Harvey Walsh Ltd - HES data retention

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: − COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2); − Electronic Prescribing and Medicines Administration (EPMA) data in Secondary Care for COVID-19

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

[37 paragraphs unchanged] • COVID 19 – Non-hospital Antigen Testing Results (Pillar 2) [1 paragraph unchanged] • COVID 19 – Electronic Prescribing and Medicines Administration (ePMA) in Secondary Care • COVID 19 – Second Generation Surveillance System (SGSS) [19 paragraphs unchanged]

Benefits reported

[11 paragraphs unchanged] UPDATED YIELDED BENEFITS JULY 2024 Incisional Hernia Patients undergoing abdominal surgery are at increased risk of incisional hernia. Harvey Walsh generated real-world evidence using the HES data on patients most at risk of incisional hernia to support the design of clinical trials for a new mesh prophylactic treatment. Harvey Walsh designed a retrospective cohort study to evaluate the risk of incisional hernia in patients undergoing abdominal surgery using the Hospital Episode Statistics (HES) Database. Patients with selected types of surgeries were identified using OPCS-4 codes and were described in terms of existing sociodemographic characteristics and comorbidities. A targeted literature review identified a risk score mentioned in clinical guidelines, the Penn Score Risk Calculator, and clinical advice was sought on its implementation in HES to assess its ability to stratify patients at higher risk of incisional hernia in England. Longitudinal analysis was performed for incident incisional hernia and surgery complications. Healthcare resource use and cost were summarised in those patients and compared with those not developing hernia. Two posters of the study were presented at international conferences with key opinion leaders in the field present. The replication of the Penn Hernia Risk Score is being used to inform the design of a planned clinical trial of mesh for prophylaxis of incisional hernia in high-risk patients. The healthcare resource use and cost findings are being used to raise awareness on the burden of incisional hernia and the need for prophylactic treatment within the NHS. Multiple Sclerosis / IBD There is an emerging body of evidence describing the co-occurrence of multiple sclerosis (MS) and inflammatory bowel disease (IBD) diagnoses. The population of people affected have not been well described, and it is not clear what could be the reason for the two conditions co-occurring. A cohort of people diagnosed with either IBD or MS between 2014 and 2020 was described, including the number who had a concurrent diagnosis or IBD & MS and the order in which these were diagnosed and the demographic and clinical characteristics of the included population. Healthcare use in the six months before the first diagnosis and after the latest diagnosis were described including hospital admissions, emergency department attendance and the receipt of high-cost drugs. This study has been published and is being championed by IBD and MS clinicians to undertake extensive reviews of both pathways to ensure that patients with co-occurrence of the conditions are being treated within the right department and the right time and that multidisciplinary teams are formed to address the unique needs of these patients High Risk COVID-19 patients Sotrovimab (Xevudy) is a monoclonal antibody product developed to treat SARS CoV-19. In the UK it is approved for patients at the highest risk of poor COVID outcomes, including patients with organ transplants and receiving treatment for cancers and has been available since December 2022. Real world evidence of the use of sotrovimab in the NHS is developing. In this study, patients were grouped as being likely to have received sotrovimab if they had a day case attendance, with admission due to COVID-19 and in the admission received a monoclonal antibody treatment against COVID-19 (OPCS-4 X89.2). The characteristics and outcomes (re admission and death within 28 days of the treatment event) were described for the included patient cohort.

Unchanged: Processing activities, Expected output, Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + HES-ID to MPS-ID HES Admitted Patient Care; + HES-ID to MPS-ID HES Outpatients

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

OPEN HEALTH is a business comprising of several legal entities which provide health economic and outcomes research, information, technology and services to healthcare. Harvey Walsh Limited is a legal entity which is part of the OPEN HEALTH group. For further details of these legal entities, please see the following link: https://www.harveywalsh.co.uk/statutory-details Harvey Walsh Ltd requires access to NHS England data for the purpose of providing services to help public healthcare organisations (clients) monitor and improve their services. Harvey Walsh Ltd provide services to help public healthcare organisations monitor and improve their services. Processing is designed to benefit patients and society through better healthcare. NHS Digital will release pseudonymised data to Harvey Walsh Limited. All data held are only in pseudonymised form. Harvey Walsh Ltd is a commercial company that generates a profit by providing analysis of health data. NHS Digital data disseminated under this agreement will not be linked to any other datasets. The data will be used to provide services to the following types of clients only: Data is only processed by substantive employees of Harvey Walsh Ltd, all of whom have been trained in data protection and confidentiality and whom undergo annual retraining and reassessment in order to keep pace with new legislation. • Pharmaceutical companies Please note the following: •      Life science industry NHS Digital require Harvey Walsh Ltd to maintain an outputs register, this is a list of the organisations who have commissioned the work to be carried out with NHS Digital data, together with confirmation that a data sharing agreement or Contract is in place with each Organisation. •      Medical Device companies The above information needs to be made available to NHS Digital upon request. Harvey Walsh Ltd is part of Open Health, however, this Agreement is solely for Harvey Walsh Ltd only to use the record level data, not the wider Open Health Group. •      Academic Health Science Networks (AHSNs) Harvey Walsh Ltd does not provide access to or extracts from the record level dataset to any third party. •      Patient Groups and Charities Any data provided will only be used by Harvey Walsh for the purposes, activities, and outputs defined in this Agreement. •      Integrated Care Systems (ICSs) Harvey Walsh is the sole data controller who process these data and uses the following pseudonymised data: •      Integrated Care Boards (ICBs) Hospital Episode Statistics Data (HES) comprising of: - Admitted Patient Care, - Outpatients - Critical Care Other data: - Emergency Care Data Set - Civil Registry Data Additional data sets: - Diagnostic Information Dataset (DIDs) - Hospital prescribing dispensed in the community (NHSBSA) - COVID vaccination - COVID testing - COVID treatments These data sets are used to undertake analysis, undertake research studies, develop services and provide solutions to providers of Healthcare and life sciences services such as: • Clinical Commissioning Groups (CCGs) • Integrated Care Services (ICSs) [2 paragraphs unchanged] • Sustainability and Transformation Partnerships (STPs) [2 paragraphs unchanged] • Life science industry • Pharmaceutical companies • Medical Device companies • Academic Heath Science Networks (AHSNs) • Patient Groups and Charities [1 paragraph unchanged] Based on current customer types for Harvey Walsh, the customer split is approximately 70% Life Science/Pharmaceutical/Medical Device companies and 30% NHS, Academic Health Science Networks (AHSNs)/Charities/Patient Groups. Harvey Walsh also has a dedicated NHS Real World Evidence Consultant, whose role is to work directly with the NHS, AHSNs and Patient Groups. NHS England require Harvey Walsh Ltd to maintain an outputs register, this is a list of the organisations who have commissioned the work to be carried out with NHS England data, together with confirmation that a data sharing agreement or contract is in place with each organisation. This information needs to be made available to NHS England upon request. The services and solutions provided include analysis and outputs for the purposes of informing commissioners, healthcare professionals and clinical networks on uptake on innovation national policy guidelines, including the National Institute for Health and Care Excellence (NICE), patient pathways, benchmarking and disease burden analytics. The insights and analysis may be on a national level or down to individual practice level. These data are also used for epidemiological and disease burden studies which are published and disseminated. The data will be used to provide the following services: Harvey Walsh also utilise the NHS Digital data to provide services to commercial organisations within the pharmaceutical, medical device industry, patient organisations, healthcare charities and Academic Health Science Networks (AHSN's). These organisations use the outputs and insights provided by Harvey Walsh to work collaboratively with NHS organisations to promote health and improve the well-being of patients. The use of the data supports the development of innovative solutions and service improvement, to track outcomes and provide the real world evidence as required by the NHS, NICE, and NHS England and NHS Improvement. The aim of which is to improve patient care and support enhanced access to improved services and innovative solutions. In addition these clients use these outputs for the purposes of providing supporting information required by the NHS for business cases, epidemiological research, pathway analysis, burden of disease analysis, health economic research, predictive analytical modelling, NICE submissions and quality and outcome analysis. The outputs of which are shared directly or indirectly with the NHS to support improvements in patient care. All outputs are aggregated with small numbers suppressed in line with the HES analysis guide and the mental health suppression rules. • Benchmarking When processing the data, Harvey Walsh determine the methods and purpose of processing, and are sole Data Controller. The data are processed as a legitimate interest under General Data Protection Regulation Article 6 (1) (f). A full legitimate interest assessment has been completed and the data are processed under strict conditions to minimise impact and the processing is proportionate to the purpose. The balancing test demonstrates that the risk to the individual is minimised and individuals are made aware of how and why their data are processed and informed that data sent from NHS Digital to Harvey Walsh follows the national opt out policy therefore opt outs will not be applied. • Service evaluation Additionally, this processing is necessary to deliver the purpose of improved outcomes for patients and benefits to the wider health and social care arena and therefore Article 9(2)(j) is also applied. • Service analysis For clarity, Harvey Walsh is the sole Data Controller for the data from NHS Digital and therefore all other organisations under the OPEN Health Group hold no influence over the data, nor are they data processors on behalf of Harvey Walsh. Harvey Walsh are a separate legal, geographical and financial entity to Open Health (the parent). • Care pathway analysis In addition to this analytical work, Harvey Walsh also provide a tool called AXON 360. AXON 360 incorporates aggregated HES, Quality and Outcomes Framework (QOF) and primary care prescribing data, this tool allows users to analyse healthcare data, derive a range of insights and produce reports to support improvements in patient care and provide insights and evidence for commissioners and healthcare professionals. Data is also analysed for the purposes of informing commissioners, clinicians and clinical networks on uptake on innovation, national policy guidelines, including NICE, patient pathways, benchmarking and disease burden analytics. The insights and analysis may be on a national level or down to individual practice level. All data is aggregated and small numbers are suppressed, including secondary suppression as per the HES analysis guide. • Hospital feedback services The outputs that utilize the data are provided directly to the NHS and AHSNs or will be provided indirectly to the NHS via the pharmaceutical and device companies and AHSNs using bespoke outputs, reports, dashboards, research papers and via a tool called AXON 360 produced by Harvey Walsh. All of the outputs from the analysis of the data are used directly or indirectly for the provision or promotion of health and improved patient care and are not wholly commercial. AXON 360 holds the latest available for the current year and data for the previous 3 years. • Health economics and outcomes research studies Harvey Walsh request to continue to hold data for 10 years, this is so longitudinal disease burden and outcome analysis can be undertaken, and not for any other purpose. Harvey Walsh have a standard operating procedure to determine the maximum amount of data necessary for each project. • Epidemiology studies Justification for requesting additional data sets: • Clinical trial analysis The following additional data sets have been requested, the reasons for the additional requests are listed below, for clarity the COVID datasets requested will only be used for COIVD-19 research/activities. • Burden of Disease COVID-19 Second Generation Surveillance System / Non-hospital Antigen Testing Results (SGSS/Pillar 2), Vaccination and hospital treatment • Predictive Analytical Modelling Harvey Walsh has undertaken numerous studies during the COVID pandemic using HES, the team now have studies pending that require analysis of hospital admissions on patients with a confirmed diagnosis of COVID, confirmed by testing (SGSS/Pillar 2), the treatment they received whilst in hospital to see if there is a difference in the effectiveness of treatments and also to see if the vaccine prevented serious disease. The following NHS England data will be accessed: - The studies that are pending on the receipt of COVID-19 data, (the team also have other studies that are currently in the development stage and more will follow). • Hospital Episode Statistics (HES) 1. Healthcare resource us in patients hospitalised with confirmed COVID-19 (2 o Admitted Patient Care (APC) studies, one looking at variation across Geography and the other looking at o Critical Care (CC) variation across the COVID waves) o Outpatients (OP) 2. Risk of hospitalisation with COVID-19 based on vaccination status • Emergency Care Data Set (ECDS) 3. The comparison of healthcare resource use in vaccinated and unvaccinated • Diagnostic Imaging Dataset (DIDS) patients during the COVID-19 pandemic • Civil Registration Mortality 4. Risk of admission compared to NHS Risk Group vaccination status in 2021 • Summary Hospital-level Mortality Indicator (SHMI) 5. Impact of COVID-19 on cancer presentation, diagnosis and staging • Medicines Dispensed in Primary Care (NHSBSA Data) DIDs • COVID 19 – Non-hospital Antigen Testing Results (Pillar 2) Harvey Walsh undertakes a significant amount of work in Oncology related areas using HES and a number of existing and pending studies require the linkage of diagnostic data sets e.g. lung biopsy for lung cancer, prostate sampling for prostate cancer (Prostate Cancer UK). • COVID 19 – Vaccination Status NHSBSA • COVID 19 – Electronic Prescribing and Medicines Administration (ePMA) in Secondary Care Harvey Walsh undertakes a significant amount of pathway and outcomes work, there is a need to understand better, patients who may receive their hospital treatments in the community or at home and NHSBSA will allow analysis of hospital prescription dispensed in the community. This analysis may enable better understanding of the variation and effectiveness of medicines. This may in turn enable further review and ongoing monitoring of these patterns and proposed changes. • COVID 19 – Second Generation Surveillance System (SGSS) These data sets are used to undertake analysis, undertake research studies, develop services and provide solutions to providers of Healthcare and life sciences services, they are necessary as they are required for national pathway analysis across disease burdens to look for variance and outcomes. The COVID datasets requested will only be used for COVID-19 research/activities. Harvey Walsh has undertaken numerous studies during the COVID pandemic using HES, the team have studies that require analysis of hospital admissions on patients with a confirmed diagnosis of COVID, confirmed by testing (SGSS/Pillar 2), the treatment they received whilst in hospital to see if there is a difference in the effectiveness of treatments and also to see if the vaccine prevented serious disease, whilst also looking at variation in Geography across the COVID waves, including but not limited to the impact on cancer presentation, diagnosis and staging during this time. NHSBSA data is necessary, as analysis may enable better understanding of the variation and effectiveness of medicines. This may in turn enable further review and ongoing monitoring of these patterns and proposed changes. The level of the data will be pseudonymised. Harvey Walsh Ltd must only hold 10 years worth of data (plus current year to date), anything over that time period must be destroyed and a data destruction certificate provided to NHS England. Harvey Walsh Ltd is the data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above. The lawful basis for processing personal data under the UK GDPR is: Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party. Harvey Walsh Ltd has determined the processing is necessary for its legitimate interests in being able to provide tools and services that will benefit healthcare organisations. Harvey Walsh’s legitimate interest to deliver improved outcomes for patients and benefits to the wider health and social care arena has been fulfilled through the successful management and completion of various projects within the healthcare sector, allowing for earlier diagnosis of certain diseases, uptake of innovation and national policy guidelines, epidemiological research and disease burden analytics. The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. The funding will come from multiple sources, dependent on the study being commissioned and then conducted by Harvey Walsh Ltd. Harvey Walsh are collaborating with DATA-CAN Public and Patient Engagement Group and have had workshops and meetings with them and are working with them to ensure that patients' views are incorporated into their work. In addition, through Harvey Walsh's work in Rare Diseases, the team are liaising with a number of patient groups, through their Director of Rare Diseases, to help them understand where their work should be focused to provide the best benefits in terms of new evidence to support patients with these diseases. Harvey Walsh are also working with Prostate Cancer UK on two studies on the impact of COVID in the diagnosis and staging of prostate cancer. Harvey Walsh also has a dedicated NHS Real World Evidence Consultant, whose role is to work directly with the NHS, AHSNs and Patient Groups.

