The GM Secure Data Environment (SDE)
How data from the GM Care Record is being used by researchers for population health research
Greater Manchester’s Secure Data Environment (GM SDE) is being designed to unlock the potential of health data to support advanced research and development in health and care, enabled by the highest standards of data protection and governance.
Secure Data Environments (SDEs) are highly secure computing environments that provide access to health data to use in health and care research. Utilising anonymised primary care data from the GM Care Record, linked with other key datasets (e.g. secondary care), Health Innovation Manchester (HInM) is developing the GM SDE service and infrastructure in partnership with NHS GM Integrated Care Board (ICB) and University of Manchester.
The GM SDE will provide the infrastructure and analytical tools for clinical trials, real world studies, translational research, epidemiological studies and health systems research here in GM for the benefit of our citizens.
The SDE is a secure ‘box’ within the existing GM ICS Advanced Data Science Platform (ADSP) that has the required safety and security measures in place to grant access to health and care data for research and development purposes. The technology supporting the GM SDE within the ADSP– referred to as ‘Elabs’ – has been tested and developed by the University of Manchester.
Our vision for the Secure Data Environment is ambitious:
- Improved Health Outcomes: By enabling cutting-edge research, the GM SDE is helping to address major health challenges faced by the population of Greater Manchester.
- Economic Growth: Through collaboration with the life sciences and tech sectors, the SDE is driving innovation, creating jobs, and furthering economic development.
- Data-Driven Care: The insights generated through the GM SDE and related platforms will support more personalised, effective care, improving health outcomes for millions of people.
The platform is backed by £2.5 million from NHS England as part of the development of 11 regional SDEs, along with a national SDE, within the NHS Research SDE Network. These platforms will become the main route for accessing NHS data for research in future. More information is on the NHS SDE network page.
The North West SDE is a collaboration between three Integrated Care Boards covering the North West of England, including the development of the Greater Manchester SDE.
Researchers can rely on the SDE to provide the infrastructure, tools, and governance needed to conduct pioneering studies that translate into real-world health improvements.
Exemplar projects in Greater Manchester include:
- Virtual Wards: Exploring the early impacts of virtual wards in Greater Manchester, a comparative analysis.
- Diabetes Research: Using advanced data analytics to detect early signs of diabetes and heart failure.
- Cancer Care: Managing long-term cancer survivors and optimising lung cancer screening for underserved communities
Potential users of data in the GM SDE will need to go through a data access request process to ensure the data request and the requester meet requirements in line with the Five Safes framework. The Five Safes are a set of standards which enable data services to provide safe research access to data.
The principles are:
1. Safe Data: data is treated to protect any confidentiality concerns.
2. Safe Research: research projects are approved by data owners for the public good.
3. Safe People: researchers are trained and authorised to use data safely.
4. Safe Settings: a SecureLab environment prevents unauthorised use.
5. Safe Outputs: screened and approved outputs that are non-disclosive.
Read more information for the public on how data from the GM Care Record, utilising the GM SDE, supports care and research in Greater Manchester: https://gmwearebettertogether.com/
Read further information on work taking place across the North West and the development of a regional SDE: https://northwestsde.nhs.uk/
For more information on the GM SDE, please contact: gm.sde@healthinnovationmanchester.com
Frequently Asked Questions - General
The Security Data Environment (SDE) is a secure, centralised platform designed to store, manage, and process pseudonymised patient data for authorised users. It ensures that data is handled in compliance with security, Information Governance and SATRE requirements along with privacy regulations.
The SDE can be used to access health and care data for research and development. Data will be available to support the following:
- AI/Algorithm development
- clinical trial activities
- real world studies
- translational research
- epidemiological studies
- health systems research.
The data on the SDE can be accessed for NHS, academic and commercial purposes by experts in those fields. Every application undergoes a strict validation process including reviewing the public benefit.
Approved user(s) will be appropriately trained in respect of their use of the SDE and in relation to data protection, confidentiality, governance and security.
Read more about the process on our Apply to use the SDE page.
The standard features of the GM SDE include:
- Data Protection: All data is pseudonymised or anonymised as needed.
