Health Data For Research Purposes Research Articles

A Social Media Campaign (#datasaveslives) to Promote the Benefits of Using Health Data for Research Purposes: Mixed Methods Analysis.

BackgroundSocial media provides the potential to engage a wide audience about scientific research, including the public. However, little empirical research exists to guide health scientists regarding what works and how to optimize impact. We examined the social media campaign #datasaveslives established in 2014 to highlight positive examples of the use and reuse of health data in research.ObjectiveThis study aims to examine how the #datasaveslives hashtag was used on social media, how often, and by whom; thus, we aim to provide insights into the impact of a major social media campaign in the UK health informatics research community and further afield.MethodsWe analyzed all publicly available posts (tweets) that included the hashtag #datasaveslives (N=13,895) on the microblogging platform Twitter between September 1, 2016, and August 31, 2017. Using a combination of qualitative and quantitative analyses, we determined the frequency and purpose of tweets. Social network analysis was used to analyze and visualize tweet sharing (retweet) networks among hashtag users.ResultsOverall, we found 4175 original posts and 9720 retweets featuring #datasaveslives by 3649 unique Twitter users. In total, 66.01% (2756/4175) of the original posts were retweeted at least once. Higher frequencies of tweets were observed during the weeks of prominent policy publications, popular conferences, and public engagement events. Cluster analysis based on retweet relationships revealed an interconnected series of groups of #datasaveslives users in academia, health services and policy, and charities and patient networks. Thematic analysis of tweets showed that #datasaveslives was used for a broader range of purposes than indexing information, including event reporting, encouraging participation and action, and showing personal support for data sharing.ConclusionsThis study shows that a hashtag-based social media campaign was effective in encouraging a wide audience of stakeholders to disseminate positive examples of health research. Furthermore, the findings suggest that the campaign supported community building and bridging practices within and between the interdisciplinary sectors related to the field of health data science and encouraged individuals to demonstrate personal support for sharing health data.

Legal and Ethical Issues in Secondary Use of Administrative Health Data: The Case of Latvian Healthcare Monitoring Datalink.

The paper presents analysis of the legal and ethical issues surrounding establishment of the Latvian Healthcare Monitoring Datalink. The paper covers three interconnected issues in the context of the use of administrative health data for research purposes - anonymization of data, concept of 'public interest' and involvement of research ethics committees. The analysis has been put into broader context of interaction between General Data Protection Regulation (GDPR), national legislative measures and practical needs of researchers. Neither GDPR, nor Latvian legal framework regulate the particularities on the use of potentially identifiable health data in research. Also, the practical use of 'public interest' as a basis for lawful processing of personal data concerning health for research purposes is not clear. More extended involvement of research ethics committees might serve as useful tool for determination the 'public interest' and for the evaluation of proportionality when balancing the aims of the research and the personal data protection.

COVID-19: Putting the General Data Protection Regulation to the Test.

The coronavirus disease (COVID-19) pandemic is very much a global health issue and requires collaborative, international health research efforts to address it. A valuable source of information for researchers is the large amount of digital health data that are continuously collected by electronic health record systems at health care organizations. The European Union’s General Data Protection Regulation (GDPR) will be the key legal framework with regard to using and sharing European digital health data for research purposes. However, concerns persist that the GDPR has made many organizations very risk-averse in terms of data sharing, even if the regulation permits such sharing. Health care organizations focusing on individual risk minimization threaten to undermine COVID-19 research efforts. In our opinion, there is an ethical obligation to use the research exemption clause of the GDPR during the COVID-19 pandemic to support global collaborative health research efforts. Solidarity is a European value, and here is a chance to exemplify it by using the GDPR regulatory framework in a way that does not hinder but actually fosters solidarity during the COVID-19 pandemic.

Cancer Patient Perspectives on Sharing of Medical Records and Mobile Device Data for Research Purposes.

