NHS Digital Data Release Register - reformatted

Our Future Health projects

66 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).


Our Future Health Outcomes TRE Data Linkage Application with Sublicensing — DARS-NIC-411795-X5N2V

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: Yes (Charity)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2023-11-29 — 2026-11-28 2023.12 — 2024.05.

Access method: Ongoing

Data-controller type: OUR FUTURE HEALTH

Sublicensing allowed: Yes

Datasets:

  1. Civil Registrations of Death
  2. Demographics
  3. Emergency Care Data Set (ECDS)
  4. Hospital Episode Statistics Accident and Emergency (HES A and E)
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)
  6. Hospital Episode Statistics Critical Care (HES Critical Care)
  7. Hospital Episode Statistics Outpatients (HES OP)
  8. National Diabetes Audit
  9. NDRS Cancer Pathway
  10. NDRS Cancer registration (pre-1995)
  11. NDRS Cancer Registrations
  12. NDRS National Radiotherapy Dataset (RTDS)
  13. NDRS Somatic Molecular Dataset
  14. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Expected Benefits:

Our Future Health aims to build a resource that gives health researchers an opportunity to discover and test more effective ways to predict, detect and treat common diseases such as dementia, cancer, diabetes, heart disease and stroke. This aims to include:
>Identifying new signals that could be used to detect diseases much earlier than is currently possible, leading to new or improved screening and prevention programmes and earlier treatment;
>Discovering new ways to predict with better accuracy who is at higher risk of diseases and would benefit from faster access to screening and prevention interventions; and
>Developing more targeted or personalised treatments, tools and technologies to delay the onset of disease, or change the course of disease progression; to reduce disease risks; and more targeted ways to investigate diseases for people at higher risk.

Our Future Health hopes to be uniquely valuable in terms of the scale and diversity of high-quality data and samples that aim to be made available for health research. Several key considerations have been identified regarding the scale of Our Future Health required to facilitate discovery research, including common and rare disease ‘event’ rates; more nuanced ‘event’ rates; age ranges for different diseases/traits; timeframe for value of resource; and potential for translational research.

Our Future Health aims to also help establish effective platforms and processes that support collaboration across the four countries on evaluation and implementation of genomic health insights. Our Future Health plans to build on its national strengths and complement existing prospective cohort resources and translational research efforts in the UK.

The aim is that researchers from universities, the NHS and companies involved in health research will have the chance to apply to use Our Future Health to conduct studies that could improve the way Our Future Health diagnose and treat diseases. The aspiration is that researchers will be given time to analyse and interpret the findings of their research and assess their significance. The aim is for a list and summary of all approved research studies to be published on the Our Future Health website so there is full visibility of who is using Our Future Health and for what purpose. Data generated by all researchers from additional studies using Our Future Health must also be provided back to Our Future Health for other researchers to use in the future once any exclusivity period has expired. This should mean that the programme will constantly grow in breadth and depth for the future public benefit.

Our Future Health wants to see any product developed or device tested in a study using Our Future Health made available in the UK. This includes work done by researchers working for private companies. Our Future Health’s industry funding partners have agreed to make reasonable efforts to ensure that innovations developed using Our Future Health’s resources are made available to benefit health in England and Wales.

Outputs:

Our Future Health will be a long-term cohort, designed to support a wide range of potential studies into disease development, identification, and treatment. It will provide a resource and facilitate both basic and translational research across the UK, on a very large, national scale. In line with the objectives and aims described in 5a, with most cases, Our Future Health will not be generating the outputs. Rather, these will be generated by the researchers who have approval from the Our Future Health Access Board to use the Our Future Health resource. Outputs will include peer-reviewed journal articles as well as presentations at conferences.

Outputs produced from the Our Future Health dataset will be presented in aggregate form only with suppression of small numbers in line with Office for National Statistics guidance and the HES analysis guide to avoid inadvertent identification. In cases where founding members have indicated preference for the release of non-identifiable but person-level data, this form of outputs may be made available (but will not be publicly available). These conditions will be detailed in a governance policy describing the statistical non-disclosure policies (please refer to above mentioned Access process description).

Our Future Health has dedicated communications and partnerships teams that will ensure substantial reach and awareness across the research community. This includes regular and in-depth engagement with numerous organisations and networks across the life sciences industry, academia, public sector, research charities and patient groups. Networking and presentations at conferences are envisioned to be a significant part of work to disseminate findings. Newsletters, bulletins and updates on digital platforms and social media will be provided to aim for regular and ongoing dissemination across the wider research community.

