NHS Digital Data Release Register - reformatted

Uk Health Security Agency projects

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


National Registry for Radiation Workers — DARS-NIC-682588-Z0V8G

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Statutory exemption to flow confidential data without consent)

Legal basis: Health and Social Care Act 2012 - s261(5)(d); Other-Regulation 3 of the associated Health Service (Control of Patient Information) Regulations 2002.

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2023-06-28 — 2026-04-30

Access method: One-Off

Data-controller type: DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations

Objectives:

The UK Health Security Authority (UKHSA), an executive agency of the Department of Health and Social Care (DHSC) requires access to NHS England data for the purpose of the National Registry for Radiation Workers (NRRW).

The National Registry for Radiation Workers (NRRW) was established in 1975 by the National Radiological Protection Board (NRPB) as an epidemiological study of the mortality of those exposed to ionising radiation in the course of their work. It was later expanded to include the study of cancer incidence. NRPB became part of the Health Protection Agency which itself became part of Public Health England (PHE). Following the dissolution of PHE in October 2021 the functions of NRPB were transferred to the UK Health Security Agency (UKHSA) which is now responsible for the study.

The aim of the NRRW study is to investigate the effects of long-term occupational exposure to radiation on the health of workers and assess whether radiation protection regulations and guidelines provide an adequate level of protection for UK radiation workers. The study is particularly interested in the mortality and morbidity from cancers, and mortality from all non-cancer related diseases.

The study hopes to achieve the aim identified by combining NHS England data with information about the cohort members' radiation doses to generate population-level dose-response models that provide evidence about the effects of radiation exposure on health.

This is a very long-term study that has been in operation for over 40 years to date. It is expected to continue to operate for approximately ten more years (i.e. at least 2033).

The National Registry for Radiation Workers is to receive data under DARS-NIC-682588-Z0V8G and DARS-NIC-148219-ZHB4Z. The former permits the release of National Disease Registration Service (NDRS) Cancer Registry data, while the latter permits the release of demographics data. Data disseminated under both agreements are used for identical purposes. The NDRS data were previously accessed internally within Public Health England (PHE) when they were the controller for the NDRS Data. Following the dissolution of PHE in October 2021 the function of the NDRS transferred to NHS Digital which merged into NHS England in February 2023.

The following NHS England data will be accessed:
• Demographics – necessary to better understand cohort population characteristics and to flag embarkations (to be obtained under DARS-NIC-148219-ZHB4Z)
• National Disease Registration Service (NDRS) cancer registration data – necessary to better understand the health outcomes of radiation workers.

Individual-level data are necessary.

The level of the data will be:
• Identifiable – necessary so that participants’ health can be linked to the specific test attendances and to measurements of radiation exposure they had received during the tests.

The data will be minimised as follows:
• Limited to a study cohort of past and present radiation workers employed by organisations that agreed to support the NRRW and who are individually monitored for radiation exposure

New radiation workers are continually added to the study as they begin radiation work for participating employers.

The lawful basis for processing personal data under the UK General Data Protection Regulation (GDPR) is:
Article 6(1) (e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful bases for processing special category data under the UK GDPR are:
Article 9 (2) (i) - processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care, and
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The data are processed for two different purposes: surveillance (Article 9(2)(i)) and statistical purposes (Article 9(2)(j)).

The study is in the interests of the public because it provides direct evidence used to help justify the radiation protection legislation that protects workers and the public from harm due to radiation exposure.

The funding is provided by the Ministry of Defence. The funding is specifically for the NRRW study described. Funding is currently in place until 31st March 2025 however is expected to be extended as it approaches its expiry date.

DHSC is the data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The UK Health Security Agency (UKHSA) is a data processor. UKHSA is an executive agency of the DHSC. UKHSA is responsible for the operation and management of the NRRW study.

No other organisations are involved in the processing of the data under this Agreement. Any other organisations involved in the project are providers of the same data UKHSA seek under this Agreement but in the other constituent countries of the UK; National Records for Scotland, Public Health Wales and the Northern Irish cancer registry. In addition, data about employees who work with radiation are provided to the project by the employer organisations. UKHSA has separate data-sharing agreements with each employer.

The National Registry for Radiation Workers Governance Group (which includes workforce representatives) helped refine the purpose of the statistical research and surveillance.The group supported the collection of the data for the purposes described above while also considering the protection of participants' confidentiality.

Yielded Benefits:

Over the past 47 years, UKHSA and its predecessor organisations have used the cancer incidence data provided by NHS England with the other data in the NRRW to provide high-quality evidence about radiation workers' risks of cancer in relation to their measured occupational radiation exposure. All analyses are published open access in the scientific peer-reviewed literature. The NRRW analyses to date have shown that UK radiation workers have a greater life expectancy and healthier life than the UK general population. This is expected and can be explained by the so-called ‘healthy worker effect’, where occupational groups often display better health than the general population because those who are chronically ill are less likely to be at work. Nonetheless, the study has observed small increases in the risk of some cancers with increasing radiation exposure. The health risk estimates derived from the NRRW have shown consistency with those used by international bodies setting radiation protection standards. This indicates that the measures currently in place in the UK concerning workplace radiation exposure should provide adequate protection of the health of workers from cancer risk. It also provides the same reassurance to members of the public for whom permitted exposure levels under the regulations are lower than for workers. As the study continues to accumulate more information on cancer incidence and all causes of death of workers, it will increase its statistical power and provide more precise information about radiation risks. This evidence will add to the body of evidence that the International Commission on Radiological Protection considers when it revises its recommendations whic

Expected Benefits:

The work currently being undertaken and planned for the future provide direct evidence to Public Health planners about the potential risks of radiation exposures to those occupationally exposed to radiation and to the public.

The work also provides emergency planners at UKHSA with information to enable planning for dealing with emergency situations where radiation exposure is involved. For example, how long term rates of cancer would be affected by a population wide radiation exposure.

In the next 3-5 years the results of a fourth major analysis of the NRRW cohort will be published with extended follow-up and based on an increased number of workers. The inclusion of thousands more cancer incidences and deaths among the cohort members will increase the precision of the estimates of risk derived from these data and thereby allow this work to further contribute direct evidence to the review of ionising radiation recommendations in the future and to continue to provide reassurance to radiation workers.

This work will contribute directly to the goal of the UKHSA to deliver health security to England and across the devolved nations.

Outputs:

To date there have been four major analyses of the NRRW cohort. Summary papers detailing the results were published in the peer-reviewed scientific press and for each analysis a full report was published by the predecessor organisations to UKHSA (NRPB or Health Protection Agency (HPA) or PHE).

Analyses carried out during the era of PHE and now UKHSA has only been published as open-access papers in the peer-reviewed scientific press.

Access details for the papers (which are free to download) and layman's summaries and copies of the reports are available on www.gov.uk

https://www.gov.uk/government/publications/radiation-workers-and-their-health-national-study/nrrw-data-publications-by-study-team

Data for a fourth major analysis of the NRRW is planned to be extracted in Spring 2024. A range of papers detailing the results will be published in the peer-reviewed scientific press in the following several years.

The object of the work being carried out at this time is to improve the precision and accuracy of the estimates of disease risk from radiation exposure obtained previously from the study.

As the study collects more data, new analyses will produce estimates of risk that are closer to the true underlying but unknown risk (i.e. more accurate) and the uncertainty associated with the estimates will become smaller (i.e. more precise) and UKHSA also expect to see fewer statistically significant results occurring through random chance.

In addition, the extra data allows the detection of excess risks from smaller doses and more accurately predict the dose response relationship particularly at low doses.

Processing:

The study database at UKHSA contains details of cohort members' names, dates of birth, and NHS numbers.

UKHSA will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England data will provide the relevant records from the NDRS Cancer Registry to UKHSA. The data will contain directly identifying data items including Forename(s), Surname, NHS Number, Date of Birth and Postcode which are required to link the data at a record level with data already held by the recipient.

The data will not be transferred to any other location.

The data will be stored on servers at UKHSA.

The identifying details will be stored in a separate database (The National Radiation Epidemiology Database Management System NRED) to the linked dataset used for analysis. All analyses will use the pseudonymised dataset which is held on servers at UKHSA. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The data will be accessed by authorised personnel via remote access.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave England at any time.

Access is restricted to employees or agents of UKHSA who have authorisation from the Principal Investigator, who will only permit the data to be processed for the purposes described above.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

Any external researcher requesting access to information in the study cohort (which may include linkage to other databases) will be required to seek a separate Data Sharing Agreement with NHS England for this purpose.

The study has been analysed four times to date. The results of these analyses were published in 1988, 1993, 2003 and 2022

The data will be linked at the person record level with:

• Demographics obtained from NHS England (ref: DARS-NIC-148219-ZHB4Z)

• Civil Registration Mortality data obtained from the Office for National Statistics (ONS);

• Employment data and information on radiation exposure (obtained from the Ministry of Defence followed by workers from sites formerly managed by British Nuclear Fuels Ltd (BNFL), workers employed by the UK atomic energy authority (UKAEA) and workers employed at UK nuclear power generation sites).

These datasets are linked to mortality data of which is obtained from the Office for National Statistics directly.


UK Participants in the UK Atmospheric Nuclear Weapons Test (NWTPS) — DARS-NIC-682587-K5N5K

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Statutory exemption to flow confidential data without consent)

Legal basis: Health and Social Care Act 2012 - s261(5)(d); Other-Regulation 3 of the associated Health Service (Control of Patient Information) Regulations 2002.

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2023-06-06 — 2026-05-31

Access method: One-Off

Data-controller type: DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations

Objectives:

The UK Health Security Authority (UKHSA), an executive agency of the Department of Health and Social Care (DHSC) requires access to NHS England data for the purpose of the Nuclear Weapons Test Participants Study (NWTPS)

In 1983, scientists from the National Radiological Protection Board (NRPB) were funded by the Ministry of Defence (MoD) to carry out an independent epidemiological study of participants in the UK atmospheric nuclear weapons tests, both in the Pacific and in Australia, in the 1950’s and 60’s. NWTPS is a long-term follow-up study of the health of UK personnel who were present at UK atmospheric tests conducted between 1952 and 1967.

NRPB became part of the Health Protection Agency which itself became part of Public Health England (PHE). Following the dissolution of PHE in October 2021 the functions of NRPB were transferred to the UK Health Security Agency (UKHSA) which is now responsible for the study. The NRPB had expertise in statistical research of radiation-exposed populations and an interest in furthering the knowledge of health effects of human exposure to radiation.

The aim of the study is to determine if servicemen who attended the tests subsequently experienced a higher incidence of cancer or mortality from cancer or other diseases that could be attributed to their involvement with the tests rather than from other causes. Thus the study provides information to the test veterans about how their health has changed since the tests compared to a similar group of servicemen and to the general population of the UK.

This is a very long-term study that has been in operation for over 40 years to date. It is expected to continue to operate for approximately ten more years (i.e. at least 2033).

NWTPS is to receive data under DARS-NIC-682587-K5N5K and DARS-NIC-148161-XXPS5. The former permits the release of National Disease Registration Service (NDRS) Cancer Registry data, while the latter permits the release of demographics data. Data disseminated under both agreements are used for identification purposes. The NDRS data were previously accessed internally within Public Health England (PHE) when they were the controller for the NDRS Data. Following the dissolution of PHE in October 2021 the function of the NDRS transferred to NHS Digital which merged into NHS England in February 2023.

