Trusting the Research Environment The concept of a Trustworthy Research Environment (TRE) is central to the work of Connected Health Cities. A TRE is a secure platform to analyse data which meets the needs of the data owners, citizens, and researchers. A TRE must be also be able to meet common data standards, information governance and legal requirements for the storage and use of health data. The development of the individual TREs within the CHC regions enabled local adaptation to governance, data, and research requirements while meeting these core design principles. CHC launched six operational TREs across the North of England, including 100% coverage across the NENC region, within twenty four months.
Born in Bradford TRE
Sheffield 111 TRE
Leeds Institute for Data Analytics (LIDA) TRE
University of Manchester TRE
Establishing the TREs A Technical Working Group was established February 2017. This Group worked with the four regions to develop a common design for the essential features, or reference architecture, as a baseline for future implementation of local TREs. The key features of a TRE were identified as being:
A Data Safe Haven: A service to receive and store anonymous, patient-level data securely
A Data Catalogue: A description of the datasets and projects within the TRE
Security and Governance: Appropriate access controls, including encryption and limiting physical access to the network, with strong governance processes certified to ISO27001
A Virtual Desktop Infrastructure for researchers: The software and tools to allow the researchers access to datasets to undertake the analysis in a secure environment
Publication: The TRE service should also be able to securely publish applications and output from the researchers
Each of the TREs has been used to store a range of datasets that are available to local researchers. These include national datasets such as Secondary Uses Service hospital data, but also develop local datasets, such as the innovative linked health and social care data for the SILVER project (NENC CHC), developed in partnership with the local community of service users as well as medical and care professionals. Examples of the anonymised data that are available in the TRE include:
De-identified at source feeds of local GP records
Ambulance service and A&E data feeds
111 and 999 call data
National audit and other disease specific data
Research specific datasets, e.g. geographical mapping of services.
1. A new Maturity Index for digitally enabled Learning Health Systems With the development of the reference architecture and the implementation of TREs, there is a need to understand the critical components for a successful, digitally enabled learning health system. Following indexes such as HIMSS and KLAS for understanding digital capability, CHC Hub is leading the development of a new maturity model specifically for Learning Health Systems. This will enable any health system to understand how health data is currently used in research and if it is effective in improving the quality of care and outcomes. This will make it possible to understand the current capability of a whole pathway or region to act as an agile, digitally enabled ecosystem rather than in isolated silos. The first version of this Maturity Index will be published in Spring 2020, along with new open source tools to enable new multi-stakeholder programmes to test and implement effective learning health systems. 2. Digital familial consent with Born in Bradford project The question of consent for the use and re-use of health data was an essential question from the start of the CHC programme. Most CHC projects used anonymised data, accessed under appropriate legal purposes, but the general question of consent remained important. Two regions, NWC and NENC, both began the development of consent frameworks for data that was not anonymised and the CHC Hub supported this discussion through workshops, citizen engagement and the design of opt-out and data donorship concepts. It is through this work that Born in Bradford (BiB) partnered with CHC Hub to co-design the requirements for a digital solution for management of familial consent. BiB is one of the largest research studies in the world tracking the lives of over 30,000 Bradfordians with requirements for consent processes to be maintained over many years for a multilingual population. As a birth cohort study, consent of the mother is required for children to be included from birth and is managed for the child by their mother or guardians until they reach competence. This created a complex challenge that was previously managed on paper but, in order to support the scaling of the study, they needed a new, digital solution. A review of existing consent tools showed that there were no existing software able to meet these needs and so a new consent application was developed. This supports integration with the existing maternity record system and provides a solution for managing consent over the decades of the study. This consent application is now available as an open source solution and further development is taking place to extend the use of the system to support dynamic consent management by participants using an online portal. 3. Sustainability and Development CHC Hub are working with Innovate UK and NICE on the Digital Health Technology Catalyst (DHTC) Round 4. With funding from the Industrial Strategy Challenge Fund, £4m of funding has been allocated to support a host of small and medium enterprise (SMEs) innovators to develop their exciting digital health solutions. The sixteen successfully funded project teams have been offered the use of the NICE DataLab services which is an innovative collaborative between NICE, the University of Manchester and CHC to bring together a wide range of expertise from across the NHS, academia and NICE on health data research. The SMEs are gaining an understanding of the health economics, the constraints and standards for the use and interoperability of health and research data, and robust evidence creation to enable a stronger and more mature route to market. Outcomes from this ongoing engagement includes the development of new recommendations on guidance for digital health interventions for NICE. Reciprocity and Sustainability The sharing and use of data through the Trustworthy Research Environments is based on the principles of anonymity, security and, importantly, reciprocity. Reciprocity is demonstrated through the research of local issues with the link to how services for the community providing the data can directly benefit. CHC TREs support the idea that data should be used for the benefit of all, while recognising the challenges that can arise from conflicting needs between stakeholders. An example of this key principle of reciprocity and sustainability is the Great North Care Record, supported by the CHC programme.
The CHC Hub continues to work with cloud services providers, such as Google Cloud and Amazon Web Services, to understand how TRE environments can be utilised in the cloud. This is in response to the longer-term gains, including providing auditable trails of utilisation and versioning, reduced costs for maintaining secure data environments, and access to the latest services and tools, such as for machine learning. Cloud-based services can also enable easier collaboration between research groups, improving transparency and management of data flows. “ The Great North Care Record (GNCR) connects 372 general practices with 11 acute trusts, 2 mental health trusts and one ambulance trust to deliver vital information to the point of care whenever it is needed... It will shortly be upgraded to include patient accounts where privacy preferences can be set including willingness to be contacted about relevant research trials, producing, we hope, the most consent rich research environment in the world.” Joe Mcdonald , Consultant Psychiatrist and Director , NENC CHC