Submission of research to peer-reviewed journals will be another stream of dissemination for research and insight to gather traction and exposure to the research that is being carried out by approved researchers. Unless there is a justifiable reason for not doing so which has been agreed with the Access Board, researchers who use Our Future Health will be required to disseminate the results of their research as rapidly and widely as possible, subject to ethics and confidentiality considerations. They will be encouraged to discuss their research findings with other scientists and the public, and to share relevant materials as openly as possible. This means that Our Future Health will constantly grow in breadth and depth, to the benefit of other researchers in future.

In addition to publishing their work, Researchers are required to provide a plain language summary of their research at the point of application. This will be made publicly available at the point of approval.

Researchers will also be required to provide Our Future Health with a copy of all of results data of their research based on the Our Future Health data and samples (including any negative results data and relevant supporting data) for incorporation into a central database, upon completion of the research.

The abovementioned plans for dissemination of research outputs will be allocated to all registered research partners of Our Future Health who access and produce outputs from the programme. Our Future Health plans to provide infrastructure to third party researchers and facilitate dissemination of results through peer-reviewed publications, conferences, newsletters and ongoing updates and communications.

Registered Researchers will agree to publicise their results to promote the Our Future Health Resource and maximise its usage, whilst making knowledge advancements available to other scientists and researchers to maximise the output.

Our Future Health expects the first research outputs from the cohort to be published in 2024.

Processing:

Our Future Health will provide NHS England with a cohort file containing name, gender or sex assigned at birth, date of birth, postcode and NHS Number (where it is known to Our Future Health), for the purpose of linkage on a quarterly basis. Our Future Health will also provide a participant linkage key (a Pseudonymised Study ID) that will be returned with the record-level data provided by NHS England in order that Our Future Health might link the data back to the participant registry.

Our Future Health will only provide data on participants who have consented to join the Our Future Health programme and have not withdrawn fully or partially by the time the cohort file is prepared. It is estimated that the initial cohort file will contain approximately 250,000 individuals.

Some participants will have been included in previous quarterly cohort files, and these will already have been linked to NHS England records. Our Future Health will indicate to NHS England whether previously successful linkage has occurred and whether historic HES and NDRS (cancer) data has already been provided to Our Future Health previously. This is to limit the amount of data that needs to be provided in future.

NHS England will provide Our Future Health with a mapping file that contains the Study ID. The mapping file will include the NHS Numbers of the participants and diagnostic information relating to the reliability of the NHS Number tracing.

For new study participants, Our Future Health will require the historical HES and cancer registry data (within the time frames specified in the DSA), whereas for existing participants included in previous quarterly cohort submissions, Our Future Health may require only the recent data, unless a data quality problem has been identified with the older data. Our Future Health will include an indicator in the data set that they provide to NHS England to determine whether the historic data has been provided.

Data will flow from NHS England into the Our Future Health Data Platform via an NHS England approved secure transfer mechanism.

Once the Data has been received from NHS England it will be processed within the Our Future Health Data Platforms hosted on two private Microsoft Azure cloud platform tenancies provided by Microsoft Ltd. The Our Future Health TRE is on one of these tenancies and the TRE software functionality and support services are provided by DNAnexus. The Data will not be transferred to any other location other than the data platforms and the TRE as described

The data platform will confirm that the Data received by NHS England matches the agreed specification and ingest the Data into the primary data store where it will be stored. Identifiable Data will be processed and stored separately to the participant health information. Each quarter, Our Future Health will produce research-ready, well-curated and well-documented data releases.

These releases will be made available within the Our Future Health TRE for use by registered researchers working on a research project that has been approved by the Our Future Health Access Board. Researchers will only have access to the data associated with their study, and no other studies being completed on the TRE at the same time. Researchers will only be able to access to data associated with their study for the length of time approved by the Access Board. Researchers wishing to export results data will be subject to an Access process that includes statistical disclosure control. Results data may be shared with Our Future Health so it can be requested by researchers in their applications to the Our Future Health Access Board.

A fundamental data processing and storage principle is the separation of identifiable data from participant health data, which will always be de-identified.