- Secure Access: Users are granted access through a strict approval process.
- Data Sharing Controls: Controlled data sharing with specific collaborators.
- Audit Trail: Complete record of who accessed the data and when.
- Collaboration Tools: Facilitation of research and collaboration within the secure environment.
Software available as standard includes:
- Anaconda (includes many common R and Python packages for data science)
- R Studio desktop and web application (code editor)
- .NET (application builder)
- Visual Studio Code desktop and web application (including extension for Python) (source code editor)
- PyCharm (Python Integrated Development Environment (IDE))
- LibreOffice (creates and edits documents)
- Jupyter (provides tools for interactive computing)
- Firefox (web browser)
- Alfresco Content Management System (Enterprise Content Management (ECM) system)
- Gitea (for managing code)
The mechanism to request access to the GM SDE is still being developed but, once operational, will be facilitated by Health Innovation Manchester.
All applications follow a strict process which includes assessment by the GM Data Access Committee. Approved user(s) will need to demonstrate that they are appropriately trained in relation to data protection, confidentiality, governance and security. They will also need to specify the organisation they work for.
Yes. The SDE has operational costs and overheads that need to be funded so there will be a charge for using the SDE.
Costs will change based on a number of variables including support services, size of data cohort, technical requirements, access duration. These costs will be developed as we get a better understanding of your requirements.
Information on the research that is being carried out is available from the Data Use Register page.
Aside from the NHS, other organisations that might have access to data in the Security Data Environment (SDE) could include:
- Academic Institutions: Universities and research institutions may be granted access to anonymised or pseudonymised data for public health and medical research.
- Public Health Bodies: Organisations such as Hospital Trusts may use the data for health monitoring, disease prevention, and public health research.
- Government Agencies: Certain government departments, such as the Department of Health and Social Care (DHSC), may seek access to data for policy development and health-related decision-making.
- Pharmaceutical and Medical Technology Companies: They use data to help develop drugs, new treatments to test their effectiveness and safety.
- Regulatory Bodies: Organisations like the Medicines and Healthcare products Regulatory Agency (MHRA) could have access to data for drug safety monitoring and regulatory purposes.
- Research Collaborators: Trusted third-party research organisations or private sector entities involved in clinical trials or health research under strict agreements and compliance with GDPR.
- Charities and NGOs: Health-focused Non-Governmental Organisations (NGOs) and charities involved in public health research purposes.
- Approved Vendors or Service Providers: Companies offering technical, analytical, or data processing services under contractual agreements for specific tasks like data analysis or infrastructure management, always within regulatory frameworks.
In all instances, data is pseudonymised with access tightly controlled, governed by agreements, and subject to strict ethical, legal, and regulatory compliance, particularly with the GDPR and data protection laws.
- Regional Focus
GM SDE: Specifically designed to serve the Greater Manchester area, it aligns with local health and care priorities, focusing on improving healthcare outcomes and research specific to the region.
- Integrated Health and Social Care Data
GM SDE: One of the key features is the integration of both health and social care data. This enables a comprehensive view of the population’s well-being, supporting research and projects that address not only healthcare but also social determinants of health.
- Collaborative Ecosystem
GM SDE: It has a strong emphasis on collaboration between local NHS Trusts, public health bodies, local authorities, universities, and research organisations within Greater Manchester. This local collaboration drives research that is highly relevant to the specific health and social challenges of the region.
- Local Governance and Control
GM SDE: The governance of GM SDE is rooted in local structures and authorities, allowing Greater Manchester stakeholders more control over how data is accessed and used. The data governance framework is designed to ensure that local needs and priorities are reflected in data-sharing decisions.
- Regional Health Initiatives
GM SDE: Supports region-specific health initiatives, such as Greater Manchester’s devolution of health and social care, allowing for unique projects that align with the region’s devolved powers in healthcare.
- Data Types and Sources
GM SDE: Includes local datasets unique to Greater Manchester, such as regional NHS Trust data, local authority records, and health and care data specific to Greater Manchester.
