BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, (...) whether a formal or informal group of individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function.Main textWe propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (shrink)

This paper provides an account of the challenges and potentialities of a solidarity-based approach to data access and governance. To do that, it offers an infraethical understanding of solidarity that describes it as a structural moral enabler that can sustain collective action and risk taking. The paper ends with a brief discussion of health data access as a possible case study to test this approach.

We study the case of a Chinese industrial policy, implemented in Shanghai that makes it mandatory for car manufacturers to share electro-mechanical performance and real time navigation data from their entire fleet of electric and hybrid vehicles with local and central government authorities. This policy seeks to prevent fraud in state subsidies, reduce emissions, assess the performance of New Energy Vehicles and strengthen the competitiveness of Chinese manufacturers of these vehicles. We argue that economies of scope in data (...) aggregation may provide traditional market failure arguments in favor of government intervention and mandatory data pooling. Our paper illustrates how data access regimes could be used for economic competition. The EU and China pursue similar data sharing and pooling policy goals that hinge on economies of scope in data aggregation. However, they follow very different political processes to achieve these goals. (shrink)

BackgroundIt has been argued that ethics review committees—e.g., Research Ethics Committees, Institutional Review Boards, etc.— have weaknesses in reviewing big data and artificial intelligence research. For instance, they may, due to the novelty of the area, lack the relevant expertise for judging collective risks and benefits of such research, or they may exempt it from review in instances involving de-identified data.Main bodyFocusing on the example of medical research databases we highlight here ethical issues around de-identified data sharing (...) which motivate the need for review where oversight by ethics committees is weak. Though some argue for ethics committee reform to overcome these weaknesses, it is unclear whether or when that will happen. Hence, we argue that ethical review can be done by data access committees, since they have de facto purview of big data and artificial intelligence projects, relevant technical expertise and governance knowledge, and already take on some functions of ethical review. That said, like ethics committees, they may have functional weaknesses in their review capabilities. To strengthen that function, data access committees must think clearly about the kinds of ethical expertise, both professional and lay, that they draw upon to support their work.ConclusionData access committees can undertake ethical review of medical research databases provided they enhance that review function through professional and lay ethical expertise. (shrink)

Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of data access review decisions. However, we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, (...) we report findings from 13 semi-structured interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic data access management. Participants generally supported pilot studies that test ADS performance, for example in cataloging data types, verifying user credentials and tagging datasets for use terms. Concerns related to over-automation, lack of human oversight, low prioritization, and misalignment with institutional missions tempered enthusiasm for ADS among the DAC members we engaged. Tensions for change in institutional settings within which DACs operated was a powerful motivator for why DAC members considered the implementation of ADS into their access workflows, as well as perceptions of the relative advantage of ADS over the status quo. Future research is needed to build the evidence base around the comparative effectiveness and decisional outcomes of institutions that do/not use ADS into their workflows. (shrink)

In this paper we study the semantic data complexity of several controlled fragments of English designed for natural language front-ends to OWL (Web Ontology Language) and description logic ontology-based systems. Controlled languages are fragments of natural languages, obtained by restricting natural language syntax, vocabulary and semantics with the goal of eliminating ambiguity. Semantic complexity arises from the formal logic modelling of meaning in natural language and fragments thereof. It can be characterized as the computational complexity of the reasoning problems (...) associated to their semantic representations. Data complexity (the complexity of answering a question over an ontology, stated in terms of the data items stored therein), in particular, provides a measure of the scalability of controlled languages to ontologies, since tractable data complexity implies scalability of data access. We present maximal tractable controlled languages and minimal intractable controlled languages. (shrink)

Bioethics, Volume 35, Issue 8, Page 779-786, October 2021.

(2013). Open Access Digital Data Sharing: Principles, Policies and Practices☆. Social Epistemology: Vol. 27, No. 1, pp. 47-67. doi: 10.1080/02691728.2012.760663.

Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be (...) openly stated in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals. However, with medicine becoming a data-intense enterprise, informed consent and medical confidentiality, as mechanisms of control, are put under pressure. In this paper we explore emerging models of informational control in data-intense healthcare and clinical research, which can compensate for the limitations of currently available instruments. More specifically, we discuss three approaches that hold promise in increasing individual control: the emergence of data portability rights as means to control data access, new mechanisms of informed consent as tools to control data use, and finally, new participatory governance schemes that allow individuals to control their data through direct involvement in data governance. We conclude by suggesting that, despite the impression that biomedical big data diminish individual control, the synergistic effect of new data management models can in fact improve it. (shrink)

Patient online record access (ORA) is spreading worldwide, and in some countries, including Sweden, and the USA, access is advanced with patients obtaining rapid access to their full records. In the UK context, from 31 October 2023 as part of the new NHS England general practitioner (GP) contract it will be mandatory for GPs to offer ORA to patients aged 16 and older. Patients report many benefits from reading their clinical records including feeling more empowered, better understanding (...) and remembering their treatment plan, and greater awareness about medications including possible adverse effects. However, a variety of indirect evidence suggests these benefits are unlikely to accrue without supplementation from internet-based resources. Using such routes to augment interpretation of the data and notes housed in electronic health records, however, comes with trade-offs in terms of exposing sensitive patient information to internet corporations. Furthermore, increased work burdens on clinicians, including the unique demands of ORA, combined with the easy availability and capability of a new generation of large language model (LLM)-powered chatbots, create a perfect collision course for exposing sensitive patient information to private tech companies. This paper surveys how ORA intersects with internet associated privacy risks and offers a variety of multilevel suggestions for how these risks might be better mitigated. (shrink)

