Commercial use of health data in the dock – results of a public “trial”

Introduction Surveys suggest that there is a dichotomy in how citizens view research for public good and research for commercial gain. As a consequence, the idea that a research initiative, such as a learning health system, for both public and commercial benefit may be controversial and reduce public trust. Objectives and Approach This study aims to investigate what informed citizens considered to be appropriate uses of health data in a learning health system. Two paired four-day juries were run, with different jurors but the same purpose, expert witnesses and facilitators. Overall, 694 people applied to be jurors; 36 were selected to match criteria based on national demographics and their prior privacy views. Jurors considered whether and why eight exemplar data uses of depersonalised patient data were acceptable. The exemplars were data uses planned by the learning health system initiative to improve care pathways (planned uses), and possible unplanned data uses. Results All planned uses were considered appropriate by most, but not all, jurors, as they had the potential of benefitting the public through improving care. Positive health outcomes were more acceptable than improved efficiency of services, given jurors prior beliefs about how the NHS operates raising concerns about whether improving efficiency would lead to inequitable distribution or closure of services. The potential uses were considered appropriate where there were improvements in drugs, treatments, or lower NHS costs. Some jurors became more accepting of commercial uses as they understood them better. Commercial uses that prioritised generating profit and did not produce health benefits for the public were unacceptable, regardless of any safeguards for the data. Commercial gain that occurred secondary to achieving public benefit were generally accepted. Conclusion/Implications Juries elicit more informed and nuanced judgement from citizens than surveys. Jurors tended to be more accepting of data sharing to both private and public sector after the jury process. Many jurors accept commercial gain if public benefit is achieved. Some were suspicious of data sharing for efficiency gains

Should free text data in electronic medical records be shared for research? A citizens’ jury study in the United Kingdom

Background Use of routinely collected patient data for research and service planning is an explicit policy of the UK National Health Service and UK government. Much clinical information is recorded in free-text letters, reports and notes. These text data are generally lost to research, due to the increased privacy risk compared with structured data. We conducted a citizens’ jury which asked members of the public whether their medical free-text data should be shared for research for public benefit, to inform an ethical policy. Methods Eighteen citizens took part over 3 days. Jurors heard a range of expert presentations as well as arguments for and against sharing free text, and then questioned presenters and deliberated together. They answered a questionnaire on whether and how free text should be shared for research, gave reasons for and against sharing and suggestions for alleviating their concerns. Results Jurors were in favour of sharing medical data and agreed this would benefit health research, but were more cautious about sharing free-text than structured data. They preferred processing of free text where a computer extracted information at scale. Their concerns were lack of transparency in uses of data, and privacy risks. They suggested keeping patients informed about uses of their data, and giving clear pathways to opt out of data sharing. Conclusions Informed citizens suggested a transparent culture of research for the public benefit, and continuous improvement of technology to protect patient privacy, to mitigate their concerns regarding privacy risks of using patient text data

Tea, talk and technology: patient and public involvement to improve connected health ‘wearables’ research in dementia

Plain English summary There are a growing number of mobile phones, watches and electronic devices which can be worn on the body to track aspects of health and well-being, such as daily steps, sleep and exercise. Dementia researchers think that these devices could potentially be used as part of future research projects, for example to help spot changes in daily activity that may signal the early symptoms of dementia. We asked a range of older people, including people living with dementia and their carers, to participate in interactive discussions about how future participants might find using these devices as part of research projects. We also invited volunteers to borrow a range of devices to test at home, giving them further insights. Discussions revealed that people were generally supportive of this type of research, provided they gave informed consent and that devices were discreet, comfortable and easy to use. They also valued technical support and regular feedback on study progress to encourage ongoing participation. These findings were used to develop a pool of devices for researchers, with computer software and written guidance to help plan, design and support studies. Our work shows that when given the right opportunities, people who are affected by dementia can provide valuable insights that can enhance the design, delivery and quality of future research. Abstract Background Increasingly, researchers are recognising the potential for connected health devices, including smartphones and smartwatches, to generate high resolution data about patterns of daily activity and health outcomes. One aim of the Dementias Platform UK (DPUK) project is to provide researchers with a secure means to collect, collate and link data generated by such devices, thereby accelerating this type of research in the field of dementia. We aimed to involve members of the public in discussions about the acceptability and feasibility of different devices and research designs to inform the development of a device pool, software platform and written guidance to support future studies. Methods Over 30 people attended a series of interactive workshops, drop-in sessions and meetings in Greater Manchester. This included people living with dementia and cognitive impairments, carers and people without memory problems. Discussions were tailored to suit different audiences and focused on the feasibility and acceptability of a range of different wearable devices and research designs. We also invited volunteers to borrow a device to test at home, enabling further insights from hands-on interactions with devices. Results Discussions revealed that people were supportive of connected health dementia research in principle, provided they gave informed consent and that devices were discreet, comfortable and easy to use. Moreover, they recommended technical support and regular feedback on study progress to encourage ongoing participation. Conclusion By using a range of discussion-based and practical activities, we found it was feasible to involve people affected by dementia and use their insights to shape the development of a software platform and device pool to support future connected health dementia research. We recommend that researchers planning such studies in future pay adequate attention to designing suitable participant information, technical support and mechanisms of providing study progress updates to support sustained engagement from participants