Sharing data is critical to advancing science, improving health, and creating advances in the delivery of health care services. The value of sharing data for cancer research purposes is well established, and there are multiple initiatives under way that address this need. However, there has been less focus on cancer patient perspectives regarding the sharing of their health information for research purposes. This study examined cancer patient perspectives on the sharing of de-identified health data for research purposes including both data from medical records and mobile applications. This cross-sectional study used survey methodology to collect data from cancer patients/survivors (N = 677). Overall, we found that participants were largely willing (71%) to share de-identified medical data and were most motivated (88%) by a desire to help other cancer patients. Patients were less likely to be comfortable sharing mobile application data (34%). It is vital that we understand patient perspectives on data sharing and work with them as partners, valuing their unique contributions, and attending to their preferences.

Public Interest, Health Research and Data Protection Law: Establishing a Legitimate Trade-Off between Individual Control and Research Access to Health Data

The United Kingdom’s Data Protection Act 2018 introduces a new public interest test applicable to the research processing of personal health data. The need for interpretation and application of this new safeguard creates a further opportunity to craft a health data governance landscape deserving of public trust and confidence. At the minimum, to constitute a positive contribution, the new test must be capable of distinguishing between instances of health research that are in the public interest, from those that are not, in a meaningful, predictable and reproducible manner. In this article, we derive from the literature on theories of public interest a concept of public interest capable of supporting such a test. Its application can defend the position under data protection law that allows a legal route through to processing personal health data for research purposes that does not require individual consent. However, its adoption would also entail that the public interest test in the 2018 Act could only be met if all practicable steps are taken to maximise preservation of individual control over the use of personal health data for research purposes. This would require that consent is sought where practicable and objection respected in almost all circumstances. Importantly, we suggest that an advantage of relying upon this concept of the public interest, to ground the test introduced by the 2018 Act, is that it may work to promote the social legitimacy of data protection legislation and the research processing that it authorises without individual consent (and occasionally in the face of explicit objection).

Patients’ and public views and attitudes towards the sharing of health data for research: a narrative review of the empirical evidence

IntroductionInternational sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives...

Sharing confidential health data for research purposes in the UK: where are ‘publics’ in the public interest?

In this article I respond to the tendency of the law to approach ‘the public interest’ as a legal test, thereby drawing the criticism that this narrow notion of what purports to be in the public interest is wholly disconnected from the views of actual publics, and lacks social legitimacy. On the other hand, to simply extrapolate outputs from public engagement work into policy (or indeed law) is equally problematic, and risks being at best ineffective and at worst reinforcing existing inequalities. Given this apparent disconnect between these conceptions of the public interest, and the shortfalls inherent in each, this article scrutinises this disjuncture. I argue that the application of a processual lens to the construction of the legal and regulatory role of the public interest sheds light on how legal notions of the public interest, and attitudes of actual publics towards data sharing, might be reconciled. I characterise this processual approach as being iterative and flexible, specifically drawing attention to the way that multiple actors, processes and interests interact, change and evolve over time in the health research endeavour. This approach is elaborated through two case studies that illustrate how the public interest appears in law (broadly conceived). Its application provides novel insights into the ways in which the public interest can be crafted within and beyond the law to better inform the development of health research regulation.

To What Extent Does the EU General Data Protection Regulation (GDPR) Apply to Citizen Scientist-led Health Research with Mobile Devices?

In this article, we consider the possible application of the European General Data Protection Regulation (GDPR) to “citizen scientist”-led health research with mobile devices. We argue that the GDPR likely does cover this activity, depending on the specific context and the territorial scope. Remaining open questions that result from our analysis lead us to call for a lex specialis that would provide greater clarity and certainty regarding the processing of health data for research purposes, including by these non-traditional researchers.

Cooperating on Data: The Missing Element in Bringing Real Innovation to Europe’s Healthcare Systems

Europe’s growing awareness of gaps in its healthcare provision is not being matched by an increase in remedial action – despite the rich transformative potential of new approaches to data. The new availability of data offers policymakers tools that would allow Europe’s huge investments in health to be far better spent, by being properly targeted. The result would be far better health for far more Europeans. But that requires a step that most European policymakers have not been ready to take. They need to cooperate so that the data can be shared and its full value realised. This paper explores the potential and the challenges that stand in the way of mobilising health data for wider health benefits. This paper goes on to summarise the results of a survey on how different components of the healthcare sector perceive the opportunities from mobilising data effectively, and the barriers to doing so. The responses demonstrated a widespread genuine will to promote research and innovation, and its take-up, for the betterment of healthcare. There was strong appreciation of the merits of data sharing and readiness – under the right circumstances – to share personal health data for research purposes and to undergo genetic sequencing. This paper also suggests the strategic direction that should influence policy formation. The solution can be found without changing the EU treaties, which already provide an adequate base for cooperation. Properly handled, the problems facing European healthcare can be turned into major assets for Europe and make it easier for citizens to have equal access to high-quality care through the meaningful use of digital innovations.

