Perceptions of anonymised data use and awareness of the NHS data opt-out amongst patients, carers and healthcare staff

Abstract Background England operates a National Data Opt-Out (NDOO) for the secondary use of confidential health data for research and planning. We hypothesised that public awareness and support for the secondary use of health data and the NDOO would vary by participant demography and healthcare experience. We explored patient/public awareness and perceptions of secondary data use, grouping potential researchers into National Health Service (NHS), academia or commercial. We assessed awareness of the NDOO system amongst patients, carers, healthcare staff and the public. We co-developed recommendations to consider when sharing unconsented health data for research. Methods A patient and public engagement program, co-created and including patient and public workshops, questionnaires and discussion groups regarding anonymised health data use. Results There were 350 participants in total. Central concerns for health data use included unauthorised data re-use, the potential for discrimination and data sharing without patient benefit. 94% of respondents were happy for their data to be used for NHS research, 85% for academic research and 68% by health companies, but less than 50% for non-healthcare companies and opinions varied with demography and participant group. Questionnaires showed that knowledge of the NDOO was low, with 32% of all respondents, 53% of all NHS staff and 29% of all patients aware of the NDOO. Recommendations to guide unconsented secondary health data use included that health data use should benefit patients; data sharing decisions should involve patients/public. That data should remain in close proximity to health services with the principles of data minimisation applied. Further, that there should be transparency in secondary health data use, including publicly available lists of projects, summaries and benefits. Finally, organisations involved in data access decisions should participate in programmes to increase knowledge of the NDOO, to ensure public members were making informed choices about their own data. Conclusion The majority of participants in this study reported that the use of healthcare data for secondary purposes was acceptable when accessed by NHS. Academic and health-focused companies. However, awareness was limited, including of the NDOO. Further development of publicly-agreed recommendations for secondary health data use may improve both awareness and confidence in secondary health data use.

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Perceptions of anonymised data use and awareness of the NHS data opt-out amongst patients, carers and healthcare staff

10.1101/2020.09.12.20193276 ◽

2020 ◽

Author(s):

Catherine Atkin ◽

Benjamin L Crosby ◽

Kevin W Dunn ◽

Gary Price ◽

Eliot D Marston ◽

...

Keyword(s):

Public Involvement ◽

Public Awareness ◽

Data Use ◽

Health Data ◽

Healthcare Staff ◽

Patient Benefit ◽

The Public ◽

Healthcare Data ◽

Secondary Use ◽

Opt Out

Introduction: Public awareness and support for secondary health data use may vary by health care experience and participant demographics. England provides an example of a centralised opt-out for secondary use of anonymised health data. We explored the awareness, support for and concerns about anonymised healthcare data secondary use and the NHS data opt-out system amongst patients, carers, healthcare staff and the public within the West Midlands. Methods: A patient and public engagement program was completed, including patient and public workshops, questionnaires regarding anonymised health data use and feedback discussion groups. Results: Central concerns for health data use included unauthorised data re-use, the potential for discrimination and profit generation without patient benefit. Key priorities were projects leading to patient benefit, oversight by the NHS as a trusted organisation, increasing awareness of the NHS data opt-out, and ongoing public/patient involvement. Questionnaires showed 31.8% were aware of the NHS data opt-out. 93.8% were happy for their data to be used for NHS research, 84.8% for academic research and 68.4% by health companies. However, opinion varied with demographics (age, gender or public, patient, NHS staff and volunteers). Agreed action points for health data use were education regarding the National Data Opt-Out, public involvement in data requests, NHS oversight, and transparency. Conclusion: Use of anonymised healthcare data for secondary purposes is acceptable to most patients, carers and healthcare workers. However, awareness is limited, and initiatives to publicise potential benefits are needed amongst patients, healthcare staff and the public.