Processing activities

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). No data will flow to NHS England for the purposes of this Agreement. All data are processed under the terms of the Data Sharing Agreement. All personnel involved in the processing of record level data are substantive employees of Harvey Walsh or are a permanent contractor to which all Standard Operating Procedures apply. All individuals are trained on GDPR, DPA and the terms of this Data Sharing Agreement together with the requirements of ISO27001/2013. NHS England will provide the relevant records from the data sets to Harvey Walsh Ltd. The data will contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient. The maximum data range held at any one time will be 10 years (plus year to date). A data destruction certificate must be provided to NHS England for any data held that exceeds 10 years. AXON 360 (Harvey Walsh's health informatics platform) holds the latest available for the current year and data for the previous 3 years. NHS Digital The data disseminated under this agreement will not be linked transferred to any other datasets. location. Processing Locations: The data will be stored on servers at Harvey Walsh Ltd and/or UK Fast. The record level data (pseudonymised, non-identifiable) will only be stored in the secured local data warehouse at the Harvey Walsh facility in Cheshire on a hardware encrypted disk (for in house backup) and/or the secure approved hosting environment in the UK-based data centre at UK Fast. The main processing location is the Harvey Walsh facility in Cheshire, UK, and UK Fast Server Centre UK, both of these facilities are covered by ISO27001 and DSPT. The data will be accessed onsite at the premises of Harvey Walsh Ltd or by authorised personnel via remote access. The data will remain on the servers at Harvey Walsh Ltd and/or UK Fast at all times. Processing on receipt of data: Personnel are prohibited from downloading or copying data to local devices. On a monthly basis, NHS Digital upload the requested pseudonymised data sets to Harvey Walsh via Secure Electronic File Transfer (SEFT). The raw flat data files are downloaded from the SEFT server onto a drive on a secure dedicated hosted server within UK Fast, Manchester, England. The data are then processed with costing algorithms applying tariffs to HRGs and all records are imported into two different databases within a Structured Query Language (SQL) Server environment - A verification process takes place on row count and then additional processing is undertaken applying the NHS cost algorithms and readmission calculations, the data is then ready to be made available for further use. The data will not leave England at any time. The data are then split, for bespoke analysis by the SQL Analyst team and for the AXON 360 system. Employees or agents of Harvey Walsh Ltd are permitted to access pseudonymised data only. For bespoke analysis, the data are made available on the internal network via role-based, windows authenticated logins to the SQL Server data warehouse. OPEN HEALTH and UK Fast are not permitted to access the data. Analysts processing data utilise secure Virtual Private Network (VPN) to access a virtual machine within the Cheshire facility. No raw data is stored off site. All analysts are substantive employees of Harvey Walsh and no data is downloaded and stored outside of the approved locations. All personnel accessing the data have been appropriately trained in data protection and confidentiality. Processing for AXON 360: The data will not be linked with any other data. The AXON 360 system is processed as follows, the data are aggregated to a spell level (all related episodes made into a single spell row), and then this is further aggregated to an organisation and code level (ICD10 (International Classification of Diseases 10th Revision), OPCS (Classification of Interventions and Procedures), HRG (Healthcare Resource Group) when being rolled up into an OLAP cube. An OLAP Cube is a data structure that allows fast analysis of data and the term cube refers to a multi-dimensional dataset, . AXON 360 does not display individual episode or spell level data, the data are aggregated to an organisation or code level. The cube aggregates data at a diagnosis or organisation level which will be accessed via the AXON application’s server code via a stored procedure on SQL Server. This allows another layer of security between the data and the AXON application layer. There will be no requirement and no attempt to reidentify individuals when using the data. The data viewable in an AXON 360 report is pre-processed, aggregated and small number suppressed e.g. any number that requires suppression is suppressed in line with the HES Analysis Guide. AXON 360 is on a separate dedicated server on its own segregated network. This means that there is no access via AXON to the raw underlying HES data. The medicines data is not deemed disclosive and information on a GP level is available in the public domain. However, should the published information pose a risk of re-identification, the following suppression methodology should be applied: Data Flow / Process Overview: · Zeros should be shown. Data will be downloaded from the NHS Digital SEFT secure file server (by a named approved individual) and placed on a secure network drive within the UK Fast facility Manchester, UK. The data is then processed and loaded into the Live Cube Server. · 1-7 to be rounded to 5. The raw data files are then encrypted and loaded over an encrypted connection to a secure data location in the Cheshire facility. · Any other numbers rounded to nearest 5. The AXON 360 webserver will then be able to query the derived cube data. · Rounding unnecessary for averages etc. In addition to the live cube server, Harvey Walsh also have a development cube server. This server is used to build and test new analysis solutions prior to them being deployed to the live cube server. This cube is only accessible by approved Harvey Walsh employees and cannot be queried by the AXON 360 system. · Percentages calculated from rounded values. Access to the UK Fast data solution is only available to authorised and authenticated Harvey Walsh employees’ users via a secure encrypted connection. · If zeros need to be suppressed, round to 5. Backup of the AXON 360 system is held on a dedicated, secure, private encrypted enterprise level backup solution within UK Fast. Analysts from Harvey Walsh Ltd will analyse the data for the purposes described above. Any and all outputs of any kind visible to 3rd parties e.g. not an approved employee of Harvey Walsh will always be in an aggregate, non-identifiable form and with small numbers suppressed in line with the HES analysis guide The Data protection policy enforcement: 1. The record level data (pseudonymised, non-identifiable) will only be stored in the secured local data warehouse at the Harvey Walsh facility in Cheshire on a hardware encrypted disk (for in house backup) or the secure approved hosting environment in the UK-based data centre at UK Fast 2. All Harvey Walsh staff are instructed not to download any record level Data to local PCs, laptops or any non-encrypted device, and this is enforced by their Data Security policy (note, only approved staff will have physical access, this instruction is an additional measure for approved data-handlers to ensure data is never taken off the server, which is the only location on which it can be analysed). 3. Harvey Walsh developer and analyst teams use PC/ laptops with encrypted drives only. 4. All data transmission must be encrypted to minimise the risk. 5. All staff who have access to the raw record level data are substantive Harvey Walsh employees, who have undergone full ISO27001 and data security training, and this function is never outsourced to anyone else. 6. The AXON 360 hosting infrastructure is penetration tested by an external independent vendor in line with the Harvey Walsh Information Security Management Systems. The latest penetration tests were carried out in January 2022. Security: The machines of employees who have access to the record level data have at least 256-bit encryption and password protection. The employees who access record level data are logged on an access control register and are under contractual obligations with regards the safe and secure processing of sensitive data. Harvey Walsh is ISO27001/2013 compliant and all staff are fully trained on GDPR and undergo regular data security training.

