By Dr Paul Mills, HRA Confidentiality Advice Service Manager
Through my role supporting and advising the Confidentiality Advisory Group (CAG), I've been closely involved in one of the most significant developments in the use of health data for research in England, the creation of the NHS Research Secure Data Environment (SDE) Network.
Now, with all regional SDEs in place across England and continuing to mature, we've reached an important milestone. It's a significant achievement for researchers, NHS organisations and patients alike, and one that reflects years of collaboration between the NHS, regulators, researchers and public contributors.
At its heart, the SDE Network is about striking the right balance. Enabling high-quality research while maintaining public trust and ensuring confidential patient information remains securely within NHS control, while still being made safely accessible for approved research purposes.
The HRA, including the CAG, has a key role to play to make sure that SDEs do strike that balance as we seek to make it easier to do research that people can trust.
What is a Secure Data Environment?
SDEs were developed as part of the Department of Health and Social Care's vision for improving access to health data for research and innovation.
Historically, patient data was often shared with a range of organisations and databases to support research. While this enabled important scientific advances, it also created challenges around oversight, governance and public confidence.
SDEs take a fundamentally different approach.
Rather than data being shared out to researchers, researchers access the data they have been approved to use for their studies within a highly secure NHS-controlled environment. Data remains protected, identifiable information is safeguarded, and by default, researchers only access information in a form that does not enable individuals to be identified. Research data approved to leave the environment is subject to appropriate output controls.
A simple way to think about it is this, researchers go to the data, rather than the data going to researchers.
This model helps ensure that valuable health data can continue to support research and innovation while remaining under secure NHS oversight.
Building a network across England
Alongside the national NHS England SDE, regional SDEs have been established across England providing the capability to bring together data from hospitals, GP practices and other healthcare settings within defined geographical areas.
By enabling data from different settings to be linked securely, these environments help create a more complete picture of patient care. For example, data from a GP record can be securely linked with hospital data, enabling researchers to better understand patient journeys, treatment outcomes and population health trends.
Collectively, the regional SDE Network covers millions of patient records and represents one of the most ambitious investments in health research infrastructure in recent years.
It also provides the foundations for more collaborative research, allowing valuable insights to be generated while maintaining strong safeguards around confidentiality and privacy.
The role of CAG and Section 251 support
As with many large-scale research initiatives involving health data, creating linked datasets requires identifiable information to be used securely behind the scenes so records can be matched accurately.
Given the scale involved, obtaining consent from every individual would not be practical and, in some circumstances, this could affect the completeness and representativeness of the data available for research.
This is where the HRA's CAG has played an important role.
Through its advice on applications for support provided under Section 251 of the NHS Act 2006, the CAG helps ensure that any use of confidential patient information is necessary, proportionate and subject to appropriate safeguards. Alongside Research Ethics Committee review, this provides independent scrutiny and helps maintain public confidence in how health data is used. The governance and controls within SDEs are underpinned by the Five Safes framework, ensuring appropriate safeguards are in place for people, projects, settings, data and outputs. The SDE research databases can only go ahead once they have received CAG support and a favourable REC opinion for the use of confidential patient information to link records for research.
The development of the SDE Network reflects years of careful work to build a framework that supports research while putting in place safeguards and governance arrangements designed to maintain high standards of confidentiality, governance and accountability.
The CAG has provided advice and challenge throughout the development of the SDEs and is now satisfied that the safeguards and governance arrangements in place provide a sound basis for supporting this approach.
Trust remains central
Doing research in a way that people can trust is not new. Established research governance processes already provide important safeguards around how health data can be accessed and used. SDEs build on these foundations, rather than replacing them.
Trust is fundamental to the success of health research. Putting appropriate safeguards in place enables researchers to access the information needed to answer important questions whilst maintaining public confidence in how that data is used.
One of the most important elements of the SDE Network to earn and maintain this trust is transparency. The CAG looks for evidence that appropriate transparency and public involvement and engagement arrangements are in place when reaching its advice, underlining the importance of this work being built into the development of SDE arrangements from the outset.
SDEs are expected to engage with patients and the public, explain how health data is used and ensure communities understand the safeguards in place. Public involvement has been an important part of shaping how these environments operate and helping maintain confidence in how health data is used for research.
Researchers working within SDEs cannot download or remove patient-level datasets. Identifiable information remains protected within secure systems, and only approved outputs, such as aggregated findings, can leave the environment.
Alongside these technical safeguards, robust governance and independent oversight are essential. In addition to the approaches taken by the SDEs described above, the CAG plays an important role in providing independent advice on the use of confidential patient information for research and other purposes, including considering whether its use without consent is necessary, proportionate and subject to appropriate safeguards, helping to ensure its access is appropriate, justified and in the public interest. This scrutiny provides independent assurance that the safeguards underpinning SDE arrangements are sufficient to support the use of confidential patient information in an appropriately governed way that patients and the public can trust.
These safeguards are designed to ensure that research can flourish while patient confidentiality remains protected. As the Network continues to evolve, it will be important that SDEs continue to operate visibly in line with established research governance expectations and maintain clear and transparent communication with the public.
Looking ahead
While the establishment of the SDE Network is a major achievement, it is not the end of the journey.
Research increasingly spans geographical boundaries, meaning SDEs must work together to support projects that involve multiple regions while maintaining consistent governance and privacy standards. Work is already underway to support greater collaboration and more streamlined processes across the network, making it easier for researchers to access the data they need while ensuring appropriate safeguards remain in place.
There is also growing interest in how SDEs can support research and innovation in a wide range of areas. As these uses develop, it will be important that they remain consistent with what patients and the public would reasonably expect to happen to their health data, including being clear about any opt-outs available.
These developments present exciting opportunities to improve health outcomes and accelerate research. They also highlight the importance of continued collaboration between researchers, NHS organisations, regulators and public contributors to ensure the network develops in a way that remains trusted and transparent.
As the Network matures, maintaining consistency across regions and ensuring clear communication with patients and the public will remain key priorities.
A foundation for the future
The establishment of England's regional SDE Network marks an important milestone in strengthening health data research infrastructure.
It demonstrates how innovation and strong governance can work hand in hand to unlock the value of health data for research while maintaining public confidence.
For me, one of the most encouraging aspects of this work has been seeing organisations across the system come together with a shared goal: creating a trusted environment where health data can be used responsibly to improve treatments, services and outcomes for patients. The CAG has played a valuable role in supporting these conversations and is now able to provide assurance that the SDE Network has the safeguards and governance arrangements in place needed to support trusted research.
The SDE Network also provides a critical foundation for the development of the UK-wide Health Data Research Service (HDRS), supporting the wider ambition for a more joined-up, secure and efficient approach to providing access to health data for research purposes across the UK. The CAG looks forward to engaging as this develops so that it can assure the public that they can be confident about how their data is being accessed.
This also connects with wider work on the governance of sensitive health data, including the guidance on safeguarding UK human genomic data that the HRA has contributed to. As these national arrangements continue to develop, we will continue to feed in the lessons from SDEs and other large-scale health data resources, including the importance of clear expectations around access, use, oversight and what information can leave secure environments.
Whilst an important milestone has been reached, the challenge and opportunity ahead is to continue building on that foundation, so that secure, transparent and trustworthy use of health data remains at the centre of research and innovation across the UK.
The HRA, including the CAG, stands ready to continue to play an important role in providing independent assurance so that people can be confident in the way that their data will be accessed.