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

10.2196/preprints.7763 ◽

2017 ◽

Author(s):

Mary P Tully ◽

Kyle Bozentko ◽

Sarah Clement ◽

Amanda Hunn ◽

Lamiece Hassan ◽

...

Keyword(s):

Data Sharing ◽

Health Data ◽

Patient Records ◽

Deliberative Process ◽

Health Records ◽

Public Benefit ◽

Secondary Use ◽

Use Of Data ◽

Opt Out ◽

Access To Data

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.

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Secondary Data Usage in Direct-to-Consumer Genetic Testing: To What Extent Are Customers Aware and Concerned?

Public Health Genomics ◽

10.1159/000512660 ◽

2021 ◽

pp. 1-8

Author(s):

Janessa Mladucky ◽

Bonnie Baty ◽

Jeffrey Botkin ◽

Rebecca Anderson

Keyword(s):

Genetic Testing ◽

Secondary Data ◽

Structured Interviews ◽

Customer Data ◽

Secondary Use ◽

Data Usage ◽

Direct To Consumer ◽

New Information ◽

Opt Out ◽

Potential Risks

Introduction: Customer data from direct-to-consumer genetic testing (DTC GT) are often used for secondary purposes beyond providing the customer with test results. Objective: The goals of this study were to determine customer knowledge of secondary uses of data, to understand their perception of risks associated with these uses, and to determine the extent of customer concerns about privacy. Methods: Twenty DTC GT customers were interviewed about their experiences. The semi-structured interviews were transcribed, coded, and analyzed for common themes. Results: Most participants were aware of some secondary uses of data. All participants felt that data usage for research was acceptable, but acceptability for non-research purposes varied across participants. The majority of participants were aware of the existence of a privacy policy, but few read the majority of the privacy statement. When previously unconsidered uses of data were discussed, some participants expressed concern over privacy protections for their data. Conclusion: When exposed to new information on secondary uses of data, customers express concerns and a desire to improve consent with transparency, more opt-out options, improved readability, and more information on future uses and potential risks from direct-to-consumer companies. Effective ways to improve readership about the secondary use, risk of use, and protection of customer data should be investigated and the findings implemented by DTC companies to protect public trust in these practices.

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Protecting Sensitive Data with Secure Data Enclaves

10.31219/osf.io/jmd7t ◽

2021 ◽

Author(s):

Mark Howison ◽

Mintaka Angell ◽

Michael Hicklen ◽

Justine S. Hastings

Keyword(s):

Data Sharing ◽

Data Use ◽

Data Access ◽

Cloud Services ◽

Reference Architecture ◽

Sensitive Data ◽

Technical Requirements ◽

Data Owner ◽

Secure Data ◽

Amazon Web Services

A Secure Data Enclave is a system that allows data owners to control data access and ensure data security while facilitating approved uses of data by other parties. This model of data use offers additional protections and technical controls for the data owner compared to the more commonly used approach of transferring data from the owner to another party through a data sharing agreement. Under the data use model, the data owner retains full transparency and auditing over the other party’s access, which can be difficult to achieve in practice with even the best legal instrument for data sharing. We describe the key technical requirements for a Secure Data Enclave and provide a reference architecture for its implementation on the Amazon Web Services platform using managed cloud services.

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Alberta's Data and Analytic Strategy: Leveraging Linked Data to Drive Innovation

International Journal for Population Data Science ◽

10.23889/ijpds.v4i3.1311 ◽

2019 ◽

Vol 4 (3) ◽

Author(s):

Larry Svenson

Keyword(s):