Expected output

Harvey Walsh have undertaken numerous projects and studies utilizing HES and approximately 170 distinct projects were completed in 2021. Harvey Walsh plan to continue this level of work with HES but in addition plan to undertake additional projects and studies using the new data sets including DIDs, COVID, EPMA & NHSBSA as explained in section 5a. The expected outputs of the processing produced as a result of the data processing may include (but are not limited to) the following: The outputs produced as a result of the data processing may include (but are not limited to) the following: • Excel based reports a. Excel based reports • Dashboards b. Dashboards • Budget impact models c. Budget impact models • Health economic models d. Health economic models • System dynamic models e. System dynamic models • Health economic analysis f. Health economic analysis • Risk stratification g. Risk stratification • Submissions to peer review journals h. Submissions to peer review journals • Abstracts and manuscripts i. Abstracts and manuscripts • Reports j. Reports • Conferences k. Conferences • Presentations l. AXON 360 • AXON 360 - Harvey Walsh's health informatics platform. m. Presentations AXON 360 incorporates aggregated HES, Quality and Outcomes Framework (QOF) and primary care prescribing data, this tool allows users to analyse healthcare data, derive a range of insights and produce reports to support improvements in patient care and provide insights and evidence for commissioners and healthcare professionals. Data is also analysed for the purposes of informing commissioners, clinicians and clinical networks on uptake on innovation, national policy guidelines, including NICE, patient pathways, benchmarking and disease burden analytics. The insights and analysis may be on a national level or down to individual practice level. All data is aggregated and small numbers are suppressed, including secondary suppression as per the HES analysis guide. The outputs that utilize the data are provided directly to the NHS and AHSNs or will be provided indirectly to the NHS via the pharmaceutical and device companies and AHSNs using bespoke outputs, reports, dashboards, research papers and via a tool called AXON 360 produced by Harvey Walsh. All of the outputs from the analysis of the data are used directly or indirectly for the provision or promotion of health and improved patient care and are not wholly commercial. AXON 360 holds the latest available for the current year and data for the previous 3 years. The level of data contained in the outputs is derived and aggregated with small number suppression. The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the datasets from which the information was derived. The Diagnostic Information Dataset (DIDS) is vital as it will allow accurate analysis of what type of diagnostic tests were done and importantly on what date so that accurate representation on time from 1st appointment to diagnosis and treatment can be determined. The outputs will be communicated by the clients to the relevant recipients through the following dissemination channels: The COVID related data sets will be used in current and future studies to understand and describe events, such as the risk of being admitted to hospital with COVID, the impact of Long COVID, how new treatments such as the anti-virals are improving patient outcomes. How the different COVID waves are affecting and will continue to affect how patients are medically treated. • Reports Dissemination of results/outputs: • Stakeholder Engagement All outputs or analysis undertaken is ultimately undertaken to improve patient pathways, direct patient care or healthcare services. The dissemination activities are distinct to each project but the target audience will be from the following: healthcare professionals, patients, researchers, scientists, innovative technology focused organisations, policy and decision makers, the general public. • Conferences The dissemination channels include reports, dashboards, pathway analysis, workshops, direct engagement, publications, conferences, public reports • Publications Harvey Walsh are collaborating with DATA-CAN Public and Patient Engagement Group and have had workshops and meetings with them and are working with them to ensure that patients views are incorporated into their work. • Healthcare Professionals In addition, through Harvey Walsh's work in Rare Diseases the team are liaising with a number of patient groups, through their Director of Rare Diseases, to help them understand where their work should be focused to provide the best benefits in terms of new evidence to support patients with these diseases. • Decision makers Harvey Walsh are also working with Prostate Cancer UK on two studies on the impact of COVID in the diagnosis and staging of prostate cancer. • Websites Communication of results/outputs • Posters Results and outputs are communicated via reports, stakeholder engagement, conferences, publications, face to face with healthcare professionals and decision makers, websites, posters, dashboards and reports. • Dashboards Target dates for production of outputs Harvey Walsh has a number of rolling contracts and expects to produce these outputs up until at least 2025 and has produced a large number of historic outputs which are recorded in the data output register. Harvey Walsh have a number of rolling contracts and expect to produce these outputs up until at least 2025 and have a produced a large number of historic outputs which are recorded in the data output register. The medicines data is not deemed disclosive and information on a GP level is available in the public domain. However, should the published information pose a risk of re-identification, the following suppression methodology should be applied: · Zeros should be shown. · 1-7 to be rounded to 5. · Any other numbers rounded to nearest 5. · Rounding unnecessary for averages etc. · Percentages calculated from rounded values. · If zeros need to be suppressed, round to 5.

Expected measurable benefits

Expected Measurable Benefits: The services provided to clients are expected to identify improvement opportunities which the client may then exploit by making changes to systems, processes, resources or infrastructure in order to improve patient experience and patient care. Harvey Walsh has held a data sharing agreement for over 10 years and has provided services to the NHS (NHS England, the NHS Board, AHSNs, trusts, Clinical Care Commissioning Groups (CCGs), GP practices) and other healthcare related companies (Pharmaceutical and Device Companies, Patient Groups and Charities) during this time. Harvey Walsh has contracts which run through to 2023 and beyond and would expect to provide data outputs through to this time. The use of the data could • help the system to better understand the health and care needs of populations. • lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience. • advance understanding of regional and national trends in health and social care needs. • advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes. • inform planning health services and programmes, for example to improve equity of access, experience and outcomes. • inform decisions on how to effectively allocate and evaluate funding according to health needs. • provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from or areas of poorer practice that need to be addressed. • support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work). Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. Harvey Walsh has held a data sharing agreement for over 10 years and has provided services to the NHS (NHS England, the NHS Board, Academic Health Science Network (AHSNs), trusts, Clinical Care Commissioning Groups (CCGs), GP practices) and other healthcare related companies (Pharmaceutical and Device Companies, Patient Groups and Charities) during this time. Harvey Walsh has contracts which run through to 2025 and beyond and would expect to provide data outputs through to this time. [10 paragraphs unchanged] Legitimate Interest Harvey Walsh’s legitimate interest to deliver improved outcomes for patients and benefits to the wider health and social care arena has been fulfilled through the successful management and completion of various projects within the healthcare sector, allowing for earlier diagnosis of certain diseases, uptake of innovation and national policy guidelines, epidemiological research, disease burden analytics in order to provide the real world evidence as required by the NHS. This in turn provides evidential baselines for NHS organisation to assess, recommend and apply improvements to existing treatment pathways. When a project is undertaken, regardless of the disease area, the objectives are always around understanding the current situation, identifying variation and other outcomes. This baseline allows us to understand the impact on the number of patients affected and the potential cost / efficiency savings to the NHS. The implication for individual NHS organisations is dependent on how they implement any recommendations, guidelines or new evidence. What the team seeks to do is to provide the evidence they need to be able to make change should they chose to. The results and outcomes of any analysis will be disseminated in numerous different ways. The team’s objective is also always to have the widest influence they can. The team continue to track progress against baseline as projects evolve and changes are implemented at varying levels of speed. These magnitude of any impact is dependent on the disease area, patient burden and existing pathway. For example, access to an innovative treatment in a rare disease may only impact 10s of patients whereas a programme around closing the gap in undiagnosed atrial fibrillation may impact thousands of patients.