Linkage will only be undertaken within the Our Future Health Data Platform by authorised employees or agents of Our Future Health who have appropriate training and access using the identifiable data held on participants. All employees and contractors with access to sensitive participant information are required to complete bespoke UK GDPR training and acknowledgement form confirming their understanding of and compliance with data protection and information security principles when processing sensitive participant information. Researchers wishing to access data within the TRE will be prohibited from conducting person-level data linkage.

The Data will be accessed by authorised Our Future Health personnel via remote access. The Controller must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access by authorised Our Future Health personnel:
- Remote access will only be from secure locations situated within the territory of use stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA

All data extracts released into the OFH TRE will be de-identified, meaning that they will not contain identifiers such as name or address. In addition, each of the fields that are included within the data extracts released into the OFH TRE will be reviewed to assess the disclosure risk associated with the field and and consider systematic transformations of variables to reduce this risk. The risk associated with individual fields will be reassessed when additional data types are added to a release. To be clear, any outputs released from the OFH TRE will be aggregated with small number suppression applied.

Registered Researchers will be able to import publicly available data into the TRE, subject to the Access process.
This will be restricted to files where the intended use is in accordance with the study access agreement. Only imports that are relevant to a research project will be considered for import and clear justification will be required. Data to be imported will be checked by Our Future Health against its stated content and the Our Future Health Access process will review the risk of re-identification if such Data were to be linked to genomic or other data already in the TRE and will act to safeguard against that happening.

Participants give their consent to be re-contacted about future studies. as part of the initial consent process. In line with this consent, Our Future Health may invite participants to take part in further ”recontact“ studies. If the participant provides explicit informed consent for a recontact study, then the researcher takes over the participant relationship as the data controller for the study. The researchers will never know who the participant is unless the participant provides explicit consent.

The Access Agreement signed by the registered researchers as a condition of being granted access makes it a contractual requirement that the registered researcher does not seek to re-identify the individual participants, further it reminds them that to do so would be an offence under the Data Protection Act 2018 (to which they also contract to comply).

The Access Agreement signed by the registered researchers as a condition of being granted access makes it a contractual requirement that the researcher and any of their staff have had suitable training in data protection and confidentiality as do all UK GDPR Article 28 agreements (and SCCs) which Our Future Health has entered into with its processors. Our Future Health maintains a registry of all registered researchers.

DATA PROCESSING ARRANGEMENTS
Our Future Health’s technology infrastructure and services require employees of Our Future Health to remain up-to-date and trained through several different certifications and data protection training (see list below). Internal operation use and training to protect data and participant data across all departments including but not limited to: Business intelligence, analytics, operational monitoring, participant support, research and testing, and communications. These specifications will be required on a contractual level with all employees and/or registered researchers as well as third party suppliers.

Our Future Health formed an internal group within the organisation to seek advice and decisions on issues relating to Security, Transparency, Ethics, Privacy and Safety.

The processors listed in this DSA having been selected by OFH all have (and are contractually obliged to maintain compliance with) Cyber Essentials Plus and ISO 27001, as well as conducting penetration testing at least annually and regular vulnerability testing.

The Access Agreement does not distinguish between the registered researcher’s and the research institution’s “employees” and “contractors” i.e., all staff are required under contract to have had suitable training in data protection and confidentiality. The same approach (i.e., there being no distinction drawn between “employees” and “contractors”) is taken in all Our Future Health’s UK GDPR Article 28 agreements and Standard Contractual Clauses.


OUR FUTURE HEALTH DATA PLATFORM
The Our Future Health Data Platform will be used within Our Future Health to process, store, integrate, and process data. The Data Platform will process the data releases that are made available to registered researchers within the TRE. The Data Platform will be accessible only to Our Future Health employees and contractors.

Within the Data Platform, identifiable data will be stored separately to participant health Data and will only be accessible to a relatively small number of trained and authorised staff, where it is relevant and required for their job role. This list of trained authorised staff will be reviewed on an on-going basis.


OUR FUTURE HEALTH TRUSTED RESEARCH ENVIRONMENT (TRE)
Researchers can apply to study the data in the Our Future Health TRE. The organisation is working closely with researchers to ensure it is useful for the widest possible range of users and meets the diverse needs of the community. The OFH TRE is reached by approved Registered Researchers via a secure URL.