The following NHS England data will be accessed:
• Demographics (to be obtained under DARS-NIC-148161-XXPS5) – necessary to better understand cohort population characteristics and to flag embarkations
• National Disease Registration Service (NDRS) cancer registration data (to be obtained under DARS-NIC-682587-K5N5K) – necessary to better understand the health outcomes of radiation workers.

The data requested are necessary to enable the study to compare health outcomes between the test participants and the control group and the general population to determine if rates differ between these groups and therefore whether men who attended the nuclear tests may have had different subsequent health experiences than the controls of the general population.

Individual-level data are necessary.

The level of the data will be:
• Identifiable – necessary so that participants' health can be linked to the specific test attendances and to measurements of radiation exposure they had received during the tests.

The data will be minimised as follows:
• Limited to a study cohort of 43,690 participants* of the NTWPS study. This cohort is static and will not change over time.

*The study population comprises two groups one contains 21,357 servicemen who were identified from MoD records as having attended one or more tests and a group of 22,333 controls who were servicemen who also served abroad at the same time as the tests but whose service was unconnected with the tests.

The lawful basis for processing personal data under the UK General Data Protection Regulation (GDPR) is:
Article 6(1) (e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful bases for processing special category data under the UK GDPR are:
Article 9 (2) (i) - processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care, and;

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The data are processed for two different purposes: surveillance (Article 9(2)(i)) and statistical purposes (Article 9(2)(j)).

The study is in the interests of the public because it provides direct evidence used to help justify the radiation protection legislation that protects workers and the public from harm due to radiation exposure.

The funding is provided by the Ministry of Defence. The funding is specifically for the NWTPS study described. Funding is currently in place until 31st March 2025 however is expected to be extended as it approaches its expiry date.

DHSC is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The UK Health Security Agency (UKHSA) is a processor. UKHSA is an executive agency of the DHSC. UKHSA is responsible for the operation and management of the NWTPS study.

No other organisations are involved in the processing of the data under this Agreement. Any other organisations involved in the project are providers of the same data UKHSA seek under this Agreement but in the other constituent countries of the UK; National Records for Scotland, Public Health Wales and the Northern Irish cancer registry. In addition, data about employees who work with radiation are provided to the project by the employer organisations. UKHSA has separate data-sharing agreements with each employer.

The National Registry for Radiation Workers Governance Group (which includes workforce representatives) helped refine the purpose of the surveillance and statistical research. The group supported the collection of the data for the purposes described above while also considering the protection of participants' confidentiality.

Yielded Benefits:

The Nuclear Weapons Test Participants Study (NWTPS) began in 1983 and is a long-term follow-up study of the health of UK personnel who were present at UK atmospheric tests conducted between 1952 and 1967. It provided high-quality evidence about the potential for long term health effects among the participants. To date, it has found no difference in the long-term health between test participants and a control group of servicemen who served at the same time in similar locations. To date, four analyses have been published in the peer-reviewed scientific literature. The Ministry of Defence uses the evidence provided by this study when addressing veterans' concerns regarding their health, for example, when considering the awarding of War pensions.

Expected Benefits:

The aim of the study is to provide direct evidence and reassurance to the test participants as to whether, as a group, their health might have been affected by their participation in the test programme.

To date, the four major analyses undertaken to date did not reveal significant health issues among the test participants as compared to the controls.

Future analyses will be able to provide additional information about risks during participants' retirement years. Such analyses will also have greater statistical power compared to those already undertaken as a result of the much larger numbers of deaths and the longer follow-up period and so provide greater certainty. As occurred previously when an epidemiological analysis is undertaken the results will be provided to the main welfare organisation that looks after the interests of the veterans, the British Nuclear Test Veterans Association (BNTVA) so that the remaining veterans can be informed in the most appropriate way.

The BNTVA is the main veteran's organisation that was set up 40 years ago to provide support to veterans and advocate for them. There are no specific outputs that are undertaken in relation to or for the BNTVA. UKHSA provides support to the BNTVA in understanding the results of the work and its implications for the veterans but UKHSA does not provide specific results for them.

Outputs:

To date, there have been four analyses of the NWTPS cohort. The first 3 summary papers detailing the results were published in the peer-reviewed scientific press and for each analysis, a full report was published by the predecessor organisations to UKHSA (NRPB or Health Protection Agency (HPA) or PHE).

The fourth (published in 2022) and all subsequent analyses will be published only as open-access papers in the peer-reviewed scientific press.

Access details for the papers (which are free to download) and layman's summaries and copies of the reports are available on www.gov.uk

https://www.gov.uk/government/publications/nuclear-weapons-test-participants-study.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

No further analyses are planned for the next five years. It is likely that one or more further analyses will take place when the vast majority of the cohort is deceased - this is expected to be in 2030. Surveillance is ongoing therefore UKHSA requires the latest available data prior to 2030 to enable this surveillance.

Processing:

The study database at UKHSA contains details of cohort members' names, dates of birth, and NHS numbers.

UKHSA will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England data will provide the relevant records from the NDRS Cancer Registry to UKHSA. The data will contain directly identifying data items including Forename(s), Surname, NHS Number, Date of Birth and Postcode which are required to link the data at a record level with data already held by the recipient.

The data will not be transferred to any other location.

The data will be stored on servers at UKHSA.

The identifying details will be stored in a separate database (The National Radiation Epidemiology Database Management System NRED) to the linked dataset used for analysis. All analyses will use the pseudonymised dataset which is held on servers at UKHSA. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The data will be accessed by authorised personnel via remote access.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave England at any time.

Access is restricted to employees or agents of UKHSA who have authorisation from the Principal Investigator, who will only permit the data to be processed for the purposes described above.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

Any external researcher requesting access to information in the study cohort (which may include linkage to other databases) will be required to seek a separate Data Sharing Agreement with NHS England for this purpose.

The study has been analysed four times to date. The results of these analyses were published in 1983, 1990, 1998 and 2017

The data will be linked at the person record level with:

• Demographics Data will be obtained from NHS England under a separate DSA (ref: DARS-NIC-148161-XXPS5);

• Civil Registration Mortality data obtained from the Office for National Statistics (ONS);

The data are linked to the NWTPS cohort which was defined from archived military records and records of the Atomic Weapons Establishment at the start of the study in the mid-1980’s. They were used to confirm individuals test attendance (for the veterans) and to confirm suitability for being a control i.e. served overseas and not attending the tests. UKHSA extracted information on rank and service and radiation measurements on about 23% of the veteran's group.

Other than the datasets listed above, UKHSA do not link NHS England data to any other data.


ENHANCED SURVEILLANCE OF HUMAN PAPILLOMAVIRUS (HPV) GENOTYPES IN CERVICAL DISEASE (ODR1516_354) — DARS-NIC-656767-M5W2L

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable

Legal basis: , Health and Social Care Act 2012 – s261(7); Other-Regulation 3 of the COPI Regs

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2023-03-24 — 2024-03-24

Access method: One-Off

Data-controller type: DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations

Objectives:

Summary

UKHSA is establishing enhanced surveillance of cervical disease, starting with cancer cases in women <30 years in 2011/2012, to improve the information available about these ‘young’ cancers and to monitor the impact of the HPV immunisation programme on cervical disease endpoints in due course.

Vaccine uptake in catch-up cohorts was relatively low, and furthermore in the catch-up cohorts the vaccine was given to women with high rates of existing infection, therefore cancers in these birth cohorts, and especially those diagnosed in under 30 year olds, will continue to occur. This surveillance, monitoring the likely causative HPV type and immunisation status, will be important to maintain public trust in cervical cancer prevention programmes. It should also demonstrate the first impact of immunisation on disease end-points. Eligible cases will be identified either via cancer registries or via the network of Hospital Based Programme Coordinators (HBPC) and the relevant histopathology departments asked to submit a sample of archived lesion tissue to PHE for HPV typing. Data requested for each sample will include personal identifiable information to enable linkage to cancer registration data and to HPV vaccination records (if vaccination information unknown). A pilot in 2012 will aim to retrospectively recruit 125 cases diagnosed in 2011 (~40% of eligible cases). From 2012 onwards, we aim to prospectively identify cases via Cancer Registries. HPV type distribution in the sampled cancers will be described, overall and by vaccination status. Vaccine effectiveness against cancers in <30 year olds will be estimated by age at immunisation.

Background

HPV immunisation (against HPV types 16 and 18) is now routinely offered to all 12-13 year old girls in the UK. The programme started in September 2008 and, during the first two years, included a catch-up programme targeting girls up to the age of 18 years (five catch-up cohorts). In England, the programme has achieved over 80% coverage for each routine cohort. Coverage between 38.9%-68.6% was achieved for the catch-up cohorts (Human Papillomavirus (HPV) vaccine uptake annual survey 2009/2010). The HPV vaccine used from 2008 to 2011 provides direct, prophylactic protection against HPV types 16 and 18 (Cervarix, GlaxoSmithKline). From September 2012, 12-13 year old girls have been offered the quadrivalent vaccine (Gardasil, Sanofi Pasteur MSD) which contains against types 16 and 18 and also types 6 and 11 (associated with the majority of genital warts).

The peak of cervical cancer incidence occurs in women in their 30’s: in 2008, 322 cases were diagnosed in women aged 35-39 years and 301 in women aged 30-34 years in England (ONS, 2008). A small number of cases are diagnosed each year in women aged under 30 years: 274 cases in 25-29 year olds and 40 cases in under 24 year olds in England in 2008 (Table 1) (ONS, 2008). Our baseline survey of HPV type distribution in women undergoing cervical screening and with cervical disease (in collaboration with Manchester) found that, in England, overall HPV 16/18 are associated with 76% of cervical squamous cell carcinomas (SCC), 82% of cervical adeno-squamous carcinomas 63.2% of cervical intraepithelial neoplasia (CIN) 3 and 90.7% of cervical glandular intraepithelial neoplasia (CGIN) (Howell-Jones et al, 2010). There was some evidence that a greater proportion of cervical cancers diagnosed in younger women are attributed to HPV 16/18, than those in older women i.e. HPV 16/18 were identified in 90% of SCC in 25-29 year olds in England (Howell-Jones et al, 2010).

In the long-run, the type-specific HPV infection status of cervical cancers amongst women targeted for HPV immunisation, and individual vaccination status, will be needed in order to evaluate the effectiveness of HPV 16/18 vaccination against cancer. Efficacy against cancer has not been directly measured in clinical trials that have used CIN/CGIN as surrogate endpoints. Current reporting of cancer cases to cancer registries does not include vaccination status or HPV infection status, and HPV status is not part of clinical testing for case management.

From 2012/13 onwards, questions may start to arise about cervical cancer cases occurring in young women of the age offered HPV vaccination (aged up to 22 years by 2012). The NHS Cervical Screening Programme in England invites women for cervical screening from 25 years of age (currently in Scotland and Wales, women are invited to screening from age 20 years, as they were in England up to October 2003). Although a reduction in cervical disease should be seen in the older catch-up birth cohorts, low vaccine coverage and pre-existing infection at time of vaccination will mean cancers may continue to occur, especially under 30 years of age, at rates that if unexplained could undermine public trust in the immunisation programme.

Knowledge of the HPV types present in cervical cancers occurring in young women and of their vaccination status should enable the effectiveness of HPV 16/18 vaccination to be monitored, the occurrence of cancer in ‘vaccinated’ birth cohorts to be explained and any deviations from expected impact to be identified and investigated as necessary. Once an efficient system is in place for enhanced surveillance of HPV-related cancers in young women, PHE will look to roll-out this enhanced surveillance to include other cases of cervical disease in due course.

