NHS Digital Data Release Register - reformatted

Public Health England (PHE)

🚩 Public Health England (PHE) received multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. Public Health England (PHE) may not have compared the two datasets, but the identifiers are consistent between datasets for the same recipient, and NHS Digital does not know what their recipients actually do.

Project 1 — PHECancerReg

Opt outs honoured: No - not applicable for this dataset, No - flow to PHE under a memorandum of understanding, No - consent provided by participants of research study

Sensitive: Sensitive

When: 2016/09 — 2021/05.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Informed Patient consent to permit the receipt, processing and release of data by NHS Digital

Categories: Identifiable

Datasets:

  • Cancer Registry linked to Diagnostic Imaging Dataset

Objectives:

To extend the information available for a cancer pathway, by linking data to Cancer Registry information


Project 2 — NIC-154590-YG6QH

Opt outs honoured: No - not applicable for this dataset, No - flow to PHE under a memorandum of understanding

Sensitive: Sensitive

When: 2017/09 — 2021/05.

Repeats: Ongoing

Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Identifiable

Datasets:

  • Patient level data relating to Diabetic Retinopathy Eye Screening FOR DIRECT CARE

Objectives:

Objective for processing: The diabetic retinopathy screening program will use:• the demographic patient information transferred to invite people recently-diagnosed with diabetes for annual screening;• the relevant clinical information transferred about patients who attend clinic appointments so that appropriate patient care is provided to those patients;Processing activities:For each monthly cohort, all patients with diabetes codes (Diabetes Exclusions CST, Diabetes Resolved CST and Diabetes CST) will be identified by the HSCIC and only those who have 'Diabetes CST' as their latest code will then have demographic and clinical data extracted for them. The full list of all required demographic data will be extracted by the HSCIC alongside the latest diabetes code including the date and time of this record.The Data Provider Output (DPO) is the data that general practice system suppliers extract from general practice clinical systems and submit to the HSCIC. The DPO is based on the data extraction specification (referred to as the ‘Extraction Requirement’) that the HSCIC circulates to general practice system suppliers.There will be a small amount of data transformation performed on the DPO. The HSCIC will use the General Practice Extraction Tool - Query (GPET-Q) system to collate the general practices’ DPO data into a file and then send the resulting file to the HSCIC Data Management Environment (DME). This is the 'Full Cohort' extract.Two data attributes (NHS Number and Registered Practice Id) will be copied from the file into a further file which will be stored in the HSCIC DME. This is the 'Missing Patients' extract. It identifies the patients with diabetes extracted in the previous month’s extraction run, and the practices at which those patients were registered. Each month the HSCIC will replace the file with a new file of patient identifiers. Without that information it would be possible to send out confidential invitation letters inappropriately (e.g. to a person who has died, to the wrong address), potentially “lose” people in need of diabetic retinopathy services, and/or spend time and money investigating the "missing patients".The 'Missing Patients' and 'Full Cohort' extracts are the two data extracts that form the output files. The HSCIC processes and places the output files in a secure repository for Quicksilva (data processor for the 72 NHS diabetic retinopathy screening programmes) to download. The HSCIC retains the list of NHS numbers and GP practices until the next extract for the purpose of identifying the patients missing between months. This list will be destroyed once approved data about the missing patients has been extracted and sent to the 72 NHS diabetic retinopathy screening programmes. The data received will be stored within the central database of patient records maintained by the NHS diabetic retinopathy screening programme and used for the purposes described above.The screening database of patient records is maintained in data centres in Harrogate & London which are provided by Redcentric PLC (Redcentric PLC is certified in ISO27001, ISO9001 and NHS IG Toolkit 12 (commercial third party)). Quicksilva manage and operate the screening database and process the data to the requirements of the Public Health England. After processing activities, the data is sent using a N3 host to the 72 NHS diabetic retinopathy screening programmes dedicated systems located within secure care provider network environments (e.g. NHS trusts) and also sent to data reconciliation tools which updates patient demographic data with local clinical system data.In order that the right people get access to the right data, the screening database includes:• a mapping of the patient’s general practice to a local screening program;• role based access controls that limit what patient data can be accessed depending on a specific role;• and audit trails to detect any unauthorised and/or excessive access.In addition to the data provided to PHE, two data attributes (NHS Number and Practice) will be stored in the HSCIC DME to be used in future extractions Specific outputs expected, including target date:The data will be used on an ongoing basis within patient records maintained by the NHS diabetic retinopathy screening programme to invite patients for screening, and to enable clinicians to provide appropriate clinical care. This database will be updated monthly.Expected measurable benefits to health and/or social care including target date:See “03_GP2DRS - Benefits Plan - August 2013 (NIC-154590-YG6QH)”


Project 3 — HDIS_Public Health England (PHE)

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

Legal basis: Health and Social Care Act 2012

Categories: Anonymised - ICO code compliant

Datasets:

  • Access to HES Data Interrogation system

Objectives:

The HES (Hospital Episode Statistics) Data Interrogation System (HDIS) allows users to securely access HES, interrogate the data, perform aggregations, statistical analysis, and produce a range of different outputs. Access to HDIS is only provided to organisations who work within the public sector with a specific interest in public health. There is a strict information governance applications process in place to protect and control how the data is managed.


Project 4 — DARS-NIC-395236-V3W9P

Opt outs honoured: No - data flow is not identifiable (Does not include the flow of confidential data)

Sensitive: Non Sensitive

When: 2021/01 — 2021/05.

Repeats: Ongoing

Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Categories: Anonymised - ICO code compliant

Datasets:

  • Cardiovascular Disease Prevention Audit (CVD Prevent Audit)

Objectives:

Cardio Vascular Disease Prevent (CVDPREVENT) is a new national primary care audit being commissioned by NHS England to support the NHS Long Term Plan and the GP contract. NHSE require an initial full-year extract of data and thereafter an extract on a quarterly basis to deliver the audit programme. Public Health England (PHE) are the analytical partner of CVDPRVENT and will be the recipients of the data shared under this agreement. PHE will be making decisions about how the data will be analysed and they are joint controllers who will process the data in the agreement. The NHS Long Term Plan has identified CVD prevention as a national clinical priority, with the potential to prevent 150,000 strokes, heart attacks and cases of dementia over the next ten years by improving the detection and management of high blood pressure, high cholesterol and atrial fibrillation. Routine audit is the essential starting point for this ambition. Without real time data, GPs, practices and networks will have no indication of the scale of the problem or the opportunity for improvement for patients and populations. Audit is the only way to systematically identify individuals whose high-risk conditions are sub-optimally managed, either through non-diagnosis, under treatment or over treatment. There is robust evidence that NICE recommended treatment of cardiovascular high-risk conditions is highly effective at preventing strokes and heart attacks. But equally it is acknowledged that it is difficult to achieve optimal treatment in many individuals. For example, 44% of people with treated hypertension are not controlled to 140/90. Partly this is because these high-risk conditions often have no symptoms to alert the patient or clinician, and partly because GP consultations are complex and time-pressured with multiple priorities to address. The audit will help to focus and optimise the programme locally and nationally. The new audit and dataset will, for the first time, allow the provision of comprehensive locally specific and nationwide information related to CVD prevention and associated outcomes. This will help to highlight opportunities for broader professionally led quality improvement activity associated with the delivery of the NHS Long Term Plan. In summary, the extraction is needed because the data from the audit will support: • The monitoring and evaluation of national CVD prevention programme delivery • Local quality improvement activity • Measurement of the impact on population outcomes The aim of the audit is to support professionally led quality improvement, optimising diagnosis and treatment in these conditions to prevent heart attacks and strokes at scale. The audit will help clinicians to understand how well they are performing in the diagnosis and management of 6 high risk conditions for CVD. To deliver the audit, routinely recorded GP data about cardiovascular disease and the high-risk conditions that can cause cardiovascular disease, will be extracted by NHS Digital via General Practice Extraction Service (GPES). New additional resources are being provided to help primary care prioritise CVD prevention activity including an expanded workforce of clinical pharmacists to implement new pathways to diagnosis and treatment (and reduce burden on general practice); a CVD prevention Primary Care Network (PCN) contract (Directed Enhanced Service ʹDES ʹscheduled April 2021) that will specifically resource optimisation in the 3 high risk conditions; (AF, BP, Cholesterol) a CVD prevention QOF quality improvement module including the lowering of the Quality Outcome Framework (QOF) blood pressure target to 140/90. Outputs from the analysis of CVDPREVENT will provide data and information which will both support and show progress in CVD prevention, both nationally and locally. Data outputs from the audit will be available to all but will be targeted for use by health care economies including practices, primary care networks and Clinical Commissioning Groups (CCGs). Information will also be generated to inform national policy and improvement work. Outputs will show variation in diagnosis and treatment across areas, provide new information on the occurrence and co-existence of CVD morbidities and allow the impact of age, ethnicity and deprivation on CVD to be investigated. The adoption of the business rule set for CVDPREVENT at individual practice level will facilitate detailed case finding and quality improvement work within practices. NHS England and Public Health England are joint data controller under NIC-395236 for the CVDPREVENT Audit. Public Health England are sole data processor. NHS England are relying on Article 6(1)(e) and Article 9(2)(h) as the legal basis for processing of data. NHS England is an executive non-departmental public body of the Department of Health and Social Care. It oversees the budget, planning, delivery and day-to-day operation of the commissioning side of the NHS in England as set out in the Health and Social Care Act 2012 as such the work carried out by NHS England for the CVDPREVENT Audit is necessary for the performance of a task carried out in the public interest (Article 6(1)(e)) and is necessary for the purposes of preventive / occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional (Article 9(2)(h)). Public Health England are relying on Article 6(1)(e) and Article 9(2)(i) as the legal basis for processing of data. Public Health England is an executive agency of the Department of Health and Social Care in the United Kingdom that began operating on 1 April 2013. Its formation came as a result of the reorganisation of the National Health Service in England outlined in the Health and Social Care Act 2012. Public Health England exist to protect and improve the nation's health and wellbeing, and reduce health inequalities as such the work carried out by Public Health England for the CVDPREVENT Audit is necessary for the performance of a task carried out in the public interest (Article 6(1)(e)) and 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 of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy (Article 9(2)(i)).

Expected Benefits:

The audit will provide information on a national and local level that has not previously been available. The extract will allow analysis of primary care data beyond that currently published as part of the Quality and Outcomes Framework enabling the reporting of familiar indicators but with greater detail which will be available to inform improvements in service delivery and to reduce inequalities. For example, the audit will be able to provide data and information around blood pressure and atrial fibrillation broken down by age group which will enable Primary Care Networks to be able to optimise care. Other novel analyses will include a review of the extent to which CVD related comorbidities occur within the population. Cohort 1 of the extract will specifically audit prevention of cardiovascular disease through the management of six high risk conditions in people who have not had previous cardiovascular events such as heart attack or stroke. Optimal preventive treatment in these conditions is defined in NICE guidance. It is recognised that significant numbers of patients are not treated to NICE recommended targets, and that there is significant geographical variation in treatment. The indicator will support clinicians to identify gaps and inequalities in treatment (including both over and under treatment) to inform professionally led quality improvement. This cohort will also identify people who may have one or more of the six high-risk conditions already but have another that has not been coded as diagnosed. It is not uncommon for patients to have an abnormality recorded (for example abnormal blood pressure, cholesterol, sugar or kidney function) without appropriate clinical follow up (e.g. repeat measurement, further investigation). This may occur because patients may have no symptoms or do not make a follow up appointment with the information becoming hidden from view over time. This cohort will support clinicians to identify patients who require further assessment and who may have a further undiagnosed high-risk condition however the outputs will support clinicians to only identify the features of at risk patients, not actual individual patients. Cohort 2 of the extract will audit prevention of subsequent cardiovascular events in people with pre-existing cardiovascular disease through clinical risk factor management. Optimal secondary preventive treatment in these patients is defined in NICE guidance. It is recognised that significant numbers of patients are not treated to NICE recommended targets, and that there is significant geographical variation in treatment. Some of these patients are also at risk of treatment related harm, particularly those with multi-morbidity or frailty. The indicator will support clinicians to identify gaps and inequalities in treatment (including both over and under treatment) to inform professionally led quality improvement. This cohort will also identify people who may have CVD already but have another of the six high risk conditions. It is not uncommon for patients to have an abnormality recorded (for example abnormal blood pressure, cholesterol, sugar or kidney function) without appropriate clinical follow up (e.g. repeat measurement, further investigation). This may occur because patients may have no symptoms or do not make a follow up appointment with the information becoming hidden from view over time. This data will support clinicians to identify patients who require further assessment and who may have a further undiagnosed high-risk condition. A final cohort will audit diagnosis of the high-risk conditions for CVD (as listed in cohort 1), identifying people who may have the high-risk conditions but have not been coded as diagnosed. It is not uncommon for patients to have an abnormality recorded (for example abnormal blood pressure, cholesterol, sugar or kidney function) without appropriate clinical follow up (e.g. repeat measurement, further investigation). This may occur because patients may have no symptoms or do not make a follow up appointment with the information becoming hidden from view over time. This cohort will support clinicians to identify patients who require further assessment and who may have an undiagnosed high-risk condition. In addition, it is acknowledged that CVD outcomes are the biggest component of mortality amendable to health care and addressing them is essential if the NHS is to become the best health system in the world. The development of CVDPREVENT would assist in delivering the current NHS strategic implementation priorities including: NHS Mandate: • Objective 1 – informing better commissioning, resulting in improvements in local and national CVD health outcomes and reductions in inequalities • Objective 2 – supporting the creation of a safe, high quality health and care service • Objective 4 – contributing to a step change in the NHS in preventing ill health and supporting people to live healthier lives by improving and lengthening lives, reducing health inequalities by implementing identified preventative interventions at scale in collaboration with health and care partners Next Steps NHS Five Year Forward View: • Delivering the CVD prevention opportunities through identification and implementation of optimal value CVD interventions, improving detection and treatment of people with high risk conditions • Supporting the expanded multi-disciplinary primary care staff to focus on those patients of most need, supporting patients to manage their high-risk conditions • Getting best value out of medicines and pharmacy with a drive to improve uptake of NICE recommended medicines thereby generating downstream NHS savings. NHS RightCare CVD prevention pathway is also now being implemented across CCGs and STPs. A paper has been developed with strategic partners (NHS England, Public Health England and the British Heart Foundation) to develop a world leading plan to reduce killer cardiovascular diseases, tackle inequalities and deliver a genuine shift on prevention. Discussions continue on embedding this vision within the developing NHS Long Term Plan. The CVDPREVENT audit will also specifically support the delivery of NICE guidelines and NICE Quality Standards.

