Secure Data Environments (or SDEs) provide an online platform where large amounts of NHS patient data will be safely stored, linked together, and made accessible to approved researchers to improve services and treatments.

They uphold the highest standards of privacy and security of NHS health and social care data to be used for research and analysis.

All data available for research on the platform is pseudonymised. Researchers do not see confidential patient information, and individuals cannot be easily identified in the dataset.

In research and development patient data is used to find patterns and links, to improve people’s lives through better public health and healthcare.

It is used to better predict disease as early as possible, prevent disease, better predict the right treatment for the right person at the right time, and to develop new treatments and cures for disease.

The NHS has invested time and money in developing a huge wealth of patient data. At the moment this is available to clinicians and care providers for patient care, and for population health management, but we are only scratching the surface of its potential for research and innovation. This is a missed opportunity to save lives and improve health outcomes and we owe it to patients and the public to do better.

Nationally, the Data Saves Lives Strategy committed to increasing public confidence in how data is used and protected.

This responded to the Goldacre Review and reinforced that we would:

• Move away from data sharing to data access
• Ensure that data does not leave the NHS

Part of the Strategy is to establish the NHS Research Secure Data Environment Network. The Network covers the whole of England and is made up of 11 regional SDEs and one national environment (NHS England SDE). These centres can work individually or together to support approved research. All SDEs are NHS owned and managed.

The SDE Network will support the implementation of the Sudlow Review to make better use of the UK’s Health Data to improve people’s health and lives and accelerate research. As well as accelerating data-driven research the SDE will bring direct benefits ranging from giving patients early access to life-saving drugs through clinical trials, to cutting waiting lists and improving population health.

Although patient data is currently shared for research within the NHS and existing procedures do a good job of ensuring safety and privacy, there are significant drawbacks that present a risk if not addressed.

The current process lacks transparency, making it difficult for individuals to understand how their data is being used. The process for researchers is also inefficient and costly, slowing down the development of new treatments and improvements in NHS services.

SDEs will move research from a system of sharing data to secure data access. As a result, identifiable patient data never leaves the SDE and the NHS has full control over who can be a user, the data that users can access, what users can do in the environment, and the findings of the analysis that users can remove.

SDEs will also enhance patient privacy by applying techniques to remove personal details, increase security by hosting data on highly protected systems, and improve efficiency by enabling quicker access to larger sets of data. This will speed up decision-making, increase available insights, accelerate innovation and the discovery of new treatments and technologies.

In summary, while current data sharing procedures do bring benefits to patients, the introduction of SDEs represents an essential evolution in data management. This move towards a more secure, efficient, and transparent system holds immense potential for the betterment of healthcare, all the while safeguarding the sensitive and valuable resource of patient data that the NHS invested in recording.

NHS patient data comes from a variety of sources, but all relates to peoples’ interaction with the health and care system in some way – for example data extracted from your healthcare record, from being a participant in a clinical trial, being involved in a genomics initiative, or as a blood donor.

Your full healthcare record can only be seen by healthcare professionals who are directly involved in your care. It includes a type of data called ‘confidential patient information’. This is data that combines something that identifies you as a patient with information about your health. For example, information about the medication you are taking together with your name, contact information, date of birth, or NHS number.

We do not give access to full healthcare records or any ‘confidential patient information’ and have rigorous process in place to remove this before it is shared with researchers as non-identifiable – or depersonalised – data. However, it’s important to understand that while patient data is depersonalised, it is not entirely anonymous. The reason is that even when direct identifiers are removed, the combination of multiple data points could, in theory, allow for the re-identification of an individual when matched with other external datasets. For instance, a combination of rare medical conditions, specific medications, and unique treatment dates can create a distinctive profile. In the hands of someone with access to other detailed databases, there’s a small risk of re-identification.

This would be illegal, and we have strict controls in place to minimise this risk, ensuring that only approved researchers can access the data and use it responsibly, adhering to strict guidelines and ethical standards. The SDE will enhance security of NHS data by moving away from data sharing to data access, meaning that the raw data is not leaving the NHS, and having the ability to see and audit what researchers are doing with the de-identified data.

We all know that our health and care information is sensitive and needs to be kept safe. Protecting privacy whilst allowing researchers to access patient data is critical.