A framework to facilitate interprovincial sharing of secondary health data in Canada

IntroductionThe use of administrative health data can generate knowledge to improve the delivery and outcomes of health care. Yet, the sharing and use of secondary health data presents concerns given these data were not collected for health research purposes. The sharing of patient-level health data across Canadian provinces is uncommon.
 Objectives and ApproachThe Maritime SPOR SUPPORT Unit (a patient-oriented research unit serving the three Canadian Maritime Provinces of New Brunswick, Nova Scotia, and Prince Edward Island) struck a Working Group to develop a conceptual framework for the interprovincial sharing of secondary health data for research purposes. Membership comprised a researcher, two privacy managers/officers, and a manager of research ethics. The framework sought to: (1) facilitate researchers’ understanding of the foundational elements (legal/ethical) of interprovincial data sharing for health research; and (2) identify challenges and opportunities for improving sharing of data across the Maritime Provinces to support patient-oriented research.
 ResultsIn all three Maritime provinces, de-identified personal health information may be used for approved health research purposes, with each province having its own data holdings and repositories. Applying the applicable governance principles and regulations (i.e., the ethical governance of research involving human subjects and the legal governance of health information) and drawing on best practices nationally and internationally, a framework was developed to incorporate and address the various aspects of sharing and using health data across provinces for the purposes of health research. The resultant framework discusses when and how the legal and ethical frameworks apply, the de-identification of data, degrees of data sharing, and information governance. It also identifies challenges and opportunities to moving forward with interprovincial data sharing.
 Conclusion/ImplicationsDevelopment of this framework was the first phase of a multi-phase approach to move towards improved interprovincial data sharing for patient-oriented research. Cross-provincial sharing and linkage of data can lead to comprehensive, cost-effective, and multi-disciplinary research that benefits patients, the health system, and the public at large.

Between Scylla and Charybdis: Charting the Wicked Problem of Reusing Health Data for Clinical Research Informatics.

Summary Objectives: Recognising dilemmas posed by the sharing and reuse of health data as a classic wicked problem and uncover some current key challenges to clinical research informatics. Methods: A modified thematic review process including identification of agreed critical research questions, appropriate query terms and search strategy, identification of relevant papers in accordance with inclusion criteria, and authors' co-review of full text papers. Results: Queries returned 4,779 papers published between January 2014 and November 2017. A shortlist of 197 abstracts was analysed and 18 papers were finally selected for review. Thematic assessment of findings revealed four key challenges: (1) uncertain reliability of consent as a cornerstone of trust due to the limits to understanding and awareness of data sharing; (2) ethical challenges around equity and autonomy; (3) ambitious overly theoretical governance frameworks lacking practical validity; and (4) a clear desire for further public and individual engagement to achieve clearer and more nuanced knowledge dissemination around data sharing practice and governance frameworks. Conclusions: Understanding the wicked problem of reusing clinically acquired health data for research purposes is essential if clinical research is to benefit from informatics advances. A lack of understanding around the context of data acquisition and sharing undermines the foundations of patient-professional trust. Efforts to protect privacy, where tailoring to specific contexts is a key driver, should support the development of solutions which more adequately honour privacy needs, justify access, and protect equity and autonomy.

Health Data for Public Health: Towards New Ways of Combining Data Sources to Support Research Efforts in Europe

Summary Objectives: To present the European landscape regarding the re-use of health administrative data for research. Methods: We present some collaborative projects and solutions that have been developed by Nordic countries, Italy, Spain, France, Germany, and the UK, to facilitate access to their health data for research purposes. Results: Research in public health is transitioning from siloed systems to more accessible and re-usable data resources. Following the example of the Nordic countries, several European countries aim at facilitating the re-use of their health administrative databases for research purposes. However, the ecosystem is still a complex patchwork, with different rules, policies, and processes for data provision. Conclusion: The challenges are such that with the abundance of health administrative data, only a European, overarching public health research infrastructure, is able to efficiently facilitate access to this data and accelerate research based on these highly valuable resources.