Health System ◽

Health Information ◽

Data Warehouse ◽

Data Access ◽

Health Data ◽

Direct Access ◽

Safe Haven ◽

For Profit ◽

Secondary Use ◽

Not For Profit

BackgroundThe Province of Alberta, Canada, maintains a mature data environment with linkable administrative and clinical data dating back up to 30 years. Alberta has a single payer, publicly funded and administered, universal health system, which maintains multiple administrative data sets. Main AimThe main aim of the strategy is to fully maximize the data assets in the province to drive health system health system innovation, with a focus on improving health outcomes and quality of life. Methods/ApproachThe Alberta Ministry of Health has created the Secondary Use Data Access (SUDA) initiative to leverage its administrative health data. SUDA envisions strengthening partnerships between the public and private sectors through two main data access approaches. The first is direct access to de-identified data held within the Alberta Health data warehouse by key health system stakeholders (e.g. academic institutions, professional associations, regulatory colleges). The second is indirect access to private and not-for-profit organizations, using a data access safe haven (DASH) approach. Indirect access is achieved through private sector investments to a trusted third party that hires analysts placed within the Ministry of Health offices. ResultsStaffing agreements and privacy impact assessments are in place. Indirect access includes a multiple stakeholder steering committee to vet and prioritize projects. Private and not-for-profit stakeholders do not have access to raw data, but rather receive access to aggregated data and statistical models. All data disclosures are done by Ministry staff to ensure compliance with Alberta's Health Information Act. Direct access has been established for one professional organization and one academic institution, with access restricted to de-identified data. ConclusionThe Secondary Use Data Access initiative uses a safe haven approach to leveraging data to provide a more secure approach to data access. It reduces the need to provision data outside of the data warehouse while improving timely access to data. The approach provides assurances that people's health information is held secure, while also being used to create health system improvements.

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The French Health Data Hub and the German Medical Informatics Initiatives: Two National Projects to Promote Data Sharing in Healthcare

Yearbook of Medical Informatics ◽

10.1055/s-0039-1677917 ◽

2019 ◽

Vol 28 (01) ◽

pp. 195-202 ◽

Cited By ~ 6

Author(s):

Marc Cuggia ◽

Stéphanie Combes

Keyword(s):

Data Sharing ◽

Medical Informatics ◽

Data Privacy ◽

Data Use ◽

Health Data ◽

The European Union ◽

Global Approach ◽

Data Governance ◽

Academic Hospitals ◽

Access Data

Objective: The diversity and volume of health data have been rapidly increasing in recent years. While such big data hold significant promise for accelerating discovery, data use entails many challenges including the need for adequate computational infrastructure and secure processes for data sharing and access. In Europe, two nationwide projects have been launched recently to support these objectives. This paper compares the French Health Data Hub initiative (HDH) to the German Medical Informatics Initiatives (MII). Method: We analysed the projects according to the following criteria: (i) Global approach and ambitions, (ii) Use cases, (iii) Governance and organization, (iv) Technical aspects and interoperability, and (v) Data privacy access/data governance. Results: The French and German projects share the same objectives but are different in terms of methodologies. The HDH project is based on a top-down approach and focuses on a shared computational infrastructure, providing tools and services to speed projects between data producers and data users. The MII project is based on a bottom-up approach and relies on four consortia including academic hospitals, universities, and private partners. Conclusion: Both projects could benefit from each other. A Franco-German cooperation, extended to other countries of the European Union with similar initiatives, should allow sharing and strengthening efforts in a strategic area where competition from other countries has increased.

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Balancing Privacy and Utility in Secondary Data Use to Inform Policy

International Journal for Population Data Science ◽

10.23889/ijpds.v1i1.357 ◽

2017 ◽

Vol 1 (1) ◽

Author(s):

Xinjie Cui ◽

Robyn Blackadar

Keyword(s):