BackgroundInternationally, patient access to notes is increasing. This has been driven by respect for patient autonomy, often recognised as a primary tenet of medical ethics: patients should be able to access their records to be fully engaged with their care. While research has been conducted on the impact of patient access to outpatient and primary care records and to patient portals, there is no such review looking at access to hospital medical records in real time, nor (...) an ethical analysis of the issues involved in such a change in process.MethodsThis study employed a systematic review framework in two stems, to integrate literature identified from two searches: Medline, CINAHL and Scopus databases were conducted, (for (1) hospitalised patients, patient access to records and its effects on communication and trust within the doctor-patient relationship; and (2) patient access to medical records and the ethical implications identified). The qualitative and quantitative results of both searches were integrated and critically analysed.Results3954 empirical and 4929 ethical studies were identified; 18 papers representing 16 studies were identified for review (12 empirical and 6 ethical). The review reveals a consensus that our current approach to giving information to patients – almost exclusively verbally – is insufficient; that patient access to notes is a welcome next step for patient-centred care, but that simply allowing full access, without explanation or summary, is also insufficient. Several ethical implications need to be considered: increased information could improve patient trust and knowledge but might transfer an (unwelcome) sense of responsibility to patients; doctors and patients have conflicting views on how much information should be shared and when; sharing written information might increase the already significant disparity in access to health care, and have unforeseen opportunity costs. The impact on medical practice of sharing notes in real time will also need to be evaluated.ConclusionsThe review presents encouraging data to support patient access to medical notes. However, sharing information is a critical part of clinical practice; changing how it is done could have significant empirical and ethical impacts; any changes should be carefully evaluated. (shrink)

This article addresses the general ethical issues of accessing online personal data for research purposes. The authors discuss the practical aspects of online research with a specific case study that illustrates the ethical challenges encountered when accessing data from Kooth, an online youth web-counselling service. This paper firstly highlights the relevance of a process-based approach to ethics when accessing highly sensitive data and then discusses the ethical considerations and potential challenges regarding the accessing of public data (...) from Digital Mental Health services. It presents solutions that aim to protect young DMH service users as well as the DMH providers and researchers mining such data. Special consideration is given to service users’ expectations of what their data might be used for, as well as their perceptions of whether the data they post is public, private or open. We provide recommendations for planning and designing online research that includes vulnerable young people as research participants in an ethical manner. We emphasise the distinction between public, private and open data, which is crucial to comprehend the ethical challenges in accessing DMH data. Among our key recommendations, we foreground the need to consider a collaborative approach with the DMH providers while respecting service users’ control over personal data, and we propose the implementation of digital solutions embedded within the platform for explicit opt-out/opt-in recruitment strategies and ‘read more’ options. (shrink)

The problems of access—retrieving linguistic structure from some mental grammar —and disambiguation—choosing among these structures to correctly parse ambiguous linguistic input—are fundamental to language understanding. The literature abounds with psychological results on lexical access, the access of idioms, syntactic rule access, parsing preferences, syntactic disambiguation, and the processing of garden‐path sentences. Unfortunately, it has been difficult to combine models which account for these results to build a general, uniform model of access and disambiguation at the (...) lexical, idiomatic, and syntactic levels. For example, psycholinguistic theories of lexical access and idiom access and parsing theories of syntactic rule access have almost no commonality in methodology or coverage of psycholinguistic data. This article presents a single probabilistic algorithm which models both the access and disambiguation of linguistic knowledge. The algorithm is based on a parallel parser which ranks constructions for access, and interpretations for disambiguation, by their conditional probability. Low‐ranked constructions and interpretations are pruned through beam‐search; this pruning accounts, among other things, for the garden‐path effect. I show that this motivated probabilistic treatment accounts for a wide variety of psycholinguistic results, arguing for a more uniform representation of linguistic knowledge and for the use of probabilistically‐enriched grammars and interpreters as models of human knowledge of and processing of language. (shrink)

The presented article is devoted to the question of whether extended access therapy can or should be accompanied by research activity. It consists of three parts. The first lists the tasks that can be used for medical information regarding extended access programs, which leads to the conclusion that even taking into account the specific limitations of their cognitive value, this type of data can be meaningfully used. The second part is devoted to the limited regulations in European (...) law concerning the discussed issue, and the Polish Act on the Professions of Physician and Dentist which grants physicians/researchers broader powers. In the last part of the article, two arguments are presented to ethically justify the granting of such broad powers to researchers, and thus limiting the autonomy of patients. (shrink)

