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Background: Learning Health Systems rely on the secondary use of health data to improve care. Transparency regarding this
secondary use is frequently cited as necessary to increase patient awareness, support alternative approaches to consent, and foster
trust.
Objective: To review the current published literature to identify different stakeholders...
Contexts in source publication
Context 1
... occasionally raised the issue of communicating on measures taken to ensure data accuracy or validity [75,79,96]. Table 4 presents the major types of specific content that emerged from our review. Of note, when the comments concerned specific content, they emphasized the motivation for receiving such a content. ...Context 2
... of the public [79]) By far, the most frequent elements cited in the literature for specific information was related to the return of results from individual tests ( Table 4, row 2) and the sharing of one's data (Table 4, row 4). ...Context 3
... of the public [79]) By far, the most frequent elements cited in the literature for specific information was related to the return of results from individual tests ( Table 4, row 2) and the sharing of one's data (Table 4, row 4). ...Context 4
... and members of the public proposed that information updates be sent at the time of the secondary use of their data (Table 4, row 1). Some referred to a need for control over future use whereas others saw the ongoing relationship as a path to engagement or as a form of reciprocity. ...Context 5
... the literature, patients and members of the public alike expressed a strong expectation to be informed of results from tests done in research contexts (Table 4, row 2) even when it only concerned a marker for disease susceptibility [56], an indication of increased or decreased risk [153], exploratory (for example microbiome) research [127], and even when not performed in a certified laboratory [148]. This expectation was often merged with the request of a right to access one's clinical data, which is outside the scope of secondary use of health data for research. ...Context 6
... of global research results of projects that used one's health data (Table 4, row 3) was another important theme for several stakeholders including members of Indigenous communities. Return of global results whether positive or negative [138] feeds interest, fosters trust and can permit individuals and communities to take more informed decisions. ...Context 7
... on how to access one's data (Table 4, row 5) was not frequently mentioned in the context of governance but seemed to be increasingly mentioned in recent years by members of the public in relation to a need to take control of one's health, ensure data accuracy, and exert some control in the context of novel health data uses [44,79,85] or sharing of genomic data [155]. In the context of data mining, Watson & Payne [44] state: Structures to allow individual access are required to address inaccuracies in the data and to provide a sense of fairness and comfort in knowing that there is some recourse to address problems. ...Citations
... Several authors justified results reporting by claiming that it is a good way to provide information to patients, enhancing trust and facilitating informed decisions [65,82,83]. Others mentioned that reporting the results of all conducted analyses would decrease publication bias[48,65]. ...
We evaluated what guidance exists in the literature to improve the transparency of studies that make secondary use of health data. To find peer-reviewed papers, we searched PubMed and Google Scholar. To find institutional documents, we used our personal expertise to draft a list of health organizations and searched their websites. We quantitatively and qualitatively coded different types of research transparency: registration, methods reporting, results reporting, data sharing and code sharing. We found 56 documents that provide recommendations to improve the transparency of studies making secondary use of health data, mainly in relation to study registration (n = 27) and/or methods reporting (n = 39). Only three documents made recommendations on data sharing or code sharing. Recommendations for study registration and methods reporting mainly came in the form of structured documents like registration templates and reporting guidelines. Aside from the recommendations aimed directly at researchers, we also found recommendations aimed at the wider research community, typically on how to improve research infrastructure. Limitations or challenges of improving transparency were rarely mentioned, highlighting the need for more nuance in providing transparency guidance for studies that make secondary use of health data.
... Increasingly, the term "health data social licence" is being used to describe which datarelated activities members of the public support, and under what conditions [18,33]. For example, the use of patient data for commercial and profit purposes is considered to be outside of social licence by some people based on multiple studies that identify it as problematic [18,21,22,24,27,34]. ...
... Public/patient participants: A total of 20 Canadian participants (10 English speaking and 10 French speaking) took part in the process (Table 1 -inline). Previous studies have reported that health data sharing, linkage, use, and reuse is a complex topic that is not well understood by members of the general public [18,34]. Therefore, recruitment focused exclusively on people who had prior experience as public or patient advisors in a health-related field and/or working with health data, e.g., in community organisations, hospitals, or health research institutes with the hope that such participants would be well-positioned to engage in dialogue with each other without extensive pre-reading or background preparation. ...