Outputs:

PHE and NHS England's delivery partner organisation will work together on a joint publication/report that will be published and made publicly available. The delivery partner organisation will not access any record level data under this agreement. They will be assisting in the authoring of the report in an advisory capacity only they will have no process in determining the means by which the data will be processed. The first report will be published in the summer 2021. This report will provide the initial findings of the audit and will focus on national data. Information will also be released at lower geographies which will show variation between PCNs. The format for this has yet to be finalised but will ultimately form a dashboard as the audit develops and will present data at other NHS geographies eg practices; ICS; CCGs etc. All outputs will be anonymous and will not report on individual patients and no output will contain any personal identifiable data the outputs will support clinicians to only identify the features of at risk patients, not actual individual patients. . Data will be published only in aggregate form with appropriate suppression to ensure that no individual can be identified in any output. Information will be released in different formats for different audiences and will include written reports, slide sets, dashboards and briefings/infographics. Specifically: - A National Report: A publicly available summary and detailed report of the findings from the data extraction - An Interactive dashboard: including national and localised findings. Localised findings will be available at different healthcare geographies. It is intended that PHE and the audit partner will work collaboratively on the two proposed outputs. The report and interactive dashboard will be made publicly available. The PHE analytical team will work closely with the CVDPREVENT clinical lead and the incoming audit partner to ensure data outputs have a suitable and sensitive narrative. Future analytical work will be guided by an expert reference group to ensure the audit supports system priorities. Outputs from the audit will be designed to inform a number of different audiences, including but not limited to: - Providers of primary care; - Commissioners of the CVD prevention services; - Policy makers in government and NHS England; - Charities, patients and the public; - UK and international researchers. In the future CVDPREVENT may wish to link the primary care general practice data with secondary care Hospital Episode Statistics (HES) data and/or mortality data, in order to track the monitoring and evaluation of national programme delivery across the life course and care pathway, and to determine impact on outcomes and health inequalities. This will be subject to approval by NHS Digital and an amendment to this agreement.

Processing:

NHS Digital has been directed by NHS England under section 254 of the Health and Social Care Act 2012 (2012 Act) to establish and operate a system for the collection and analysis of the information specified for this service. All GP Practices in England are legally required to share data with NHS Digital for this purpose under section 259(1)(a) and (5) of the 2012 Act. The legal basis for the transfer of data is given in the ‘Cardiovascular Disease Prevention Audit Directions 2020’ signed on 13th October 2020 which includes 254(1) and (6), section 260(2)(d), section 260(4)(a), section 261(2)(e), section 262(5) and section 304(9), (10) and (12) of the Health and Social Care Act 20121 (the 2012 Act). For further details, please see - https://digital.nhs.uk/about-nhs-digital/corporate-information-and-documents/directions-and-data-provision-notices/data-provision-notices-dpns/cardiovascular-disease-prevention-audit. DATA FLOW: NHS Digital to PHE, in summary: a) NHS Digital will send psuedonymised data to PHE via Secure Electronic File Transfer (SEFT) or a similar secure mechanism of sharing data. b) Data will be stored by PHE either within a dedicated SQL Server 2017 Database hosted on PHE internal servers, or a dedicated network share both of which are PHE approved to store PID. Access to these is strictly controlled. Data will only be accessed by individuals within PHE who have authorisation from NHS Digital to access the data for the purpose(s) described, all of whom are substantive employees of PHE. The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide. There will be no requirement nor attempt to re-identify individuals from the data. Data Requirement All fields in the dataset are required so that PHE can provide analytical support to the ongoing monitoring of the CVDPREVENT Audit programme. This would not be possible without the full amount of data. CVDPREVENT is a national audit, so national data is required in order to assess geographical trends and identify any geographical and demographic variation in CVD risk factors. The business rule set has been developed by (and in partnership with) a wide range of national and clinical partners including primary care clinicians. It is based on an initial feasibility study carried out by PRIMIS at The University of Nottingham in June 2018 and has been kept under review by the CVDPREVENT Implementation Steering Group to ensure that only the necessary data is extracted. The extract includes three clearly defined cohorts of patients: those with one or more of the high-risk conditions for CVD, those with pre-existing CVD and those with clinical records that flag the possibility of an undiagnosed high-risk condition. Members of the Joint GP IT Committee (JGPITC) were consulted on the technical design of the extraction in December 19/January 20. The findings of the targeted stakeholder consultation have been reflected in the final data specification which has ensured data minimisation of the extraction. The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. Further linkage of the data may be sought but only after seeking the appropriate approvals needed to complete and access the linked data. Data Access There will be only one physical copy of the data, stored on one of the two servers at the storage locations detailed. The named analysts working on this project will access this unique copy of the data across the PHE network via SQL Server Management Studio. They will, in effect, only be viewing the data which will physically remain within the Server environment. If data is required for use outside of the SQL Server environment staff will be given access to a secure area of the PHE network where it can be used by other software (e.g. R or Stata). This secure area of the PHE network will also be located on the Porton or Colindale Servers. Staff will not be permitted to save the record level data on any other part of the network. Access to the data will be granted only to analysts working on the audit and on an individual basis. The data will only be accessed from within PHE offices or private residences that conform to PHE's homeworking policy and by connecting directly to the PHE network using PHE authorised equipment. Data Analysis The data will be used to create indicators which can be used to describe, measure and summarise measures of occurrence and treatment of CVD and the associated high risk conditions. This information will be reported at different geographies and by different descriptors to show variation and identify opportunities for improvement in care and outcomes. Data will be published only in aggregate form with appropriate suppression to ensure that no individual can be identified in any output. Information will be released in different formats for different audiences and will include written reports, slide sets, dashboards and briefings/infographics. Public Health England are requesting data pertaining to the three cohorts only. Public Health England will not process any data items it does not need and any extraneous data items/information that may be provided will be appropriately destroyed on landing. 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). There will be no attempts made to re-identify individuals involved in this project as there is no requirement to do so.


Project 5 — DARS-NIC-390154-Z4M0F

Opt outs honoured: No - Statutory exemption to flow confidential data without consent (Statutory exemption to flow confidential data without consent)

Sensitive: Sensitive

When: 2021/01 — 2021/03.

Repeats: One-Off

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002

Categories: Identifiable

Datasets:

  • GPES Data for Pandemic Planning and Research (COVID-19)

Objectives:

The remit letter for 2020/21 sets out the Government’s expectation that PHE will focus on the ongoing response to Covid-19, including "surveillance and modelling to inform action at national and local level … [and] identifying … the longer-term public health impacts of the pandemic”. The broad aim underpinning this request is 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, for monitoring and planning purposes. COVID-19 presents a significant threat to the population in terms of increased morbidity and mortality, particularly among vulnerable groups such as those with pre-existing disease. PHE will undertake analysis to assess the relationship between COVID-19 and potential risk factors including pre-existing medical conditions such as diabetes, heart disease, etc. behaviours such as smoking, obesity, etc. The results will contribute to future policy decisions regarding those most at risk of contracting COVID-19. On the basis of data currently accessible, Public Health England is developing a reasonably detailed understanding of what happens at secondary care level. Patients can be assessed on the basis of age, gender, underlying conditions, ethnicity and so on, but are however a subset of the broader general population which provides the basis. To complete the epidemiological understanding of the epidemic a more granular view of determinants, pathways and outcomes at population level, as opposed to hospital level, is required. PHE therefore wish to address a number of questions for both monitoring and planning purposes, e.g: • The impact of health-related risk factors (e.g. obesity, smoking status) and comorbidities (e.g. CVD, hypertension, diabetes, chronic kidney disease, COPD) on COVID19 infection, complications and outcomes. • The impact of demographic risk factors (e.g. age, sex, ethnicity, place of residence, deprivation, occupation) on COVID19 infection, complications and outcomes. • The impact of wider determinants of health (e.g. homelessness, migrant status, disabilities, asylum seekers and refugees, mental health conditions, learning disabilities) on COVID19 infection, complications and outcomes. The incident uses a series of daily line-lists – lists of cases and COVID related deaths – to manage the outbreak. The line lists underpin PHE’s understanding of the epidemiology of the disease, drive disease surveillance, feed disease modelling and forecasting and assist evaluation – which in turn feed daily decision making and policy formulation. The lists are enriched through linkage to other datasets – for example PHE link to HES data sets to improve ethnicity coding of cases and link to daily mortality data to estimate survival and recovery. PHE aim to further gain an understanding of the pathway of the COVID19 infection and the risk factors which affect this at each stage. In order to deliver the outputs above PHE will link the GPES Data for Pandemic Planning and Research (GDPPR) to the following datasets: • Second Generation Surveillance System (SGSS) - PHE - this produces the line list for cases • Covid-19 Hospitalisation in England Surveillance System (CHESS) - PHE • Hospital Episode Statistics (HES) - NHS Digital • Secondary Use Service Data (SUS+) - NHS Digital • Emergency Care Dataset (ECDS) – NHS Digital • ONS death registrations - ONS • Primary Care Prescribing data (all items) - NHS Business Services Authority • Extra-Corporeal Membrane Oxygenation Data (ECMO) - NHS England Data This linked identifiable data set will be analysed by PHE to identify the epidemiological characteristics of patients with Covid-19, including their demographic characteristics, geographic location, date of infection and risk factors, as detailed above. The data will also be used by PHE to monitor changes over time in these patients’ epidemiological characteristics, and to monitor their clinical outcomes from Covid-19 and any other health problems such as healthcare associated infections. PHE has the remit to investigate the impact of multi-morbidity, ethnicity and deprivation, and other dimensions of inequality on the infection and transmission rates and on COVID mortality and morbidity. It also is required to assess and monitor the wider impact of COVID on outcomes and inequalities. LEGAL BASIS The lawful basis for processing data under GDPR has been reviewed against the guidance provided by IGARD and been assessed as acceptable. Article 6(1)(e) ‘Public Task 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)’. public Health England exists to protect and improve the nation's health and wellbeing, and reduce health inequalities and is an executive agency, sponsored by the Department of Health & Social Care. And because health data is a special category of data under the GDPR, Article 9(2)(h) ‘processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services’ and 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 of medicinal products or medical devices’. PHE have a Caldicott Guardian who has overall responsibility for the use of healthcare data. The legal basis for identifiable data to flow from NHS Digital to PHE is under Regulation 3(4) of the National Health Service (Control of Patient Information Regulations) 2002 (COPI).

Expected Benefits:

The UK government set out its four-stage strategy in response to the pandemic, which includes a better understand the virus and the actions that will lessen its effect on the UK population; innovate responses, including diagnostics, drugs and vaccines, and use the evidence to inform the development of the most effective models of care. For that purpose, broader understanding of risk factors, population susceptibility, wider determinants, patient pathways, difference in outcomes, impact on and use of health services is required. This will allow PHE to identify population sub-groups at risk, monitor the progression of the epidemic, and develop appropriate models of care. In addition, it will play an important role in feeding back to the UK population the actions taken by the government and the background to certain interventions and measures prescribed, in order to enhance compliance and allay fears. The PHE remit letter, dated April 2020, sets out Public Health England’s role across the health and care system, how PHE should perform that role, and the Government’s priorities of PHE from April 2020 to March 2021: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/882570/PHE_Remit_Letter_from_Jo_Churchill_to_Duncan_Selbie.pdf This includes: • surveillance and modelling to inform action at national and local level; • monitoring the impact of social and behavioural interventions over time; • providing expert advice to DHSC, other Government departments and scientific advisory groups, including national work to support vulnerable groups; • supporting and delivering evidence-based public health communications and guidance; • identifying and implementing lessons from the management of the incident both during and after the outbreak and the longer-term public health impacts of the pandemic. The work that the GDPPR data will support is essential to deliver all of these requirements. The overarching benefit will be the contribution towards reducing the COVID reproductive rate and reducing the prevalence of infection. For all thematic areas outlines above, outputs based on this would be in aggregate anonymised format to prevent identification of persons or GP practices. This would include, but would not be restricted to, non-public facing data to support PHE and DHSC policy and public-facing data in PHE tools, reports and bulletins, presentations and journal papers. The statistical outputs based on the linked data are published by PHE as aggregate counts and rates, with small numbers suppressed in accordance with NHS Digital (as outlined in Section "Processing Activities") and Office for National Statistics guidance.

Outputs:

Main thematic areas: This GPES data intends to enable enquiry by multiple PHE researchers into the broader phenomenology of COVID, beyond the narrow clinical secondary care environment. There are specific individual projects within PHE requiring access to GPES, at different stages of definition and implementation. It is more convenient to list the following main areas of investigation: • Descriptive statistics Data currently accessible have allowed increased understanding of epidemiological features at secondary care level. Patients can be assessed on the basis of age, gender, underlying conditions, ethnicity and so on, but are however a subset of the broader general population which provides the basis. To complete the epidemiological understanding of the epidemic, any research will require a more granular view of determinants, pathways and outcomes at population level, as opposed to hospital level. Therefore, a comprehensive picture of population demographics, population subgroups (age, gender, ethnicity, deprivation, location, occupation) becomes necessary. This, in turn, needs to be linked to outcomes (mortality, LOS, ICU use) to understand different risk profiles. As an example, assessing the epidemiology of positive tests (age, gender, ethnicity, deprivation, Acorn scores, etc) and the trends in testing and positive tests. • Risk factors and wider determinants GPES data will be used by PHE to analyse the relationship between COVID-19 (infection and/or complications) and potential risk factors including pre-existing medical conditions such as diabetes, heart disease, etc. behaviours such as smoking, obesity, and population characteristics such as deprivation, ethnicity, location. This is expected to be published in September 2020, i.e. a publicly available report or paper for a medical journal. Research here will help understand whether the risk of COVID-19 infection and complications is greater in vulnerable groups such as homeless people, migrants, people with disabilities, asylum seekers and refugees, and people with learning disabilities. • Patient flows through the system The epidemic has shown different pathways for COVID cases. Combining GDPPR data, hospital data, mortality data and testing data, we intend to describe the progress through the pathway, and the different outcomes. There is a need to understand more in detail progression from infection to admission and final outcome, time lags and movements of patients between home, community care, primary care and hospital. • Impact of specific programmes - Health Checks (NHSHC) Research is needed to investigate if CVD risk assessment captured as part of the NHSHC programme can be used to identify persons at risk of severe COVID-19 outcomes. This research will inform part of the review of the NHSHC programme. This work will be published in academic papers, and as part of the review of the NHSHC programme. The intention is to link GDPPR data to HES, mortality data and Health Checks data. • Wider impact GPES data will be linked to hospital data, mortality data, Syndromic Surveillance data, CHESS data, survey data (Lifestyle & Opinion Survey), Suicide Surveillance data, data on employment, social care, consumer habits. These will allow to monitor, on a timely basis, the indirect effects of the pandemic and impact of social distancing measures. In addition to morbidity and mortality resulting directly from COVID-19 infection, adverse outcomes may result indirectly from COVID-19 health-system pressures, or as an unintended consequence of the delay measures, such as exacerbating poor mental health or domestic violence. Projects to be supported by these data include the monitoring of national and inequalities data, new Fingertips profiles with Local Authority data, Mortality Trends and Exceedances Monitoring, Changes in service provision using real time data sources including CVD trends - Mortality, & Case Fatality. Results will take the form of reports, dashboards, and indicator production. Target date Q3 2020. There are inevitably areas of overlap and mutual support. For most of the questions raised, the GPES extract needs to cover both positive and negative tests. Minimising the data to only positive COVID participants would reduce the effectiveness of the analysis. There are immediate outputs, such as reports, academic publications, inputs into dashboards and production of Fingertips indicators. There are additional outputs such as contributing to an early warning system and increased understanding of the requirements of near-real time surveillance. Beyond that, this research clarifies operational developments around one of Public Health England’s strategic priorities, i.e. PHE's 5-Year Strategy, priority 9, “Enhanced data and surveillance capabilities”, and the development of the Public Health Intelligence System (PHISy) (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/830105/PHE_Strategy__2020-25__Executive_Summary.pdf) Patient and Public Involvement (PPI) - PHE's public involvement team give advice and guidance on public involvement activity, commission an annual public opinion survey carried out by Ipsos MORI and manage the PHE's People's Panel. The People's Panel is a group of 500 members of the public who have expressed an interest in being involved at a level that suits them: from completing online surveys to taking part in a focus group or sitting on a committee. It will work with the incident management team which is the overall Governance Group during the current epidemic response. The PPI group will specifically be used to hold focus groups and surveys on the uses of the GDPPR data within PHE to gain insight and feedback from patients directly. The PPI group has been used in the past by OHE to do such work on other disease areas and with other datasets. It is intended that any outputs which would compile of any externally published report at the pre-release / pre-publication stage, but also any internal pre-release or pre-publication material (that could inform a published report) that is sent to external individuals such as policymakers, think-tanks, NHS Commissioning organisations or other research groups, would also be a flow into BMA/RCGP for information and contributing to professional assurance, not for approval.