Data platforms represent a new paradigm for carrying out health research. In the platform model, datasets are pooled for remote access and analysis, so novel insights for developing better stratified and/or personalised medicine approaches can be derived from their integration. If the integration of diverse datasets enables development of more accurate risk indicators, prognostic factors, or better treatments and interventions, this obviates the need for the sharing and reuse of data; and a platform-based approach is an appropriate (...) model for facilitating this. Platform-based approaches thus require new thinking about consent. Here we defend an approach to meeting this challenge within the data platform model, grounded in: the notion of ‘reasonable expectations’ for the reuse of data; Waldron’s account of ‘integrity’ as a heuristic for managing disagreement about the ethical permissibility of the approach; and the element of the social contract that emphasises the importance of public engagement in embedding new norms of research consistent with changing technological realities. While a social contract approach may sound appealing, however, it is incoherent in the context at hand. We defend a way forward guided by that part of the social contract which requires public approval for the proposal and argue that we have moral reasons to endorse a wider presumption of data reuse. However, we show that the relationship in question is not recognisably contractual and that the social contract approach is therefore misleading in this context. We conclude stating four requirements on which the legitimacy of our proposal rests. (shrink)

An ‘Information Centre’ has recently been established by law which has the power to collect, collate and provide access to the medical information forall patients treated by the National Health Service in England, whether in hospitals or by General Practitioners. This so-called ‘care.data’ scheme has given rise to major and ongoing controversies. We will sketch the background of the scheme and look at the responses it has elicited from citizens and medical professionals. In Autumn 2013, NHS England set (...) up a care.data website where citizens could record their concerns regarding the collection of health-related data by the Information Centre. We have reviewed all the comments on this website up until June 2015. We have also analysed the readers’ comments on the coverage of the care.data scheme in one of the main national UK newspapers. When discussing the responses of citizens, we will make a distinction between the problems that citizens detect and the solutions they propose. The solutions that are being perceived as the most relevant ones can be summarized as follows: citizens wish to further the common good without being manipulated into doing it, while at the same time being safeguarded against various abuses. The issue of trust turns out to figure prominently. Our analysis of reactions to the scheme in no way pretends to be exhaustive, yet it provides various relevant insights into the concerns identified by citizens as well as medical professionals. These concerns, moreover, have a more general relevance in relation to other contexts of medical data-mining as well as biobank research. Our analysis also offers important pointers as to how those concerns might be addressed. (shrink)

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to (...) be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These (...) principles require us to look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research. (shrink)

Though full of promise, Big Data research success is often contingent on access to the newest, most advanced, and often expensive hardware systems and the expertise needed to build and implement such systems. As a result, the accessibility of the growing number of Big Data-capable technology solutions has often been the preserve of business analytics. Pay as you store/process services like Amazon Web Services have opened up possibilities for smaller scale Big Data projects. There is high (...) demand for this type of research in the digital humanities and digital sociology, for example. However, scholars are increasingly finding themselves at a disadvantage as available data sets of interest continue to grow in size and complexity. Without a large amount of funding or the ability to form interdisciplinary partnerships, only a select few find themselves in the position to successfully engage Big Data. This article identifies several notable and popular Big Data technologies typically implemented using large and extremely powerful cloud-based systems and investigates the feasibility and utility of development of Big Data analytics systems implemented using low-cost commodity hardware in basic and easily maintainable configurations for use within academic social research. Through our investigation and experimental case study, we found that not only are solutions like Cloudera’s Hadoop feasible, but that they can also enable robust, deep, and fruitful research outcomes in a variety of use-case scenarios across the disciplines. (shrink)

Certain combinations of attitudes are manifestly unreasonable. It is unreasonable to believe that dogs bark, for example, if one concedes that one has no justification to believe this. Why are the irrational combinations irrational? One suggestion is that these are attitudes that a subject cannot have justification to have. If this is right, we can test claims about the structure of propositional justification by relying on our observations about which combinations of attitudes constitute Moorean absurd pairs. In a recent defense (...) of access internalism, Smithies argues that only access internalism can explain why various combinations of attitude are irrational. In this paper, I shall argue that access internalism cannot explain the relevant data. Reflection on Moore's Paradox will not tell us much of anything about propositional justification and cannot support access internalism. (shrink)

According to the “adequacy-for-purpose” view of data evaluation, data should be evaluated as better or worse relative to a given research purpose and corresponding research context. In this paper, I apply the adequacy-for-purpose view to a novel case study—concerning the use of paleoecological data to make predictions about coral reef response to contemporary climate change—and then use the case study to suggest two extensions to the adequacy-for-purpose view. First, I argue that we can evaluate research purposes according (...) to their productivity (how well these research purposes serve other, more ultimate purposes). Second, I argue that we can also evaluate research purposes according to their plausibility (including whether we have access to data that are adequate for these research purposes). The relationship between data evaluation and purpose setting should be seen as an iterative one, in which both data and purposes are refined in concert over time. (shrink)

It is typically assumed that while we know other people’s mental states by observing and interpreting their behavior, we know our own mental states by introspection, i.e., without interpreting ourselves. In his latest book, The opacity of mind: An integrative theory of self-knowledge, Peter Carruthers (2011) argues against this assumption. He holds that findings from across the cognitive sciences strongly suggest that self-knowledge of conscious propositional attitudes such as intentions, judgments, and decisions involves a swift and unconscious process of self-interpretation (...) that utilizes the same sensory channels that we employ when working out other people’s mental states. I provide an overview of Carruthers’ book before discussing a pathological case that challenges his account of self-knowledge and mentioning empirical evidence that undermines his use of a particular kind of data in his case against introspection of conscious attitudes. (shrink)