Developing on Shifting Sands: A Case Study of a Workplace Safety Monitoring App During the COVID-19 Pandemic

Drawing on Foucauldian perspectives, this article takes as a case study the workplace safety app Hygieia, which emerged in response to the COVID-19 pandemic. We explore how the app’s users were positioned in relation to questions of responsibility, agency, potential surveillance, and the app’s general features. We used qualitative, semistructured interviews with nine of Hygieia’s developers and conducted an autoethnographic analysis of the app, drawing on the “walkthrough” method. This combination allowed for a robust analysis of envisioned and actual functionalities. Developers’ own ideas about workplace safety were realized in their design choices, creating a network of actors and informational flows coordinated by the app. We argue that the app produces instances of responsibilization in which users are individualized, depersonalized, and encouraged to use the app in particular ways. We question this configuration by emphasizing potential implications for agency, accountability, and privacy, and highlight how ordinary employees appear to shoulder a burden of responsibility for workplace safety against a backdrop of uncertainty, heightened surveillance, and moral obligations. At the same time, some levels of responsibilization and surveillance were also necessary in the context of the pandemic. This article makes a novel contribution to digital surveillance and organization studies by applying Foucauldian perspectives to the new context of developing monitoring support technologies during the COVID-19 pandemic

Disparities in COVID-19 infection, hospitalisation and death in people with schizophrenia, bipolar disorder, and major depressive disorder: a cohort study of the UK Biobank

People with severe mental illness (SMI; including schizophrenia/psychosis, bipolar disorder (BD), major depressive disorder (MDD)) experience large disparities in physical health. Emerging evidence suggests this group experiences higher risks of infection and death from COVID-19, although the full extent of these disparities are not yet established. We investigated COVID-19 related infection, hospitalisation and mortality among people with SMI in the UK Biobank (UKB) cohort study. Overall, 447,296 participants from UKB (schizophrenia/psychosis = 1925, BD = 1483 and MDD = 41,448, non-SMI = 402,440) were linked with healthcare and death records. Multivariable logistic regression analysis was used to examine differences in COVID-19 outcomes by diagnosis, controlling for sociodemographic factors and comorbidities. In unadjusted analyses, higher odds of COVID-19 mortality were seen among people with schizophrenia/psychosis (odds ratio [OR] 4.84, 95% confidence interval [CI] 3.00–7.34), BD (OR 3.76, 95% CI 2.00–6.35), and MDD (OR 1.99, 95% CI 1.69–2.33) compared to people with no SMI. Higher odds of infection and hospitalisation were also seen across all SMI groups, particularly among people with schizophrenia/psychosis (OR 1.61, 95% CI 1.32–1.96; OR 3.47, 95% CI 2.47–4.72) and BD (OR 1.48, 95% CI 1.16–1.85; OR 3.31, 95% CI 2.22–4.73). In fully adjusted models, mortality and hospitalisation odds remained significantly higher among all SMI groups, though infection odds remained significantly higher only for MDD. People with schizophrenia/psychosis, BD and MDD have higher risks of COVID-19 infection, hospitalisation and mortality. Only a proportion of these disparities were accounted for by pre-existing demographic characteristics or comorbidities. Vaccination and preventive measures should be prioritised in these particularly vulnerable groups

Using discrete choice experiments to elicit preferences for digital wearable health technology for self-management of chronic kidney disease

Objectives: Wearable digital health technologies (DHTs) have the potential to improve chronic kidney disease (CKD) management through patient engagement. This study aimed to investi gate and elicit preferences of individuals with CKD toward wearable DHTs designed to support self-management of their condition. Methods: Using the results of our review of the published literature and after conducting qualitative patient interviews, five-choice attributes were identified and included in a discrete choice experiment. The design consisted of 10-choice tasks, each comprising two hypothetical technologies and one opt-out scenario. We collected data from 113 adult patients with CKD stages 3–5 not on dialysis and analyzed their responses via a latent class model to explore preference heterogeneity. Results: Two patient segments were identified. In all preference segments, the most important attributes were the device appearance, format, and type of information provided. Patients within the largest preference class (70 percent) favored information provided in any format except the audio, while individuals in the other class preferred information in text format. In terms of the style of engagement with the device, both classes wanted a device that provides options rather than telling them what to do. Conclusions: Our analysis indicates that user preferences differ between patient subgroups, supporting the case for offering a different design of the device for different patients’ strata, thus moving away from a one-size-fits-all service provision. Furthermore, we showed how to leverage the information from user preferences early in the R&D process to inform and support the provision of nuanced person-centered wearable DHT

Investigating the Extent to Which Patients Should Control Access to Patient Records for Research: A Deliberative Process Using Citizens� Juries