Our Future Health aims to ensure that its TRE meets high standards of data governance and cyber security, as well as operational, privacy and technical requirements to receive NHS England Data. This is based on existing, well-established standards and frameworks, such as the Office for National Statistics Five Safes framework, the UK GDPR, and international cyber security standard ISO 27001.

At all times, researchers will only be able to access and store Our Future Health data:
a. Within a project-specific workspace within the TRE
b. If they are a registered researcher
c. As part of a study approved by the Access Board
d. For the purpose approved by the Access Board
e. For the duration allowed by the Access Board

Before any data is accessed (in the Our Future Health TRE), the following must be true:

1. The researcher who is requesting access to the data has gone through researcher registration process which checks the credentials and experience of each researcher and ensures they are trained in data governance and safe data handling processes. It also includes researchers agreeing to Terms regarding the use of the data and individual responsibilities using the resource.
2. The Our Future Health Access Board has approved the project, including the study scope, duration and data requested. The Board will only approve health-related research that is in line with the consent participants provided, is for public good and is aligned to Our Future Health objectives.
3. At the point of gaining an Approved Study, the institution will agree to the Resource Terms which will include responsibilities and liabilities for their researchers using the resource.
4. The researcher has agreed terms relating to the use of the Our Future Health Resource.

All research project applications will be subjected to the same scientific assessment processes to ensure that use of the Resource is scientifically robust, and that high quality research is prioritised.

Our Future Health will use storage locations that are entirely based in the UK with Microsoft Ltd. Microsoft Ltd will support the service but will not have access to data held in the datacentres.

Microsoft Ltd’s storage service encryption for data at rest ensures that data is automatically encrypted before persisting it to storage and decrypted before retrieval. All data written to storage as well as all backups are encrypted through 256-bit AES encryption. Our Future Health will use their own encryption keys for storage encryption at rest and manage these keys in a secure key vault. Storage service encryption is enabled by default for all new and existing storage accounts and cannot be disabled.

Identifiable data is always held and encrypted separately from participant health Data. There will be no access to the systems where the primary data store is hosted other than by technical systems administration staff, that will be time-limited and audited.

Conditions to ensure transparency to the public include access agreement and fees for research applicants as well as publicly available registry of projects that are accepted along with their details and parties or organisations that are involved.

Our Future Health will maintain an up-to-date list of approved projects by the Access Board which will include information on the Registered Researchers and their affiliations along with a plain language summary of research and overall findings so that participants, the wider public, researchers and policymakers can see how Our Future Health resources are being used and what studies are being carried out.


Our Future Health Recruitment Programme — DARS-NIC-414067-K8R6J

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Anonymised - ICO Code Compliant (Section 251 NHS Act 2006)

Legal basis: National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(4); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: Yes (Charity)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2022-06-07 — 2023-06-06

Access method: One-Off

Data-controller type: OUR FUTURE HEALTH

Sublicensing allowed: No

Datasets:

  1. Demographics
  2. Customer - Data Quality Report - Aggregate (Recruitment)
  3. Mailing - Cohort - Non-aggregate (Comms & Recruitment)

Expected Benefits:

Our Future Health aims to give researchers from universities, charities, the NHS and companies involved in health research an opportunity to discover and test more effective ways to predict, detect and treat common diseases such as dementia, cancer, diabetes, heart disease and stroke.

The scale, depth and detail of Our Future Health should make it a world-leading resource for health research. The programme is designed to truly reflect the UK population, including groups of people that have previously been under-represented in health research.

This hopes to be achieved via a cohort selection and invitation process designed to monitor and subsequently over-sample people from under-represented groups, and by targeting areas of the country where people from these groups are resident.
This will occur in addition to a range of other activities planned and/or underway including:
• engagement & awareness activities with national and local community stakeholders and community representatives;
• the establishment of a Diversity & Inclusion Advisory Board who are bringing a wealth of expertise, relevant networks, and experience of engaging under-represented groups in health research and other activities
• over time, developing materials in multiple languages and for different accessibility needs.
In all public consultation, involvement and engagement activities, using qualitative, quantitative and co-design methodological approaches, Our Future Health actively stratify recruitment to oversample individuals from under-represented groups, so that insights they are gaining about attitudes, beliefs and behaviours towards the programme consider these populations.
While consent will be electronic and remote in the first instance, consent rates and acceptability of this approach by underrepresented groups aim to be carefully monitored and explored via conversion rate metrics and analyses, and via public involvement and engagement on this topic; alternative methods hope to be explored over time to reach those who are digitally excluded.