This project builds upon collaborations with the NHS Cervical Screening Programme and colleagues in histopathology and virology at Manchester and some methods used in a study of HPV in archived cancers, CIN3/CGIN lesions and women undergoing cervical screening (Howell-Jones et al, Br J Ca 2010).

Aims:

· To establish systems for prospective enhanced surveillance of HPV type-specific infections and HPV vaccination history for cervical disease.

Objectives of pilot

· To identify (retrospectively) up to 125 cancers in women under 30 years in 2011.

· To pilot systems for the collection of enhanced surveillance data (vaccination status and type-specific HPV infection status), including systems for type-specific HPV testing of biopsy material.

Expected Benefits:

These data will be used to produce evidence and outputs that will inform the monitoring and evaluation of national HPV vaccination in females in England. This will inform policy to improve health outcomes in this population.

Outputs:

Using this data, UKHSA will conduct analyses of the rate of cervical cancer diagnoses in females under the age

of 30 years, stratified by birth cohort, from 2000 to 2017 (i.e. the most recently available cancer registration data). Analyses will also be conducted comparing women ineligible for vaccination (i.e. born between

01/09/1985 and 31/08/1990), women eligible for older catch-up vaccination (i.e. vaccinated at 16-18 years of age), eligible for younger catch-up vaccination (i.e. vaccinated at 14-15 years of age), and eligible for

routine vaccination (i.e. vaccinated at 12-13 years of age).


D1.1 - PHE Single Data Sharing Agreement — DARS-NIC-343380-H5Q9K

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, No - data flow is not identifiable, No - consent provided by participants of research studYes - patient objections upheld, No - flow to PHE under a memorandum of understanding, No - PHE has been granted specific exemptions from national data opt outs by the Secretary of State in recognition of its national role in protecting and improving public health., Anonymised - ICO Code Compliant, Identifiable, No, Yes (Section 251, Mixed, Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006, Mixture of confidential data flow(s) with support under section 251 NHS Act 2006 and non-confidential data flow(s))

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(7), National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(7); Other-National Health Service Act 2006 - s251 - 'Control of patient information'., Other-National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 - s261(5)(d), Health and Social Care Act 2012 – s261(2)(a),

Purposes: No, Yes (Agency/Public Body)

Sensitive: Sensitive, and Non Sensitive, and Non-Sensitive

When:DSA runs 2020-06-11 — 2022-06-10 2017.09 — 2024.04.

Access method: Ongoing, One-Off, System Access
(System access exclusively means data was not disseminated, but was accessed under supervision on NHS Digital's systems)

Data-controller type: PUBLIC HEALTH ENGLAND (PHE), DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Accident and Emergency
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Critical Care
  4. Hospital Episode Statistics Outpatients
  5. Standard Monthly Extract : SUS PbR A&E
  6. Standard Monthly Extract : SUS PbR APC Episodes
  7. Standard Monthly Extract : SUS PbR APC Spells
  8. Standard Monthly Extract : SUS PbR OP
  9. Diagnostic Imaging Dataset
  10. Mental Health Services Data Set
  11. National Child Measurement Programme (NCMP)
  12. Sexual and Reproductive Health Activity Data (SRHAD)
  13. Cancer Registration Data
  14. Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics
  15. Primary Care Mortality Database
  16. ONS Births
  17. Vital Statistics Service
  18. Primary Care Mortality Data
  19. HES:Civil Registration (Deaths) bridge
  20. MRIS - Scottish NHS / Registration
  21. Civil Registration - Deaths
  22. Mental Health Minimum Data Set
  23. MRIS - Bespoke
  24. MSDS (Maternity Services Data Set)
  25. Community Services Data Set
  26. National Cancer Waiting Times Monitoring DataSet (CWT)
  27. Emergency Care Data Set (ECDS)
  28. National Diabetes Audit
  29. Improving Access to Psychological Therapies Data Set
  30. SUS plus - Admitted Patient Care (beta version)
  31. NHS 111 Online Dataset
  32. Civil Registration (Deaths) - Secondary Care Cut
  33. Health Survey for England
  34. HES-ID to MPS-ID HES Admitted Patient Care
  35. HES-ID to MPS-ID HES Outpatients
  36. Mental Health and Learning Disabilities Data Set
  37. National Cancer Waiting Times Monitoring DataSet (NCWTMDS)
  38. National Child Measurement Programme
  39. Sexual and Reproductive Health Services Activity Data Set
  40. Secondary Uses Service Payment By Results Accident & Emergency
  41. Secondary Uses Service Payment By Results Outpatients
  42. Secondary Uses Service Payment By Results Spells
  43. Improving Access to Psychological Therapies Data Set_v1.5
  44. MSDS (Maternity Services Data Set) v1.5
  45. Mental Health Services Data Set (MHSDS) v5.0
  46. Civil Registrations of Death - Secondary Care Cut
  47. Community Services Data Set (CSDS)
  48. Diagnostic Imaging Data Set (DID)
  49. Hospital Episode Statistics Accident and Emergency (HES A and E)
  50. Hospital Episode Statistics Admitted Patient Care (HES APC)
  51. Hospital Episode Statistics Critical Care (HES Critical Care)
  52. Hospital Episode Statistics Outpatients (HES OP)
  53. Improving Access to Psychological Therapies (IAPT) v1.5
  54. Maternity Services Data Set (MSDS) v1.5
  55. Mental Health and Learning Disabilities Data Set (MHLDDS)
  56. Mental Health Services Data Set (MHSDS)
  57. COVID-19 Electronic Prescribing and Medicines Administration (ePMA) in Secondary Care
  58. Covid-19 UK Non-hospital Antibody Testing Results (Pillar 3)
  59. COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2)
  60. Maternity Services Data Set (MSDS) v2
  61. Mental Health Minimum Data Set (MHMDS)
  62. Medicines dispensed in Primary Care (NHSBSA data)

Objectives:

The DIDS data contains information on the diagnostic imaging tests, such as x-rays and MRI scans, carried out on cancer patients treated in NHS hospitals in England. The identifiable patient data provided by NHSD to PHE is linked to the records of patients with cancer held by PHE on the National Cancer Register (https://www.gov.uk/guidance/national-cancer-registration-and-analysis-service-ncras). PHE has Section 251 support to collect information on all cases of cancer diagnosed in NHS hospitals in England and to link this to other sources of information on the diagnosis (such as DIDS), treatment and outcomes of these patients. The intelligence generated by cancer registration is used to improve the early detection and treatment of cancer, both by supporting direct patient care (for example, through genetic counselling services) and informing the commissioning and provision of improved diagnostic and treatment services.PHE is only provided with DIDS data for patients on the cancer register. PHE provides NHSD with a file containing NHS Number and the date of birth of cancer patients, which is then used to extract the relevant records from the DIDS system. This linked data is used to produce a range of statistics and analyse trends in the incidence and prevalence of different cancers, and to understand how effective different treatments are in improving patient outcomes. The results of these analyses are published by PHE in a range of indicators, analytical tools and reports such as the CancerData website at www.cancerdata.nhs.uk. The findings derived from the cancer register data are also used to inform the development and monitor the effectiveness of national policies and initiatives such as the National Cancer Strategy Implementation Plan. The HES data contains information on the diagnosis and treatment of all patients admitted to or attending NHS hospitals in England. The identifiable patient data provided by NHSD to PHE is linked to the records of patients with cancer held by PHE in the National Cancer Register. PHE has Section 251 support to collect information on all cases of cancer diagnosed in NHS hospitals in England and to link this to other sources of information on the diagnosis, treatment (such as HES) and outcomes of these patients. The HES data linked to cancer registration records is used to produce a range of statistics and analyse trends in the incidence and prevalence of different cancers, and to understand how effective different treatments are in improving patient outcomes. The results of these analyses are published by PHE in a range of indicators, analytical tools and reports such as the CancerData website at www.cancerdata.nhs.uk. The findings derived from the cancer register data are also used to inform the development and monitor the effectiveness of national policies and initiatives such as the National Cancer Strategy Implementation Plan.The patient identifiable HES data provided by NHSD to PHE is linked to a number of collections of information on patients with infectious diseases to monitor, investigate and manage: a)     antimicrobial resistanceb)    healthcare associated infectionsc)     respiratory diseasesd)    vaccine safetye)     vaccine efficacy and cost effectiveness. PHE is responsible for providing the national infrastructure for health protection including: an integrated surveillance system; specialist services such as diagnostic and reference microbiology; investigation and management of outbreaks of infectious diseases; ensuring effective emergency preparedness, resilience and response for health emergencies, including work on antimicrobial resistance; and evaluating the effectiveness of immunisation programmes and providing vaccines. HES is linked to laboratory data on antimicrobial resistance and healthcare associated infections to analyse the length of time affected patients spend in hospital and what their outcomes are in order to improve the way these threats to public health are managed. It is linked to laboratory data on infectious respiratory diseases to analyse the effectiveness of the treatments provided to patients. It is also linked to vaccination records to identify any health issues associated with new and existing vaccines, and to assess the efficacy and cost effectiveness of vaccines in preventing disease. The findings derived from the linked HES data primarily are used to inform the development and assess the effectiveness of clinical guidelines to improve the control of infections, the management of antimicrobial resistance and the treatment of respiratory diseases. The findings are also used to produce a range of indicators and reports such as the healthcare associated infections data at https://www.gov.uk/government/collections/healthcare-associated-infections-hcai-guidance-data-and-analysis and the vaccination information at https://www.gov.uk/government/collections/vaccine-uptake.The patient identifiable HES data provided by NHSD to PHE is linked to the records of individuals with a congenital anomaly or rare disease (CARD) held by PHE in the National Congenital Anomaly and Rare Diseases Register (https://www.gov.uk/guidance/the-national-congenital-anomaly-and-rare-disease-registration-service-ncardrs). PHE has Section 251 support to collect information on cases of CARDs in England and to link this to other sources of information on the diagnosis, treatment (such as HES) and outcomes of these individuals. This linked data is used to understand more about the incidence and prevalence of different CARDs in England, and about the treatment and outcomes of these individuals. A CARDS annual report will be produced in 2017/18 and prevalence statistics and prenatal detection rates are submitted to the European Surveillance of Congenital Anomalies (EUROCAT) network (http://www.eurocat-network.eu/). The findings derived from the CARDs register data are also used to inform the development and monitor the effectiveness of national policies and initiatives such as the UK Strategy for Rare Diseases.SUS data is essentially an earlier, less ‘clean’ version of the HES data described above (for example, not all duplicate records have been removed) and contains information on the diagnosis and treatment of all patients admitted to or attending NHS hospitals in England. The identifiable patient data provided by NHSD to PHE is linked to the records of patients with cancer held by PHE in the National Cancer Register. Data is only provided by NHSD for patients with a cancer-related ICD-10 diagnosis code. This linked data is used for the specific purpose of producing a set of monthly-updated cancer outcomes metrics on the performance of the NHS in diagnosing and treating cancer patients as soon as possible, such as cancer stage at diagnosis and the percentage of cases diagnosed as an emergency. These metrics, as well as other statistics based on the analysis of data from the cancer register, are published at http://www.ncin.org.uk/cancer_type_and_topic_specific_work/topic_specific_work/cancer_outcome_metrics. The HES data contains information on the diagnosis and treatment of all patients admitted to or attending NHS hospitals in England. The anonymised data provided by NHSD to PHE is used to produce a range of statistics and analyse trends in the incidence and prevalence of a wide range of conditions such as heart disease and stroke, mental health and respiratory disease. The results of these analyses are published by PHE in a range of indicators, analytical tools and reports such as the Public Health Outcomes Framework at http://www.phoutcomes.info/. The findings derived from HES data are used to inform the development and monitor the effectiveness of national policies and initiatives aimed at protecting and improving public health and reducing health inequalities. The HES data is also analysed by PHE to produce statistics to help Local Authorities fulfil their statutory duty to improve the health of their local population, for example through the production of joint strategic needs assessments and local health and wellbeing strategies. The MHSDS contains information on the diagnosis and treatment of patients admitted to or attending NHS hospitals and treatment centres with mental health problems in England. The anonymised data provided by NHSD to PHE is used to produce a range of statistics and analyse trends in the incidence and prevalence of mental health problems such as dementia and depression and anxiety. The results of these analyses are published by PHE in a range of indicators, analytical tools and reports such as the Common Mental Health Disorders Profiling Tool at https://fingertips.phe.org.uk/profile-group/mental-health/profile/common-mental-disorders. The findings derived from MHSDS are also used by PHE to develop and assess the effectiveness of national policies aimed at improving the lives of people with mental health problems, and by Local Authorities to provide mental health services at a local level. The NCMP provides information on the height and weight of all children in reception (aged 4-5 years) and year 6 (aged 10-11 years) in schools in England. PHE is the sponsor on behalf of the Secretary of State of the national collection of NCMP data by NHSD from all Local Authorities. The anonymised data provided by NHSD to PHE is used to analyse variations and trends in the percentages of children who are underweight, normal weight, overweight and obese. The results of these analyses are published by PHE in a range of indicators, analytical tools and reports such as the local authority profiles at http://fingertips.phe.org.uk/profile/national-child-measurement-programme. PHE also use the data to provide statistics to schools on the percentage of children who are an unhealthy weight.The NCMP findings are used by PHE to develop national policies to increase the proportion of children who are normal weight, and by Local Authorities to provide services that support families to make healthy lifestyle changes. The SRHAD collects information on the contraception, sexually transmitted infections (STI) and reproductive health advice and care provided to patients attending sexual and reproductive health (SRH) services in England. PHE is the sponsor on behalf of the Secretary of State for the national collection of SRHAD data by NHSD from all SRH services. The anonymised data provided by NHSD to PHE is used to monitor the implementation of key national sexual health policy objectives such as: increasing access to all methods of contraception, including long acting reversible contraception and emergency contraception, and reducing inequalities in access to services; reducing teenage conceptions; and reducing unintended pregnancies. The results of these analyses are published by PHE in a range of indicators, analytical tools and reports such as the local authority sexual and reproductive health profiles at https://fingertips.phe.org.uk/profile/sexualhealth. The SRHAD findings are used by PHE to develop and monitor national policies for Sexual Health and HIV, and by Local Authorities to provide SRH services to improve sexual and reproductive health across England.

