily nor always a positive development. We argue that there is a new problem of trade-offs between the expected benefits of personalization and new and exacerbated issues – results that have serious implications for strategies of mitigation and ethical concerns on big data and machine learning.

Over the past few years, mobile health applications (mHealth apps) have gained popularity regarding the management of chronic conditions, such as diabetes, as they are considered to enhance follow‐up and treatment. Indeed, these applications are powerful tools that support individualised pharmaceutical and non‐pharmaceutical care by remotely monitoring the patient's health status in real‐time. Nevertheless, concerns have been raised regarding trust and trustworthiness towards their use, in particular, when they are powered by Artificial Intelligence (AI). Trust in AI is a multifaceted notion that encompasses aspects such as reliance, risk, as well as ethical principles (e.g., respect for human autonomy and prevention of harm). In this paper, we provide an analysis of trust and trustworthiness in AI‐powered mHealth apps for diabetes through the lens of philosophy and risk analysis to promote the patient's well‐being.

When does more data help and when does it not in the sciences? In the past decade, this question has become central because of the phenomenon of Big Data. While these discussions started as a result of somewhat naive ideas that have been closely analyzed and mostly rejected in the philosophy of data, the question about the epistemic difference that more or less data makes still matters, especially in light of the impressive performance of data science and machine learning tools, which seem to improve their outcomes when they are trained on large volumes of data. In several areas of the sciences, having more data is also connected to methodological and epistemic benefits and more generally something that research should strive toward. More data is often equated to better science: this elicits crucial questions about the epistemic value of the quantity of data. In this chapter, we discuss this problem in light of current discussions in the life and health sciences and the philosophy of data.

Although the ‘metaverse’ is still the feverish pipedream of tech companies and venture capitalists, it is also a powerful imaginary for channelling enormous resources towards deepening and extending ongoing processes of digitalization and datafication. It is thus likely that an increasing amount of human activity – both professional as well as leisure-related – will take place in metaversal spaces, and that the paradigm of ‘Big Data’ is about to be expanded with massive amounts of new and varied or multimodal data that capture even more (corporeal, sensorial, spatial, and temporal) information produced by and about people as well as their interactions as these unfold in (mixed) spaces over time. Much like the rise of big data, the emergence of metaversal data gives rise to important tensions and issues. From the perspective of critical data studies, media studies, and science and technology studies, this paper spotlights the role of data obtained about, in, and through metaverse technologies and environments as well as how this can be understood as both an intensification and extension of the datafication of social life, the quantification of research methodologies, and the exacerbation of social inequality. We discuss these issues through a series of six provocations that each address a distinct tension between metaverse data, the production of knowledge, research methodologies, and various social issues that are central to the datafication of contemporary societies.

Digital technologies hold promise to modernize healthcare. Such opportunity should be leveraged also to address the needs of rapidly ageing populations. Against this backdrop, this paper examines the use of wearable devices for promoting healthy ageing. Previous work has assessed the prospects of digital technologies for health promotion and disease prevention in older adults. However, to our knowledge, ours is one of the first attempts to specifically address the use of wearables for healthy ageing, and to offer ethical insights for assessing the prospects of leveraging wearable devices in this context. We provide an analysis of the considerable opportunities associated with the use of wearables for healthy ageing, with a focus on the five domains of intrinsic capacity: locomotion, sensory functions, psychological aspects, cognition, and vitality. We then highlight current limitations and ethical challenges of such approach to healthy ageing, including issues related to access, inclusion, privacy, surveillance, autonomy, and regulation. We conclude by discussing the implications of our analysis in light of current debates on the ethics of digital health, and suggest measures to address the identified challenges.

Per conoscere la medicina sono necessari strumenti teorici, pratici, tecnologici e culturali, ma non solo: come mostra il volume, anche la riflessione filosofica può svolgere un ruolo cruciale sui suoi vari aspetti. Analizzando esempi concreti e grazie ai contributi di medici, epidemiologi e ingegneri, il libro fornisce strumenti filosofici per leggere le caratteristiche fondamentali della medicina contemporanea, i suoi recenti sviluppi e le sfide che è chiamata ad affrontare: una lente di grande utilità per la formazione dei medici e per la ricerca dei filosofi che vogliano guardare realmente da vicino le scienze biomediche.