Purpose Digital health literacy has emerged as a critical determinant of equitable healthcare delivery in the information society. This study aims to examine evolving trends, thematic patterns and ethical considerations, with a focus on global policy responses and technological developments in 2023–2025. Design/methodology/approach A systematic literature review was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Seventy-two studies published between 2015 and 2025 (with a small number of earlier studies retained due to their continued conceptual and ethical (...) relevance) were selected through database searches (PubMed, Scopus, Web of Science) and manual reference checks. Data were extracted and synthesised thematically, integrating recent policy documents and conceptual analyses relevant to ethics and equity. Findings Five dominant themes emerged: access and infrastructure inequities; misinformation and infodemic management; usability and user-centred design; health data poverty; and ethical governance. While digital health tools proliferated globally, disparities in access, representation and trust remain significant. Developments from 2023 to 2025 (e.g. artificial intelligence-driven health chatbots, TikTok-based health campaigns and updated World Health Organization infodemic guidelines) not only offer opportunities but also introduce new risks. Research limitations/implications The findings position digital health literacy as a core ethical construct within information systems and health policy scholarship, extending digital divide theory beyond access and skills to include justice, autonomy and data representation. This reframing underscores the need to integrate ethical governance and power asymmetries into models of digital health adoption. Practical implications Policymakers and health system designers should embed equity-by-design principles into digital health initiatives, prioritising inclusive usability, misinformation mitigation and representative data practices. Co-ordinated regulatory frameworks and targeted literacy interventions are essential to ensure emerging digital health technologies reduce, rather than reproduce, health inequalities. Originality/value This systematic review contributes to the discourse on information ethics in healthcare by explicitly linking digital health literacy to principles of justice, autonomy and beneficence. It offers a comprehensive synthesis that is policy-oriented, globally comparative and grounded in the latest literature. (shrink)

The human propensity for possession and ownership has been a defining characteristic throughout history, influencing the structuring of societies. The advent of digital technology, however, challenges traditional notions of possession and necessitates a redefinition of the concept. This paper aims to explore the resignification of possession in the digital age through a philosophical reflection based on an anthropological analysis. It contrasts two paradigmatic forms of possession: the material collection in the ‘thing’ civilization and the data-based access in the (...) digital civilization. Ultimately, the research shows, analyzing the OnlyFans platform model, how the digital age has fundamentally changed the human mode of possession, demanding a new paradigm in both virtual and augmented reality, while emphasizing the irreplaceable material reference when it comes to the intimate aspects of Homo Sapiens. The transition from material collection to digital access signifies a profound change in human self-perception and social structures and reflects the general cultural and existential changes triggered by technological progress. (shrink)

Genomic data sharing enhances efficiency in medical practice by facilitating faster data access and collaboration across settings. However, the same arrangements that enable efficiency could also raise legal inequalities, especially concerning data ownership and access. Yet these inequities are intensified in cross-border collaborations where power dynamics disadvantage low and middle income (LMIC) researchers. A qualitative phenomenological study was conducted in Uganda. Key informant interviews (KIIs) were conducted with 49 stakeholders working at different points across the (...) genomic research landscape and four focus group discussions (FGDs) were conducted with people currently or previously enrolled in genomic studies, or their caretakers. The stakeholders who took part in the KIIs included genomic researchers (16), research ethics committee (REC) members (14), practicing lawyers (3), community advisory board (CAB) members (8) and national research regulators (8). A theory of decolonization was used to clarify rooted power imbalances and unfairness. Through thematic analysis six concerns were identified: (1) inadequate regulatory frameworks, (2) limited access to the shared data, (3) unclear data ownership (4) absence of benefit sharing frameworks, (5) contested intellectual property rights and (6) rethinking power asymmetries and struggles. The wide spread perception by research participants that the Global North collaborators owned the data, eroded community trust. There was limited clarity on data ownership, with Ugandan researchers expressing differing views, on ownership, custodianship, and shared ownership leading to calls for co-ownership. In the absence of benefit-sharing frameworks to regulate the distribution of commercial value, data commercialization disadvantaged Ugandan researchers and participants, reinforcing colonial-like inequalities. Current governance systems mirror colonial patterns in the control and sharing of genomic data in Uganda. These patterns are reinforced not only by cross-border power asymmetries but also by internal power dynamics within the country, including institutional hierarchies and regulatory gaps that limit local decision-making authority. Addressing this requires rethinking governance structures and promoting local or co-ownership models that reflect African interests and support decolonized approaches to data governance. Not applicable. This study did not involve a clinical trial. (shrink)