Yielded Benefits:

The PHE remit letter, dated March 2018, sets out PHE’s role across the health and care system, how PHE should perform that role, and the Government’s priorities of PHE from April 2018 to March 2019: https://www.gov.uk/government/publications/phe-remit-letter-2018-to-2019

Expected Benefits:

The benefits arising from PHE’s data processing are manifest in the improvements to population health and wellbeing across England.

This includes:
- making the public healthier and reducing differences between the health of different groups by promoting healthier lifestyles, advising government and supporting action by local government, the NHS and the public
- improving the health of the whole population by sharing information and expertise, and identifying and preparing for future public health challenges
- supporting local authorities and the NHS to plan and provide health and social care services such as immunisation and screening programmes, and to develop the public health system and its specialist workforce
- researching, collecting and analysing data to improve understanding of public health challenges, and come up with answers to public health problems

The PHE remit letter: 2017 to 2018 confirms the role the government expects PHE to play in the health and care system in 2017 to 2018: https://www.gov.uk/government/publications/phe-remit-letter-2017-to-2018

Outputs:

Diagnostic Imaging Dataset (DIDs)
PURPOSE: (PHE National Cancer Register) The results of the analyses undertaken by PHE are published in a range of indicators, analytical tools and reports such as the CancerData website at www.cancerdata.nhs.uk. The findings derived from the cancer register data are also used to inform the development and monitor the effectiveness of national policies and initiatives such as the National Cancer Strategy Implementation Plan.

Hospital Episodes Statistics (HES)
PURPOSE 1: (PHE National Cancer Register) The results of the analyses undertaken by PHE are published in a range of indicators, analytical tools and reports such as the CancerData website at www.cancerdata.nhs.uk. The findings derived from the cancer register data are also used to inform the development and monitor the effectiveness of national policies and initiatives such as the National Cancer Strategy Implementation Plan.
PURPOSE 2: (PHE Health protection work programme) The findings derived from the linked HES data primarily are used to inform the development and assess the effectiveness of clinical guidelines to improve the control of infections, the management of antimicrobial resistance and the treatment of respiratory diseases. The findings are also used to produce a range of indicators and reports such as the healthcare associated infections data at https://www.gov.uk/government/collections/healthcare-associated-infections-hcai-guidance-data-and-analysis and the vaccination information at https://www.gov.uk/government/collections/vaccine-uptake.
PURPOSE 3: (PHE National Congenital Anomaly & Rare Diseases Register) This linked data is used to understand more about the incidence and prevalence of different CARDs in England, and about the treatment and outcomes of these individuals. A CARDS annual report is produced and prevalence statistics and prenatal detection rates are submitted to the European Surveillance of Congenital Anomalies (EUROCAT) network (http://www.eurocat-network.eu/). The findings derived from the CARDs register data are also used to inform the development and monitor the effectiveness of national policies and initiatives such as the UK Strategy for Rare Diseases.

Linked HES & Civil Registry Deaths
PURPOSE: (PHE End of life care work programme) The results of the analyses undertaken by PHE are published in the End of Life Care Profiles at https://fingertips.phe.org.uk/. These profiles are provided by Local Authority and Clinical Commissioning Group and are used to support local health and social care commissioning, for example by providing statistics on the place of death and nursing and care home bed rates.

Primary Care Mortality Data Set (PCMD)
PURPOSE: (PHE Health improvement work programme and analytical support to Local Authority public health teams) The results of the analyses undertaken by PHE are published in a range of different public health profiles at https://fingertips.phe.org.uk/. PHE also undertakes ad hoc analyses of PCMD to support both the statutory health improvement duty of Local Authorities and their joint public health service commission responsibilities with Clinical Commissioning Groups (CCGs). These results of these analyses are provided directly to Local Authorities in the form of aggregate statistics and tables.

Secondary Use Service (SUS)
PURPOSE: (PHE National Cancer Register) The linked SUS and National Cancer Register data is used by PHE for the specific purpose of producing a set of monthly-updated cancer outcomes metrics on the performance of the NHS in diagnosing and treating cancer patients as soon as possible, such as cancer stage at diagnosis and the percentage of cases diagnosed as an emergency. These metrics, as well as other statistics based on the analysis of data from the cancer register, are published at http://www.ncin.org.uk/cancer_type_and_topic_specific_work/topic_specific_work/cancer_outcome_metrics.

Health Survey for England
PURPOSE: (PHE Healthy lifestyles work programme) The data which has been anonymised and provided to PHE is used to estimate excess calorie intakes for children and teenagers. The results of these analyses are providing the evidence for a national calorie reduction campaign led by PHE.

Hospital Episode Statistics (HES)
PURPOSE: (PHE Health improvement work programme and analytical support to Local Authority public health teams) The results of the analyses undertaken by PHE are published in a range of indicators, analytical tools and reports such as the Public Health Outcomes Framework at http://www.phoutcomes.info/. The findings derived from HES data are used to inform the development and monitor the effectiveness of national policies and initiatives aimed at protecting and improving public health and reducing health inequalities. The HES data is also analysed by PHE to produce statistics to help Local Authorities fulfil their statutory duty to improve the health of their local population, for example through the production of joint strategic needs assessments and local health and wellbeing strategies.

Mental Health Services Data Set (MHSDS)
PURPOSE: (PHE Mental health work programme) The results of the analyses undertaken by PHE are published in a range of indicators, analytical tools and reports such as the Common Mental Health Disorders Profiling Tool at https://fingertips.phe.org.uk/profile-group/mental-health/profile/common-mental-disorders. The findings derived from MHSDS are also used by PHE to develop and assess the effectiveness of national policies aimed at improving the lives of people with mental health problems, and are used by Local Authorities to support the commissioning and provision of mental health services at a local level.

National Child Measurement Programme (NCMP)
PURPOSE: (PHE Child health work programme) The data which has been anonymised and provided to PHE is used to analyse variations and trends in the percentages of children who are underweight, normal weight, overweight and obese. The results of these analyses are published by PHE in a range of indicators, analytical tools and reports such as the local authority profiles at http://fingertips.phe.org.uk/profile/national-child-measurement-programme. PHE also use the data to provide statistics to schools on the percentage of children who are an unhealthy weight. The NCMP findings are used by PHE to develop national policies to increase the proportion of children who are normal weight, and are used by Local Authorities to commission and provide services that support families to make healthy lifestyle changes.

Personal Social Services Survey of Adult Carers in England (PSS- SACE)
PURPOSE: (PHE Mental health work programme) The results of the analyses undertaken by PHE are being used to develop further indicators of care-giving across demographic groups and geographic areas for inclusion in the Dementia Profile published at https://fingertips.phe.org.uk/profile-group/mental-health. The results of these analyses are being used to understand more about the care provided to people with dementia as set out in the Prime Minister's Challenge on Dementia 2020 and in the NHS England Five Year Forward View for Mental Health.

Recorded Dementia Diagnoses (RDD) Data Set
PURPOSE: (PHE Mental health work programme) The results of the analyses undertaken by PHE are published in a range of indicators, analytical tools and reports such as the Dementia Profile and the Common Mental Health Disorders profile at https://fingertips.phe.org.uk/profile-group/mental-health. The findings of these analyses are also used to monitor progress in improving the diagnosis and treatment of dementia as set out in the Prime Minister's Challenge on Dementia 2020 and in the NHS England Five Year Forward View for Mental Health.

Sexual and Reproductive Health Activity Data (SRHAD)
PURPOSE: PHE Health protection work programme) The results of the analyses undertaken by PHE are published in a range of indicators, analytical tools and reports such as the local authority Sexual and Reproductive Health Profiles at https://fingertips.phe.org.uk/profile/sexualhealth. The SRHAD findings are used by PHE to develop and monitor national policies for Sexual Health and HIV, and by Local Authorities to provide SRH services to improve sexual and reproductive health across England.

Processing:

The patient identifiable DIDS data provided by NHSD is held by PHE in the secure National Cancer Register system. Access to the identifiable data is limited to named PHE staff who are responsible for ensuring the completeness of the cancer registration records and the accuracy of the linkage to the DIDS data.
Some of the analysis of the linked data is undertaken using identifiable data but the bulk is carried out using a version of the data that has had direct patient identifiers removed and replaced with pseudonyms.
The analysis of the DIDS data is undertaken for the purposes described in this table. The DIDS data is not used for any purpose other than to analyse the treatment of patients with cancer.
While the DIDS data is identifiable, the 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE cancer register uses of DIDS.