BackgroundThe secondary use of health data for research raises complex questions of privacy and governance. Such questions are ill-suited to opinion polling where citizens must choose quickly between multiple-choice answers based on little information.ObjectiveThe aim of this project was to extend knowledge about what control informed citizens would seek over the use of health records for research after participating in a deliberative process using citizens' juries.MethodsTwo 3-day citizens' juries, of 17 citizens each, were convened to reflect UK national demographics from 355 eligible applicants. Each jury addressed the mission "To what extent should patients control access to patient records for secondary use?" Jurors heard from and questioned 5 expert witnesses (chosen either to inform the jury, or to argue for and against the secondary use of data), interspersed with structured opportunities to deliberate among themselves, including discussion and role-play. Jurors voted on a series of questions associated with the jury mission, giving their rationale. Individual views were polled using questionnaires at the beginning and at end of the process.ResultsAt the end of the process, 33 out of 34 jurors voted in support of the secondary use of data for research, with 24 wanting individuals to be able to opt out, 6 favoring opt in, and 3 voting that all records should be available without any consent process. When considering who should get access to data, both juries had very similar rationales. Both thought that public benefit was a key justification for access. Jury 1 was more strongly supportive of sharing patient records for public benefit, whereas jury 2 was more cautious and sought to give patients more control. Many jurors changed their opinion about who should get access to health records: 17 people became more willing to support wider information sharing of health data for public benefit, whereas 2 moved toward more patient control over patient records.ConclusionsThe findings highlight that, when informed of both risks and opportunities associated with data sharing, citizens believe an individual's right to privacy should not prevent research that can benefit the general public. The juries also concluded that patients should be notified of any such scheme and have the right to opt out if they so choose. Many jurors changed their minds about this complex policy question when they became more informed. Many, but not all, jurors became less skeptical about health data sharing, as they became better informed of its benefits and risks

Toward the development of data governance standards for using clinical free-text data in health research: position paper

Background: Clinical free-text data (eg, outpatient letters or nursing notes) represent a vast, untapped source of rich information that, if more accessible for research, would clarify and supplement information coded in structured data fields. Data usually need to be deidentified or anonymized before they can be reused for research, but there is a lack of established guidelines to govern effective deidentification and use of free-text information and avoid damaging data utility as a by-product. Objective: This study aimed to develop recommendations for the creation of data governance standards to integrate with existing frameworks for personal data use, to enable free-text data to be used safely for research for patient and public benefit. Methods: We outlined data protection legislation and regulations relating to the United Kingdom for context and conducted a rapid literature review and UK-based case studies to explore data governance models used in working with free-text data. We also engaged with stakeholders, including text-mining researchers and the general public, to explore perceived barriers and solutions in working with clinical free-text. Results: We proposed a set of recommendations, including the need for authoritative guidance on data governance for the reuse of free-text data, to ensure public transparency in data flows and uses, to treat deidentified free-text data as potentially identifiable with use limited to accredited data safe havens, and to commit to a culture of continuous improvement to understand the relationships between the efficacy of deidentification and reidentification risks, so this can be communicated to all stakeholders. Conclusions: By drawing together the findings of a combination of activities, we present a position paper to contribute to the development of data governance standards for the reuse of clinical free-text data for secondary purposes. While working in accordance with existing data governance frameworks, there is a need for further work to take forward the recommendations we have proposed, with commitment and investment, to assure and expand the safe reuse of clinical free-text data for public benefit

Investigating the Extent to Which Patients Should Control Access to Patient Records for Research: A Deliberative Process Using Citizens� Juries (Preprint)

BACKGROUND The secondary use of health data for research raises complex questions of privacy and governance. Such questions are ill-suited to opinion polling where citizens must choose quickly between multiple-choice answers based on little information. OBJECTIVE The aim of this project was to extend knowledge about what control informed citizens would seek over the use of health records for research after participating in a deliberative process using citizens’ juries. METHODS Two 3-day citizens’ juries, of 17 citizens each, were convened to reflect UK national demographics from 355 eligible applicants. Each jury addressed the mission “To what extent should patients control access to patient records for secondary use?” Jurors heard from and questioned 5 expert witnesses (chosen either to inform the jury, or to argue for and against the secondary use of data), interspersed with structured opportunities to deliberate among themselves, including discussion and role-play. Jurors voted on a series of questions associated with the jury mission, giving their rationale. Individual views were polled using questionnaires at the beginning and at end of the process. RESULTS At the end of the process, 33 out of 34 jurors voted in support of the secondary use of data for research, with 24 wanting individuals to be able to opt out, 6 favoring opt in, and 3 voting that all records should be available without any consent process. When considering who should get access to data, both juries had very similar rationales. Both thought that public benefit was a key justification for access. Jury 1 was more strongly supportive of sharing patient records for public benefit, whereas jury 2 was more cautious and sought to give patients more control. Many jurors changed their opinion about who should get access to health records: 17 people became more willing to support wider information sharing of health data for public benefit, whereas 2 moved toward more patient control over patient records. CONCLUSIONS The findings highlight that, when informed of both risks and opportunities associated with data sharing, citizens believe an individual’s right to privacy should not prevent research that can benefit the general public. The juries also concluded that patients should be notified of any such scheme and have the right to opt out if they so choose. Many jurors changed their minds about this complex policy question when they became more informed. Many, but not all, jurors became less skeptical about health data sharing, as they became better informed of its benefits and risks. </sec