Timely and accurate information is vital to the success of row crop farmers in the United States. Information access is also critical to conservation efforts due to its influence on best management practice adoption. Public information sources like extension educators have been declining in importance for farmers, raising concerns around what information farmers receive on conservation practices and the accessibility of agronomic information. In this study we investigate farmers’ changing information source consultation by broadly considering the agricultural information landscape, (...) exploring whether farmers have displayed clear trends in access between public and private sources and whether certain farmer or operational characteristics predict public or private source access. We utilize data from a 2018 survey of farmers in four Corn Belt states to examine farmers’ information seeking behaviors and predict the number of total, public, and private sources accessed using structural equation modeling with latent variables. Our findings elaborate on the public-to-private source shift and reveal that farmers continue to seek information from both private and public sources, though the frequency, mode of contact, and types of farmers contacting these sources differ. Results suggest public information sources are still influential, but they are accessed less frequently, tend to appeal to farmers with stronger environmental concerns, and have less appeal to older farmers compared to private information sources. Our findings indicate the potential for extension and other public sources to diversify modes of communication to further their reach. (shrink)

This paper adopts a relational, also known as a topological, approach to food accessibility—the idea that food spaces are best understood as relational becomings rather than as voids filled exclusively with mass and address. It is animated by an experimental spirit, in terms of the methods employed, the data collected, and by how those data are brought together, which together better enriches inductive theorizing. The project looks at the daily macro-mobilities—trips from one GPS coordinate to another—of 70 Coloradoans, (...) triangulated with qualitative semi-structured interview data. Data collection occurred over three phases: baseline interviews, which lasted approximately 45 min; 30-day study period, which involved using a GPS tracking app. on their mobile phones; and follow-up interviews that lasted roughly two hours. The paper, through inductive theorizing and methodological experimentation, contributes to the critical food mapping scholarship in three ways: first, by looking at rural and urban food environments and livelihoods ; second, by focusing on mobilities as opposed to fixities ; and, lastly, by its conceptual innovations attributed to phenomena such as life course and geographies of care. (shrink)

This study examined if the announcement of the EU AI Act was associated with changes in market access and the pace of innovation for AI-enabled healthcare devices within the European Union. The analysis compared pre- and post-announcement periods to determine whether challenges and criticisms identified in prior research corresponded with significant changes in market access or pace of innovation. Specifically, the study investigated market access by analyzing the number of regulatory approvals for AI-enabled medical devices and the (...) rate of innovation, measured by the number of new patent filings for AI-enabled healthcare products. The analysis also considered the volume of venture capital funding directed toward AI healthcare startups and small and medium-sized enterprises in the EU. Data were collected from publicly available sources, including the FDA, OECD Policy Observatory, Health AI Register, and WIPO Patentscope, over a 6-year period. The findings reveal no sustained, statistically significant change in the post-intervention period across all data sources except the OECD data, where descriptive statistics indicated a difference in mean values between EU and non-EU countries. Overall, the study found that the announcement of the EU AI Act did not lead to significant changes in the number of approved devices in the EU, contrary to what previous research had suggested. These results provide policymakers, economic operators in the AI medical device/healthcare sector, and global regulators with insights into the relationship between AI-specific regulations and economic outcomes. (shrink)

There are conceptual and ethical challenges to defining adolescents’ autonomy to access health care, and these can lead to health care norms and practices that could be maladjusted to the needs and preferences of adolescents. Particularly sensitive is access to sexual and reproductive health care services (SRHS). Yet, while there has been substantial conceptual work to conceptualize autonomy (e.g., as independence), there is a lack of empirical research that documents the perceptions of adolescents regarding on how they (...) class='Hi'>access or wish to access health care services. The main objectives of this research were to (a) understand how adolescents in Colombia interpret the concept of “autonomy,” (b) describe how these adolescents articulate their autonomy (i.e., preferences) in accessing SRHS, and (c) analyze the ethical issues emerging from these data. Forty-five semi-structured interviews were conducted with participants aged 14 to 23 years old in the Departments of Antioquia and Valle del Cauca in Colombia. Our study showed that participants’ understanding of autonomy was context-based and highly dependent on personal experiences, and these influenced their choice in how to access SRHS. Seen through the ethical lens of a reproductive justice framework, our results highlight the unequal opportunities for adolescents in terms of autonomy to access SRHS. (shrink)

Surveillance is essential for communicable disease prevention and control. Traditional notification of demographic and clinical information, about individuals with selected infectious diseases, allows appropriate public health action and is protected by public health and privacy legislation, but is slow and insensitive. Big data–based electronic surveillance, by commercial bodies and government agencies, which draws on a plethora of internet- and mobile device–based sources, has been widely accepted, if not universally welcomed. Similar anonymous digital sources also contain syndromic information, which can (...) be analysed, using customised algorithms, to rapidly predict infectious disease outbreaks, but the data are nonspecific and predictions sometimes misleading. However, public health authorities could use these online sources, in combination with de-identified personal health data, to provide more accurate and earlier warning of infectious disease events—including exotic or emerging infections—even before the cause is confirmed, and allow more timely public health intervention. Achieving optimal benefits would require access to selected data from personal electronic health and laboratory records and the potential to re-identify individuals found to be involved in outbreaks, to ensure appropriate care and infection control. Despite existing widespread digital surveillance and major potential community benefits of extending its use to communicable disease control, there is considerable public disquiet about allowing public health authorities access to personal health data. Informed public discussion, greater transparency and an ethical framework will be essential to build public trust in the use of new technology for communicable disease control. (shrink)