The term "social licence" has been used to describe which uses and users of health data the public supports - and under what conditions. From November 2022 to January 2023, Health Data Research Network Canada was funded by the Public Health Agency of Canada to explore whether there was consensus among experienced public and patient advisors on: (i) uses of health data that all members supported or opposed and (ii) what constitutes an essential requirement for a health data use or user to be within social licence. The project was conducted in English and French in collaboration with the Interdisciplinary Research Group in Health Informatics (GRIIS) at the University of Sherbrooke. It involved 20 public/patient advisor "participants" and an additional 13 public/patient advisors who served as peer-reviewers, all of whom had prior experience working in a health-related field and/or with health data. The process followed inclusive design principles in that it captured views held by the majority and minority of participants, including views expressed by only one or two participants. After two 2-hour facilitated sessions, participants agreed that it is within social licence for health data to be used (i) by healthcare practitioners to improve patient care, (ii) by governments and administrators to improve the health system, and (iii) by university-based researchers to understand disease and well-being. There was consensus opposition to (i) an individual or organisation selling someone else's identified health data and (ii) health data being used for a purpose that has no public or societal benefit. There was no consensus about what constitutes an essential requirement for a use or users of health data to be with social licence. The results of the process have been published in a non-peer-reviewed report co-authored with participants. This paper has been co-authored with a subset of the participants and peer-reviewers to present a high-level summary of the findings, methodological details, and templates to enable other groups to adapt the process to their own settings. It also presents the results of an anonymous evaluation of the process using the Public and Patient Engagement Evaluation Tool (PPEET), which were mostly positive and identified some areas for improvement.
... In addition, the argument that specific consent may be preferred when more validity is needed can be considered a challenge to the frequent use of broad consent by interviewees [49]. Finally, prior to reusing previously collected data, app users could be asked for their explicit consent [59]. For data reuse, some have argued that considering data as the user's or collector's private property, or alternatively public property, may lead to undesirable outcomes (e.g., loss of public trust in apps, insufficiently representative datasets), whereas a middle way could better respect the various stakeholder interests (e.g., regulating or overseeing who can access the data and for which purposes) [60,61]. ...
Mental health-related data generated by app users during the routine use of Consumer Mental Health Apps (CMHAs) are being increasingly leveraged for research and product improvement studies. However, it remains unclear which ethical safeguards and practices should be implemented by researchers and app developers to protect users during these studies, and concerns have been raised over their current implementation in CMHAs. To better understand which ethical safeguards and practices are implemented, why and how, 17 app developers and researchers were interviewed who had been involved in using CMHA data for studies. Interviewees discussed the impact on stakeholder interests, sufficiency thresholds and procedural alterations of informed consent, data protection, gathering app user perspectives and representing users in app design and study conduct, and ensuring adequate support. Although the reasoning behind how and why these ethical safeguards and practices should be implemented showed considerable variability and several gaps, interviewees converged on various general lines of reasoning. This allowed for the development of a coherent and nuanced account that could prove useful for future CMHA studies and which could stimulate further normative investigation of the role of ethical safeguards and practices in these studies.
... c) Research Design: Researchers used a mixed methods approach that combined quantitative and qualitative methods. According to Johnson, Onwuegbuzie, and Turner (2007), this design allows researchers to overcome the weaknesses of each method by combining their strengths (Cumyn et al., 2023;Zhang & Sun, 2021). Schools and students who will be research subjects were selected using purposive sampling to ensure the relevance and validity of the results. ...
Penelitian ini bertujuan untuk mengevaluasi efektivitas “Model E-RAISE” dalam meningkatkan hasil belajar IPA di SMP Yayasan Assyfa Learning Center (YALC) Pasuruan dengan mengintegrasikan tantangan sains dengan nilai-nilai budaya lokal Jawa Timur. Penelitian ini menggunakan pendekatan metode campuran komprehensif yang menggabungkan metode kuantitatif dan kualitatif, sehingga memberikan gambaran yang kuat dan dapat diandalkan. Subjek penelitian melibatkan 21 siswa kelas VII dari YALC dan siswa dari sekolah lain di daerah berbeda. Pengumpulan data dilakukan melalui survei dengan skala likert, tes hasil belajar IPA terstandar, observasi kelas, dan wawancara mendalam terhadap siswa dan guru. Hasil penelitian menunjukkan adanya peningkatan yang signifikan pada hasil belajar IPA siswa, dengan rata-rata nilai siswa meningkat dari 71,16 pada Siklus I menjadi 89,93 pada Siklus II. Integrasi kearifan lokal terbukti membantu siswa menghubungkan konsep ilmiah dengan konteks budayanya, sehingga meningkatkan motivasi dan keterlibatan mereka dalam belajar. Analisis statistik deskriptif kuantitatif dan analisis data wawancara dan observasi kualitatif menegaskan bahwa Model E-RAISE berkhasiat dalam meningkatkan pemahaman dan keterampilan siswa dalam sains. Penelitian ini memberikan kontribusi penting dalam bidang pendidikan dengan menunjukkan bahwa pendekatan yang menggabungkan tantangan ilmiah dan nilai-nilai budaya dapat meningkatkan prestasi akademik siswa. Temuan ini menekankan pentingnya inovasi pendidikan yang kontekstual dan relevan untuk meningkatkan literasi sains dan lingkungan belajar siswa. Hasil penelitian ini diharapkan dapat memberikan rekomendasi praktis bagi guru dan pendidik untuk mengembangkan pendekatan pembelajaran yang lebih inovatif dan bermakna.