Health and life sciences research is a highly regulated environment. SDEs must comply with the UK’s high data protection standards, including:

• Caldicott Principles
• Data Protection Act (2018)
• General Data Protection Regulation (GDPR)
• Common Law Duty of Confidentiality
• NHS Constitution
• Health and Social Care Act
• Freedom of Information Act
• Equality impact assessment
• Data impact assessment
• ICO data sharing code of practice
• Data sharing agreements

Nationally, in line with the recommendations from the Sudlow Review and guidance from the Department of Health and Social Care, an assessment framework is being developed for all SDEs. This will ensure that SDEs are regularly evaluated and demonstrate that they are achieving the highest levels of safety and security for NHS data to accelerate the safe use of health data for patient and public benefit.

Data is stored in a secure ‘digital lab’ environment with controlled access and robust IT systems to keep data safe. Only approved users, with approved projects, will be allowed into the digital lab to access and analyse data. Access requests for data must have an explicit aim to benefit patients or the NHS.

Once a research project is approved, a legal contract must be signed before data can be accessed. This contract will set out strict rules about what an organisation or individual can do with the data, when it must be deleted, and has clear restrictions on what is not allowed.

Inside the digital lab users are given a ‘locked room’ to work in that only they have access to. From there they are given access only to the minimum amount of patient data needed to complete their agreed research. Once the research is complete, we ensure that researchers can only take approved non-identifiable outputs. An audit trail is maintained to record all access to patient data and use of the secure data environment.

This approach follows the Five Safes Framework, which is recognised as the UK’s best practice for keeping your data safe.

To analyse and make best use of all the data held by the NHS for the benefit of patients, the NHS, and our care system, we need to work in partnership with a wide range of organisations:

• Charities need data to evaluate services, advocate for patient communities and identify ways to improve care.
• Pharmaceutical companies use data to help develop drugs or test their effectiveness or safety.
• BioTech and MedTech companies use the data to test possible changes to improve patient pathways when receiving care and new inventions and ideas to treat patients more effectively.
• Academic researchers may be able to answer important new questions using data.
• Commercial analytical companies may have the best expertise and technologies for making sense of large and complex information from hospitals and GP practices.

There are strict rules on what’s allowed and not allowed, and there are also exceptions. By law, everyone working in, or on behalf of the NHS and social care, must respect your privacy and keep all information about you safe.

Decisions on who can become a user will be made on the basis of a clear governance policy, which will be created and policed in partnership with the SDE’s public and stakeholders.

All data access requests, to use NHS data for research, must have an explicit aim to benefit for patients and/or the NHS. Data access requests will be assessed by an independent Data Access Committee, who ensure that the researchers and projects looking to access patient data are appropriate. The SDE will have clear policies about what projects will and will not be allowed. The public will be involved in deciding what this policy says, how it should be implemented and will be represented on the Data Access Committee taking the decisions.

Data must never be shared for insurance or marketing purposes.

It is important to acknowledge that using NHS patient data will never be totally risk-free. There must be robust measures in place to reduce the risks as much as possible. There are also risks around not using data.

We know that patients have concerns about loss of privacy, or information about their medical history being revealed to others. People may also be concerned about losing control of their data if it is passed outside the NHS, including data being used to discriminate against individuals or groups or for insurance and targeted marketing. There is also the possibility of cyber-attacks or hacking.

There are also risks around not sharing patient data, including inefficient use of NHS resources and potential wastage. It hinders monitoring drug safety and effectiveness, limits understanding of specific patient group needs, and can delay the invention and delivery of new treatments and technologies.

There are legitimate questions about where we strike the balance between benefits and risks. Across the SDE Network, locally and nationally, we are working with patients and the public to promote an informed debate and design the SDEs and governance processes to get this balance right.

You can choose whether your confidential patient information and de-identified patient data can be used to help with research and planning.

In some cases, you can also make a choice for someone else, like your children (under 13) or someone you care for.

Your choice will not affect your care. 

Donating your patient data ensures that researchers have more complete and representative information for research into new treatments and technologies.

If you’re happy with your information being used, you do not need to do anything.

Further information about your choices and how to opt-out is available on the NHS website – your NHS data matters.

Ongoing consideration is being given to a potential local opt-out option. This is being discussed with the NHS Research SDE Network, Health Research Authority and members of the public.

We recognise that the input and support of the public is vital to creating an SDE Network that is trusted and valued by the people that it serves.