Data Sharing ◽

Data Security ◽

Privacy Protection ◽

Human Subjects ◽

Scientific Discovery ◽

Data Use ◽

Secondary Data ◽

Governance Structure ◽

Information Privacy ◽

Community Research

ABSTRACT ObjectivesUsing existing data for research can generate new knowledge and evidence for policy with relatively little cost. Privacy concerns are paramount in such secondary usage of data collected on human subjects. Information privacy protection and data security are critical considerations in reuse and repurposing of data especially linked data, longitudinal data, and large amounts of data. Data sharing and privacy protection are both in the public interest and we need to assess the risk of “doing” (sharing) as well as the risk of “not doing” (not sharing or not protecting). ApproachThe Alberta Centre for Child Family and Community Research (the Centre) establishes the Child Youth Data Lab that links and analyzes administrative data from multiple provincial ministries and the Child Data Centre of Alberta that repurposes research data and manages its access for reuse. The Centre partners with provincial Office of the Information Privacy Commissioner, Research Ethics Boards and leaders in the research communities and technology industry to design and develop measures to enable secondary use while safeguarding the data, and to explore and adopt best practices on data sharing processes, governance, and technologies. ResultsIn principle current privacy laws and regulations provide good guidance in collection, use, and disclosure of data, however there is a lack of consistency in the interpretation of these laws at the operational level with regard to secondary data use. The experiences of establishing different data sharing models at the Centre through multiple initiatives are discussed. Cross-sectoral broad partnership brings understanding and builds trusting relationships, which are crucial to establishing data sharing processes. The recognition of the significance of secondary data use to provide direction for policy and program development at the executive level provides commitment for data sharing initiatives. Strong governance structure consists multi-level ministry and multiple stakeholder involvement ensures ongoing support and engagement. The highest data security standards and anonymous solution for data linkage enables the sharing of data with good privacy protection. ConclusionSecondary use of data to improve system performance and contributing to scientific discovery has been broadly recognized. A balance between utility and privacy can be realized through broad partnership in building proper governance, technology, processes and policies.

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Accelerating Health Data Sharing: A Solution Based on the Internet of Things and Distributed Ledger Technologies (Preprint)

10.2196/preprints.13583 ◽

2019 ◽

Author(s):

Xiaochen Zheng ◽

Shengjing Sun ◽

Raghava Rao Mukkamala ◽

Ravi Vatrapu ◽

Joaquín Ordieres-Meré

Keyword(s):

Health Care ◽

Internet Of Things ◽

Data Sharing ◽

Data Access ◽

Health Data ◽

Security And Privacy ◽

Access Management ◽

Related Data ◽

Distributed Ledger ◽

Health Related

BACKGROUND Huge amounts of health-related data are generated every moment with the rapid development of Internet of Things (IoT) and wearable technologies. These big health data contain great value and can bring benefit to all stakeholders in the health care ecosystem. Currently, most of these data are siloed and fragmented in different health care systems or public and private databases. It prevents the fulfillment of intelligent health care inspired by these big data. Security and privacy concerns and the lack of ensured authenticity trails of data bring even more obstacles to health data sharing. With a decentralized and consensus-driven nature, distributed ledger technologies (DLTs) provide reliable solutions such as blockchain, Ethereum, and IOTA Tangle to facilitate the health care data sharing. OBJECTIVE This study aimed to develop a health-related data sharing system by integrating IoT and DLT to enable secure, fee-less, tamper-resistant, highly-scalable, and granularly-controllable health data exchange, as well as build a prototype and conduct experiments to verify the feasibility of the proposed solution. METHODS The health-related data are generated by 2 types of IoT devices: wearable devices and stationary air quality sensors. The data sharing mechanism is enabled by IOTA’s distributed ledger, the Tangle, which is a directed acyclic graph. Masked Authenticated Messaging (MAM) is adopted to facilitate data communications among different parties. Merkle Hash Tree is used for data encryption and verification. RESULTS A prototype system was built according to the proposed solution. It uses a smartwatch and multiple air sensors as the sensing layer; a smartphone and a single-board computer (Raspberry Pi) as the gateway; and a local server for data publishing. The prototype was applied to the remote diagnosis of tremor disease. The results proved that the solution could enable costless data integrity and flexible access management during data sharing. CONCLUSIONS DLT integrated with IoT technologies could greatly improve the health-related data sharing. The proposed solution based on IOTA Tangle and MAM could overcome many challenges faced by other traditional blockchain-based solutions in terms of cost, efficiency, scalability, and flexibility in data access management. This study also showed the possibility of fully decentralized health data sharing by replacing the local server with edge computing devices.