... In Canada, in 2019, respondents had mixed and more negative reactions when there was private sector involvement regarding research based on linked administrative health data [55]. In 2023, a review of the literature found that patients generally expect high transparency and have high concerns about sharing their data with private sector entities [56]. According to our results, Polish society trusts doctors and scientists the most. ...
Biotechnology is developing at an ever-increasing pace, and the progressive computerization of health care and research is making it increasingly easy to share data. One of the fastest growing areas is biobanking. However, even with the best equipment and the best trained staff, a biobank will be useless without donors. For this reason, we have decided to gauge Polish citizens’ awareness and attitudes towards biobanking and their willingness to donate biological samples. For this purpose the survey was conducted among a nationwide group of 1052 Poles aged 18 and over where the totals for gender, age and place of residence were selected according to their representation in the total population of adult Poles. The survey was conducted using the Computer Assisted Web Interview (CAWI) technique. Approximately two thirds of respondents N = 701 (66.6%) indicated that they had heard of scientific studies in which samples of biological material such as blood, saliva or urine are collected. More than half of respondents (N = 613, 58.3%) had a positive opinion regarding scientific research in which samples of biological material are taken. Only N = 220 (20.9%) of respondents had previously encountered the term biobanking. More than a half N = 687 (65.3%) of respondents would participate in a scientific study that biobanked biological material and health information. Almost half of the respondents (48.0%) would like specific consent to be used in biobanking. In our study we observed a negligible correlation between socio-demographic factors and a willingness to donate biological material to a biobank. Considering the results presented above, the level of knowledge and awareness of biobanks, and their role in scientific research and the health care system, among Polish citizens is low and requires education and information activities.
Precision medicine holds promise for improving health care by tailoring disease treatment and prevention efforts to the needs of individual patients. It also raises ethical questions related to equitable distribution of the benefits of precision medicine; data management, including the terms of data ownership, sharing, and security; and, the nature and extent of community engagement in and oversight of research. These questions are particularly salient for minoritized communities that have been harmed by unethical research practices and often deprived the full benefit of advances in medical science. Understanding the perspectives of these communities is essential to the design and conduct of ethical and effective precision medicine research. This study explored perspectives on the acceptability, feasibility, value, and benefits and harms of precision medicine research among Alaska Native and American Indian (ANAI) peoples. We conducted four focus groups with ANAI individuals who receive primary care from a Tribal health organization in Anchorage, Alaska. Participants were willing to engage in precision medicine research provided specific requirements were met. Research must be conducted by the Tribal health organization or another trusted partner, community health priorities must drive the research agenda, and researchers must employ robust data protections to guard against loss of data security and maintain control over data use and access. These requirements work collectively to ensure research benefits and respects Tribal sovereignty. These findings could help inform efforts to design and implement precision medicine research programs tailored to concerns of ANAI peoples.
Background
The European Union’s General Data Protection Regulation (GDPR) has profoundly influenced health data management, with significant implications for clinical data warehouses (CDWs). In 2021, France pioneered a national framework for GDPR-compliant CDW implementation, established by its data protection authority (Commission Nationale de l’Informatique et des Libertés). This framework provides detailed guidelines for health care institutions, offering a unique opportunity to assess practical GDPR implementation in health data management.
Objective
This study evaluates the real-world applicability of France’s CDW framework through its implementation at a major university hospital. It identifies practical challenges for its implementation by health institutions and proposes adaptations relevant to regulatory authorities in order to facilitate research in secondary use data domains.