Oversight of EU medical data transfers \u2013 an administrative law perspective on cross-border biomedical research administration

The notion of privacy has long had a central role in human rights law, not least in connection to health and medicine. International, regional and national bodies have enacted a number of binding and non-binding document for physicians and researchers to adhere to, in order to protect the autonomy, dignity and privacy of patients and research subjects. With the development of new technologies, the right to privacy has gained a new perspective; the right to protection of personal data within information and communication technologies. The right to data protection has been attributed an increasing importance within EU law. Accordingly, the use of health data in medical research in general and in biobank-related medical research in particular, has made data protection law highly relevant. In medical research involving biobanks, transferring human biological samples and/or individual health data is taking place on a daily basis. These transfers involve several oversight bodies, institutional review boards (IRBs), research ethics committees, or even data protection authorities. This article investigates the role of these national oversight bodies in the transfer of health data in cross-border research, from an EU law point of view. A special focus is laid on transfer of health data for research purposes from the EU to the US, in the light of the recently enacted EU-US Privacy Shield. The main question posed is how American oversight bodies for medical research can be expected to handle the increasingly strict EU requirements for the processing of health data in medical research review.

Health Data for Public Health: Towards New Ways of Combining Data Sources to Support Research Efforts in Europe.

Objectives: To present the European landscape regarding the re-use of health administrative data for research. Methods: We present some collaborative projects and solutions that have been developed by Nordic countries, Italy, Spain, France, Germany, and the UK, to facilitate access to their health data for research purposes. Results: Research in public health is transitioning from siloed systems to more accessible and re-usable data resources. Following the example of the Nordic countries, several European countries aim at facilitating the re-use of their health administrative databases for research purposes. However, the ecosystem is still a complex patchwork, with different rules, policies, and processes for data provision. Conclusion: The challenges are such that with the abundance of health administrative data, only a European, overarching public health research infrastructure, is able to efficiently facilitate access to this data and accelerate research based on these highly valuable resources.

Public responses to the sharing and linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies.

BackgroundThe past 10 years have witnessed a significant growth in sharing of health data for secondary uses. Alongside this there has been growing interest in the public acceptability of data sharing and data linkage practices. Public acceptance is recognised as crucial for ensuring the legitimacy of current practices and systems of governance. Given the growing international interest in this area this systematic review and thematic synthesis represents a timely review of current evidence. It highlights the key factors influencing public responses as well as important areas for further research.MethodsThis paper reports a systematic review and thematic synthesis of qualitative studies examining public attitudes towards the sharing or linkage of health data for research purposes. Twenty-five studies were included in the review. The included studies were conducted primarily in the UK and North America, with one study set in Japan, another in Sweden and one in multiple countries. The included studies were conducted between 1999 and 2013 (eight studies selected for inclusion did not report data collection dates). The qualitative methods represented in the studies included focus groups, interviews, deliberative events, dialogue workshops and asynchronous online interviews.ResultsKey themes identified across the corpus of studies related to the conditions necessary for public support/acceptability, areas of public concern and implications for future research. The results identify a growing body of evidence pointing towards widespread general—though conditional—support for data linkage and data sharing for research purposes. Whilst a variety of concerns were raised (e.g. relating to confidentiality, individuals’ control over their data, uses and abuses of data and potential harms arising) in cases where participants perceived there to be actual or potential public benefits from research and had trust in the individuals or organisations conducting and/or overseeing data linkage/sharing, they were generally supportive. The studies also find current low levels of awareness about existing practices and uses of data.ConclusionsWhilst the results indicate widespread (conditional) public support for data sharing and linkage for research purposes, a range of concerns exist. In order to ensure public support for future research uses of data greater awareness raising combined with opportunities for public engagement and deliberation are needed. This will be essential for ensuring the legitimacy of future health informatics research and avoiding further public controversy.