Our Future Health may hold the key to huge numbers of discoveries, such as:
* New signals that could be used to detect diseases much earlier than is currently possible, leading to new or improved screening and prevention programmes and earlier treatment
* New ways to predict with better accuracy who is at higher risk of diseases and would benefit from faster access to screening and prevention interventions
* More targeted or personalised treatments, tools and technologies to delay the onset of disease, or change the course of disease progression; to reduce disease risks; and more targeted ways to investigate diseases for people at higher risk.

The intention is that the Our Future Health programme will provide two key types of resource for health research:
1) A prospective observational dataset for basic science/epidemiological, discovery and aetiological research e.g. on the causes and early signs of disease; and
2) A translational research platform comprising a cohort of people who can be re-contacted for translational/implementation research to develop and test new diagnostic technologies, prevention strategies and treatments.

Outputs:

As a result of this recruitment agreement with NHS DigiTrials, the Our Future Health programme team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.

Identifiable health data requested from NHS Digital will only be used to identify and invite potential participants. NHS Digital record Level Identifiable data will not be reported, and participants will be anonymised in all outputs and publications through aggregation and suppression.

Our Future Health intend to create a long term cohort, to support a wide range of potential studies into disease development, identification and treatment. The first priority in the lifespan of this Data Sharing Agreement will be recruitment to the cohort, and the collation of data from the consented participants within a single secure Our Future Health TRE.

Progress against recruitment targets may be reported to the Our Future Health Executive Board, the HRA and Founders Advisory Board and the Public Advisory Board, in aggregated and suppressed format.

Key recruitment targets have been set for 2022 and will be closely monitored and reported. NHS DigiTrials forms one route to recruitment amongst a range that will help meet the target.

A careful social media and marketing campaign may include key aggregate facts and figures about the recruitment progress.

Processing:

As data controller, Our Future Health will provide to NHS Digital the core eligibility criteria for those potential participants who will receive invitations. Our Future Health refine the population that receive these invitations based on first half of a postcode, making adjustments as required to ensure adequate representation of target populations.

NHS Digital would be using an established contract with a mailing provider (APS Group) to fulfil the communications. The APS Group are also used by NHS England and NHS Improvement as a marketing service group that is a recognised and trusted provider of NHS Services. They are used frequently to co-ordinate mail outs for NHS Bodies. APS Group will use Research Ethics Committee (REC)-approved template invitation letters and would add address details onto the letters prior to mailing it out. All identifiable data provided to APS Group by NHS Digital will be done so under the legal basis of Section 251 support as provided by the Confidentiality Advisory Group (CAG) for this particular programme.

Data processing is carried out by substantive employees of NHS Digital who have been appropriately trained in data protection and confidentiality. NHS Digital will access records allowing them to gather the following information needed to determine suitability for invitation to the Our Future Health programme.

COHORT SPECIFICATION:
• Our Future Health are accountable for providing the specification to NHS Digital for each mail out. These specifications will be based on a combination of multiple postcodes, age limits, gender balances and ethnicities for potential participants. The information they will provide to NHS Digital on each occasion is:
• An Invitation code for each request (this will be generic for each mailing, not participant specific)
• Lower and upper age limits (18 and over as per the inclusion criteria).
• Male / female percentage split, if required.
• A selection of postcodes (first half of postcode only), if required.
• The number of invitations required for each request.
• The geographical specifications are based on the locations of the mobile clinics where potential participants will be invited to take part in the programme.
• At a pre-determined point, Our Future Health will transfer details of the specification to NHS Digital via SEFT. This will be on a flexible adhoc basis, determined by the number of responses received for each request.

COHORT IDENTIFICATION:
• Using the inclusion and exclusion criteria as specified by Our Future Health, NHS Digital will interrogate the Patient Demographics Service (PDS) dataset and extract all those potential participants who meet the criteria within the latest specification as provided by Our Future Health.
• NHS Digital will then remove any records where a national Data opt-out or an Our Future Health programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.
• The remaining records will have their relevant contact details (Forename, Surname, Address, Postcode) extracted ready for despatch to APS Group, as well as a mailing-specific invitation code.