Methods
A systematic assessment was conducted in May 2023 at the University Hospital of Rennes, which manages data for over 2 million patients through the eHOP CDW system. The evaluation examined 116 criteria across 13 categories using a dual-assessment approach validated by information security and data protection officers. Compliance was rated as met, unmet, or not applicable, with criteria classified as software-related (n=25) or institution-related (n=91).
Results
Software-related criteria showed 60% (n=15) compliance, with 28% (n=7) noncompliant or partially compliant and 12% (n=3) not applicable. Institution-related criteria achieved 72% (n=28) compliance for security requirements. Key challenges included managing genetic data, implementing automated archiving, and controlling data exports. The findings revealed effective privacy protection measures but also highlighted areas requiring regulatory adjustments to better support research.
Conclusions
This first empirical assessment of a national CDW compliance framework offers valuable insights for health care institutions implementing GDPR requirements. While the framework establishes robust privacy protections, certain provisions may overly constrain research activities. The study identifies opportunities for framework evolution, balancing data protection with research imperatives.
Objectives This study aimed to (1) empirically investigate current practices and analyze ethical dimensions of clinical data sharing by health care organizations for uses other than treatment, payment, and operations; and (2) make recommendations to inform research and policy for health care organizations to protect patients' privacy and autonomy when sharing data with unrelated third parties.
Methods Semistructured interviews and surveys involving 24 informatics leaders from 22 U.S. health care organizations, accompanied by thematic and ethical analyses.
Results We found considerable heterogeneity across organizations in policies and practices. Respondents understood “data sharing” and “research” in very different ways. Their interpretations of these terms ranged from making data available for academic and public health uses, and to health information exchanges; to selling data for corporate research; and to contracting with aggregators for future resale or use. The nine interview themes were that health care organizations: (1) share clinical data with many types of organizations, (2) have a variety of motivations for sharing data, (3) do not make data-sharing policies readily available, (4) have widely varying data-sharing approval processes, (5) most commonly rely on Health Insurance and Portability and Accountability Act (HIPAA) de-identification to protect privacy, (6) were concerned about clinical data use by electronic health record vendors, (7) lacked data-sharing transparency to the general public, (8) allowed individual patients little control over sharing of their data, and (9) had not yet changed data-sharing practices within the year following the U.S. Supreme Court 2022 decision denying rights to abortion.
Conclusion Our analysis identified gaps between ethical principles and health care organizations' data-sharing policies and practices. To better align clinical data-sharing practices with patient expectations and biomedical ethical principles, we recommend updating HIPAA, including re-identification and upstream sharing restrictions in data-sharing contracts, better coordination across data-sharing approval processes, fuller transparency and opt-out options for patients, and accountability for data-sharing and consequent harms.
Context.—:
Technology companies and research groups are increasingly exploring applications of generative artificial intelligence (GenAI) in pathology and laboratory medicine. Although GenAI holds considerable promise, it also introduces novel risks for patients, communities, professionals, and the scientific process.
Objective.—:
To summarize the current frameworks for the ethical development and management of GenAI within health care settings.
Data sources.—:
The analysis draws from scientific journals, organizational websites, and recent guidelines on artificial intelligence ethics and regulation.
Conclusions.—:
The literature on the ethical management of artificial intelligence in medicine is extensive but is still in its nascent stages because of the evolving nature of the technology. Effective and ethical integration of GenAI requires robust processes and shared accountability among technology vendors, health care organizations, regulatory bodies, medical professionals, and professional societies. As the technology continues to develop, a multifaceted ecosystem of safety mechanisms and ethical oversight is crucial to maximize benefits and mitigate risks.
La notion de transparence ressort régulièrement des discussions autour des utilisations secondaires des données de santé. Peu d’études se penchent toutefois sur les impacts de la présence ou de l’absence de transparence ou de son absence sur les membres du public. Cette revue de littérature répond à cette lacune. Elle résulte d’une analyse secondaire de 124 textes issus d’une recension de la portée sur la transparence conformément aux lignes directrices PRISMAS-ScR. Les résultats contribuent à identifier les impacts négatifs ou positifs et à les associer à certaines composantes communicationnelles relatives aux utilisations secondaires de données de santé. Ils permettent également d’identifier les composantes associées à une communication jugée transparente ou opaque par les parties prenantes. La transparence, et plus particulièrement la continuité de la communication, est fortement associée à une augmentation de la confiance et de l’acceptabilité sociale alors qu’en général, les membres du public perçoivent négativement un manque de transparence. Cette revue de littérature approfondit également les connaissances sur les risques d’impacts négatifs de la communication transparente.