The COVID-19 pandemic has been the scene of several epistemic battles at the science-society interface, creating deadlocks that have been hard to overcome. To cut through the paralysing elements of these discussions, we present an analysis of three epistemic battles, concerning empirical evidence, expertise, and model projections. Our analysis singles out a crucial factor that drives unhelpful disputes like these: the contested prioritisation of specific types of scientific knowledge, which are considered adequate for policy only if they meet predetermined standards. To move beyond these deadlocks, we introduce the conceptual tools of epistemic pluralism and contextualism, which give concrete indications in the three controversies we discuss and show us the way forward in debates on science-based policy.

Wearable devices are increasingly present in the health context, as tools for biomedical research and clinical care. In this context, wearables are considered key tools for a more digital, personalised, preventive medicine. At the same time, wearables have also been associated with issues and risks, such as those connected to privacy and data sharing. Yet, discussions in the literature have mostly focused on either technical or ethical considerations, framing these as largely separate areas of discussion, and the contribution of wearables to the collection, development, application of biomedical knowledge has only partially been discussed. To fill in these gaps, in this article we provide an epistemic (knowledgerelated) overview of the main functions of wearable technology for health: monitoring, screening, detection, and prediction. On this basis, we identify 4 areas of concern in the application of wearables for these functions: data quality, balanced estimations, health equity, and fairness. To move the field forward in an effective and beneficial direction, we present recommendations for the 4 areas: local standards of quality, interoperability, access, and representativity.

Artificial intelligence systems have been widely applied to various contexts, including high-stake decision processes in healthcare, banking, and judicial systems. Some developed AI models fail to offer a fair output for specific minority groups, sparking comprehensive discussions about AI fairness. We argue that the development of AI systems is marked by a central paradox: the less participation one stakeholder has within the AI system’s life cycle, the more influence they have over the way the system will function. This means that the impact on the fairness of the system is in the hands of those who are less impacted by it. However, most of the existing works ignore how different aspects of AI fairness are dynamically and adaptively affected by different stages of AI system development. To this end, we present a use case to discuss fairness in the development of corporate wellness programs using smart wearables and AI algorithms to analyze data. The four key stakeholders throughout this type of AI system development process are presented. These stakeholders are called service designer, algorithm designer, system deployer, and end-user. We identify three core aspects of AI fairness, namely, contextual fairness, model fairness, and device fairness. We propose a relative contribution of the four stakeholders to the three aspects of fairness. Furthermore, we propose the boundaries and interactions between the four roles, from which we make our conclusion about the possible unfairness in such an AI developing process.

I propose an approach that expands philosophical views of scientific change, on the basis of an analysis of contemporary biomedical research and recent developments in the philosophy of scientific change. Focusing on the establishment of the exposome in epidemiology as a case study and the role of data as a context for contrasting views on change, I discuss change at conceptual, methodological, material, and social levels of biomedical epistemology. Available models of change provide key resources to discuss this type of change, but I present the need for an approach that models transfer, alignment, and influence as key processes of change. I develop this as a pragmatic approach to scientific change, where processes might change substantially depending on specific circumstances, thus contributing to and complementing the debate on a crucial epistemological issue.

In this paper, we analyse the relation between the use of environmental data in contemporary health sciences and related conceptualisations and operationalisations of the notion of environment. We consider three case studies that exemplify a different selection of environmental data and mode of data integration in data-intensive epidemiology. We argue that the diversification of data sources, their increase in scale and scope, and the application of novel analytic tools have brought about three significant conceptual shifts. First, we discuss the EXPOsOMICS project, an attempt to integrate genomic and environmental data which suggests a reframing of the boundaries between external and internal environments. Second, we explore the MEDMI platform, whose efforts to combine health, environmental and climate data instantiate a reframing and expansion of environmental exposure. Third, we illustrate how extracting epidemiological insights from extensive social data collected by the CIDACS institute yields innovative attributions of causal power to environmental factors. Identifying these shifts highlights the benefits and opportunities of new environmental data, as well as the challenges that such tools bring to understanding and fostering health. It also emphasises the constraints that data selection and accessibility pose to scientific imagination, including how researchers frame key concepts in health-related research.

Research, innovation, and progress in the life sciences are increasingly contingent on access to large quantities of data. This is one of the key premises behind the “open science” movement and the global calls for fostering the sharing of personal data, datasets, and research results. This paper reports on the outcomes of discussions by the panel “Open science, data sharing and solidarity: who benefits?” held at the 2021 Biennial conference of the International Society for the History, Philosophy, and Social Studies of Biology, and hosted by Cold Spring Harbor Laboratory.