Data Protection Compliance in the Age of Digital Health.

Advances in technology are transforming the way that health data is collected and used. This includes improvements in existing technology as well as innovations in mobile technology such as smartphone apps and wearables. Health data is strictly regulated under the EU Data Protection Directive 95/46/EC. Under current data protection rules, health data is broadly interpreted and will, in most circumstances not connected to the provision of healthcare, require organisations to obtain explicit consent from individuals for its collection and use. Further data protection compliance issues arise such as identifying who is a controller, ensuring transparency, using health data for research purposes and keeping health data secure. As the EU data protection landscape is due to change in the next few years and will affect the collection and use of health data, the forthcoming Data Protection Regulation also deserves attention.

Unleashing the power of administrative health data: the Scottish model.

Data and information generated through the provision and administration of health and social care provide potentially valuable untapped resources that can contribute to the development of effective and efficient services. We describe the Scottish system, which seeks to unleash, at scale, the power of administrative and health service data as part of the UK-wide Farr Institute of Health Informatics Research program. The 'Scottish model' balances current public attitudes and views around the use of administrative and health data for research purposes with researchers' data requirements, and does so within Scotland's legal framework. The past 3 years has seen the completion of more than 150 projects by researchers from industry (17%), academia (53%) and health service providers (30%). In the future, the aim will be to ensure that research findings are disseminated widely and used to both improve health service provision and further develop public trust.

Privacy Preserving Interoperability for Personalized Medicine

Development and implementation of a new approach for therapeutic drug monitoring and dosage individualization for the patients will significantly improve modern therapeutics. To make it possible we aim at tackling the following questions: how to achieve (semantic) interoperability and medical data integration in a distributed environment; and how to ensure privacy of the patients in case of sharing and aggregation health data for research purposes.

Reflecting on participatory methodologies: research with parents of babies requiring neonatal care

This article concerns a study that examines the attitudes of parents, who have had babies in neonatal care, to sharing their babies’ routinely collected health data for research purposes. A participatory methodology was applied to the design of the study; a group of eleven parents who had all previously had babies in neonatal care were involved in designing a large-scale questionnaire survey. The article addresses the rationale for taking this approach, highlighting how it differs from the more common models of patient and public involvement. It presents the five themes that emerged from parents’ discussion in the course of engaging in the questionnaire design: legitimation, expertise, experiential knowledge, a different epistemology, power and control. How these shaped the design of the survey is employed in this article as a means of providing a commentary on the participatory research process itself. The article concludes by reflecting on whether participatory research can achieve its aims of promoting social justice when used for instrumental purposes such as the refinement of a data collection tool.

‘Nothing is really safe’: a focus group study on the processes of anonymizing and sharing of health data for research purposes

The availability of anonymized data is a keystone of medical research, yet little is known about lay views towards the process of anonymization or on the way that anonymized medical data are transferred to researchers. During May and June 2009, as part of a wider consultation on methods for releasing data to researchers, three focus groups (n = 19) were conducted exploring lay attitudes towards the traditional 'warehouse' model commonly used in medical research for delivering anonymized National Health Service (NHS) data to researchers. The focus groups explored different processes such as the copying of data, use of programmers for linkage and anonymization, the transfer of data and governance. The recognition of the positive aspects of medical research and desire to support it formed the context for discussions. Nonetheless, individuals varied in their attitudes to the use of anonymized data extracts for research from their health records (without consent); although some appeared positive wanted to be asked to consent for this use. Furthermore, participants were acutely aware of security breaches of NHS information nevertheless, they continued to display a high level of trust in NHS staff. Participants were concerned about the practicalities of the warehouse model and relied on their own life experiences to make sense of the model (using analogies with 'banks' or 'libraries'). The general attitude towards the processes underlying the warehouse model might best be captured by the term 'ambivalence'. This research (1) offers unique insights into views of anonymization of health data extracts, how it is undertaken and data are transferred and (2) adds to an increasing body of work that demonstrates that a minority of individuals are concerned about consent, even when data are anonymized although (3) those concerned about anonymization do not necessarily seek resolution through gaining consent.