Processing:

METHOD: 1. Record level patient identifiable PID-level GPES Data for Pandemic Planning and Research (GDPPR) data extract is required to flow from NHS Digital to PHE. Data which flows from NHS Digital to PHE will not be minimised as it has been assessed that the all fields required for analysis and linkage by PHE are necessary. PHE themselves will minimise the data once linked for specific usages, PHE analysts will apply to the applicant team in order to access the GDPPR data set and linked data sets, who will ensure the purpose of data processing is COVID-19 related and apply appropriate data minimisation according to the needs of the individual project. 2. In order to deliver the outputs above PHE will link the GDPPR to the following datasets: • Second Generation Surveillance System (SGSS) - PHE • Covid-19 Hospitalisation in England Surveillance System (CHESS) - PHE • Hospital Episode Statistics (HES) - NHS Digital • Secondary Use Service Data (SUS+) - NHS Digital • Emergency Care Dataset (ECDS) – NHS Digital • ONS death registrations - ONS • Primary Care Prescribing data (all items) - NHS Business Services Authority • Extra-Corporeal Membrane Oxygenation Data (ECMO) - NHS England Data 3. PHE reviews access requests from PHE analysts PHE will not share data with any third parties not named in this agreement. There are specific individual projects within PHE requiring access to GDPPR data, at different stages of definition and implementation. PHE analysts will apply to the applicant team in order to access the GDPPR data set and linked data sets, who will ensure the purpose of data processing is COVID-19 related, and apply appropriate data minimisation according to the needs of the individual project. PHE estimate the number of PHE analysts working on this data to be 50 during the lifetime of this agreement. This approach was the basis on which the NHS Digital CMO prioritisation was given for this release. It is a special condition of this agreement that any PHE study wishing to access the record-level data for the purposes of research will be required to apply for a separate data sharing agreement with NHS Digital, and provide the appropriate Ethics approval for the research. PHE currently have no oversight of the proposed GDPPR research planning applications. PHE will not use the data for performance management DATA MINIMISATION All fields of data are required. Data Minimisation will occur at a Local Level by PHE to align to the data requirements of each PHE team using the data. For most of the questions raised, the GPES extract needs to cover both positive and negative tests. Minimising the data to only positive COVID participants would reduce the effectiveness of the data analysis. SECURITY Data provided by NHS Digital are held by PHE in a secure data service. The primary users of the data will be substantive PHE analytical staff working on the incident and its impacts. PHE has several GP data sets but this will be the most comprehensive in terms of coverage, and the most contemporaneous. PHE have a number of experienced primary care data analysts who will work with epidemiological scientists on data processing and analysis. Access to the data is limited to substantive employees of PHE or individuals under an Academic Honorary contract with PHE who are only allowed to use the data for the purposes described in this agreement. Academic Honorary contracts are approved on a case by case basis by the Academic Public Health Research Strategy section (APHRS). Those on an Honorary contract will access these data through PHE systems using PHE laptops for network connection and follow the IG training and access controls required of all PHE staff. It is estimated that the number of Honorary contract holders working on this data to be 10 during the lifetime of this agreement. No pseudonymised data can or will be downloaded to a laptop that is not encrypted at rest. Any local devices are not included within the definition of the environment. The GDPPR data will be held in the PHE Data Lake and access to the data will be governed by the existing access management controls and governance arrangements. These controls include • PHE Caldicott sign off for all processing of patient identifiable data to ensure it is appropriate and proportionate • Confirmation from deputy director (or their named deputy) that the use of the proposed use of the GDPPR data conforms to the uses outlined in this agreement and is required to deliver PHE’s business plan and core remit. • Confirmation from each individual that they understand the conditions of supply and agree to abide by the terms of this agreement. Access to data is role based and access is only granted to individuals who have been appropriately authorised. All users must renew their access agreements every 12 months. All data shared under this agreement is processed and stored in secure locations within England and Wales and will not be shared outside PHE, other than in the form of aggregated outputs with small numbers suppressed. Record level data flowing under this agreement is not permitted to be onwardly shared without an amendment and approval being granted by NHS Digital. PHE separate Person Identifiable Data (PID) from non-PCD data. PHE created a pseudonymised version of data for analysis. Access to PID and non-PID are managed separately. Access to record level data is controlled through a system of approvers and for PID generally goes through the IG team and for Caldicott review. The statistical outputs based on the linked data are published by PHE as aggregate counts and rates (for example, at https://www.gov.uk/government/organisations/public-healthengland/about/statistics), with small numbers suppressed in accordance with NHS Digital (see Disclosure Rules below) and Office for National Statistics guidance. 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). GDPPR Disclosure Controls / Suppression Rules Whilst there are no specific GDPPR disclosure controls, outputs for public consumption should follow the Government (ONS) Statistical Service disclosure controls. We recommend that users review and follow the disclosure control guidelines as set out within the HES Analysis Guide. Some, but not all requirements are outlined below: - Disclosure control only needs to be applied to values relating to individuals. - No rounding or suppression is required for values not relating to individuals, such as a count of providers. - No small number suppression is required for national totals. - For any sub national geographies e.g. NHS Commissioning Region / Government Office Region or smaller, then the following apply: • Zeroes can be shown. • Values between 1-7 to be displayed as “*”. • Any other numbers rounded to nearest 5. • Percentages calculated from rounded values PHE will not share any NHS Digital data with any third parties.