Ongoing efforts among federal agencies to expunge public health data from websites and other media in line with Trump administration directives on “gender ideology” and other themes has led to widespread confusion, angst, and concern among health officials, medical practitioners, and patients. It has also generated legal claims seeking to reverse and stop public health data purges. Framed within statutory or constitutional limits, legal strategies countering these data policies help assure access to core public health information (...) essential to specific services, care, and outcomes. (shrink)

Moral distress refers to the emotional distress experienced when an individual’s moral or ethical beliefs are violated. This concept has been widely studied in a number of disciplines, but limited attention has been given to the moral distress experienced by researchers in the humanitarian setting. This paper aims to explore the ethical challenges and resulting moral distress faced by paediatric humanitarian research students in the Mavrovouni Closed Controlled Access Center, Lesvos, Greece. Based on a qualitative approach, we conducted three (...) ethics support workshops with 5 to 10 participants each, in which they were invited to discuss the moral dilemmas they were experiencing in their research work. Sessions were audio-recorded and transcribed; transcripts were analysed using reflexive thematic analysis. Seven main themes were developed: community and system-level considerations, witnessing and moral responsibility, conflicting duties, participant benefit misconception, coping strategies, cultural aspects, and theories of change. These themes highlight the diverse ethical dilemmas research students face in this field. The results of this study will contribute to the development of support systems for researchers working in sensitive data collection and promote a more sustainable and healthy research practice. (shrink)

Today data art is a full-fledged and maturing artistic practice. Like painting, artists are creating new visuals and representations with data. Like sculpture, artists are recombining bits to build something new out of the commonplace. Like photography, artists are using data to mirror or reflect contemporary society. In my own practice for the last 15 years I have been using data to make works at the intersection of art, design and activism with a recent focus on (...) environmental topics. It is my belief that through improved representation of, access to and public involvement with data we can increase understanding of important issues and provoke behavioural and systemic change. In this paper, I will examine the evolution of my work using data as my medium as well as outline tactics for data art to promote change. (shrink)

The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a (...) new vision of care. Molecular tumor boards are one response to these changes and are now providing better access to next-generation sequencing and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent documents at all academic medical centers and to introduce dynamic and electronic informed consent. (shrink)

The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a (...) new vision of care. Molecular tumor boards are one response to these changes and are now providing better access to next-generation sequencing and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent documents at all academic medical centers and to introduce dynamic and electronic informed consent. (shrink)

The sensitivity of human tissue and previous instances of misuse have, rightfully, led to the introduction of far-reaching oversight and regulatory mechanisms for accessing, storing and sharing samples. However, these restrictions, in tandem with more broad-based privacy regulations, have had the unintended consequence of obstructing legitimate requests for medical materials. This is of real detriment to ambitions for biomedical research, most notably the precision medicine agenda. As such, this paper makes the case for facilitating authorised researcher access to human (...) tissue and associated data along practical medical ethics lines, detailing how liberating samples from unfit regulations, re-evaluating biobanks, diversifying considerations for donor benefit-risk, future proofing donor consent and flattening hierarchies of donation acceptability equate to a more cohesive and respectful means of managing biological samples and information than is achieved at present. (shrink)

Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for depression but may not be equitably accessible. Anecdotally, rTMS research enrolls few racialized participants. We assessed disparities and contributing factors through (1) systematic review of reported demographics in U.S. rTMS clinical trials for depression (n = 24 studies); (2) a nationwide, representatively sampled survey of potential patients and psychiatrists examining willingness to seek rTMS and perceived barriers (n = 603). Racialized non-white populations are underrepresented in rTMS clinical trials for (...) depression in the USA. Survey data suggests this is not due to the lack of acceptance of rTMS; there was no difference in willingness to seek rTMS based on respondent race (p = 0.18). Potential patients’ perceived barriers to rTMS care were similar regardless of race. Potential patients reported the primary barrier was lack of sufficient scientific evidence, while psychiatrists predicted that patients’ primary barriers to care were financial. Many publications did not report demographic data. Survey methodology is limited in predicting technology adoption behavior from stated attitudes. This work quantifies racial disparities within rTMS. Because access to care is the final step of translational research, increasing research participation in racialized groups should be a priority for the field. (shrink)

Background During recent decades, providing patients with access to their electronic health records (EHRs) has advanced in healthcare. In the European Union (EU), the General Data Protection Regulation provides individuals with the right to check their data in registries such as EHRs. A proposal for a European Health Data Space has been launched, which will further strengthen patients’ right to have online access to their EHRs throughout Europe. Against these policy changes, scant attention has been (...) paid to the ethical question about whether adolescents and parents should access the adolescent’s EHR, and if so, under what conditions. Methods In this paper, we apply biomedical ethical principles to explore key questions about adolescents’ and parents’ access to adolescents’ EHRs, with the aim of informing future discussions about the development of ethical and policy practice guidelines. Results Drawing on current empirical research, we find preliminary evidence that in some contexts, patient online record access (ORA) could help to facilitate autonomy for adolescents and parents as well as offering support in managing appointments and medications. Notably, however, we find contrasting perspectives between adolescents’ and parents’ experienced benefits and healthcare professionals’ (HCPs) perceived potential harm, with the latter worried about decreased documentation quality after access. Concerns about capacity to understand their health information, and increased anxiety among adolescents obstruct the support of adolescent autonomy among parents and HCPs. Still, research is limited, particularly with respect to adolescents’ experiences of reading their EHRs, and differences across settings have not been closely examined. Conclusions To advance more comprehensive understanding of the effects of ORA, and to inspire greater attention to, and development of, evidence-informed ethical guidance in this domain of clinical practice, we outline a range of empirical questions regarding adolescents’ and parents’ experiences that now warrant further study. (shrink)