The patient identifiable HES data provided by NHSD is held by PHE in the secure National Cancer Register system. Access to the identifiable data is limited to named PHE staff who are responsible for ensuring the completeness of the cancer registration records and the accuracy of the linkage of the HES data.
Some of the analysis of the linked data is undertaken using identifiable data but the bulk is carried out using a version of the data that has had direct patient identifiers removed and replaced with pseudonyms.
The analysis of the HES data is undertaken for the purposes described in this table.
While the HES data is identifiable, the 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE cancer register uses of HES.
All the data fields held by PHE in the cancer register are described in the Cancer Outcomes and Services Data set (COSD), which has been approved by the Standardisation Committee for Care Information based in NHS Digital (content.digital.nhs.uk/isce/publication/SCCI1521).

The patient identifiable HES data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named staff in the PHE National Infection Service who are only allowed to use the data for the purposes described in this table.
The information systems holding the linked data on antimicrobial resistance and healthcare associated infections, infectious disease control, respiratory diseases, and vaccine safety and effectiveness are all held and managed separately.
While the HES data is identifiable, the 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the health protection uses of HES by PHE described here.

The patient identifiable HES data provided by NHSD is held by PHE in the secure CARDS register system. Access to the identifiable data is limited to named PHE staff who are responsible for ensuring the completeness of the CARDS registration records and the accuracy of the linkage of the HES data.
Some of the analysis of the linked data is undertaken using identifiable data but the bulk is carried out using a version of the data that has had direct patient identifiers removed and replaced with pseudonyms.
The analysis of the HES data is undertaken for the purposes described in this table.
While the HES data is identifiable, the 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE CARDS register uses of HES.

The patient identifiable SUS data provided by NHSD is held by PHE in the secure National Cancer Register system. Access to the identifiable data is limited to named PHE staff who are responsible for ensuring the completeness of the cancer registration records and the accuracy of the linkage of the SUS data.
Some of the analysis of the linked data is undertaken using identifiable data but the bulk is carried out using a version of the data that has had direct patient identifiers removed and replaced with pseudonyms.
The analysis of the SUS data is undertaken for the purposes described in this table.
While the SUS data is identifiable, the 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE cancer register use of SUS.

The anonymised HES data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named PHE staff who are only allowed to use the data for the purposes described in this table.
The 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE uses of HES.
The HES data is anonymised so cannot and will not be directly linked by PHE to any other data, but it is analysed alongside other related sources of information such as local area deprivation scores to assess whether there are differences in disease rates and inequalities in the provision of hospital treatment between groups in the population.
PHE only provides aggregate statistics and data tables based on HES data to Local Authorities. Local Authority access to anonymised HES extracts of data for individual patients is managed directly by NHSD.

The anonymised MHSDS data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named PHE staff who are only allowed to use the data for the purposes described in this table.
The 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE uses of MHSDS.
The MHSDS data is anonymised so cannot and will not be directly linked by PHE to any other data, but it is analysed alongside other related sources of information such as substance misuse data.

The anonymised NCMP data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named PHE staff who are only allowed to use the data for the purposes described in this table.
The 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE uses of NCMP.
The NCMP data is anonymised so cannot and will not be directly linked by PHE to any other data, but it is analysed alongside other related sources of information such as the location of fast food outlets to see if there is any association between this and levels of childhood obesity.

The anonymised SHRAD data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named PHE staff who are only allowed to use the data for the purposes described in this table.
The 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE uses of SRHAD.
The SRHAD data is anonymised so cannot and will not be directly linked by PHE to any other data but it is analysed alongside other related sources of information such as the Genitourinary Medicine Clinic Activity Dataset (GUMCAD) to monitor STI rates and the treatments received by patients from SRH clinics.

The patient identifiable PCMD data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named staff who are only allowed to use the data for the purposes described in this table.
While the PCMD data is identifiable, the 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the uses of PCMD by PHE described here.
The PCMD data is not directly linked by PHE to any other data but it is analysed alongside other related sources of information such as local area deprivation scores to assess whether there are differences in death rates between groups in the population and between different geographic areas.
PHE only provides aggregate statistics and data tables based on PCMD data to Local Authorities and CCGs. Most Local Authorities have direct access to PCMD, which is managed by NHSD.
The patient identifiable Linked HES/ONS Mortality data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named staff in the PHE End of Life Care team who are only allowed to use the data for the purposes described in this table.
While the Linked HES/ONS Mortality data is identifiable, the 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the uses of Linked HES/ONS Mortality by PHE described here.
The Linked HES/ONS Mortality data is not directly linked by PHE to any other data.

The anonymised HSE data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named PHE staff who are only allowed to use the data for the purposes described in this table.
The 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE uses of HSE.
The HSE data is anonymised so cannot and will not be directly linked by PHE to any other data.
The anonymised PSS-SACE data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named PHE staff who are only allowed to use the data for the purposes described in this table.
The 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE uses of PSS-SACE.
The PSS-SACE data is anonymised so cannot and will not be directly linked by PHE to any other data.

The anonymised RDD data provided by NHSD is held by PHE in a secure data server. Access to the data is limited to named PHE staff who are only allowed to use the data for the purposes described in this table.
The 12 ‘limited access controls’ set out by the ICO for anonymised data and described in Appendix C of this Memorandum apply to all the PHE uses of RDD.
The RDD data is anonymised so cannot and will not be directly linked by PHE to any other data.

The patient identifiable data provided by PHE to NHSD is held on secure server with access controls restricting access only to authorised internal users. Access is provided to staff directly involved in providing data to approved customers via the NHSD Data Access Request Service and to support PHE in query resolution and the accurate identification of cancer patients.
Where cancer registration data is linked to other NHSD data sets, this is only undertaken where this is required and justified for internal use or to support authorised access to the patient status and tracking service where a legal basis is in place.
Identifiable and non-identifiable data items are stored in separate tables to allow access to be granted independently as required for user needs.
Where required for internal analysis, this is undertaken where possible on the non-identifiable table, including where linked to other data sets via a common NHSD pseudonymisation key.


MR47 - National Registry for Radiation Workers — DARS-NIC-148219-ZHB4Z

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N, Identifiable, No (Statutory exemption to flow confidential data without consent)

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 - s261(5)(d); Other-Regulation 3 of the associated Health Service (Control of Patient Information) Regulations 2002.

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2023-06-05 — 2026-05-31 2016.04 — 2023.07.

Access method: Ongoing

Data-controller type: DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Scottish NHS / Registration
  4. MRIS - Members and Postings Report
  5. Demographics
  6. MRIS - Flagging Current Status Report

Objectives:

The data supplied to HPA CRCE Epidemiology Section will be used only for the approved medical research - MR47 National Registry for Radiation Workers

Yielded Benefits:

Over the past 47 years, UKHSA and its predecessor organisations have used the cancer incidence data provided by NHS England with the other data in the NRRW to provide high-quality evidence about radiation workers' risks of cancer in relation to their measured occupational radiation exposure. All analyses are published open access in the scientific peer-reviewed literature. The NRRW analyses to date have shown that UK radiation workers have a greater life expectancy and healthier life than the UK general population. This is expected and can be explained by the so-called ‘healthy worker effect’, where occupational groups often display better health than the general population because those who are chronically ill are less likely to be at work. Nonetheless, the study has observed small increases in the risk of some cancers with increasing radiation exposure. The health risk estimates derived from the NRRW have shown consistency with those used by international bodies setting radiation protection standards. This indicates that the measures currently in place in the UK concerning workplace radiation exposure should provide adequate protection of the health of workers from cancer risk. It also provides the same reassurance to members of the public for whom permitted exposure levels under the regulations are lower than for workers. As the study continues to accumulate more information on cancer incidence and all causes of death of workers, it will increase its statistical power and provide more precise information about radiation risks. This evidence will add to the body of evidence that the International Commission on Radiological Protection considers when it revises its recommendations which form the basis of the regulations which protect UK workers and the public.

Expected Benefits:

The work currently being undertaken and planned for the future provide direct evidence to Public Health planners about the potential risks of radiation exposures to those occupationally exposed to radiation and to the public.

The work also provides emergency planners at UKHSA with information to enable planning for dealing with emergency situations where radiation exposure is involved. For example, how long term rates of cancer would be affected by a population wide radiation exposure.

In the next 3-5 years the results of a fourth major analysis of the NRRW cohort will be published with extended follow-up and based on an increased number of workers. The inclusion of thousands more cancer incidences and deaths among the cohort members will increase the precision of the estimates of risk derived from these data and thereby allow this work to further contribute direct evidence to the review of ionising radiation recommendations in the future and to continue to provide reassurance to radiation workers.

This work will contribute directly to the goal of the UKHSA to deliver health security to England and across the devolved nations.

Outputs:

To date there have been four major analyses of the NRRW cohort. Summary papers detailing the results were published in the peer-reviewed scientific press and for each analysis a full report published by the predecessor organisations to UKHSA (NRPB or Health Protection Agency (HPA) or PHE).

Analyses carried out during the era of PHE and now UKHSA has only been published as open access papers in the peer reviewed scientific press.

Access details for the papers (which are free to download) and layman's summaries and copies of the reports are available on www.gov.uk

https://www.gov.uk/government/publications/radiation-workers-and-their-health-national-study/nrrw-data-publications-by-study-team

Data for a fourth major analysis of the NRRW is planned to be extracted in Spring 2024. A range of papers detailing the results will be published in the peer reviewed scientific press in the following several years.

The object of the work being carried out at this time is to improve the precision and accuracy of the estimates of disease risk from radiation exposure obtained previously from the study.

As the study collects more data, new analyses will produce estimates of risk that are closer to the true underlying but unknown risk (i.e. more accurate) and the uncertainty associated with the estimates will become smaller (i.e. more precise) and UKHSA also expect to see fewer statistically significant results occurring through random chance.

In addition, the extra data allows the detection of excess risks from smaller doses and more accurately predict the dose response relationship particularly at low doses.

Processing:

The study database at UKHSA contains details of cohort members' names, dates of birth, and NHS numbers.

UKHSA will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England data will provide the relevant records from the Demographics datasets to UKHSA. The data will contain directly identifying data items including Forename(s), Surname, NHS Number, Date of Birth and Postcode which are required to link the data at a record level with data already held by the recipient.

Study ID and NHS number are necessary so UKHSA can link to their database records, Reason for removal is necessary to understand why records have been removed and to identify appropriate follow-up routes. The fact of death and Formal date of death allow UKHSA to crosscheck against the ONS mortality data they receive and the Date GP registrations notify UKHSA whether their participants are registered within the NHS.

All other identifying details, including but not limited to the Latest address, Person's Surname and Gender are required for validation and cross-checking purposes (verify participants' details in the event of matching errors and to ensure details held about participants are accurate - limiting discrepancies in matching)

The data will not be transferred to any other location.

The data will be stored on servers at UKHSA.

The identifying details will be stored in a separate database (The National Radiation Epidemiology Database Management System NRED) to the linked dataset used for analysis. All analyses will use the pseudonymised dataset which is held on servers at UKHSA. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The data will be accessed by authorised personnel via remote access.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave England at any time.

Access is restricted to employees or agents of UKHSA who have authorisation from the Principal Investigator, who will only permit the data to be processed for the purposes described above.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

Any external researcher requesting access to information in the study cohort (which may include linkage to other databases) will be required to seek a separate Data Sharing Agreement with NHS England for this purpose.

The study has been analysed four times to date. The results of these analyses were published in 1988, 1993, 2003 and 2022

The data will be linked at person record level with:

• National Disease Registration Service (NDRS) will be obtained from NHS England under a separate DSA (ref: DARS-NIC -682588-Z0V8G);

• Civil Registration Mortality data obtained from the Office for National Statistics (ONS);

• Employment data and information on radiation exposure (obtained from the Ministry of Defence followed by workers from sites formerly managed by British Nuclear Fuels Ltd (BNFL), workers employed by the UK atomic energy authority (UKAEA) and workers employed at UK nuclear power generation sites).