Project 6 — DARS-NIC-381634-X8H0H

Opt outs honoured: No - Statutory exemption to flow confidential data without consent (Statutory exemption to flow confidential data without consent)

Sensitive: Non Sensitive

When: 2021/03 — 2021/04.

Repeats: One-Off

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002

Categories: Anonymised - ICO code compliant

Datasets:

  • Secondary Uses Service Payment By Results Episodes
  • COVID-19 Second Generation Surveillance System
  • Personal Demographic Service
  • COVID-19 Hospitalization in England Surveillance System
  • COVID-19 Vaccination Status

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 ********** 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.


Project 7 — DARS-NIC-343380-H5Q9K

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. (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))

Sensitive: Sensitive, and Non Sensitive

When: 2017/09 — 2021/05.

Repeats: Ongoing, One-Off, System Access

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'.

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Outpatients
  • Standard Monthly Extract : SUS PbR A&E
  • Standard Monthly Extract : SUS PbR APC Episodes
  • Standard Monthly Extract : SUS PbR APC Spells
  • Standard Monthly Extract : SUS PbR OP
  • Diagnostic Imaging Dataset
  • Mental Health Services Data Set
  • National Child Measurement Programme (NCMP)
  • Sexual and Reproductive Health Activity Data (SRHAD)
  • Cancer Registration Data
  • Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics
  • Primary Care Mortality Database
  • ONS Births
  • Vital Statistics Service
  • Primary Care Mortality Data
  • HES:Civil Registration (Deaths) bridge
  • MRIS - Scottish NHS / Registration
  • Civil Registration - Deaths
  • Mental Health Minimum Data Set
  • MRIS - Bespoke
  • MSDS (Maternity Services Data Set)
  • Community Services Data Set
  • National Cancer Waiting Times Monitoring DataSet (CWT)
  • Emergency Care Data Set (ECDS)
  • National Diabetes Audit
  • Improving Access to Psychological Therapies Data Set
  • SUS plus - Admitted Patient Care (beta version)
  • NHS 111 Online Dataset

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.


Project 8 — DARS-NIC-201243-R7L2M

Opt outs honoured: No - data flow is not identifiable (Does not include the flow of confidential data)

Sensitive: Non Sensitive

When: 2020/06 — 2020/08.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012 - s261(5)(d)

Categories: Anonymised - ICO code compliant

Datasets:

  • NHS Health Checks

Objectives:

BACKGROUND TO HEALTH CHECKS DATA COLLECTION: The NHS Health Check is a health check-up for adults in England aged 40-74. It's designed to spot early signs of stroke, kidney disease, heart disease and type 2 diabetes. People aged 65 to 74 having an NHS Health Check are also told the signs and symptoms of dementia to be aware of and advised of ways to reduce their risk of dementia. As people get older, there is a higher risk of developing one of these conditions and an NHS Health Check helps find ways to manage or lower this risk. • NHS Health Checks are carried out by health professionals – often a nurse or healthcare assistant. • A range of data items are collected, including demographic and health items such as date of birth, NHS number, blood pressure and risk of cardiovascular disease. • 1.3 million people attend an NHS Health Check each year across England. The NHS Health Check has been in place since 2009, but there has been a lack of data collected on the programme. To date, this information has not been collected on a national scale. This new data collection will provide elements not currently available, including: • A national data collection of the range of data items relevant to delivery of and outcomes from the programme (in contrast to the current data availability, which includes only offers and uptake). • Up-to-date data, allowing more real time programme monitoring and response. • Data at local authority / CCG level, as well as national level data, which will allow commissioners, providers and clinicians to better understand delivery and make local improvements. • Understanding, at a local level, of demographic and other characteristics in order to minimise inequalities of access and uptake, and follow up interventions. • Future linkage to HES and mortality data, subject to approval of further application. This will enable assessment of impact of the NHS Health Check on population health outcomes. In most cases, general practices carry out the NHS Health Check. If third party providers carry out the NHS Health Check, in most cases they send their outcome data to the patients GP. General Practice are the data controller of their patients’ data as it is stored in their system. These data will be collected via NHS Digital’s General Practice Extraction Service (GPES). This will involve an extract (a copy) of these data that are held by general practices being provided to NHS Digital via the third-party IT system suppliers. The existing third-party IT system suppliers act as the Data Processors on behalf of the general practices. NHS Digital are responsible for the collection and processing of NHS Health Checks data, and for creating a national dataset. PHE are responsible for the analysis and evaluation of the dataset, and will work in collaboration with NHS Digital on this analysis. See “Purpose of this Application” below for further information. PURPOSE OF THE APPLICATION: The purpose of this application is to request NHS Health Check data to be shared with PHE to undertake vital programme monitoring and allow the agency and wider system to understand the benefits of NHS Health Checks for patients and establish whether the programme provides value for money for health and care economy. On average, local government spends £65 million of the yearly Public Health Grant on commissioning the NHS Health Check programme. Without this data collection, PHE is unable monitor the NHS Health Check programme and will not be able to review how effective it has been for members of the public. Currently, the only data available nationally describe the number of NHS Health Check offered and completed in each of the 152 local authorities in England. This new data extract will allow PHE to examine in more details the delivery of the NHS Health Check programme and to highlight good practice and opportunities for improvement. For example, PHE will investigate whether some categories of patients might be less likely to attend a NHS Health Check. A better understanding of the type of patients not taking up the opportunity of this free NHS Health Check will allow local commissioners and providers to modulate the way they deliver the programme to ensure equity of access to all members of public, in particular those at greatest risk of preventable ill health and death. Analysis conducted by PHE will also report on the cardiovascular risk factors of patients offered and / or having a check. As the findings will be presented at local authority and CCG level, the local economy will be able to better plan interventions aiming to help patients reducing their risks, such as smoking cessation services or high blood pressure clinics. A series of monitoring questions have been developed and agreed: a list is available in Appendix G of the attached Primary Care Data Information Form. In addition to information recorded for patients aged 40-74 years (the age group that the NHS Health Check is aimed at), PHE will also use the information recorded for people aged 18-39 years who have been invited for and/or attended an NHS Health Check (Cohort 4). Some areas choose to extend the NHS Health Check offer to people who have not reached the eligible age of 40 but little data is available on the impact of this permitted practice. Although PHE anticipates the numbers in this group to be small, this information will help in understanding the benefits of extending the age range. Analytical strategy PHE and NHS Digital have worked together to produce an Analytical Strategy for the data extraction, described as follows: The analytical plan covers four areas: process, health data, outcomes and models. The intention is that the first two stages - process and health data - will be the primary focus of the initial data analysis. This is expected to last 6-12 months from receipt of the data. Stages 1 and 2 deal with the monitoring focus of the data extract, as indicated in Appendix G of the Primary Care Data Application Form (PCDAF) for the data extract. After the process and health data stages are complete, PHE will explore stages 3 and 4 as an extension of its monitoring of the impact of the programme. Stages 3 and 4 will evaluate longer term outcomes following an NHS Health Check and explore the development of models to evaluate risk prediction, economic impact and interventions related to the check. For stages 3 and 4, PHE will approach IGARD for further review of its uses of the data. 1. Stage 1: Process • Aims to understand the achievements and ongoing challenges to highlight specific opportunities to enhance delivery of the NHS Health Check programme. 2. Stage 2: Health Data • To describe the health measures in relation to demographics (e.g. age, ethnicity, gender, socioeconomic factors) in both the NHS Health Check population and, where possible, in those invited for NHS Health Checks, but who did not take up the offer. The health data will include information about the follow-up management and referral of patients who have had their NHS Health Check and those who have been invited for their check, but did not attend. 3. Stage 3: Outcomes • To determine the relationship between health measures linked to the NHS Health Check and important medical outcomes including mortality and medical events (e.g. Office for National Statistics mortality data, Hospital Episode Statistics, other cardiovascular relevant databases such as the National Institute for Cardiovascular Outcomes Research (NICOR). 4. Stage 4: Models • To create models to:  Predict risk of future health and social events;  Estimate economic impact to individuals and society of the health measures collected in NHS Health Checks; and  Evaluate potential benefits from interventions (targeted and universal) on individual and population health.