Women are the primary microfinance client while microfinance serves as a vital mechanism for enhancing women's financial independence and potentially reducing intimate partner violence (IPV). This study examines the influence of financial independence, access, education, and income on the prevalence of IPV, encompassing physical, sexual, psychological, and economic violence. An online questionnaire was distributed to women aged over 18 who have got married or previously married and had accessed microcredit from financial institutions. Out of the responses, 250 met the (...) criteria for analysis. Binary logistic regression was employed to assess IPV as an outcome variable, defined by whether respondents had ever experienced violence in any of the four forms. The Wald test results reveal that education significantly impacts IPV prevalence, while financial access and independence do not. To address outlier data, a robust estimator was applied, confirming the significance of education as a determinant. These findings suggest that access to financial resources alone may be insufficient to alter power dynamics within intimate relationships. The study underscores the necessity of a multi-faceted approach to addressing IPV, integrating educational initiatives with financial empowerment strategies to create meaningful and sustainable change. (shrink)

International access to and sharing of biospecimens is critical to answer important questions about complex diseases, and to ensure the diversity in biospecimen collection necessary to advance science and develop therapies that benefit all. However, many challenges exist. These include the lack of harmonized ethical, legal, and policy frameworks regarding secondary uses of biospecimens and associated data; regulatory and policy hurdles; and differences in cultural perspectives and practices across regional and national jurisdictions.In this manuscript, a set of ethical (...) principles is presented with the intent to address some of these challenges by ensuring better alignment in ethical practices related to biobanking and the global use of human biospecimens. In addition, these principles could serve as a basis for promoting more consistency among national regulations and policies. The ultimate goal is to develop an international framework for global biospecimen and data sharing. (shrink)

The life sciencesLife sciencesindustryIndustry standards is increasingly facing challenges related to environmental, social, and governance (ESG) issues, which impact its long-term sustainabilitySustainability. Real World EvidenceReal world evidence and Market AccessMarket access (RWEMA) functions play a crucial role in addressing these challenges by integrating real-world data to support ESG program implementations. The purpose of this study is to evaluate how ESG program implementations, guided by RWEMA, can enhance strategic leadershipStrategic leadership and value creationValue creation within the life sciencesLife sciences (...) sector. A systematic literature review was conducted, focusing on real-world evidence and market accessMarket access perspectives in the context of ESG integrationESG integration. The research design included analyzing multiple documents and bibliographic sources to understand the impact of ESG practices on sustainabilitySustainability, compliance, and corporate valueCorporate value. The findings reveal that RWEMA has the potential to drive ESG integrationESG integration, significantly improving brand reputation, financial stability, and adaptability in life sciencesLife sciences companies. The transformation of RWEMA from a supporting function to a strategic leader is critical in overcoming barriers to ESG adoption, thereby enhancing overall market credibility and sustainabilitySustainability. This research contributes to the understanding of ESG integrationESG integration by providing an actionable framework for leveraging RWEMA as a strategic driver. The insights presented here offer valuable guidance for life sciencesLife sciences companies aiming to align their operations with broader sustainabilitySustainability goals, ultimately ensuring long-term viability and stakeholder trustStakeholder trust. (shrink)

If there is to be a natural theory of consciousness that would satisfy both philosophers and scientists, it must be based on naturalistic data and minimal clutter accumulated from semantic arguments. Carruthers offers a 'natural' theory of consciousness that is rather myopic. To explore the evolutionary basis of consciousness, a natural theory should include comparative psychological and neurological data that encompass nonlinguistic measures. Such an approach could provide a clearer picture of the adaptive function, mechanisms, and origins of (...) consciousness. (shrink)

Objective: To determine the views of people with multiple sclerosis (MS) and professionals in relation to confidentiality, consent and access to data within a proposed MS register in the UK. Design: Qualitative study using focus groups (10) and interviews (13). Setting: England and Northern Ireland. Participants: 68 people with MS, neurologists, MS nurses, health services management professionals, researchers, representatives from pharmaceutical companies and social care professionals. Results: People with MS expressed open and altruistic views towards the use of (...) their personal information to facilitate service provision and research, placing trust in responsible guardianship and legitimate use of their information. Participant’s proposed that people with MS should be able to select their individual level of involvement in a register using levels of consent. It was agreed that access to the register should be governed by a guardianship committee composed of a range of stakeholders. People with MS did not wish their details to be used by marketing agencies and did not consider this a legitimate use of their data. Whilst participants were positive of the role a register could play in promoting research, participants felt that access to data by pharmaceutical industries should be administered by the guardianship committee. People with MS are concerned should their employers be able to access their personal information. Professionals were more cautious than people with MS in their approach to the use of patient personal data within a register. Conclusions: Whilst all stakeholders were positive of the benefits of an MS register, development of such a resource must incorporate robust data security and guardianship measures in order to ensure that, whilst opportunities are maximised, risks to the privacy of individuals and legal challenges to professionals are avoided. (shrink)