Deciding how patient data is used for R&D isn’t just a technical issue for managers, it is an ethical issue and different people have different perspectives and opinions. New technologies always open up new opportunities and new risks, and we must strike a balance that the public feels is acceptable.

The NHS Research SDE Network and the regional SDEs have been actively involving the public from the start. The National team has developed an approach to build public trust and confidence by generating opportunities for the public to meaningfully influence policies and programmes.

This approach combines three tiers of engagement, repeated three times across 2024/25. Each cohort of engagement comprises:

Core deliberations: bringing together 120 people who are reflective of the population of England, coming together over 3 days to discuss and deliberate key questions. These deliberations will be held in four in person meetings in regional hubs, linked together through technology.

Inclusive engagement: to engage groups for whom participation in deliberations is unsuitable, we plan to run 10, one day workshops, with around 8-12 people per workshop. We will primarily work with intermediary groups to reach this audience.

Deliberative survey: designed to bridge the gap between deliberation participants and the public, we will conduct deliberative polling with a nationally representative survey of 1,000 respondents.

Further details on the topics that will are being discussed are provided on the NHS England website.

Patients and the public will be at the heart of decision making for the Wessex SDE. We have been working collaboratively with our local communities to help co-design the Wessex SDE, including working together to set the values that guide it, the rules that govern it, and agree how it is run. Further information, including how you can get involved, is provided in response to Q13 in the next section of this FAQ and on our Wessex SDE website.

The Wessex Secure Data Environment will unlock the potential of your NHS data to support research, create life-saving new treatments and medicines, and bring wider benefits to patients and our NHS.

Our mission is to build an online platform where large amounts of NHS patient data can be stored, linked together, and accessed by researchers.

The Wessex public has helped to identify 8 strategic priorities for the Wessex SDE. These priorities will help us to prioritise the changes and improvements that the public wants to see as a result of the SDE. They are set out below along with the types of projects and activities that we will prioritise locally to deliver them:

Save the NHS money through prevention and long-term health improvements for everyone: health systems research projects will provide an evidence base for changes to patient pathways and public health activity that deliver more streamlined services, reduce costs and reduce waiting times.

Improve public health, quality of life, and reduce health inequalities: studies that look at impacts on large groups of people (epidemiological studies) will help us to better understand environmental and lifestyle factors, allowing us to provide better public health information and guidance so that people live healthier for longer.

Clear aims, measurable outcomes, and align with Wessex’s health needs: we already know a lot about the burden of disease in Wessex from our Integrated Care Partnerships (ICPs) and NHS partners. By working collaboratively across the region, we can prioritise projects which will have a direct benefit and impact on local issues.

Create new knowledge and avoid unnecessary repetition: by capturing learning and outcomes from the research projects using the Wessex SDE will we help to embed learning that drives new innovation and research, accelerating system and patient outcome improvements.

Clearly costed, financially sustainable, and delivering value for money: the NHS spends a lot of time and money capturing data which is not currently used to its greatest effect. The Wessex SDE will help us to maximise the use and value of this precious data by making available in research ready formats in a single place and enabling national research to consistent standards.

Create financial sustainability for the Wessex SDE to support the NHS in the future: the SDE Network is working collaboratively to develop a costing model to ensure that the NHS and patients receive fair value (not just £ but also wider value) from the system. Research to test, train, check and introduce new forms of technology (such as AI) will also help to reduce the burden on the NHS into the future.

Quickly deliver results using existing data and resources: our first priority for Wessex is to map that data that is currently held by NHS and university partners across the region. This will be an ongoing activity which helps us to accelerate health innovation for real world impact, putting new discoveries into practice in health care settings (also known as ‘translational research’).

A public benefit that would raise awareness of the SDE and build reputation: all research projects that want to use the SDE must demonstrate value to the public and NHS. This will be evaluated by the Wessex SDE’s Data Access Committee which will include professional and public members. Guidance on how projects should be evaluated are being developed in collaboration with the public.

The Wessex SDE is committed to putting patients and the public at the heart of decision making. We are working together to set the values that guide it, the rules that govern it and agree how it is run.

We have taken a strategic approach to delivering a large programme of engagement to invite patients and the public to help us to design and operate the SDE in a way that can be trusted. This started with a review of the extensive work undertaken at a national level on public views on data sharing to inform our approach.