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Citizens, research ethics committee members and researchers’ attitude toward information and consent for the secondary use of health data: Implications for research within learning health systems

10.31124/advance.13527221 ◽

2021 ◽

Author(s):

Annabelle Cumyn ◽

Roxanne Dault ◽

Adrien Barton ◽

Anne-Marie Cloutier ◽

Jean-François Ethier

Keyword(s):

Health System ◽

Research Ethics ◽

Data Use ◽

Ethics Committee ◽

Health Data ◽

Research Ethics Committee ◽

Secondary Use ◽

Learning Health System ◽

Public Perspectives ◽

Advance Knowledge

A provincial survey was conducted to assess citizens, research ethics committee (REC) members and researchers’ attitude toward information and consent for the secondary use of health data for research within a learning health system (LHS). The results show that: 1) reuse of health data for research to advance knowledge and improve care is values by all parties; 2) consent regarding health data use for research is fundamental particularly to citizens, even when the data are de-identified; 3) a secure website to support the information and consent processes was appreciated by all. Researchers were more comfortable with the use of de-identified health data for research without informing nor seeking consent from people than citizen and REC member respondents. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models in Quebec to take into consideration the unique features of LHS. The revised consent model will need to ensure that citizens are given the opportunity to be better informed about incoming researches with their health data and have their say, when possible, in the use of their data.

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A systematic literature review of attitudes towards secondary use and sharing of health administrative and clinical trial data: a focus on consent

Systematic Reviews ◽

10.1186/s13643-021-01663-z ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Elizabeth Hutchings ◽

Max Loomes ◽

Phyllis Butow ◽

Frances M. Boyle

Keyword(s):

Clinical Trial ◽

Literature Review ◽

Systematic Literature Review ◽

Clinical Trial Data ◽

Secondary Data ◽

Health Data ◽

Trial Data ◽

Cochrane Library ◽

Original Research ◽

Secondary Use

Abstract Background We aimed to synthesise data on issues related to stakeholder perceptions of consent for the use of secondary data. To better understand the current literature available, we conducted a systematic literature review of healthcare consumer attitudes towards the secondary use and sharing of health administrative and clinical trial data. Methods EMBASE/MEDLINE, Cochrane Library, PubMed, CINAHL, Informit Health Collection, PROSPERO Database of Systematic Reviews, PsycINFO and ProQuest databases were searched. Eligible articles included those reporting qualitative or quantitative original research and published in English. No restrictions were placed on publication dates, study design or disease setting. One author screened articles for eligibility and two authors were involved in the full-text review process. Conflicts were resolved by consensus. Quality and bias were assessed using the QualSyst criteria for qualitative studies. Results This paper focuses on a subset of 47 articles identified from the wider search and focuses on the issue of consent. Issues related to privacy, trust and transparency, and attitudes of healthcare professionals and researchers to secondary use and sharing of data have been dealt with in previous publications. Studies included a total of 216,149 respondents. Results indicate that respondents are generally supportive of using health data for research, particularly if the data is de-identified or anonymised. The requirement by participants to obtain consent prior to the use of health data for research was not universal, nor is the requirement for this always supported by legislation. Many respondents believed that either no consent or being informed of the research, but not providing additional consent, were sufficient. Conclusions These results indicate that individuals should be provided with information and choice about how their health data is used and, where feasible, a mechanism to opt-out should be provided. To increase the acceptability of using health data for research, health organisations and data custodians must provide individuals with concise information about data protection mechanisms and under what circumstances their data may be used and by whom. Systematic review registration PROSPERO CRD42018110559 (update June 2020).

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