Land is a constitutional issue in Ethiopia. Article 40 of the FDRE constitution enshrines governing provisions about rural and urban land. Legislation power is given to the federal government (Article 51(5) of the constitution) although this power can be delegated to regions (Article 50(9) of the same constitution). In contrast, administration power is allocated to regions (Article 52 (2(d)) of the constitution). The federal government has enacted the Rural Land Administration and Use Proclamation 456/2005. Both federal and regional land laws (...) have Alternative Dispute Resolution clauses. However, the opportunities and challenges of these clauses from the access to justice perspective are not studied very well. The main objective of this paper is to assess the legal framework and practice of ADR mechanisms in the rural land administration system from the access to justice perspective and come up with a policy option. Doctrinal type of legal research is applied where it involves theory testing which deals with studying existing laws (both federal and regional laws). In addition, both primary and secondary sources have been used. Primary qualitative data was collected through semi-structured interviews. The study found that there are legal constraints. One significant legal constraint is the requirement for mandatory mediation in certain regional states before seeking recourse in a court of law. Mediation is not clearly and uniformly applied per the law and in practice (often the practice and legal framework confuse mediation with arbitration, inappropriately giving decision-making powers to mediators, and turning them into arbiters). Women and Vulnerable Groups are generally more negatively affected by the overreaching of mediators into decision-making, because the mediators are more easily influenced by the party opposing women and Vulnerable Groups, and/or the mediators are culturally biased. This study recommends that mediation should be made optional, where mediators are chosen by the parties and the legal framework is clear that the role of the mediators does not involve imposing decisions. For Oromia and SNNPR, the legal regime of mediation should be clarified to avoid confusion with the arbitration. It is necessary to train community-level mediators in the law and the protection of land rights of Vulnerable Groups against gender discrimination. (shrink)

In an increasingly globalized world, the accessibility of healthcare and medication has expanded beyond local healthcare systems and national borders. This study aims to investigate the transnational health and self-care experiences of 11 Japanese women who have resided in South Korea for a minimum of six months and have utilized oral contraceptives, including those that were acquired over-the-counter (OTC). Data were gathered through semi-structured interviews and analyzed by utilizing the NVivo software. The analysis yielded three significant thematic categories, namely (...) (1) experiences and perceptions of obtaining and utilizing contraceptive pills, including OTC access; (2) individual and social perceptions of pills and their accessibility in Japan, insights from actual users; and (3) enhancing pill accessibility, transnational health and self-care experiences and perspectives. Participants acknowledged that oral contraceptives are a global product and experienced communication challenges with healthcare providers as a result of differing understandings of these medications. Additionally, this study identified transnational strategies, such as purchasing an adequate supply of pills just before departure and seeking pills from local families or acquaintances. This study not only highlights the implications of clinical care for transnational patients but also underscores their critical global perspectives on access to oral contraceptives. Furthermore, it proposes two models for improving accessibility within the Japanese healthcare system, even in prescription-only contexts, by introducing OTC options. (shrink)

This chapter examines the role of food distribution channels in shaping physical access and its impact on food security in Latin America. The authors argue that the structure of downstream food supply chains—the relative prominence of modern supermarkets, traditional markets, and intermediate local stores—plays a critical but underexplored part in determining affordability and dietary choices.Drawing on household survey data from Brazil, Ecuador, Peru, and Uruguay, the authors classify food retail outlets into three distinct channels and analyze their relationship (...) with diet composition and nutritional intake. The descriptive findings reveal significant cross-country differences in food distribution models, with lower-income and rural populations tending to rely more on traditional and intermediate channels that offer lower prices.However, the analysis uncovers a disconnect between these price differences and actual purchasing behavior, suggesting that physical accessibility may be a key barrier. The results of a probability model confirm that the type of food retail outlet accessed is strongly associated with the likelihood of meeting minimum dietary requirements, even after controlling for income, location, and other factors.The chapter underscores the need for further research and tailored policy interventions that recognize the centrality of physical access in ensuring food security and promoting healthy diets. (shrink)

Mucopolysaccharidosis type I (MPS I) is a rare lysosomal storage disorder treated with bone marrow transplantation or enzyme replacement therapy with laronidase, a high-cost orphan drug. Laronidase was approved by the US Food and Drug Administration and the European Medicines Agency in 2003 and by the Brazilian National Health Surveillance Agency in 2005. Many Brazilian MPS I patients have been receiving laronidase despite the absence of a governmental policy regulating access to the drug. Epidemiological and treatment data concerning (...) MPS I are scarce. This study aims to present a demographic profile of Brazilian patients with MPS I, describe the routes of access to laronidase in Brazil, and discuss associated ethical issues relating to public funding of orphan drugs. (shrink)