In this paper, we use the case of the COVID-19 pandemic in Europe to address the question of what kind of knowledge we should incorporate into public health policy. We show that policy-making during the COVID-19 pandemic has been biomedicine-centric in that its evidential basis marginalised input from non-biomedical disciplines. We then argue that in particular the social sciences could contribute essential expertise and evidence to public health policy in times of biomedical emergencies and that we should thus strive for a tighter integration of the social sciences in future evidence-based policy-making. This demand faces challenges on different levels, which we identify and discuss as potential inhibitors for a more pluralistic evidential basis.

In this commentary, I propose a framework for thinking about data quality in the context of scientific research. I start by analyzing conceptualizations of quality as a property of information, evidence and data and reviewing research in the philosophy of information, the philosophy of science and the philosophy of biomedicine. I identify a push for purpose dependency as one of the main results of this review. On this basis, I present a contextual approach to data quality in scientific research, whereby the quality of a dataset is dependent on the context of use of the dataset as much as the dataset itself. I exemplify the approach by discussing current critiques and debates of scientific quality, thus showcasing how data quality can be approached contextually.

In this commentary, I discuss the scientific changes brought by the exposome, asking what is new about this approach and line of research. I place the exposome in a historical perspective, by analyzing the conditions under which the exposome has been conceived, developed and established in the context of contemporary epidemiological research. I argue that the exposome has been developed by transferring approaches, methods and conceptualizations from other lines of research in the life and health sciences. I thus discuss the conceptual and methodological innovations of the exposome as a result of the merging and adaptation of these elements for new uses and purposes. On this basis, I argue that the novelty of the exposome should be seen in incremental rather than revolutionary terms and, in this sense, the exposome shares significant elements with other projects and repertoires in postgenomics. I conclude by discussing the consequences of this analysis for the potential limitations and future development of exposome research.

How is scientific data used to represent phenomena and as evidence for claims about phenomena? In this paper, I propose that a specific type of claims – evidential claims – is involved in data practices to define and restrict the representational and evidential content of a dataset. I present an account of data practices in the epidemiology of the exposome based on the notion of evidential claims, which helps unpack the approaches, assumptions and warrants that connect different stages of research. I identify three different strategies to generate different types of evidential claims in this case. The macro strategy, which individuates the dataset that serves as the initial evidential space for research. The micro strategy, which is used to generate evidential claims about the microscopic and individual component of target phenomena. The association strategy, that uses evidence from the other strategies to identify a dataset as representation of the different levels and relations of exposure and disease. Differentiating between these strategies sheds light on the multi-faceted landscape of biomedical research on environment and health; and the roles of data and evidence in the process of inquiry.

In current philosophical discussions on evidence in the medical sciences, epidemiology has been used to exemplify a specific version of evidential pluralism. According to this view, known as the Russo–Williamson Thesis, evidence of both difference-making and mechanisms is produced to make causal claims in the health sciences. In this paper, I present an analysis of data and evidence in epidemiological practice, with a special focus on research on the exposome, and I cast doubt on the extent to which evidential pluralism holds in this case. I start by focusing on the claim that molecular data allows for the production of mechanistic evidence. On the basis of a close look at the ways in which molecular data is used in exposome research, I caution against interpretations in terms of mechanistic evidence. Secondly, I expand my critical remarks on the thesis by addressing the conditions under which data is categorised as evidence in exposome research. I argue that these show that the classification of a dataset as a type of evidence is dependent on the ways in which the data is used. This is in contrast with the approach of evidential pluralism, where evidence is classified in different types on the basis of its intrinsic properties. Finally, I come back to what I consider the core of the thesis and suggest that the epidemiological research analysed in the paper indicates different interpretations of evidential pluralism and its applicability in the health sciences.

Recently, it has been argued that the use of Big Data transforms the sciences, making data-driven research possible and studying causality redundant. In this paper, I focus on the claim on causal knowledge by examining the Big Data project EXPOsOMICS, whose research is funded by the European Commission and considered capable of improving our understanding of the relation between exposure and disease. While EXPOsOMICS may seem the perfect exemplification of the data-driven view, I show how causal knowledge is necessary for the project, both as a source for handling complexity and as an output for meeting the project’s goals. Consequently, I argue that data-driven claims about causality are fundamentally flawed and causal knowledge should be considered a necessary aspect of Big Data science. In addition, I present the consequences of this result on other data-driven claims, concerning the role of theoretical considerations. I argue that the importance of causal knowledge and other kinds of theoretical engagement in EXPOsOMICS undermine theory-free accounts and suggest alternative ways of framing science based on Big Data.