These datasets are linked to mortality data of which is obtained from the Office for National Statistics directly.


D24 - Request to share data for Covid-19 purposes – HOSTED Project — DARS-NIC-381634-X8H0H

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - Statutory exemption to flow confidential data without consent, Anonymised - ICO Code Compliant (Statutory exemption to flow confidential data without consent, Does not include the flow of confidential data)

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002, Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Agency/Public Body, Ministerial Department)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2020-05-27 — 2021-03-31 2021.03 — 2021.04.

Access method: One-Off

Data-controller type: PUBLIC HEALTH ENGLAND (PHE), DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. Secondary Uses Service Payment By Results Episodes
  2. COVID-19 Second Generation Surveillance System
  3. Personal Demographic Service
  4. COVID-19 Hospitalization in England Surveillance System
  5. COVID-19 Vaccination Status
  6. GPES Data for Pandemic Planning and Research (COVID-19)
  7. Hospital Episode Statistics Accident and Emergency
  8. Hospital Episode Statistics Admitted Patient Care
  9. Hospital Episode Statistics Outpatients
  10. COVID-19 Ethnic Category Data Set
  11. Covid-19 UK Non-hospital Antigen Testing Results (pillar 2)
  12. COVID-19 Second Generation Surveillance System (SGSS)
  13. COVID-19 General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR)
  14. Hospital Episode Statistics Accident and Emergency (HES A and E)
  15. Hospital Episode Statistics Admitted Patient Care (HES APC)
  16. Hospital Episode Statistics Outpatients (HES OP)
  17. COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2)
  18. COVID-19 SGSS First Positives (Second Generation Surveillance System)

Objectives:

Data is to be shared for the purpose of supporting a Public Health England (PHE) surveillance system on household transmission of COVID-19 to enhance the national public health surveillance of Covid-19 infections in the population of England as explained in more detail below.

Currently, there is no national data set to support analyses of the epidemiology of Covid-19 infections in households. Covid-19 laboratory and case data from PHE can be linked to NHS Digital-controlled data sets using one-way encrypted versions of the NHS Number and Unique Property Reference Number to identify the household contacts of Covid-19 patients. This linked data set (called ‘HOSTED’) will be used to establish the Covid-19 status and associated outcomes of these household contacts.

Specifically, the HOSTED data set will be used to identify:
a) the testing status of household contacts
b) secondary cases of Covid-19 infection among household contacts
c) hospital admissions for Covid-19 among household contacts
d) risk factors for Covid-19 among household contacts
e) deaths from Covid-19 among household contacts.
The analysis is for Secondary Use Purpose - HOSTED will not be used for Direct Care purposes.

The HOSTED dataset will not be sufficiently accurate for use for direct patient care or enhancing the national shielding programme. But it will be used by PHE to enhance the national public health surveillance of Covid-19 by enabling a range of longitudinal analyses of the epidemiology of the infection which are not possible currently.
Linkage and analysis by NHS Digital to produce the HOSTED dataset and to support PHE to undertake the following public health surveillance purposes:
1. understanding Covid-19 and risks to public health, trends in Covid-19 and such risks, and controlling and preventing the spread of Covid-19 and such risks;
2. identifying and understanding information about patients or potential patients with or at risk of Covid-19, information about incidents of patient exposure to Covid-19 and the management of patients with or at risk of Covid-19 including: locating, contacting, screening, flagging and monitoring such patients and collecting information about and providing services in relation to testing, diagnosis, self-isolation, fitness to work, treatment, medical and social interventions and recovery from Covid-19;
3. understanding information about patient access to health services and adult social care services as a direct or indirect result of Covid-19 and the availability and capacity of those services;
4. monitoring and managing the response to Covid-19 by health and social care bodies and the Government including providing information to the public about Covid-19 and its effectiveness and information about capacity, medicines, equipment, supplies, services and the workforce within the health services and adult social care services;
5. research and planning in relation to Covid-19

NHS Digital is the Controller for the data which has been requested by the Recipient. The data to be shared by NHS Digital with the Recipient itself does not identify individual patients but in some cases where there are small numbers of individuals represented in the data for certain data fields, it may be possible for the Recipient to identify individual patients. The underlying data which has been analysed and linked by NHS Digital to produce the data to be shared is comprised of information that is identifiable data that has been obtained by the NHS and NHS Digital, in confidence. It also provides information about the health of the patients. The data is therefore considered to be confidential information and subject to a duty of confidence under the common law.
The purposes for sharing the requested data are set out below (Agreed Purposes):
- NHS Digital has agreed to share the data identified with the Recipient and its Processors (as defined in GDPR) identified below to support the analyses of the epidemiology of Covid-19 infections in households and to undertake household transmission modelling during the course of the pandemic.
- The Disclosed Data will not contain any patient identifiers and will comprise of a pseudonymised dataset which will identify: the testing status of household contacts of patients diagnosed with COVID-19 o secondary cases of Covid-19 infection among household contacts, hospital admissions for Covid-19 among household contacts and risk factors for Covid-19 among household contacts o deaths from Covid-19 among household contacts.
The Disclosed Data will not be sufficiently accurate for use for direct patient care or enhancing the national shielding programme. Taking action at a specific individual household level would be inappropriate and unsafe given that there will be errors in the data. This is tolerable for a surveillance system but not for a clinical management system. The Disclosed Data will not and should not be used by the Recipient for clinical management or intervention at a specific household level.
The Disclosed Data will be used by the Recipient to enhance the national public health surveillance of Covid-19 by enabling a range of longitudinal analyses of the epidemiology of the infection which are not possible currently. Where any significant findings are made that would warrant advice on policy, these will be shared by the Recipient with the PHE Incident Director as part of the incident response who would incorporate this into the advice to government as appropriate.

• Aggregate level data from analysis of the Disclosed Data will be shared by the Recipient for the purposes of providing routine and bespoke aggregate level small number suppressed reports. These are:
- Routine reports to be produced for inclusion in the PHE surveillance report and for the PHE Sitrep on a weekly basis. These are shared with PHE and DHSC colleagues.
- Additional public-facing reports will also be produced, consisting of surveillance reports and peer-reviewed journal articles.
All such reports produced will be at an aggregate level with small numbers suppressed in accordance with NHS Digital and Office for National Statistics guidance. NHS Digital should be quoted as the source of the Disclosed Data together with other sources.
The Recipient is not permitted to share the Disclosed Data with any third parties, except to the extent set out above. Should any third party wish to have access to the Disclosed Data, the Recipient will re-direct them to NHS Digital who will consider their request.
The Recipient is not permitted to share the Disclosed Data with any third parties, except to the extent set out above. Should any third party wish to have access to the Disclosed Data, the Recipient will re-direct them to NHS Digital who will consider their request.

Legal Basis for NHS Digital to Share the Disclosed Data
NHS Digital is able to share Disclosed Data with the Recipient for the Agreed Purposes under a notice issued to NHS Digital by the Secretary of State for Health and Social Care under Regulation 3(4) of the Health Service Control of Patient Information Regulations (COPI) dated 17 March 2020 (the NHSD COPI Notice), as the Recipient is an organisation covered by Regulation 3(3) of COPI and the Agreed Purposes for which the Disclosed Data is being shared is covered by Regulation 3(1) of COPI. Under GDPR, NHS Digital is relying on Article 6(1)(c) – Legal Obligation, to share the Disclosed Data with the Recipient for the Agreed Purposes above. As this is health information and therefore special category personal data NHS Digital is also relying on Article 9(2)(g) – substantial public interest and para 6 of Schedule 1 DPA – statutory purpose, to share the Disclosed Data for the Agreed Purposes. NHS Digital will publish details about the sharing of the Disclosed Data with the Recipient in its Data Release Register.

Legal Basis for the Recipient to receive the Disclosed Data
The Recipient is able to receive and process the Disclosed Data under a notice issued to the Recipient by the Secretary of State for Health and Social Care under Regulation 3(4) of COPI dated 20th March (the Recipient COPI Notice). The Recipient can also receive and process the Disclosed Data for the Agreed Purposes under COPI, as it is an organisation covered by Regulation 3(3) and the Agreed Purposes for which the Disclosed Data is being shared are covered by Regulation 3(1) of COPI. Under GDPR, the Recipient can rely on Article 6(1)(c) – Legal Obligation and Article 6(1)(e) public task, to receive and process the Disclosed Data from NHS Digital for the Agreed Purposes under the Recipient COPI Notice and under COPI. As this is health information and therefore special category personal data the Recipient can also rely on Article 9(2)(i) – public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health to process the Disclosed Data for the Agreed Purposes.

Cohort information
The precise number of records will not be known until the asset is built and will depend on the number of cases.
As a rough estimate for illustrative purposes, as at 22 April 2020, there have been ~99,000 diagnosed cases in England. Assuming an average household size of 2.4, this would represent ~238,000 individuals living in the same household as a diagnosed case, who would thus be eligible for inclusion in the dataset. This number will grow as the number of diagnoses increases over the course of the epidemic.

**********

Amendment to Existing Agreement:

The HOSTED system provides a unique opportunity to evaluate the impact of any vaccine on transmission. Existing vaccine phase 3 studies identify whether people are likely to become ill with Covid19. These studies do not confirm whether the vaccine eliminates infection altogether or whether it simply reduces clinical severity.

NHSD already holds the core HOSTED dataset. When the Covid 19 vaccine is rolled out the vaccination status of recipients will be retained centrally by NHSD in the National Immunisation Management System (NIMS). This will enable the addition of a “date of vaccine dose” “eligibility for vaccine” “risk group” and “date invited” fields to the HOSTED dataset. The HOSTED dataset is used to monitor the rates and risks of household transmission. This linkage will enable live monitoring of the impact of the vaccine on the population. It would allow stratified analysis by age, ethnicity and prior infection status.

Without this amendment to include vaccinations data it will not be possible to monitor the effect of the vaccine on household transmission, or trends across the pre- and post-vaccine periods due to the impact of vaccination at a national level. The scale of the HOSTED system will enable evaluation within sub groups.

Currently, routine reports include trends in the proportion of household contacts who become cases within 2-14 days of the index case in the same household, stratified by age, region and other relevant covariates. These trends will be presented by vaccination status.

Multivariable modelling is also conducted to simultaneously estimate (and control for) the effects of demographic variables, socio-economic status (IMD), geography and household composition on secondary transmission within households. This will be extended to include the impact of vaccination on secondary transmission, and how this might vary across specific subgroups (such as age, geography and household transmission). These effects will be assessed via interaction terms or stratified analysis, as appropriate.

In the event that the effect of vaccination is confounded with age, IMD, geography or some complex combination of variables, a matched case-control study will be conducted to ensure that these factors are balanced between vaccinated and unvaccinated groups. Analyses may also be restricted to specific groups to answer key policy questions: for instance, couples, older household contacts living in multi-generational houses, parents and their children.

There are two facets to the impact of vaccination:
1. Protection: the protection of vaccinated household contacts that are exposed via a case in their household
2. Transmission: the reduction in infectiousness of index cases who have been vaccinated.

This results in 4 potential groups: both index case and contact not vaccinated, discordant vaccination status for index case/contact (2 groups), and both vaccinated. Preliminary analyses will be conducted to determine the importance of these effects and whether/how the effect on protection needs to be accounted for to estimate the effect on transmission. The effects may combine multiplicatively in terms of the odds of becoming a secondary case, or may interact (i.e., need to be considered as 4 distinct groups).