COHORT DISSEMINATION AND MAILOUT:
• Each time NHS Digital create and disseminate an extract, the records will be added to a mailing list cohort dataset. Every time a fresh extract is produced, it will be checked to ensure that any records appearing in this mailing list dataset are removed in order to prevent potential participants receiving multiple invitations. This mailing list dataset will be maintained for six months after the invitation process is complete in case this is required for analysis purposes by Our Future Health. Only aggregated data would be used for such analysis.
• NHS Digital will provide APS Group with Forename, Surname, Address, Postcode and Invitation code via Secure Electronic File Transfer (SEFT.)
• APS will then mail out to individuals as required.
• All potential participants will receive an invitation letter containing their Name, Address and Postcode and Invitation code. When the recipient goes to register into the programme they will be asked to provide an Invitation code. Our Future Health will use this code only to identify which mail-out / recruitment method the recipient received.
• APS will destroy all data received from NHS Digital two weeks after mailing as instructed by NHS Digital.

COHORT ANALYSIS:
• After each request for invitation, NHS Digital will provide Our Future Health with a summary report containing non-identifiable information in an aggregate formation with small numbers suppressed, relating to how that request was met, for example, number of invitations requested versus number of invitations actually sent. This will aid planning for subsequent invitation requests.

PILOT MAIL OUT
NHS Digital and Our Future Health are analysing different variants of invite letters and inserts to determine the best way to reassure recipients as to trustworthiness (both in terms of the letter not being a scam and in terms of the intentions of the letter being as stated). Differences in the response rates from these methods will be evaluated to inform which will be used in the long term. The analysis will also help determine the wording which appeals most to people to then visit the Our Future Health website for more information and/or actively sign up to the programme. Interested patients will be directed to the Our Future Health web-based system, where they can electronically consent to participate. Only at this point will Our Future Health receive patient information.

As part of pre-testing, NHS Digital circulated different variants of Our Future Health invite letters to participants of a market research panel. Each participant received a randomly selected letter variant (seven variants in total made up of one control and six experimental), and were asked questions about their perceptions of it. NHS Digital analysed the results which showed that two of the variants outperformed the control and both reported likelihood to visit the website and likelihood to take part in research. These two letter variants, a further variant which will undergo more pre-testing, and the control letter (the original recruitment letter used by Our Future Health) will be sent to the public as part of Our Future Health's invitation to health research, commencing in summer 2022 after an initial testing period. Each invitee will receive one of the four letter variations either as an invitation letter without insert, an invitation letter plus a short leaflet, or an invitation letter plus the full participant information sheet.

No patient data will flow from Our Future Health to NHS Digital and vice versa.

The permitted territory of use for data provided by NHS Digital for this agreement is England and Wales.

Potential participants will receive one postal invitation from NHS Digitrials; there will be no attempts to remind or re-approach patients who do not respond to the postal invitation. Over time, and in parallel to each other, Our Future Health will invite potential participants via multiple invitation partners, of which NHS Digitrials will be one. In order to mitigate the risk of individuals signing up to the programme via more than one invitation route, the invitation letter from Our Future Health will include a paragraph identifying that the invitation letter has been issued randomly, and if the recipient has already joined the programme, or if the recipient has joined and then withdrawn, they should ignore the letter.

An aggregate report with small numbers supressed (as per the HES Analysis Guide) containing information about gender, ethnicity, age and geographic demographics of the mailing cohort will be provided to Our Future Health from NHS Digital for the purposes of confirming that inclusion and exclusion criteria have been met for each mailing. This report will also contain the total number of people who received the mail out and the number of people removed from the cohort prior to mailing based on trial-specific opt out, national data opt out and special categories of people for whom the data should not be disseminated, such as those on a witness protection programme.

In order to create the cohort, the Hospital Episode Statistics (HES) Admitted Patient Care (APC) dataset will be cross referenced with the Demographics dataset (meeting the inclusion and exclusion criteria as determined by Our Future Health). This is being done in order to extract ethnicity data, which cannot be obtained from the Demographics dataset alone. Please note, however, that HES APC is not considered a data product on this Data Sharing Agreement as no record level HES APC data will be shared with either Our Future Health or APS Group. The processing of HES APC data is covered under a separate Data Processing Agreement between NHS Digital and Our Future Health.

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. The data from NHS Digital will not be linked to any other data other than those outlined in this Agreement.