Benefits reported

[1 paragraph unchanged] Cutaneous T-cell lymphoma (CTCL) Myasthenia Gravis https://www.nice.org.uk/guidance/ta754/documents/final-appraisal-determination-document-2 (this was a study that was completed using HES and utilised by National Institute for Health and Care Excellence (NICE) To date there are few studies that highlight the burden Myasthenia Gravis (MG) presents to the National Health Service (NHS). A study undertaken by Harvey Walsh used Hospital Episode Statistics to estimate healthcare resource use and associated costs of patients in England with MG between 30th June 2014 and 30th June 2021. Myasthenic crisis and disease exacerbation in MG were associated with significant healthcare resource utilisation and frequently required inpatient hospitalisation, particularly in the first year after diagnosis. Newly diagnosed MG patients had more inpatient hospitalisations in the first year after diagnosis. Up to 90% received a MG diagnosis during hospitalisation. In addition, around 13% of MG patients need rescue therapy, over and above the first line medications for MG. This evidence is currently supporting MG multi-disciplinary teams and payors to allocate the right resources and investment in MG service delivery. The results of the study were presented at 2022 ISPOR EU and is being submitted for publication in a clinical journal that will highlight the burden of MG on NHS and to provide input data for a cost calculator providing ICS’ and local areas to fully understand the costs of existing versus optimised MG treatment pathways. This study has provided and demonstrated that patient choice is limited and current treatment pathways are often invasive. As payors and MG multi-disciplinary teams conclude their reviews of these current pathways as a result of this study, new, innovative non-invasive pathways will become available, leading to improved patient outcomes and better disease control. With the reduction in healthcare resource use for these patients, it is also anticipated that wait times for treatment will be reduced not only for MG patients, but other patients accessing Neurology services within England. HES was used to quantify the burden of disease for patients with a rare cancer called Cutaneous T-cell lymphoma (CTCL) which is a type of blood cancer which produces symptoms that appear on the skin. There was very little published data on how these patients are managed and treated within the NHS. Harvey Walsh undertook a study in HES analysing in which departments these patients were seen in, how long it took for them to get a diagnosis of CTCL and what the outcomes were for these patients. This analysis was then used to provide evidence to NICE who were evaluating a new treatment for the condition. NICE accepted the analysis of HES data as evidence to support the unmet needs of patients and now patients with CTCL have access to a new treatment option. Healthcare Resource Utilisation and Costs in Hospitalised COVID-19 Patients in England Irritable Bowel Syndrome (IBS) The COVID-19 pandemic has placed significant strain on healthcare resources, particularly in the management of patients who required hospitalisation due to severe disease. Harvey Walsh performed a study using HES data to analyse the resource utilisation and associated costs amongst all patients hospitalised for COVID-19 between January 2020 and May 2022 across 6 pandemic waves/variants. Patients who were admitted for COVID-19 typically had severe symptoms, required intensive treatment (such as respiratory support and ECMO), had poorer outcomes, and incurred greater resource utilisation and costs. High-risk COVID-19 patients represent a substantial cost and resource burden to hospital services across England. The results of the study were presented at 2022 ISPOR EU to provide real-world evidence to contextualise the burden of COVID-19 on NHS and to provide input data for the cost-effectiveness evaluation of a novel treatment targeting high-risk COVID-19 patients. The results of the study have resulted in robust clinical evidence leading to high risk patients being offered preventative treatment to mitigate the risk of patients requiring hospital treatment that included potentially life threatening, invasive treatment. Harvey Walsh are working with an organisation specialising in IBS. There is a new, non-invasive technology that enables accurate diagnosis of IBS, which can also be utilised at home, in the community or in GP surgeries. This new test means that patients do not have to go to hospital for invasive diagnostic tests and instead so a simple test at home, the results of these tests are returned to the GP within 48 hours allowing for accurate treatment and advice to be given to the patient. Previously patients would have to go through the healthcare system for several years before receiving an accurate diagnosis. The team utilised the HES data to analyse the number of patients by CCG who attended for invasive diagnostic testing, quantified the cost, and modelled the numbers of patients who had no further activity and thus provided each CCG with a baseline of potential cost savings. This has resulted in less patients having to undergo invasive diagnostic procedures such as endoscopy or colonoscopy, whilst still not receiving an accurate diagnosis. This has led to improved patient experience, improved patient management and outcomes with patients then being able to undergo treatment far earlier. It will also result in financial savings to the NHS and will reduce the numbers of patients requiring the invasive diagnostic tests. Study on the provision of resective surgery and vagus nerve stimulation to patients with epilepsy Cardiovascular Disease (CV) Health Check programme Approximately one in three patients with epilepsy do not respond well to medications, and still experience seizure. Harvey Walsh performed a study to better understand patient’s access to alternative treatments to medications. We observed a very low rate of resective surgery and vagus nerve stimulation across England, with regional variations. This study is published within a clinical journal that highlights the lack of access to alternative treatments in patients with epilepsy; it is being used to raise awareness amongst clinicians and policy-makers of alternatives available to medications, which the study demonstrates substantially improve patients’ outcomes and wellbeing. These findings of this study are also being presented as a dashboard which is being used as training material for clinicians in regions with poor access to resective surgery and vagus nerve stimulation to help remove barriers for access to suitable treatment in the large population of patients with drug-resistant epilepsy. Harvey Walsh are supporting an Academic Health Science Network (AHSN) and University of Chester by producing data model to evaluate the impact of the a CV health check programme across two localities and review patient groups at high CV risk. This has enabled the localities to offer treatment and advice to patients at risk that could prevent progress to a future CV event. The model is being reviewed constantly and regular updates of HES are used to evaluate the effectiveness on the healthcare system to ensure at risk patients are being provided the correct treatment and that Quality and Outcome Framework (QOF) scores improve across areas that require better outcomes. Arteriovenous Dialysis Access Cardiac Implantations Arteriovenous (AV) access functionality is essential for efficient haemodialysis, and thus it plays a major role in haemodialysis patients life expectancy. Recently, novel concepts of haemodialysis graft have been introduced, that can lead to constant improvement in vascular access performance. Harvey Walsh undertook analysis of the HES data to demonstrate the longitudinal pathways of patients that have an AV fistula created, demonstrating the cost and resource use implications of patients that experience AV fistula failure, resulting in a central venous catheter being inserted and continual attempts to mature the AV fistula. This has been presented to a number of NHS Trusts and NHS Supply Chain, outlining the cost implications of the current pathway and scale of cost savings that can be realised with the alternative novel graft concepts. This has led to new graft availability for patients and NHS providers alike, leading to cost savings and efficiency savings within the treatment pathway. Cardiac implants currently all have different systems to remotely manage the patients. Harvey Walsh worked with an Academic Health Science Network (AHSN) and an organisation that have developed software that enables the trust and teams to have one system that can monitor all patients. Given NHS targets are encouraging more remote follow ups for patients, alongside the looming winter pressures, this project enabled the AHSN and the organisation to present the new software as an enabler of system improvement. The data have been used to analyse current activity at trust level and to identify those trusts that may benefit from full evaluation of the system, thereby leading to a case for change to enable remote management of appropriate patient cohorts. Progress is tracked by regular updates of HES so that non-elective activity can be tracked in organisations who adopt the technology, a reduction in non-elective activity saves the NHS money, reduces the burden on beds and provides better outcomes for patients. Cervical Cancer Surgical Site Infection (SSI) Dashboards Nearly all cervical cancers are caused by an infection from certain types of human papillomavirus (HPV). The optimal screening strategy should identify those cervical cancer precursors likely to progress to invasive cancers (maximizing the benefits of screening) and avoid the detection and unnecessary treatment of transient HPV infection and its associated benign lesions that are not destined to become cancerous (minimizing the potential harms of screening). Harvey Walsh undertook a project that analyses HES data and localised screening rates to demonstrate to regional decision makers the number of potentially unnecessary colposcopies that currently take place. This analyses has resulted in a local pathway and scenario tool that provides local insight into the capacity and cost savings associated with optimal screening and the number of patients that are prevented from having avoidable, invasive procedures unnecessarily. There is a national target of reducing infection, both community and hospital acquired. Harvey Walsh have worked with a wound care company to produce a dashboard that is being used in ongoing engagements with providers and commissioners to review SSI rates in their local area, types of SSI and model the changes in treatment pathways that demonstrate the change in SSI rates and variation over time. This has led to a decrease in preventable surgical site infections in UK hospitals, resulting in fewer patients having preventable infections post-surgery, less hospital follow up and lesser financial consequences for the NHS. Each admission for SSI costs on average £1800, so each time one is prevented there is a direct financial saving to the NHS and one less patient is admitted to hospital. Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) Incidence of veno-occlusive disease/sinusoidal obstruction syndrome after haematopoietic cell transplantation and the associated burden of disease in England: a retrospective analysis of Hospital Episode Statistics© data (2010-2020). This study was undertaken by Harvey Walsh in 2020/21 and presented as a poster and a number of Haematology conferences and scientific congresses. The benefits for patients, health and social care are to highlight the underreporting of this serious condition and provide evidence on the prevalence to NICE and the clinical community. Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a potentially fatal complication that can occur after haematopoietic cell transplantation (HCT) conditioning or chemotherapy with or without HCT. The most severe form of VOD/SOS is associated with multi-organ dysfunction/failure and a mortality rate of >80% if untreated. The evidence generated from this study (by analysing the HES data) has been shared at medical congresses and published in a medical journal, the benefit for health and social care is that it has provided insights on the burden of this disease and how patients benefit from newer more innovative treatments. Patients will benefit because more patients may be treated with innovative treatments and may have improved outcomes. The analysis enabled providers in need of further disease education throughout the disease pathway to ensure that the lessons from poor historical outcomes were learned. Poster presented at the British Society of Haematology (BSH) Virtual Meeting 9–14 November 2020. Head and Neck Cancer In the current standard of care for Head and Neck cancer, patients eligible for curative treatment receive either surgery (with or without postoperative radiotherapy) or definitive radiotherapy (with chemotherapy). Harvey Walsh have worked with an Academic Health Science Network (AHSN) and an organisation to present analysis that for alternative treatment pathways that reduce the need for chemotherapy. The data enabled the organisation to engage with key opinion leaders at national level and at The Royal College of Radiologists. A steering committee has been set up with a high level of interest as the benefits for both the patients and the NHS continue to be evaluated, especially throughout the COVID pandemic. These benefits include: • Radiotherapy department efficiencies, with more accurate Radiotherapy and less chance of misfire • Enablers – more patients are able to be treated effectively • Reduction in need for chemotherapy, thus reducing potentially unnecessary side effects on patients, improving their quality of life and freeing up chemotherapy capacity for other patients

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset; + COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2); + COVID-19 Vaccination Status