Although vaccine efficacy (protection) has been established in trials (at around 90%) and will be analysed through other channels, it is worth comparing this within the HOSTED dataset and in the context of household transmission. The effect of vaccination on onward transmission within households is unique to HOSTED, although due to the potential rarity of vaccinated individuals who become index cases (assuming 90% efficacy) power may be low for some comparisons. This will be evaluated as data come in through the surveillance system.

Finally, the analyses described above initially considered vaccination status to be binary. However, the effect of vaccination on both protection and transmission may decline over time, and timing of vaccination in both index cases and contact need be considered. Duration will initially be divided into 3-month groups, and the potential impact of timing on both protection and transmission considered, depending on available sample sizes and the observed relationships.

These changes are legally permitted under the existing regulation 3 powers granted to PHE.

Expected Benefits:

The data asset will enable estimation of transmission dynamics within households (as opposed to other community transmissions within public transport, work settings, etc) with minimal lag, which is not currently possible.

This will directly benefit the Covid-19 response and inform government action as it will enable the monitoring and evaluation of the effectiveness of behavioural and social interventions (BSIs) such as social distancing, school closures and mass gatherings. The data will also directly feed into national modelling workstreams which are critical to the advice provided to the government by the Scientific Pandemic Influenza Group on Modelling (SPI-M).
The data asset will enable estimation of transmission dynamics of within households with minimal lag, which is not currently possible. This will directly benefit the Covid-19 response and inform government action as it will enable the monitoring and evaluation of the effectiveness of behavioural and social interventions (BSIs) such as social distancing, school closures and mass gatherings. The data will also directly feed into national modelling workstreams which are critical to the advice provided to the government by the Scientific Pandemic Influenza Group on Modelling (SPI-M).

Outputs:

- PHE will use the data to produce routine and bespoke reports.
- Routine reports will be produced for inclusion in the PHE surveillance report and for the PHE Sitrep on a weekly basis. These are shared with PHE and DHSC colleagues.
- Additional public-facing reports will also be produced, consisting of surveillance reports and peer-reviewed journal articles.
- All reports will all be at an aggregate level with small numbers suppressed in accordance with NHS Digital and Office for National Statistics guidance.

Along with the weekly routine outputs, the modelling cell in PHE will use the pseudonymised record level data to undertake household transmission modelling during the course of the pandemic.
The HOSTED data set will not be sufficiently accurate for use for direct patient care or enhancing the national shielding programme. This is due to both, accepted errors within surveillance system datasets and the time lag required to generate the full dataset.
The pseudonymised data disseminated to PHE will be used to enhance the national public health surveillance of Covid-19 infections in the population of England. At no point will an identifiable linked dataset be produced; so no Duty of Care will be owed or could be acted upon.
The record level data set will not be disseminated to other organisations by PHE. PHE will produce aggregate reports with small number suppression.

Processing:

The dataset is pseudonymised and no direct patient or contact identifiers will be included in the HOSTED data set itself.

The following will not be disseminated: Name, address, postcode, date of birth, NHS number, Unique lab result ID (from SGSS), unique property reference number.

The source data sets will be linked by NHS Digital. The dataset which is outputted after data linkage will not hold any identifiable data items; individuals and households will be identified by unique IDs generated through encryption of identifiers in the source data.

Records which are s-flagged in the NHS Spine will not be included in the dataset.

The Recipient will ensure that it and any of its Processors (as defined in GDPR) who process the Disclosed Data comply with the GDPR, the Data Protection Act 2018, all applicable law concerning privacy or the processing of personal data and the Duty of Confidence when processing the Disclosed Data. 2. The Recipient may process the Disclosed Data for the Agreed Purposes only. 3. NHS Digital will share the Disclosed Data securely with the Recipient on or around 23 May 2020 and weekly thereafter until the earlier of the date the parties agree to stop the flow or the End Date (as defined below). 4. The Recipient will store the Disclosed Data securely in their systems and stored in a secure cloud and all processing will be carried out from within England.

The Recipient and the Processor will on completion of the processing activity for the Agreed Purposes securely destroy the Disclosed Data (including any copies it was necessary for it take for the Agreed Purposes) and on the request of NHS Digital shall provide a data destruction certificate signed by the Recipient’s and Processor’s Data Protection Officers.

The Disclosed Data is confidential patient information and is provided by NHS Digital in confidence to the Recipient and to its Processor. The Disclosed Data must be maintained by the Recipient and its Processor as confidential in accordance with Duty of Confidence. In particular, the Recipient must comply with its legal responsibilities under COPI when processing the Disclosed Data, including the restrictions laid down in Regulation 7 of COPI. This requires the Recipient when processing the Disclosed Data under COPI:
- not to process the Disclosed Data more than is necessary to achieve the purposes for which the Recipient is permitted to process that information under Regulation 3(1) of COPI and the Agreed Purposes;
- so far as it is practical to do so, to remove from the Disclosed Data any particulars which identify the person to whom it relates which are not required for the purposes for which it is, or is to be, processed;
- not allow any person access to that information other than a person who, by virtue of their contract of employment or otherwise, is involved in processing the information for one or more of those purposes and is aware of the purpose or purposes for which the information may be processed;
- not allow any person to process the Disclosed Data unless that person is a health professional or a person who in the circumstances owes a duty of confidentiality which is equivalent to that which would arise if that person were a health professional;
- to ensure that appropriate technical and organisational measures are taken to prevent unauthorised processing of the Disclosed Data.
The Recipient will notify NHS Digital as soon as reasonably practicable after it becomes aware of any Personal Data Breach (as defined in GDPR) by the Recipient or a Processor concerning the Disclosed Data provided under the terms of this letter.

Any dispute in respect of these terms or their subject matter will be escalated to appropriately senior officers of the Recipient and NHS Digital for resolution

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Amendment to Existing Agreement:

New fields from the COVID-19 Vaccination Status dataset will be added to the NHSD HOSTED collection.

Records will be extracted by interrogating the fields PERSON_ID, DATE_AND_TIME, Vaccine_manufacturer and Batch_Number.

From these it will be ascertained as to which was the first administered vaccine for a patient based on the date and time.

The output will be as follows:
- NHS Number (Person ID)
- First vaccination date
- First vaccination type
- First vaccination batch number
- Second vaccination date
- Second vaccination type
- Second vaccination batch number

In line with the existing arrangement a de-identified version of data will be provided to PHE to allow analysis.


MR571A - NATIONAL REGISTER OF HEPATITIS 'C' VIRUS — DARS-NIC-148465-PJQ4L

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, No - flow to PHE under a memorandum of understanding, Identifiable, No (Statutory exemption to flow confidential data without consent)

Legal basis: Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); Other-Regulation 3 of The Health Services Regulations 2002

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2019-03-01 — 2020-02-29 2016.04 — 2019.12.

Access method: Ongoing, One-Off

Data-controller type: PUBLIC HEALTH ENGLAND (PHE), DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report
  5. Cancer Registration Data
  6. Civil Registration - Deaths
  7. Civil Registrations of Death

Objectives:

To describe the current biochemical, histological and clinically apparent liver disturbance in cases of HCV infection, and to relate current status to the interval since presumed infection and other potential prognostic factors.

Yielded Benefits:

Regarding yielded benefits, these data are critical for PHE's modelling of the HCV epidemic in England. Public Health England employ a Bayesian back-calculation approach, combining data on severe HCV-related liver disease and disease progression, to reconstruct historic HCV incidence and estimate current prevalence. PHE use these data to define disease progression rates to inform their modelling of the HCV disease burden in England and the UK. Modelling results are presented in a variety of papers and reports, including the annual national HCV in England reports that are available via this link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk In addition to the recent publications in the above link, past publications are also listed below, but it is important to note that most of the publications currently in preparation are being held up until this DSA is renewed, so PHE cannot currently update the survival analyses or respond to any requests in this area that are likely to come PHE's way from the government’s ongoing Infected Blood Enquiry. Ross J. Harris HH, Sema Mandal, Mary Ramsay, Peter Vickerman, Matthew Hickman, Daniela De Angelis. Monitoring the hepatitis C epidemic in England and evaluating intervention scale-up using routinely collected data. Journal of Viral Hep.2019;00:1-12. Hepatitis C: Estimating Disease Burden. Updated November 2018. https://www.gov.uk/government/publications/hepatitis-c-commissioning-template-for-estimating-disease-prevalence Harris RJ, Martin, N. K., Rand E, Mandal S, Mutimer D, Vickerman P, Ramsay ME, et al. New treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission in England. Journal of Viral Hepatitis. 2016(8):631-43. Increased uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease in England: Modelling the predicted impact of treatment under different scenarios. Journal of Hepatology 2014; 61: 530-7. Hepatitis C in England/the UK, annual reports from 2005-2019 (https://www.gov.uk/government/publications/hepatitisc-in-the-uk) Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; 2012 Oct;140(10):1830-7 The impact of mode of acquisition on biological markers of paediatric hepatitis C virus infection. Journal of Viral Hepatitis. 2011; 18: 533-541. Spontaneous loss of hepatitis C virus RNA from serum is associated with genotype 1 and younger age at exposure. Journal of Medical Virology 2011; 83: 1338-1344. Harris HE, Costella A, Amirthalingam G, Alexander G, Ramsay ME, Andrews N; the UK HCV National Register Collaborators. Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; Nov 29:1-8. The burden of Hepatitis C in England. Journal of Viral Hepatitis 2007; 14 (8): 570􀍴576. Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis 2007; 14: 213-220. Harris HE, Mieli-Vergani G, Kelly D, Davison S, Gibb D and Ramsay ME. A national sample of individuals who acquired their hepatitis C virus infections in childhood/adolescence – risk factors for advanced disease. Journal of Paediatric Gastroenterology and Nutrition 2007; 45 (3); 335-341. H.E. Harris, K.P. Eldridge, S. Harbour, G. Alexander, C.-G. Teo, M.E. Ramsay and The HCV National Register Steering Group. Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis March 2007; 14 (3):213-20. Survival of a national cohort of hepatitis C virus infected patients, 16 years after exposure Epidemiology and Infection 2006; 134: 472-477. Estimated progression rates in three United Kingdom hepatitis C cohorts differed according to method of recruitment. Journal of Clinical Epidemiology 2006; 59: 144-152. Sweeting MJ, De Angelis D, Neal KR, Ramsay ME, Wright M, Brant L, Harris HE and the Trent HCV Study Group. Estimating progression to cirrhosis in three UK hepatitis C cohorts: the effect of recruitment bias. Journal of Clinical Epidemiology 2006; 59: 144-152. Pathways of care and resource utilization in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-626. Harris HE, Ramsay ME, Andrews NJ. Survival of a national UK cohort of hepatitis C virus infected patients 16 years after exposure. Epidemiology and Infection 2006; 134: 472-7. Harris HE, Ramsay ME, Andrews NJ - Epidemiology and Infection 2006; 134: 472-7 (PDF, 98 KB) © Cambridge University Press 2005 Cambridge Journals Online - Epidemiology and Infection Brant L, Harris HE, Ramsay ME, Grieve, R, Roberts J on behalf of the HCV national register steering group. Pathways of care and resource utilisation in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-26. Helen E Harris, Mary E Ramsay, Nick Andrews, Keith P Eldridge on behalf of the HCV National Register Steering Group. Clinical course of hepatitis C virus during the first decade of infection: cohort study. BMJ 2002; 324:1-6. H. E. Harris, M. E. Ramsay, J. Heptonstall, K. Soldan, K. P. Eldridge, on behalf of the HCV National Register Steering Group. The HCV National Register: towards informing the natural history of hepatitis C infection in the UK. Journal of Viral Hepatitis November 2000; 7 (6): 420-7.