Stage1: Seldom heard groups outreach

Comparatively little research had been done on the voices of seldom heard groups, people who represent underserved parts of our communities less likely to be heard by professionals, health services research and decision-makers. Wessex SDE prioritised these groups for early engagement because we believe it is important to involve people who are most marginalised in our society, including those who may have sensitive health data.

We used NHS England’s Core20PLUS5 criteria (an approach to healthcare inequalities that includes the most deprived 20% of the population, marginalised groups and clinical areas of focus) to identify 600 grassroots organisations and network groups. We contacted the leaders and coordinators and asked if their groups would be interested in participating.

Between November 2023 and April 2024, we worked through community groups, charities, and faith groups, to visit 40 organisations. Through workshops and discussions with these groups, held in their own individual locations and settings, we spoke to over 560 people representing seldom-heard communities across Dorset, Hampshire and the Isle of Wight.

Our participants included carers, people living with long-term and/or complex conditions, people with a history of substance abuse, people in economic disadvantage, settled travellers, people with English as an additional language, veterans, disabled people, older people and young people.

Detailed outputs of the engagement [will be/are] available on our SDE website [LINK].

Stage 2: Wessex Public Panel on ‘The use of NHS data for research’

The principles that came out of the Seldom Heard Groups report were integrated into our planning for a series of public deliberation events held over summer 2024.

50 public members selected by lottery from across Wessex to provide a representative sample of the Wessex population, ensuring diversity in age, gender, ethnicity, socio-economic background, and other demographic factors. The public panel was run as 3 full day events in Bournemouth and Southampton (25 members each) and a final 4th session brining all the participants together.

To maximise value and minimise repetition, we did not re-validate findings from previous national work on the opinions of the public on the use of health data, which are already well understood and captured in our literature review.

Case studies were used to show what research will be enabled, the value that the research delivers to the public, the need for different datasets and the value, risks or challenges. The four sessions covered:

• Day 1: Developing understanding of data driven research, different types of data and the role of the SDE
• Day 2: Concerns, risks and value exchange
• Day 3: Implementing values-based principles in the SDE governance
• Day 4: Recommendation setting for trusted SDE design, operation and decision making

Outputs from this event are currently being bought together and a copy of report will be published on our website.

Stage 3: Large scale promotion of the SDE

From the start of 2025 we are launching our ‘Improving tomorrow’s health’ campaign. We will be sharing information about the SDE and validating the outputs from our public panel, inviting people across Wessex to tell us what they think about the project and giving them the opportunity to get their questions answered.

Further information about the campaign and how the public can get involved will be posted on our website.

Overarching governance and decision-making standards are set for the Wessex SDE by the NHS Health Research Authority (HRA) and the NHS Research SDE Network.

This includes the development of regional ‘Data Access Committees’. These committees will include both professional and public members to decide which projects are prioritised to use the SDE, and to approve the researchers and organisations who will access the data.

We are currently in the process of developing the Wessex SDE governance and decision-making processes with input from the public.

While we test our pre-release version of the platform, to undertake user testing, we have implemented interim governance arrangements, as approved by the HRA.

The pre-release platform will be available to a selected group of approved researchers as ‘platform as a service’. To ensure appropriate use, researchers will be required to obtain suitable governance approvals, including HRA consent or equivalent legal and ethical authorisations. Interim SDE governance and quality assurance is provided by the Data Access Committee at University Hospital Southampton.

As the SDE is a large and complex programme of work there are multiple stages that need to be delivered to ensure that we meet the highest standards of privacy, safety and security of NHS data expected by the public.

Broadly these are defined as:

1. Pilot: initial development and testing of the SDE and SDE Network to ensure viability (completed [date])
2. Pre-release: a 5-stage process to incrementally test and develop the SDE:
3. 1. Technical, safe settings: platform functionality is established and security standards met
   2. Data flow, safe data and safe projects: interim governance and standard operating procedures are in place
   3. Data access, safe projects and safe people: all compliance standards met and documented, and interim governance and approvals processes in place
   4. Data egress, safe outputs: output review procedures and checking processes are in place
4. Full release (Go-Live): compliance with all Health Regulation Authority requirements has been evidenced, data sharing agreements in place with NHS partners across Wessex (planned for end March 2025)

Further detail regarding our progress is available on our website in our Project Highlights section on the Home Page.

Should you have any additional questions or feedback regarding the Wessex SDE, please complete our ‘Contact us’ form and one of our team will get back to you.