Yielded Benefits:

n/a

Expected Benefits:

The NHS Health Check programme has been operating for a number of years with only two data indicators available to track progress (offer and uptake). The GPES extract will enable for the first time the analysis of a range of data items relevant to delivery and outcomes of the programme across the country. PHE will produce a suite of analytical products: • Reports: a series of publicly available reports, presenting aggregated data on the characteristics and CVD risks factors of the people offered or having a check. • Interactive dashboard: a digital dashboard of the information broken down into national and local area data • Other reports and peer reviewed publications: as discovery of this complex dataset progresses, more detailed analysis will be performed using sophisticated statistical testing. Data presented will include, for example, characteristics of the two cohorts of individuals (offered and having a check) vs (offered and not having a check) per year, split by age group, gender, ethnicity, socioeconomic group; and comparisons between the two groups. Significance testing and logistic regression methods will be applied to estimate the likelihood of certain events occurring. The key audiences for these products will include i) providers of the NHS Health Check, ii) commissioners of the NHS Health Check, and iii) other stakeholders (for instance, the primary care and public health community, charities, UK and international researchers) who wish to better understand the status and outcomes related to the NHS Health Check programme. The dashboard will particularly interest local commissioners and providers, while the reports and publication will primarily interest other stakeholders noted above. In England, millions of persons are unaware that they have conditions such as hypertension or atrial fibrillation, making them particularity susceptible to heart attack or stroke. Amongst those, many would be eligible for an NHS Health Check. The latest statistics on the programme activity show that if most eligible persons are offered an NHS Health Check, in some area less than a third of people take up the offer, therefore missing an opportunity to address their risk of cardiovascular disease. The information published by PHE will aim to support local health economies in understanding the characteristics of those not taking up an NHS health Check offer. Patients found out by the NHS Health Check programme to be at high risk of CVD would be expected to receive information, advice, lifestyle or clinical intervention. Patients diagnosed of a CVD condition following an NHS Heath Check would be expected to be offered relevant treatment or intervention. The information published by PHE will aim to support local health economies in planning and refining their approach to risk factors management and CVD prevention according to the needs of their population. Finally, the NHS Health Programme is arguably one of the largest prevention programmes of its type in the world and the findings published as a result of this data extract will be of high interest to other countries considering the development of such a programme. What is the logical sequence of events that would need to take place in order for such benefits to be achieved including actions/decisions by third parties? • findings published by PHE in collaboration with NHS Digital • local health economies consider the findings to understand delivery at local level, using for example benchmarking and triangulating against local intelligence • local health economies identify areas for improvement (attendance, risk identification, risk management) local health economies implement changes (for example, provide NHS health Check appointments in alternative location) Why is it reasonable to expect that the expected benefits will be realised (e.g. has there been prior engagement with key decision/policy makers?)? Currently, the only data available nationally describe the number of NHS Health Checks offered and completed in each of the 152 England local authorities. Research datasets have been so far the only data source available to monitor and evaluate the programme. The PHE CVD Prevention Team has actively encouraged policy makers, decision makers, commissioners and providers to use published research to inform delivery of the programme. For example, infographics and Top Tips were produced based on the findings from Queen Mary, Imperial Collage and Cambridge universities. These tools have been extremely well received and used by local health economies. However, there are some limits to how relevant findings from a research dataset are to specific local areas. Across the country, there is a wide diversity of delivery methods for the programme: this allows each local government to commission a programme best adapted to their local residents. In terms of evaluation, however, it means that findings from a research paper might not be directly applicable to a specific local economy. Outputs from the data extract and in particular the dashboard will address this need for local granular data. Anticipated date to complete the local reports is by March 2019. What are the actual expected benefits and how do these benefit healthcare users? (e.g. cost/efficiency savings which would enable commissioners/care providers to reallocate funding to other areas of care benefitting care users; improved quality of care/reduced waiting times/improved ability of care providers to meet demand; improved survival rates; improved quality of life post-treatment/care, etc.). The expected benefits of the extraction include: • More up-to-date information on the programme, as current published research evaluations only cover the period up to 2013. • Information at local authority/CCG level that will allow commissioners, providers and clinicians to improve the effectiveness and cost-effectiveness of their local services. • Information needed to assess and address any inequalities of access and uptake of checks and of follow up interventions. • Potential for future linkage of the extracted data to subsequent HES and mortality data subject to future approvals. Having this information will carry the following expected benefits for service users: • Enhanced opportunity of access (where inequalities have been recorded) • Improvements in the local NHS Heath Check provided (where gaps in delivery have been recorded and where cases of good practice are uncovered and picked up in other areas) • Improvements in follow up management and referral (where gaps have been recorded and where cases of good practice are uncovered) • The above could lead to improved patient outcomes, in terms of diagnosis of conditions, prevention of conditions from developing, and management of conditions, where diagnosed. This has the potential to further reduce the incidence of cardiovascular conditions and incidents. Research to date has revealed that the NHS Health Check has likely prevented thousands of heart attacks and strokes. For instance, one study revealed that up to 8,400 heart attacks and strokes have been prevented over five years (http://www.pulsetoday.co.uk/news/clinical-news/nhs-health-checks-have-prevented-8400-heart-attacks-and-strokes-claims-study/20033492.article). This data will help local commissioners and providers to work towards further enhancing this number through localised improvement opportunities. The expected benefits for commissioners/care providers includes: • Information on local delivery of the programme, including gaps and what is working well, and allow comparisons with other areas • Information on what works well, which can help poor performing areas make improvements to their delivery • Improved recording of the NHS Health Check and follow up management (where gaps in recording data have been recorded). Clarify the expected magnitude of the impact. i.e. How many care users are expected to benefit? What is the expected impact in terms of cost/efficiency savings? On average, local government spends £65 million of the yearly Public Health Grant on commissioning the NHS Health Check programme. 15.5 million persons are eligible for a 5-yearly NHS Health Check. Since 2009, over 9 million people have had a check; since full roll out of the programme, around 1.3 million persons have had a check every year. It is too early to quantify the exact impact of the outputs, as the programme is implemented in a very diverse way across the country. However, over 5.6 million adults have undiagnosed hypertension in England and the NHS Health Check provides a cornerstone for the prevention of high blood pressure as well as six others of the top eight risk factors for early death and disability identified in the Global Burden of Disease (GBD) study. Any evidence allowing policy makers, deciders, commissioners and providers to make more informed decisions will impact through better planning of services to better address population health needs. For instance, where there is poor recording of diagnosis and measurement of risk, poor treatment of those at risk and low levels of referral to relevant services where appropriate, there will be opportunities to make improvements to planning and the allocation of resources. PHE analysis of the GPES extract will appear at a time when a large programme of work on CVD prevention is taking place in England: this will see (i) the publication of a tool showing the return on investment offered by a range of CVD prevention interventions, (ii) the development of an interactive model to explore NHS Health Check cost-effectiveness under different scenario. The information provided by these new tools, combined with the local intelligence derived from the data extract will give local health economies the strong evidence-based information they need to maximise the impact of the NHS Health Check programme. For example: Dashboard based on data extract: What CVD risks are identified in a local area? What interventions currently are offered to patients at high risk of CVD? Return on investment tool: What intervention would be best adapted to this local area? NHS Health Check cost effectiveness model: how could local delivery of the programme be improved to increase detection of risks?