Expected Benefits:

The HCV National Register population is one of the largest cohorts of patients in Europe who acquired their HCV infections on a known date and so the information on progression of their liver disease post-infection, and their clinical outcomes, are invaluable. Now that it is virtually impossible to acquire hepatitis C via blood transfusion in the UK due to screening, the possibility of recruiting such a large group of individuals who acquired their HCV infection on a known date (in who statistically reliable findings are possible) is now virtually impossible.

The HCV Register is supported by clinicians and patients throughout the country and response rates to clinical follow-up have never fallen below 90% to date (well above usual levels). Because the natural history/clinical course is long and many of the patients in the Register have now been infected for more than 20-30 years, the Register contains a wealth of data that is becoming increasingly valuable as the years go by.

The objective for processing of the data has been to describe the current biochemical, histological and clinically apparent liver disturbance in cases of HCV infection, and to relate current status to the interval since presumed infection and other potential prognostic factors. The HCV National Register uses all of the collected data to address these questions and to assess the burden of HCV-related disease. In addition, data are used to produce peer reviewed scientific publications, and to inform Public Health England modelling work on the future burden of HCV in the NHS. These data are used to inform national policy on how best to tackle hepatitis C infection in UK countries and help monitor the progress of HCV elimination strategies. The outputs help to determine the current and future burden of HCV-related disease on health care services and to assess the impact of currently available treatment as well as those that may become available in the future. This is important for the commissioning of treatment and care services, and for monitoring the progress of the WHO Global Health Sector Strategy to eliminate hepatitis C as a major public health threat by 2030, that the UK government is signed up to.

It is also key that PHE follow this group as they largely comprise transfusion recipients who received HCV infected blood from National Health services prior to the introduction of HCV screening of the blood supply. These individuals are subject to the ongoing government Infected Blood Enquiry, and information on disease in this cohort helps to inform compensation payments.

Outputs:

Data on disease progression and clinical outcome from the HCV National Register are used by PHE’s statisticians in mathematical models that help predict numbers of patients with HCV infection and the burden this will place on NHS health services. This is important for local planning of treatment and care services and to inform commissioners of the need to provide these services to the population. Information from these analyses are also used to monitor progress against WHO targets, that UK governments are signed up to, to eliminate HCV by 2030.

Data are processed to produce peer reviewed scientific publications, presentations at scientific meetings on the natural history/outcome/burden of HCV infection. These results of these analyses will be published in the HCV in the UK 2019 report (published around September 2019) and the HCV in England 2020 report (published around March 2020). These are both annual reports which have been published since 2005 and can be seen at the following link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

An updated survival analysis is planned once the data subject to this application are available, along with further analyses to inform HCV disease progression rates/outcomes (2019-2021).

Processing:

Data from NHS Digital include death notifications, such as full details of cause of death and date of death, and cancer events, including details of the type and site of cancer. In addition, Public Health England (PHE) also receives information from NHS Digital to contact Health Administration Centres to allow PHE to re-establish links via the participant's current general practitioner if they become lost to follow-up.

Each patient enrolled into the HCV National Register is given a unique identifier. This identifier is used to link data received from NHS Digital to existing clinical data for each patient. These data enable PHE to establish which patients in the HCV National Register have died and the cause of their death and whether they have been diagnosed with cancer (and whether any deaths or cancers might be related to their HCV infections). The HCV National Register does not contain patient names or addresses; the data contained in the Register are identifiable but anonymised. PHE do not request name or address of flagged patients from NHS Digital, therefore patient identifiers such as NHS number and date of birth sent to PHE by NHS digital are data PHE already has for each patient.

NHS Digital data are received via a secure file transfer system and downloaded into a secure folder on a secure PHE network. Only key authorized users can access this folder. The data are then imported into the HCV National Register which is held in a password protected Access database on a secure network drive at PHE’s Colindale site. Only key authorized personnel have access to the database. PHE encrypted laptops will be used to access and process the data. The data is never stored on local hard drives.

NHS Digital data are kept in separate tables within the register database i.e. one table for members and postings, one for deaths and one for cancer events; these tables are linked to other data within the Register via their unique register number. The data are not linked to any external data. Outputs from the Register, like presentations or papers in peer review journals, contain no information on individual patients or any information that could be linked by others to individual patients; only aggregated data are shared

Every 3-5 years, patients are followed-up. Letters are sent out to patients’ GP or consultant asking for an update on their patients’ health. If the GP or consultant no longer cares for the patient, PHE are informed. NHS Digital flagging data are then used to find the region in which the patient has currently registered with a GP. PHE are then able to contact the regional health administration centres to obtain details of the patient’s current GP. This process enables PHE to re-establish contact to obtain follow-up clinical information.

Authorised users of the HCV National Register, including the data received from NHS Digital, are obliged to fully comply with the Data Protection Act 2018, together with all other related and relevant legislation (as amended or replaced from time to time) and with Department of Health directives covering issues of data sharing. All staff authorised to access the HCV National Register data have completed mandatory Information Governance training (Public Health England, Civil Service learning – Responsible for Information Asset Owner (IOA) Including Government Security Classifications 2014 and NHS Health Education England, NHS Data security Awareness level 1). A System Level Security Policy has been produced which records processing activities specifically for the HCV National Register, along with a Risk Assessment and Privacy Impact Assessment; these are held in an Asset Register at PHE.

Electronic data are stored on secure PHE networks in folders that have restricted access to authorised personnel only. Any paper copies of forms are held in cupboards that are locked and held on a secure site. No data are given out that could lead to the identification of any individual patient either directly or via linkage to other data sources. These data are not shared with any third party in the format provided by the NHS Digital. Although no data are stored on the hard drive of computers at PHE, any computers that reach the end of their life are disposed of according to PHE policies which require hard disks to the erased or, where this is not possible, crushed by an official approved service provider.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).


MR185 - UK Participants in the UK Atmospheric Nuclear Weapons Test (NWTPS) — DARS-NIC-148161-XXPS5

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, Identifiable (Statutory exemption to flow confidential data without consent)

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 - s261(5)(d); Other-(Regulation 3 of the associated Health Service (Control of Patient Information) Regulations 2002.), Health and Social Care Act 2012 - s261(5)(d); Other-(Regulation 3 of the associated Health Service (Control of Patient Information) Regulations 2002)

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2023-06-05 — 2026-05-31 2016.04 — 2016.11.

Access method: Ongoing

Data-controller type: DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Scottish NHS / Registration
  4. Demographics
  5. MRIS - Flagging Current Status Report
  6. MRIS - Members and Postings Report

Objectives:

The data supplied to the HPA CRCE Epidemiology Section will be used only for the approved Medical Research project - MR185 - UK Participants in the UK Atmospheric Nuclear Weapons Test (NWTPS)

Yielded Benefits:

The Nuclear Weapons Test Participants Study (NWTPS) began in 1983 and is a long-term follow-up study of the health of UK personnel who were present at UK atmospheric tests conducted between 1952 and 1967. It provided high-quality evidence about the potential for long term health effects among the participants. To date, it has found no difference in the long-term health between test participants and a control group of servicemen who served at the same time in similar locations. To date, four analyses have been published in the peer-reviewed scientific literature. The Ministry of Defence uses the evidence provided by this study when addressing veterans' concerns regarding their health, for example, when considering the awarding of War pensions.

Expected Benefits:

The aim of the study is to provide direct evidence and reassurance to the test participants as to whether, as a group, their health might have been affected by their participation in the test programme.

To date the four major analyses undertaken to date did not reveal significant health issues among the test participants as compared to the controls.

Future analyses will be able to provide additional information about risks during participants retirement years. Such analyses will also have greater statistical power compared to those already undertaken as a result of the much larger numbers of deaths and the longer follow-up period and so provide greater certainty. As occurred previously when an epidemiological analysis is undertaken the results will be provided to the main welfare organisation that looks after the interests of the veterans, the British Nuclear Test Veterans Association (BNTVA) so that the remaining veterans can be informed in the most appropriate way.

The BNTVA is the main veteran's organisation that was set up 40 years ago to provide support to veterans and advocate for them. There are no specific outputs that are undertaken in relation to or for the BNTVA. UKHSA provides support to the BNTVA in understanding the results of the work and its implications for the veterans but UKHSA do not provide specific results for them.

Outputs:

To date there have been four analyses of the NWTPS cohort. For the first 3 summary papers detailing the results were published in the peer reviewed scientific press and for each analysis a full report published by the predecessor organisations to UKHSA (NRPB or Health Protection Agency (HPA) or PHE).

The fourth (published in 2022) and all subsequent analyses will be published only as open access papers in the peer reviewed scientific press.

Access details for the papers (which are free to download) and layman's summaries and copies of the reports are available on www.gov.uk

https://www.gov.uk/government/publications/nuclear-weapons-test-participants-study.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

No further analyses are planned for the next five years. It is likely that one or more further analysis will take place when the vast majority of the cohort are deceased - this is expected to be in 2030. Surveillance is ongoing therefore UKHSA require latest available data prior to 2030 to enable this surveillance.

Processing:

The study database at UKHSA contains details of cohort members' names, dates of birth, and NHS numbers.

UKHSA will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England data will provide the relevant records from the Demographics datasets to UKHSA. The data will contain directly identifying data items including Forename(s), Surname, NHS Number, Date of Birth and Postcode which are required to link the data at a record level with data already held by the recipient.

Study ID and NHS number are necessary so UKHSA can link to their database records, Reason for removal is necessary to understand why records have been removed and to identify appropriate follow-up routes. The fact of death and Formal date of death allow UKHSA to crosscheck against the ONS mortality data they receive and the Date of GP registrations notify UKHSA whether their participants are registered within the NHS.

All other identifying details, including but not limited to the Latest address, Person's Surname and Gender are required for validation and cross-checking purposes (verify participants' details in the event of matching errors and to ensure details held about participants are accurate - limiting discrepancies in matching)

The data will not be transferred to any other location.

The data will be stored on servers at UKHSA.

The identifying details will be stored in a separate database (The National Radiation Epidemiology Database Management System NRED) to the linked dataset used for analysis. All analyses will use the pseudonymised dataset which is held on servers at UKHSA. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The data will be accessed by authorised personnel via remote access.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave England at any time.

Access is restricted to employees or agents of UKHSA who have authorisation from the Principal Investigator, who will only permit the data to be processed for the purposes described above.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

Any external researcher requesting access to information in the study cohort (which may include linkage to other databases) will be required to seek a separate Data Sharing Agreement with NHS England for this purpose.

The study has been analysed four times to date. The results of these analyses were published in 1983, 1990, 1998 and 2017

The data will be linked at person record level with:

• National Disease Registration Service (NDRS) will be obtained from NHS England under a separate DSA (ref: DARS-NIC-682587-K5N5K);

• Civil Registration Mortality data obtained from the Office for National Statistics (ONS);

The data are linked to the NWTPS cohort which was defined from archived military records and records of the Atomic Weapons Establishment at the start of the study in the mid 1980’s. They were used to confirm individuals test attendance (for the veterans) and to confirm suitability for being a control i.e. served overseas and not attending the tests. UKHSA extracted information on rank and service and radiation measurements on about 23% of the veterans group.

Other than the datasets listed above, UKHSA do not link NHS England data to any other data.