A new blog from Dr Paul Mills, who supports and advises the Confidentiality Advisory Group (CAG), has highlighted an important national milestone for the NHS Secure Data Environment Network, highlighting the safeguards, governance and public involvement that allow health data to support research while remaining securely controlled.
Secure Data Environments (SDEs) provide researchers with access to health data in highly controlled settings. Instead of patient-level data being sent to researchers, approved researchers come to the data and work with it inside the secure environment. Data cannot simply be downloaded or removed, and research outputs are checked before they leave.
Wessex SDE is one of the regional SDEs that make up the national Network, providing secure access to NHS data for approved research that can improve health and care.
Professor Chris Kipps, Senior Responsible Officer for Wessex SDE, said:
“Secure Data Environments give us an opportunity to make much better use of NHS data for research while strengthening the safeguards around how that information is accessed and used.
CAG’s independent scrutiny of the SDE approach is important because trust cannot be created through technology alone. It depends on strong governance, transparency and meaningful involvement from patients and the public.
In Wessex, our public contributors are part of the way we make decisions, challenge ourselves and improve how we work. As SDEs increasingly collaborate across England and we move towards the Health Data Research Service, maintaining that trust must remain at the heart of what we do.
The CAG blog provides an important reflection on how far the national SDE programme has come, but it also sets out the challenge for its next phase: making it easier for high-quality research to take place across the NHS while continuing to protect confidentiality and earn public confidence.”
Independent assurance for the SDE approach
The Confidentiality Advisory Group (CAG) provides independent advice on the use of confidential patient information. Dr Paul Mills and the HRA Confidentiality Advice Service support and advise CAG in carrying out this role. CAG has provided advice and challenge throughout the development of the SDE Network, including on how confidential patient information is used and protected.
In the blog, Dr Mills explains that CAG is now satisfied that the safeguards and governance arrangements in place provide a sound basis for supporting the SDE approach.
This independent scrutiny is important. It provides assurance around the use of confidential patient information within the SDE arrangements. With the right safeguards, health data can be used to answer important research questions while maintaining confidentiality and public trust.
The blog highlights the Five Safes framework, which underpins the SDE approach. This considers whether the people using data are appropriately authorised, whether the research has a clear and appropriate purpose, whether the data provided is suitable and limited to what is needed, whether it is accessed in a secure environment, and whether outputs are safe before they can leave.
Where confidential patient information is needed to link records for research, SDE research databases can be subject to independent review, including CAG advice and a favourable and Research Ethics Committee opinion.
Public involvement and transparency are essential
The blog also makes clear that technology and security are only part of what makes an SDE trustworthy.
Transparency and meaningful involvement of patients and the public need to be built into the way SDEs operate from the outset. People should be able to understand how their information is being used, why it is needed, what safeguards are in place and what benefits research is intended to deliver.
This has been a central part of the Wessex SDE approach.
Our Digital Critical Friends (DCFs), members of the public who work alongside the SDE, contribute directly to discussions about how data should be accessed and used. Public representatives are involved in our governance and Data Access Committee, helping to challenge proposals and ensure that public perspectives are considered when decisions are made.
Their feedback has also helped shape how we communicate about the use of data, including our transparency information and Data Use Register, where people can see which projects have been approved to use data through Wessex SDE.
This work continues as new technologies, research methods and uses of health data develop. Paul stresses that new approaches should remain consistent with what patients and the public would reasonably expect to happen with their health information.
From regional SDEs to a national research capability
The next stage is increasingly about helping researchers answer questions that cannot be addressed using data from one region alone.
Many important health questions cross geographical boundaries. Researchers may need to study larger or more diverse populations, understand differences between regions, or investigate conditions where relatively small numbers of patients are treated in any individual area.
Looking ahead, he highlights the importance of SDEs working together, with more streamlined and consistent approaches across the Network while maintaining strong standards for privacy and governance.
Wessex is already contributing to this development, including work to enable approved research involving data held across multiple SDEs. Public involvement is an important part of that work too, helping us understand the safeguards and information people expect when research involves data from different parts of the country.
The aim is not to create a single national pool of patient data. Instead, regional SDEs can work together so that approved research can make use of the information it needs while data remains protected within secure NHS-controlled environments.
Building the foundations for the future
Paul’s blog also describes the SDE Network as a critical foundation for the developing UK-wide Health Data Research Service (HDRS).
This represents an important shift in focus. Considerable work has gone into establishing the secure infrastructure, governance and public involvement needed to support trusted access to NHS data. The opportunity now is to build on those foundations so that researchers can use health data more effectively to answer important questions, develop new treatments and technologies, and improve NHS care.
For Wessex SDE, that means continuing to improve the service available to researchers while maintaining the safeguards, transparency and public involvement that make trusted research possible.
Read Paul Mills blog on the HRA website: Secure Data Environments: reaching a national milestone for trusted research.