- Local Research and Innovation
GM SDE: Positioned to support Greater Manchester’s research ecosystem, fostering collaboration between local universities, hospitals, and research bodies. It helps drive local innovations in healthcare that address population health challenges specific to the area.
- Patient and Public Involvement
GM SDE: Places strong emphasis on patient and public engagement within Greater Manchester, ensuring local communities are involved in how their data is used for research and service improvements.
- Impact on Local Health Services
GM SDE: Insights gained from data analysis and research are used to directly influence health service delivery and population health management within Greater Manchester.
Frequently Asked Questions - SDE Process
Guidance and support are available through documentation and help desks available on the website.
To express an interest in accessing the GM SDE, please contact the corporateoffice@healthinnovationmanchester.com mailbox and a member of the team will get in touch with you.
Please see the “Accessing the GM SDE” section for details regarding the application process.
The time taken to process applications will vary depending on the quality and complexity of each request. The SDE network will work together to complete this as soon as possible.
As your application progresses, you will be provided with updates at each stage and informed of the next steps.
Individual data controllers (health and care service providers) will have signed data sharing agreements for access to the data they hold.
Data Access Committees (DACs) decide whether applications will be approved or not. The standard membership of a DAC includes:
- patient and public representatives
- GPs / clinical advisors
- information governance
- academic reviewers
- ethics reviewers
- data processors
- data controllers
Your application will be processed through the various assurance steps and once approved, access will be facilitated working with our Data Engineers and Technical Developers to onboard you to the platform.
You will receive notifications via email at the key milestones of your application.
Your project will be assessed at several stages for its viability. An initial assessment will confirm if your project is feasible based on the data held in the SDE, if technical requirements can be met and if the request is legal.
Following this initial assessment full data, technical and Information Governance specifications will be drafted to confirm your exact requirements, and these will go through formal governance before a final decision is made to approve access or not.
There will be a one-off application fee payable once your project has undergone its initial viability assessment. Once you have had your access approved, a contract will be sent which will include the ongoing “run-costs” associated with housing your datasets in the GM SDE.
An initial contract will be produced to facilitate the paying of the application fee. Once an application has been approved, a second contract will be signed to cover the ongoing costs for providing access to the GM SDE.
A feedback mechanism will be provided during the course of the application process to enable the raising of issues and facilitate ongoing improvements to the SDE and its processes.
Frequently Asked Questions - Data
The research requests for accessing data have to demonstrate a positive impact to the GM population; both in terms of the services the NHS offer, and the treatment and care patients receive. Patient data is handled in compliance with GDPR regulations and relevant data protection policies. Only authorised personnel can access the data for approved purposes. All patient data for the purpose of research is deidentified in all instances unless explicit patient consent has been provided to a particular study.
Yes, you have the option to opt out of sharing your confidential patient information for research and planning. There is no deadline for opting out and you can make or change your choice at any time. Please see here for more information about Opting Out of Sharing your Health Records.
Data that is already in the SDE has Confidentiality Advisory Group (CAG) approval to be linked.
If you wish to bring in your own data set, there will be information governance steps that we need to take in order for you to be able to link data.
Data needs to be pseudonymised before being brought into the GM SDE, a process which is facilitated by the Data Services for Commissioners Regional Office (DSCRO)
The GM SDE adheres to the Five Safes Framework.
We will provide a Data Asset Catalogue for an indicative view of the data we can provide you access to – coming soon.
Duration of access will be defined by the terms specified in your application. There are ongoing monthly costs associated with access to the GM SDE so this will need to be weighed against project requirements when you submit your application.
The SDE contains pseudonymised data, with all identifying (or personal) patient information such as names, addresses or NHS numbers replaced with artificial, or ‘pseudo’, information.
A national data catalogue is available through HDR UK. On registration and validation users will have access to this catalogue to inform their research. This will allow an understanding of the assets.
A local data catalogue is also being built that will allow users to understand lineage and provenance of datasets.
For the purposes of this website, we use ‘data is’ when talking about the data on the SDE. We appreciate ‘data are’ is the wording used in scientific publishing. Our website has a wide audience, so the language used reflects that.