Outputs:

PHE and NHS Digital will work together on a joint publication/report that will be published and made available to the public. There is a working group in place, and this advisory board will advise where and how this will be published. Currently, there is no confirmed target date for this. However, PHE would aim for the release of head line findings by March 2019. All outputs will be anonymous and will not report on individual patients. No outputs will contain any personal identifiable data, and individual GP practices will not be identifiable. The following outputs as a minimum will result from stages 1 and 2 (Process and Health data stages, as described above): 1. Report: A publicly available summary and detailed report of the findings from the data extraction 2. Publication: A publication resulting from the findings of the data analysis, intended for journal submission 3. Interactive dashboard: As a dashboard of information providing using Power BI, broken down into national and localised findings. Localised findings will be by local authority and clinical commissioning group areas. It is intended that PHE and NHS Digital will work collaboratively on the three proposed outputs. The report and interactive dashboard would be made publicly available on the PHE and NHS Digital websites, while the publication would depend upon the journal in which it appears. The dashboard might be a similar design to the NHS Digital/PHE work on learning disabilities: https://digital.nhs.uk/GP-data-hub/health-care-learning-disabilities-in-GP-data-hub The data is intended to be useful to the following audiences: • Providers of the NHS Health Check • Commissioners of the NHS Health Check • Other stakeholders (for instance, NHS England, patients and the public, the primary care community, government, policy makers, charities, UK and international researchers) who wish to better understand the status and outcomes related to the NHS Health Check programme. It is envisaged that the outputs from stages 3 and 4 (Outcomes and Models, as described above) would be an extension of PHE’s monitoring of the impact of the NHS Health Check programme, and include: 1. Collaborative reports and research publications created with academic partnerships 2. Linked datasets demonstrating the relationship between the NHS Health Check and longer term health outcomes, mortality, and social (non-medical) issues 3. New models that link the NHS Health Check with risk prediction, economic impact and interventions. As detailed previously, stages 3 and 4 will be subject to a further application and subsequent IGARD review.

Processing:

DATA FLOW: NHS Digital to PHE a) NHS Digital sends psuedonymised data to PHE via Secure Electronic File Transfer (SEFT) or a similar secure mechanism of sharing data. b) Data will be stored by PHJE either within a dedicated SQL Server 2017 Database hosted on PHE internal servers, or a dedicated network share both of which are PHE approved to store PID. Access to these is strictly controlled Data will only be accessed by individuals within PHE who have authorisation from NHS Digital to access the data for the purpose(s) described, all of whom are substantive employees of PHE. There will be no requirement nor attempt to re-identify individuals from the data. The data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide. Data Requirement The full amount of health check data being collected (for the cohorts defined) is required so that PHE can undertake monitoring the NHS Health Check programme. It is a national programme, so national data is required in order to assess geographical trends and identify any groups of patients that are not attending their NHS Health Check. There was a lengthy consultation process in order to gain approval for the data collection and it went through the SCCI approval process twice. Consideration was given to the amount of data to be collected and concerns were raised during the first SCCI consultation about the collection being excessive. Many attempts were made to minimise the amount of data involved. As a result of further consultation, the Royal College of General Practitioners (RCGP) and the British Medical Association (BMA) agreed to the collection and SCCI assurance was provided on 31 August 2017. A post implementation review will take place after the first data collection to check that the purposes of the extract were met and that the amount of data collected is not excessive. 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data). There will be no requirement nor attempt to re-identify individuals from the data. The data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the PHE standard for statistical disclosure control. The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement and no further linkages will be permitted under this agreement. Data Access There will be only one physical copy of the data, stored on one of the two servers at the storage locations detailed. The named analysts working on this project will access this unique copy of the data across the PHE network via SQL Server Management Studio. They will, in effect, only be viewing the data which will physically remain within on the Server. If data is required for use outside of the SQL Server environment staff will be given access to a secure area of the PHE network where it can be used by other software (e.g. SPSS or STATA). This secure area of the PHE network will also be located on the Porton or Colindale Servers. Staff will not be permitted to download or save the record level data on any other part of the network. Access to the data will be granted to analysts on an individual basis. The data will only be accessed from within PHE offices and by connecting directly to the PHE network.


Project 9 — DARS-NIC-148473-G85HC

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/09.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Other-NHS Regulations (3), Health and Social Care Act 2012 – s261(2)(c)

Categories: Identifiable

Datasets:

  • MRIS - Cohort Event Notification Report
  • MRIS - Cause of Death Report
  • MRIS - Flagging Current Status Report

Objectives:

To describe the clinical state at diagnosis and long-term outcome of HTLV infected individuals, 2). To investigate factors associated with transmission, disease an survival in HTLV infected individuals. Uninfected recipients (of donated blood) identified in the 'lookback' will provide a comparative group.


Project 10 — DARS-NIC-148465-PJQ4L

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

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/12.

Repeats: Ongoing, One-Off

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)

Categories: Identifiable

Datasets:

  • MRIS - Cohort Event Notification Report
  • MRIS - Cause of Death Report
  • MRIS - Flagging Current Status Report
  • MRIS - Members and Postings Report

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).


Project 11 — DARS-NIC-148219-ZHB4Z

Opt outs honoured: Y, N

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/11.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - Cohort Event Notification Report
  • MRIS - Cause of Death Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Members and Postings 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


Project 12 — DARS-NIC-148161-XXPS5

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/11.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - Cohort Event Notification Report
  • MRIS - Cause of Death Report
  • MRIS - Scottish NHS / Registration

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)


Project 13 — DARS-NIC-148119-WLQ4M

Opt outs honoured: Y, No - flow to PHE under a memorandum of understanding

Sensitive: Non Sensitive, and Sensitive

When: 2016/04 (or before) — 2020/03.

Repeats: Ongoing

Legal basis: Other-NHS Regulations (3), Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, 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), NHS Regulations (3), Health and Social Care Act 2012 – s261(7)

Categories: Identifiable

Datasets:

  • MRIS - Cohort Event Notification Report
  • MRIS - Cause of Death Report
  • MRIS - Flagging Current Status Report
  • MRIS - Scottish NHS / Registration

Objectives:

Enhanced surveillance of individuals identified as at increased risk of vCJD/CJD in the UK due to iatrogenic exposures or other indicators of increased risk. This is a long term follow up study of people who have been placed at additional risk of contracting CJD. The aim of this work is to ascertain any CJD-related deaths amongst individuals identified by actions recommended by the CJD Incidents Panel as at increased risk of CJD. This information is critical to: a) improve assessment of the risks experienced by these individuals, and others in similar circumstances, b) inform and evaluate public health measures relating to these individuals; c) investigate factors associated with transmission, disease and survival in these individuals.


Project 14 — DARS-NIC-147794-JDPT1

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2016/11.

Repeats: Ongoing

Legal basis: Other-NHS Regulations (3)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

Objectives:

Survival analysis of a cohort of Clostridium difficile infected and non- infected patients admitted to Addenbrooke’s Hospital between 2005 and 2007 To determine if Clostridium difficile (C. difficile) infection is associated with excess all cause mortality.