Objective for processing

OPEN HEALTH is a business comprising of several legal entities which provide [14 words unchanged] is a legal entity which is part of the OPEN HEALTH group. For further details of these legal entities, please see the following link: https://www.harveywalsh.co.uk/statutory-details Harvey Walsh use pseudonymised, monthly refreshed Hospital Episode Statistics Data comprising of Admitted Patient Care, Outpatients, Critical Care, A&E (ECDS) and Civil Registry Data to undertake analysis, develop services and provide solutions to providers of Healthcare and life sciences services such as: Harvey Walsh Ltd provide services to help public healthcare organisations monitor and improve their services. Processing is designed to benefit patients and society through better healthcare. NHS Digital will release pseudonymised data to Harvey Walsh Limited. All data held are only in pseudonymised form. NHS Digital data disseminated under this agreement will not be linked to any other datasets. Data is only processed by substantive employees of Harvey Walsh Ltd, all of whom have been trained in data protection and confidentiality and whom undergo annual retraining and reassessment in order to keep pace with new legislation. Please note the following: NHS Digital require Harvey Walsh Ltd to maintain an outputs register, this is a list of the organisations who have commissioned the work to be carried out with NHS Digital data, together with confirmation that a data sharing agreement or Contract is in place with each Organisation. The above information needs to be made available to NHS Digital upon request. Harvey Walsh Ltd is part of Open Health, however, this Agreement is solely for Harvey Walsh Ltd only to use the record level data, not the wider Open Health Group. Harvey Walsh Ltd does not provide access to or extracts from the record level dataset to any third party. Any data provided will only be used by Harvey Walsh for the purposes, activities, and outputs defined in this Agreement. Harvey Walsh is the sole data controller who process these data and uses the following pseudonymised data: Hospital Episode Statistics Data (HES) comprising of: - Admitted Patient Care, - Outpatients - Critical Care Other data: - Emergency Care Data Set - Civil Registry Data Additional data sets: - Diagnostic Information Dataset (DIDs) - Hospital prescribing dispensed in the community (NHSBSA) - COVID vaccination - COVID testing - COVID treatments These data sets are used to undertake analysis, undertake research studies, develop services and provide solutions to providers of Healthcare and life sciences services such as: [1 paragraph unchanged] • Integrated Care Services (ICS’s) (ICSs) [2 paragraphs unchanged] • Public Health England [9 paragraphs unchanged] The services and solutions provided include analysis and outputs for the purposes of informing commissioners, healthcare professionals and clinical networks on uptake on innovation national policy guidelines, including NICE, patient pathways, benchmarking and disease burden analytics. The insights and analysis may be on a national level or down to individual practice level. Based on current customer types for Harvey Walsh, the customer split is approximately 70% Life Science/Pharmaceutical/Medical Device companies and 30% NHS, Academic Health Science Networks (AHSNs)/Charities/Patient Groups. Harvey Walsh also has a dedicated NHS Real World Evidence Consultant, whose role is to work directly with the NHS, AHSNs and Patient Groups. Harvey Walsh also utilise the NHS Digital data to provide services to commercial organisations within the pharmaceutical, medical device industry, patient organisations, healthcare charities and AHSNs. These organisations use the outputs and insights provided by Harvey Walsh to work collaboratively with NHS organisations to promote health and improve the well-being of patients. The use of the data supports the development of innovative solutions and service improvement, to track outcomes and provide the real world evidence as required by the NHS, NICE, Monitor and NHS England. The aim of which is to improve patient care and support enhanced access to improved services and innovative solutions. In addition these clients use these outputs for the purposes of providing supporting information required by the NHS for business cases, epidemiological research, pathway analysis, burden of disease analysis, health economic research, predictive analytical modelling, NICE submissions and quality and outcome analysis. The outputs of which are shared directly or indirectly with the NHS to support improvements in patient care. All outputs are aggregated with small numbers suppressed in line with the HES analysis guide and the mental health suppression rules. The services and solutions provided include analysis and outputs for the purposes of informing commissioners, healthcare professionals and clinical networks on uptake on innovation national policy guidelines, including the National Institute for Health and Care Excellence (NICE), patient pathways, benchmarking and disease burden analytics. The insights and analysis may be on a national level or down to individual practice level. These data are also used for epidemiological and disease burden studies which are published and disseminated. Dependent upon the purpose of processing as outlined above the HES data are processed as a legitimate interest under General Data Protection Regulation Article 6 (1) (f). Additionally, this processing is necessary to deliver the purpose of improved outcomes for patients and benefits to the wider health and social care arena and therefore Article 9(2)(j) is also applied. When processing the data, Harvey Walsh determine the methods and purpose of processing, and act as sole Data Controller. A full legitimate interest assessment has been completed and the data are processed under strict conditions to minimise impact and the processing is proportionate to the purpose. The balancing test demonstrates that the risk to the individual is minimised and individuals are made aware of how and why their data are processed and informed that data sent from NHS Digital to Harvey Walsh follows the national opt out policy therefore opt outs will not be applied. Harvey Walsh also utilise the NHS Digital data to provide services to commercial organisations within the pharmaceutical, medical device industry, patient organisations, healthcare charities and Academic Health Science Networks (AHSN's). These organisations use the outputs and insights provided by Harvey Walsh to work collaboratively with NHS organisations to promote health and improve the well-being of patients. The use of the data supports the development of innovative solutions and service improvement, to track outcomes and provide the real world evidence as required by the NHS, NICE, and NHS England and NHS Improvement. The aim of which is to improve patient care and support enhanced access to improved services and innovative solutions. In addition these clients use these outputs for the purposes of providing supporting information required by the NHS for business cases, epidemiological research, pathway analysis, burden of disease analysis, health economic research, predictive analytical modelling, NICE submissions and quality and outcome analysis. The outputs of which are shared directly or indirectly with the NHS to support improvements in patient care. All outputs are aggregated with small numbers suppressed in line with the HES analysis guide and the mental health suppression rules. When processing the data, Harvey Walsh determine the methods and purpose of processing, and are sole Data Controller. The data are processed as a legitimate interest under General Data Protection Regulation Article 6 (1) (f). A full legitimate interest assessment has been completed and the data are processed under strict conditions to minimise impact and the processing is proportionate to the purpose. The balancing test demonstrates that the risk to the individual is minimised and individuals are made aware of how and why their data are processed and informed that data sent from NHS Digital to Harvey Walsh follows the national opt out policy therefore opt outs will not be applied. Additionally, this processing is necessary to deliver the purpose of improved outcomes for patients and benefits to the wider health and social care arena and therefore Article 9(2)(j) is also applied. [1 paragraph unchanged] In addition to this analytical work, Harvey Walsh also provide a tool called AXON 360. AXON 360 incorporates aggregated HES, QOF Quality and Outcomes Framework (QOF) and primary care prescribing data, this tool allows users to analyse healthcare [77 words unchanged] numbers are suppressed, including secondary suppression as per the HES analysis guide. The outputs that utilize the HES data are provided directly to the NHS and AHSNs or will be [27 words unchanged] produced by Harvey Walsh. All of the outputs from the analysis of HES the data are used directly or indirectly for the provision or promotion of health and improved patient care and are not wholly commercial. AXON 360 holds the latest available for the current year and data for the previous 3 years. [1 paragraph unchanged] Justification for requesting additional data sets: The following additional data sets have been requested, the reasons for the additional requests are listed below, for clarity the COVID datasets requested will only be used for COIVD-19 research/activities. COVID-19 Second Generation Surveillance System / Non-hospital Antigen Testing Results (SGSS/Pillar 2), Vaccination and hospital treatment Harvey Walsh has undertaken numerous studies during the COVID pandemic using HES, the team now have studies pending that require analysis of hospital admissions on patients with a confirmed diagnosis of COVID, confirmed by testing (SGSS/Pillar 2), the treatment they received whilst in hospital to see if there is a difference in the effectiveness of treatments and also to see if the vaccine prevented serious disease. - The studies that are pending on the receipt of COVID-19 data, (the team also have other studies that are currently in the development stage and more will follow). 1. Healthcare resource us in patients hospitalised with confirmed COVID-19 (2 studies, one looking at variation across Geography and the other looking at variation across the COVID waves) 2. Risk of hospitalisation with COVID-19 based on vaccination status 3. The comparison of healthcare resource use in vaccinated and unvaccinated patients during the COVID-19 pandemic 4. Risk of admission compared to NHS Risk Group vaccination status in 2021 5. Impact of COVID-19 on cancer presentation, diagnosis and staging DIDs Harvey Walsh undertakes a significant amount of work in Oncology related areas using HES and a number of existing and pending studies require the linkage of diagnostic data sets e.g. lung biopsy for lung cancer, prostate sampling for prostate cancer (Prostate Cancer UK). NHSBSA Harvey Walsh undertakes a significant amount of pathway and outcomes work, there is a need to understand better, patients who may receive their hospital treatments in the community or at home and NHSBSA will allow analysis of hospital prescription dispensed in the community. This analysis may enable better understanding of the variation and effectiveness of medicines. This may in turn enable further review and ongoing monitoring of these patterns and proposed changes.

Processing activities

Data Sharing Framework Contract and “Personnel”: 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). [1 paragraph unchanged] NHS Digital data disseminated under this agreement will not be linked to any other datasets. [1 paragraph unchanged] The main processing location is the Harvey Walsh facility in Cheshire, UK, and UK Fast Server Centre UK, both of these facilities are covered by ISO27001 and DSP. DSPT. [1 paragraph unchanged] On a monthly basis, NHS Digital upload the requested pseudonymised data sets to Harvey Walsh via Secure Electronic File Transfer (SEFT). The raw flat data files are downloaded from the SEFT server onto [24 words unchanged] HRGs and all records are imported into two different databases within a SQL Structured Query Language (SQL) Server environment - A verification process takes place on row count and then additional processing is undertaken applying the NHS cost algorithms and readmission calculations, the data is then ready to be made available for further use. then ready to be made available for further use. [2 paragraphs unchanged] Analysts processing data utilise secure VPN Virtual Private Network (VPN) to access a virtual machine within the Cheshire facility. No raw data is stored off site. All analysts are substantive employees of Harvey Walsh and no data is downloaded and stored outside of the approved locations. [1 paragraph unchanged] The AXON 360 system is processed as follows, the data are aggregated [13 words unchanged] and then this is further aggregated to an organisation and code level (ICD10, OPCS, HRG) (ICD10 (International Classification of Diseases 10th Revision), OPCS (Classification of Interventions and Procedures), HRG (Healthcare Resource Group) when being rolled up into an OLAP cube. An OLAP Cube is a data structure that allows fast analysis of data and the term cube refers to a multi-dimensional dataset, . AXON 360 does not display individual episode or spell level data, the [38 words unchanged] another layer of security between the data and the AXON application layer. [2 paragraphs unchanged] Data will be downloaded from the NHSD NHS Digital SEFT secure file server (by a named approved individual) and placed on [11 words unchanged] The data is then processed and loaded into the Live Cube Server. [8 paragraphs unchanged] 2. All Harvey Walsh staff are instructed not to download any record level Data to local PCs, laptops or any non-encrypted device, and this is enforced by our their Data Security policy (note (note, only approved staff will have physical access, this instruction is an additional [12 words unchanged] server, which is the only location on which it can be analysed). [3 paragraphs unchanged] 6. The AXON 360 hosting infrastructure is penetration tested by an external independent vendor in line with the Harvey Walsh Information Security Management Systems. The latest penetration tests were carried out in January 2017 and penetration testing is booked for October 2021. 2022. [2 paragraphs unchanged]

Expected output

Harvey Walsh undertake numerous projects utilizing HES on a yearly basis, approximately 170 distinct projects were completed in 2020/2021. The outputs produced as a result of the data processing may include (but are not limited to) the following: Harvey Walsh have undertaken numerous projects and studies utilizing HES and approximately 170 distinct projects were completed in 2021. Harvey Walsh plan to continue this level of work with HES but in addition plan to undertake additional projects and studies using the new data sets including DIDs, COVID, EPMA & NHSBSA as explained in section 5a. The outputs produced as a result of the data processing may include (but are not limited to) the following: [13 paragraphs unchanged] the The level of data contained in the outputs is derived and aggregated with small number suppression suppression. The Diagnostic Information Dataset (DIDS) is vital as it will allow accurate analysis of what type of diagnostic tests were done and importantly on what date so that accurate representation on time from 1st appointment to diagnosis and treatment can be determined. The COVID related data sets will be used in current and future studies to understand and describe events, such as the risk of being admitted to hospital with COVID, the impact of Long COVID, how new treatments such as the anti-virals are improving patient outcomes. How the different COVID waves are affecting and will continue to affect how patients are medically treated. [3 paragraphs unchanged] Harvey Walsh are collaborating with DATA-CAN Public and Patient Engagement Group and have had workshops and meetings with them and are working with them to ensure that patients views are incorporated into their work. In addition, through Harvey Walsh's work in Rare Diseases the team are liaising with a number of patient groups, through their Director of Rare Diseases, to help them understand where their work should be focused to provide the best benefits in terms of new evidence to support patients with these diseases. Harvey Walsh are also working with Prostate Cancer UK on two studies on the impact of COVID in the diagnosis and staging of prostate cancer. [1 paragraph unchanged] Results and outputs are communicated via reports, stakeholder engagement, conferences, publications, face to face with healthcare professionals and decision makers, websites, posters, dashboards and reports reports. [2 paragraphs unchanged] The medicines data is not deemed disclosive and information on a GP level is available in the public domain. However, should the published information pose a risk of re-identification, the following suppression methodology should be applied: · Zeros should be shown. · 1-7 to be rounded to 5. · Any other numbers rounded to nearest 5. · Rounding unnecessary for averages etc. · Percentages calculated from rounded values. · If zeros need to be suppressed, round to 5.

Expected measurable benefits

[1 paragraph unchanged] Harvey Walsh has held a data sharing agreement for over 10 years and has provided services to the NHS (NHS England, the NHS Board, AHSNs, trusts, CCGs, Clinical Care Commissioning Groups (CCGs), GP practices) and other healthcare related companies (Pharmaceutical and Device Companies, Patient [10 words unchanged] which run through to 2023 and beyond and would expect to provide HES data outputs through to this time. The solutions and projects that Harvey Walsh undertake have utilized utilised cohort data from 2011 to date, and have been used for numerous [17 words unchanged] direct and indirect to the patient and health and social care environment. Below are examples of recent publications with direct benefits to patients and the NHS: High burden of hospital resource utilization in patients with hidradenitis suppurativa in England: a retrospective cohort study using hospital episode statistics https://pubmed.ncbi.nlm.nih.gov/27534703/ Incidence of veno-occlusive disease/sinusoidal obstruction syndrome after haematopoietic cell transplantation and the associated burden of disease in England: a retrospective analysis of Hospital Episode Statistics data https://dialog.proquest.com/professional/docview/2533042741?accountid=164245 [8 paragraphs unchanged] This is a retrospective observational cohort study based on secondary use of [145 words unchanged] occurrence of unplanned hospital admissions, and healthcare resource use and associated costs. Our The findings intend to inform guidelines and support the continuous management of patients with advanced melanoma during, and through the recovery from, the pandemic. [2 paragraphs unchanged] When a project is undertaken, regardless of the disease area, the objectives are always around understanding the current situation, identifying variation and other outcomes. This baseline allows us to understand the impact on the number of patients affected and the potential cost / efficiency savings to the NHS. The implication for individual NHS organisations is dependent on how they implement any recommendations, guidelines or new evidence. What the team seeks to do is to provide the evidence they need to be able to make change should they chose to. The results and outcomes of any analysis will be disseminated in numerous different ways. The team’s objective is also always to have the widest influence they can. The team continue to track progress against baseline as projects evolve and changes are implemented at varying levels of speed. These magnitude of any impact is dependent on the disease area, patient burden and existing pathway. For example, access to an innovative treatment in a rare disease may only impact 10s of patients whereas a programme around closing the gap in undiagnosed atrial fibrillation may impact thousands of patients.

Benefits reported

Analysis of treatment patterns and outcomes for patients with therapy-related acute myeloid leukaemia (T-AML) and acute myeloid leukaemia with myelodysplasia-related changes (AML-MRC) using HES data Below are a list of examples for some of the projects that Harvey Walsh have undertaken with their customers. A comparison of treatment patterns and outcomes among patients with t-AML, AML-MRC, and de novo AML in recent years in England is lacking in the published literature. Cutaneous T-cell lymphoma (CTCL) A retrospective study was performed utilising the Hospital Episodes Statistics (HES) database to describe the historical treatment patterns in England (2011–2016) and analyse long-term outcomes for these patients. This analysis had a large sample size with nationwide coverage of data from England via the HES database and results could be linked to long-term OS data. https://www.nice.org.uk/guidance/ta754/documents/final-appraisal-determination-document-2 (this was a study that was completed using HES and utilised by National Institute for Health and Care Excellence (NICE) This large, retrospective analysis using the HES database confirmed the poor historical outcomes for patients diagnosed with t-AML and AML-MRC in England and more effective agents are needed to address this unmet need. HES was used to quantify the burden of disease for patients with a rare cancer called Cutaneous T-cell lymphoma (CTCL) which is a type of blood cancer which produces symptoms that appear on the skin. There was very little published data on how these patients are managed and treated within the NHS. Harvey Walsh undertook a study in HES analysing in which departments these patients were seen in, how long it took for them to get a diagnosis of CTCL and what the outcomes were for these patients. This analysis was then used to provide evidence to NICE who were evaluating a new treatment for the condition. NICE accepted the analysis of HES data as evidence to support the unmet needs of patients and now patients with CTCL have access to a new treatment option. The analysis enabled providers in need of further disease education throughout the disease pathway to ensure that the lessons from poor historical outcomes were learned. Irritable Bowel Syndrome (IBS) Poster presented at the British Society of Haematology (BSH) Virtual Meeting 9–14 November 2020. Harvey Walsh are working with an organisation specialising in IBS. There is a new, non-invasive technology that enables accurate diagnosis of IBS, which can also be utilised at home, in the community or in GP surgeries. This new test means that patients do not have to go to hospital for invasive diagnostic tests and instead so a simple test at home, the results of these tests are returned to the GP within 48 hours allowing for accurate treatment and advice to be given to the patient. Previously patients would have to go through the healthcare system for several years before receiving an accurate diagnosis. The team utilised the HES data to analyse the number of patients by CCG who attended for invasive diagnostic testing, quantified the cost, and modelled the numbers of patients who had no further activity and thus provided each CCG with a baseline of potential cost savings. This has resulted in less patients having to undergo invasive diagnostic procedures such as endoscopy or colonoscopy, whilst still not receiving an accurate diagnosis. This has led to improved patient experience, improved patient management and outcomes with patients then being able to undergo treatment far earlier. It will also result in financial savings to the NHS and will reduce the numbers of patients requiring the invasive diagnostic tests. Cardiovascular Disease (CV) Health Check programme Harvey Walsh are supporting an Academic Health Science Network (AHSN) and University of Chester by producing data model to evaluate the impact of the a CV health check programme across two localities and review patient groups at high CV risk. This has enabled the localities to offer treatment and advice to patients at risk that could prevent progress to a future CV event. The model is being reviewed constantly and regular updates of HES are used to evaluate the effectiveness on the healthcare system to ensure at risk patients are being provided the correct treatment and that Quality and Outcome Framework (QOF) scores improve across areas that require better outcomes. [1 paragraph unchanged] Cardiac implants currently all have different systems to remotely manage the patients. [96 words unchanged] a case for change to enable remote management of appropriate patient cohorts. Progress is tracked by regular updates of HES so that non-elective activity can be tracked in organisations who adopt the technology, a reduction in non-elective activity saves the NHS money, reduces the burden on beds and provides better outcomes for patients. Surgical Site Infection (SSI) Dashboards There is a national target of reducing infection, both community and hospital acquired. Harvey Walsh have worked with a wound care company to produce a dashboard that is being used in ongoing engagements with providers and commissioners to review SSI rates in their local area, types of SSI and model the changes in treatment pathways that demonstrate the change in SSI rates and variation over time. This has led to a decrease in preventable surgical site infections in UK hospitals, resulting in fewer patients having preventable infections post-surgery, less hospital follow up and lesser financial consequences for the NHS. Each admission for SSI costs on average £1800, so each time one is prevented there is a direct financial saving to the NHS and one less patient is admitted to hospital. Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) Incidence of veno-occlusive disease/sinusoidal obstruction syndrome after haematopoietic cell transplantation and the associated burden of disease in England: a retrospective analysis of Hospital Episode Statistics© data (2010-2020). This study was undertaken by Harvey Walsh in 2020/21 and presented as a poster and a number of Haematology conferences and scientific congresses. The benefits for patients, health and social care are to highlight the underreporting of this serious condition and provide evidence on the prevalence to NICE and the clinical community. Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a potentially fatal complication that can occur after haematopoietic cell transplantation (HCT) conditioning or chemotherapy with or without HCT. The most severe form of VOD/SOS is associated with multi-organ dysfunction/failure and a mortality rate of >80% if untreated. The evidence generated from this study (by analysing the HES data) has been shared at medical congresses and published in a medical journal, the benefit for health and social care is that it has provided insights on the burden of this disease and how patients benefit from newer more innovative treatments. Patients will benefit because more patients may be treated with innovative treatments and may have improved outcomes. The analysis enabled providers in need of further disease education throughout the disease pathway to ensure that the lessons from poor historical outcomes were learned. Poster presented at the British Society of Haematology (BSH) Virtual Meeting 9–14 November 2020. [5 paragraphs unchanged] Cardiovascular Disease (CV) Health Check programme Harvey Walsh are supporting an Academic Health Science Network (AHSN) and University of Chester by producing data model to evaluate the impact of the a CV health check programme across two localities and review patient groups at high CV risk. This has enabled the localities to offer treatment and advice to patients at risk that could prevent progress to a future CV event. The model is being reviewed constantly to ensure at risk patients are being provided the correct treatment and that Quality and Outcome Framework (QOF) scores improve across areas that require better outcomes. Irritable Bowel Syndrome (IBS) Harvey Walsh are working with an organisation specialising in IBS. There is a new, non-invasive technology that enables accurate diagnosis of IBS, which can also be utilised at home, in the community or in GP surgeries. Results can be acquired within 48 hours allowing for accurate treatment and advice. Previously patients would have to go through the healthcare system for several years before receiving an accurate diagnosis This has resulted in less patients having to undergo invasive diagnostic procedures such as endoscopy or colonoscopy, whilst still not receiving an accurate diagnosis. This has led to improved patient experience, improved patient management and outcomes with patients then being able to undergo treatment far earlier.. Surgical Site Infection (SSI) Dashboards There is a national target of reducing infection, both community and hospital acquired. Harvey Walsh have worked with a wound care company to produce a dashboard that is being used in ongoing engagements with providers and commissioners to review SSI rates in there area, types of SSI and model the changes in treatment pathways that demonstrate the change in SSI rates and variation over time. This has led to a decrease in preventable surgical site infections in UK hospitals, resulting in fewer patients having preventable infections post-surgery, less hospital follow up and lesser financial consequences for the NHS. Stable Angina Dashboard Stable Angina (SA) is a chronic medical condition. The aim of management is to abolish or minimise symptoms, and to improve quality of life and long-term outcomes such as morbidity and mortality. Between March 2019 and February 2020, there were over 124,000 inpatient admissions with a primary diagnosis of Stable Angina and over 50,000 of these were unplanned admissions the unplanned care alone cost the NHS over £188.5 million. Harvey Walsh have developed a Stable Angina dashboard that is being used with both NHS Trusts and commissioners to demonstrate the co-morbidities, flow of patients and additional healthcare resource use that has resulted in a further review of the Stable Angina pathway. These reviews have led to further exploration of SA patients that are having falls or hospitalised for ulcerations due to the varying treatment pathways, with further objectives over the next 2 years to ensure that these unnecessary side effects or treatment are further stabilised and managed.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + COVID-19 SGSS First Positives (Second Generation Surveillance System); + Diagnostic Imaging Data Set (DID); + Electronic Prescribing and Medicines Administration (EPMA) data in Secondary Care for COVID-19; + Medicines dispensed in Primary Care (NHSBSA data) · − HES-ID to MPS-ID HES Accident and Emergency; − HES-ID to MPS-ID HES Admitted Patient Care; − HES-ID to MPS-ID HES Outpatients; − Hospital Episode Statistics Accident and Emergency (HES A and E)

Objective for processing

[3 paragraphs unchanged] • Commissioning Support Units (CSU’s) • Integrated Care Services (ICS’s) [5 paragraphs unchanged] • Clinical teams • Health and Wellbeing Boards [9 paragraphs unchanged] Dependent upon the purpose of processing as outlined above the HES data are processed as a legitimate interest under General Data Protection Regulation Article 6 (1) (f) and Article 9(2)(j). This (f). Additionally, this processing is necessary to deliver the purpose of improved outcomes for patients and benefits to the wider health and social care arena. arena and therefore Article 9(2)(j) is also applied. When processing the data, Harvey Walsh determine the methods and purpose of [71 words unchanged] the national opt out policy therefore opt outs will not be applied. [1 paragraph unchanged] In addition to this analytical work, Harvey Walsh also provide a tool called AXON 360. AXON 360 is an online tool that is hosted within the Harvey Walsh offices in a secure server room from a dedicated network. On approval of this Data Sharing Agreement, the tool will be moved and hosted by UK Fast, however, only Harvey Walsh employees will have access. AXON 360 incorporates aggregated HES, QOF and primary care prescribing data, this [83 words unchanged] numbers are suppressed, including secondary suppression as per the HES analysis guide. [2 paragraphs unchanged]

Processing activities

[2 paragraphs unchanged] Hosting and backup : Currently all data supplied to Harvey Walsh are stored and backed up at the Harvey Walsh facilities in Cheshire, UK. The data are stored in a secure on-site server centre which is fully managed by Harvey Walsh with no third party processing, back up or storage. If approved Harvey Walsh will be changing the processing activities (see documentation provided) and the data supplied will come to the Harvey Walsh facility in Cheshire, where the will be stored but in addition the data will be transferred to UK fast servers for processing and storage. [2 paragraphs unchanged] Current Processing on receipt of data: The raw flat data files are downloaded from the SEFT server onto a drive on a secure dedicated in house hosted server within Harvey Walsh offices in Cheshire, UK Fast, Manchester, England. The data are then processed with costing algorithms applying tariffs to [29 words unchanged] undertaken applying the NHS cost algorithms and readmission calculations, the data is then ready to be made available for further use. The data are then split, for bespoke analysis by the SQL Analyst team and for the AXON 360 system. For bespoke analysis, the data are made available on the internal network via role-based, windows authenticated logins to the SQL Server data warehouse. then ready to be made available for further use. Analysts processing data from the Harvey Walsh satellite office utilise secure VPN to access a virtual machine within the Cheshire facility. No raw data is stored off site. All analysts are substantive employees of Harvey Walsh and no data can be downloaded and stored outside of the approved locations. The data are then split, for bespoke analysis by the SQL Analyst team and for the AXON 360 system. For bespoke analysis, the data are made available on the internal network via role-based, windows authenticated logins to the SQL Server data warehouse. Analysts processing data utilise secure VPN to access a virtual machine within the Cheshire facility. No raw data is stored off site. All analysts are substantive employees of Harvey Walsh and no is downloaded and stored outside of the approved locations. [2 paragraphs unchanged] The data viewable in an AXON 360 report is pre-processed, aggregated and small number suppressed e.g. any number that requires suppression is suppressed. suppressed in line with the HES Analysis Guide. AXON 360 is on a separate dedicated server on its own segregated network. This means that there is no access via AXON to the raw underlying HES data that is stored on a separate dedicated server within the Harvey Walsh facility. data. Proposed Processing on receipt of data : Data Flow / Process Overview: Data Flow / Process Overview Data will be downloaded from the NHSD SEFT secure file server (by a named approved individual) and placed on a secure network drive within the UK Fast facility Manchester, UK. The data is then processed and loaded into the Live Cube Server. • Data will be downloaded from the NHSD SEFT secure file server (by a named approved individual) and placed on a secure network drive within the Harvey Walsh facility in Cheshire, UK. The raw data files are then encrypted and loaded over an encrypted connection to a secure data location in the Cheshire facility. • This data will then be loaded over an encrypted connection to the secure data solution hosted with UK Fast. Data is then processed within this solution into the required derived format and loaded into the Live Cube Server. The AXON 360 webserver will then be able to query the derived cube data. • The AXON 360 webserver will then be able to query the derived cube data. [3 paragraphs unchanged] Any and all outputs of any kind visible to 3rd parties e.g. [7 words unchanged] will always be in an aggregate, non-identifiable form and with small numbers double-suppressed suppressed in line with the HES analysis guide [6 paragraphs unchanged] 6. The AXON 360 hosting infrastructure is penetration tested by an external [8 words unchanged] Information Security Management Systems. The latest tests were carried out in January 2017. 2017 and penetration testing is booked for October 2021. [1 paragraph unchanged] The machines of employees who have access to the record level data are physically secure within a locked office and has have at least 256-bit encryption and password protection. The employees who access record [31 words unchanged] staff are fully trained on GDPR and undergo regular data security training. Outputs: No record level data is provided to any third party organisation in any format. The only allowable outputs are aggregated derived data with small numbers suppressed as described and in line with the HES Analysis Guide. All outputs are suppressed and also have secondary suppression applied. Mental Health data follows the Mental Health suppression rule as detailed below. Data linkage or re-identification of HES: All personnel are aware that the linkage or attempted re-identification of HES data is prohibited Processing for reports/studies/analysis: All projects which are for reports/studies or analysis are project managed through a system called JIRA which is managed by the compliance and workflow managers. Each request is processed through a DPIA before allocation for a data analyst to undertake the work. Datasets and period – Non NHS Organisations: The data period and dataset are determined in the project request and specification. Each output states the data set and the time period for analysis and outputs are recorded in the data output register and managed under the Data Period Standard Operating Procedure. Small number suppression rules: All outputs are aggregated, derived data with small numbers suppressed as described and in line with the HES Analysis Guide, mental health data follows the Mental Health suppression rule (see below). All outputs are suppressed and also have secondary suppression applied. Prior to presentation to customers all outputs produced are checked by a Manager to ensure compliance to the HES Analysis user guide (i.e. aggregated data with small numbers suppressed) and all outputs have the stated purposes included and since 2015 have been recorded on a data output register. Processing for dynamic presentation to 3rd parties (online tool) AXON 360 Datasets and periods for the Axon tool: AXON 360 contains 3 full years of data and the monthly refresh data of the current year. The oldest year of data are deleted once the current year is complete. Level of data included within Axon: There is no record level data viewable within AXON 360 it does not display individual episode or spell level data, the data are aggregated to an organisation or code level. The processed data are held within a cube. The cube aggregates data at a diagnosis or organisation level and all small numbers are suppressed and secondary suppressed as per the HES analysis guide within AXON 360. The data viewable in an AXON 360 report is pre-processed, aggregated and suppressed. AXON 360 is on a separate dedicated server on its own segregated network. This means that there is no access to the raw underlying HES data that is stored on a separate dedicated server within the Harvey Walsh facility or UK Fast. When derived aggregated data are displayed in AXON 360 small numbers between 1 and 5 are displayed as 5*, secondary suppression is also applied to prevent identification of the small number. Access to AXON 360: AXON 360 is a web based platform which is hosted from a dedicated server at the Harvey Walsh facility in Cheshire and UK Fast. Access to AXON 360 is strictly controlled any user is individually vetted and registered by the Harvey Walsh support desk and users receive a password and username. Usage is monitored and inactive accounts are disabled and deleted. User statistics are monitored under ISO27001. Condition on users of the tool: All users accept terms of use on log in which states that AXON 360 must only be used for the approved purposes as agreed in the DSA. General Conditions of processing and outputs: No record level data is provided to any third party organisation in any format. The only output will be aggregated data with small numbers suppressed as described and in line with the HES Analysis Guide and Mental Health suppression rule. The data are not used to target sales individuals towards specific healthcare professionals and the data are not used within sales collateral used by sales/marketing teams this includes sales brochures, emails, direct mailing or advertising of pharmaceutical products. No record level data are transferred, stored or processed outside of the Harvey Walsh facility in Cheshire or the UK Fast Server Centre in Manchester, UK. The data already supplied and the data to be disseminated as described in this agreement will be used solely for the purposes outlined within this agreement. A data destruction certificate is required for data previously supplied that is not covered within this agreement. 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).

Expected output

Harvey Walsh undertake numerous projects utilizing HES on a yearly basis, approximately 150 170 distinct projects were completed in 2019/20. 2020/2021. The outputs produced as a result of the data processing may include (but are not limited to) the following: [13 paragraphs unchanged] n. the level of data contained in the outputs is derived and aggregated with small number suppression [7 paragraphs unchanged]

Expected measurable benefits

Harvey Walsh has held a data sharing agreement for over 10 years and has provided services to the NHS (NHS England, the NHS Board, AHSNs, trusts, CCGs, GP practices) and other healthcare related companies (Pharmaceutical and Device Companies, Patient Groups and Charities) during this time. Harvey Walsh have contracts which run through to 2022 and beyond and would expect to provide HES outputs through to this time. Expected Measurable Benefits: The solutions and projects that Harvey Walsh undertake have utilized cohort data from 2009 to date, and have been used for numerous different projects. The benefits that are provided from the analysis and insights of the HES data are direct and indirect to the patient and health and social care environment. Harvey Walsh has held a data sharing agreement for over 10 years and has provided services to the NHS (NHS England, the NHS Board, AHSNs, trusts, CCGs, GP practices) and other healthcare related companies (Pharmaceutical and Device Companies, Patient Groups and Charities) during this time. Harvey Walsh has contracts which run through to 2023 and beyond and would expect to provide HES outputs through to this time. Below are examples of publications with direct benefits to patients and the NHS: The solutions and projects that Harvey Walsh undertake have utilized cohort data from 2011 to date, and have been used for numerous different projects. The benefits that are provided from the analysis and insights of the HES data are direct and indirect to the patient and health and social care environment. 1: Analysis of HES to demonstrate the secondary care treatment pathways and outcomes for patients with cutaneous t-cell lymphoma in England 2020 Below are examples of recent publications with direct benefits to patients and the NHS: 2: A Cohort Study Comparing Clinical Outcomes and Healthcare Resource Utilisation In Patients Undergoing Surgery For Osteomyelitis In England: A Case For Reorganising Orthopaedic Infection Services 2020 High burden of hospital resource utilization in patients with hidradenitis suppurativa in England: a retrospective cohort study using hospital episode statistics 3: Radical Cystectomy (Open, Laparoscopic and Robotic) in 12,625 patients in England: National trends, Peri-operative outcomes and Cost analysis from Hospital Episode Statistics data https://pubmed.ncbi.nlm.nih.gov/27534703/ Below are example of other outputs which have direct benefits to patients and the NHS Incidence of veno-occlusive disease/sinusoidal obstruction syndrome after haematopoietic cell transplantation and the associated burden of disease in England: a retrospective analysis of Hospital Episode Statistics data 1: Variation and access to specialist epilepsy services in England. https://dialog.proquest.com/professional/docview/2533042741?accountid=164245 This project is a collaboration between a device company, patient group, academic unit and healthcare professionals. Longitudinal HES data and mortality data has been analysed to determine outcomes for patients from different geographical areas and their referral and management at specialist tertiary centres. This project has now been running for 5 years and it has encompassed HES analysis, study publication, dashboard development, healthcare resource use and modelling. Below are examples of other outputs which have direct benefits to patients and the NHS The objective of these projects is to drive awareness of unmet need in the severe epilepsy patient cohort, reduce inequalities, improve survival and reduce time to specialist interventions. COVID-19 Impact Reports 2: COVID-19 Impact Reports These reports are provided to demonstrate the impact of COVID-19 on disease cohorts and treatment such as heart surgery. The aim of these reports is to support NHS organisations in capacity planning around elective surgery and interventions and for them to model the impact on delayed activity and outcomes. These reports are provided to demonstrate the impact of COVID-19 on other disease cohorts and treatments. The aim of these reports is to support NHS organisations in capacity planning around elective surgery and treatments and for them to model the impact on delayed activity and outcomes. Healthcare Resource Utilisation (HCRU) and Associated Costs in Patients with COVID-19 in England: A Retrospective Cohort Study 3: Multiple Sclerosis Resource Utilisation Toolkit The strain on healthcare resources brought forth by the recent COVID-19 pandemic has highlighted the need for efficient patient management and resource planning and allocation to support healthcare services and to improve patient care. Several co-morbid conditions have been shown to increase the risk of COVID-19, as well as the risk of severe cases. The aim of this retrospective observational study is to estimate the HCRU and associated costs in the management of high-risk patients with COVID-19 in England and to evaluate all primary and secondary objectives within subgroups of patients including by age group, co-morbidity and death status, and vaccination status This toolkit was developed for use with healthcare professionals and commissioners, the objective is to provide a quantification in terms of hospitalisations for patients with MS, demonstrating the burden of non-elective activity and infusion capacity. The aim was to support hospitals in reviewing their service provision and management of MS so that patients develop less infections thus requiring less admissions to hospital. Prostate cancer diagnosis and treatment changes during the COVID pandemic . This is a retrospective observational study of a cohort of patients diagnosed with prostate cancer using existing electronic secondary healthcare records to determine whether the men diagnosed with prostate cancer during the COVID pandemic differ from those diagnosed immediately before this time in terms of characteristics (are there missing men) or treatment. The study objectives are to understand the differences in prostate cancer pre- and during the COVID pandemic in terms of the number and characteristics of men diagnosed and treatment patterns. Diagnosis, Treatment Patterns and Clinical Outcomes in Patients With Cutaneous Melanoma Before And After The Onset Of The COVID-19 Pandemic In England: A Retrospective Cohort Study Using Hospital Episode Statistics This is a retrospective observational cohort study based on secondary use of hospital electronic medical records in England. it is of public health interest to better understand whether disruption to the National Health Service (NHS) due to the COVID-19 pandemic generated a delay in diagnosis of melanoma at early stages, reflecting lack of referral and access to diagnostic testing and treatment, and hence an increase in advanced melanoma diagnoses; and whether the impact on diagnosis differed according to age (and other characteristics). Specifically, in patients with advanced melanoma, there is a need to better understand how widespread the adaptation in treatment pathways adopted by NHS Trusts was and whether it affected patients’ clinical outcomes. The aims of this real-world study are to evaluate the impact of the COVID-19 pandemic on (i) the distribution of stages of melanoma at diagnosis, and specifically in patients with advanced melanoma; (ii) treatment pathways, clinical outcomes (including disease progression and mortality), the occurrence of unplanned hospital admissions, and healthcare resource use and associated costs. Our findings intend to inform guidelines and support the continuous management of patients with advanced melanoma during, and through the recovery from, the pandemic. Legitimate Interest Harvey Walsh’s legitimate interest to deliver improved outcomes for patients and benefits to the wider health and social care arena has been fulfilled through the successful management and completion of various projects within the healthcare sector, allowing for earlier diagnosis of certain diseases, uptake of innovation and national policy guidelines, epidemiological research, disease burden analytics in order to provide the real world evidence as required by the NHS. This in turn provides evidential baselines for NHS organisation to assess, recommend and apply improvements to existing treatment pathways.

Benefits reported

Harvey Walsh has delivered numerous projects in 2019/20, below are examples showing how HES data has been used with both the NHS and commercial clients to benefit patients and Health and Social Care: Analysis of treatment patterns and outcomes for patients with therapy-related acute myeloid leukaemia (T-AML) and acute myeloid leukaemia with myelodysplasia-related changes (AML-MRC) using HES data NHS England & Imperial College Health Partners A comparison of treatment patterns and outcomes among patients with t-AML, AML-MRC, and de novo AML in recent years in England is lacking in the published literature. Suspicion of Sepsis Interactive data dashboard to support clinicians in recognising the suspected symptoms of Sepsis and the risk rate per hospital/provider/CCG Improved awareness resulting in faster diagnosis and treatment. A retrospective study was performed utilising the Hospital Episodes Statistics (HES) database to describe the historical treatment patterns in England (2011–2016) and analyse long-term outcomes for these patients. This analysis had a large sample size with nationwide coverage of data from England via the HES database and results could be linked to long-term OS data. B Braun Orthopaedic This large, retrospective analysis using the HES database confirmed the poor historical outcomes for patients diagnosed with t-AML and AML-MRC in England and more effective agents are needed to address this unmet need. Pathways Analysis Capacity and outcomes model for use with Healthcare Professionals to benchmark and highlight variation in care, time to treatment and outcomes in hip, knee and spine surgery. Reduction in variation of outcomes and financial savings to the NHS. The analysis enabled providers in need of further disease education throughout the disease pathway to ensure that the lessons from poor historical outcomes were learned. LivaNova Healthcare Poster presented at the British Society of Haematology (BSH) Virtual Meeting 9–14 November 2020. Utilisation pre and post treatment with innovative device for Epilepsy Management Numerous outputs, including publication, model and interactive dashboard. The dashboard was developed in 2018 and shows the variation in referral for specialist Epilepsy Management in England Improved referral for patients with Epilepsy and outcome evaluation to demonstrate savings for both patients and the NHS. Cardiac Implantations RNIB 5 Year Review of Ophthalmology Services in England Cardiac implants currently all have different systems to remotely manage the patients. Harvey Walsh worked with an Academic Health Science Network (AHSN) and an organisation that have developed software that enables the trust and teams to have one system that can monitor all patients. Given NHS targets are encouraging more remote follow ups for patients, alongside the looming winter pressures, this project enabled the AHSN and the organisation to present the new software as an enabler of system improvement. The data have been used to analyse current activity at trust level and to identify those trusts that may benefit from full evaluation of the system, thereby leading to a case for change to enable remote management of appropriate patient cohorts. A review of services in Ophthalmology across disease type in England, comparing outcomes between CCGs and Providers published as a report. Driving service equity to improve access to treatment and speed of referral for patients. Head and Neck Cancer Pfizer Pathway analysis on Renal Cancer across England In the current standard of care for Head and Neck cancer, patients eligible for curative treatment receive either surgery (with or without postoperative radiotherapy) or definitive radiotherapy (with chemotherapy). Harvey Walsh have worked with an Academic Health Science Network (AHSN) and an organisation to present analysis that for alternative treatment pathways that reduce the need for chemotherapy. The data enabled the organisation to engage with key opinion leaders at national level and at The Royal College of Radiologists. A steering committee has been set up with a high level of interest as the benefits for both the patients and the NHS continue to be evaluated, especially throughout the COVID pandemic. These benefits include: An interactive narrative dashboard for use with NHS Commissioners and Healthcare Professionals. The objective of which is to provide insights for local services and to provide support for service evaluation and improvement Improved referral to specialist centres and increased time to treatment. • Radiotherapy department efficiencies, with more accurate Radiotherapy and less chance of misfire • Enablers – more patients are able to be treated effectively • Reduction in need for chemotherapy, thus reducing potentially unnecessary side effects on patients, improving their quality of life and freeing up chemotherapy capacity for other patients Cardiovascular Disease (CV) Health Check programme Harvey Walsh are supporting an Academic Health Science Network (AHSN) and University of Chester by producing data model to evaluate the impact of the a CV health check programme across two localities and review patient groups at high CV risk. This has enabled the localities to offer treatment and advice to patients at risk that could prevent progress to a future CV event. The model is being reviewed constantly to ensure at risk patients are being provided the correct treatment and that Quality and Outcome Framework (QOF) scores improve across areas that require better outcomes. Irritable Bowel Syndrome (IBS) Harvey Walsh are working with an organisation specialising in IBS. There is a new, non-invasive technology that enables accurate diagnosis of IBS, which can also be utilised at home, in the community or in GP surgeries. Results can be acquired within 48 hours allowing for accurate treatment and advice. Previously patients would have to go through the healthcare system for several years before receiving an accurate diagnosis This has resulted in less patients having to undergo invasive diagnostic procedures such as endoscopy or colonoscopy, whilst still not receiving an accurate diagnosis. This has led to improved patient experience, improved patient management and outcomes with patients then being able to undergo treatment far earlier.. Surgical Site Infection (SSI) Dashboards There is a national target of reducing infection, both community and hospital acquired. Harvey Walsh have worked with a wound care company to produce a dashboard that is being used in ongoing engagements with providers and commissioners to review SSI rates in there area, types of SSI and model the changes in treatment pathways that demonstrate the change in SSI rates and variation over time. This has led to a decrease in preventable surgical site infections in UK hospitals, resulting in fewer patients having preventable infections post-surgery, less hospital follow up and lesser financial consequences for the NHS. Stable Angina Dashboard Stable Angina (SA) is a chronic medical condition. The aim of management is to abolish or minimise symptoms, and to improve quality of life and long-term outcomes such as morbidity and mortality. Between March 2019 and February 2020, there were over 124,000 inpatient admissions with a primary diagnosis of Stable Angina and over 50,000 of these were unplanned admissions the unplanned care alone cost the NHS over £188.5 million. Harvey Walsh have developed a Stable Angina dashboard that is being used with both NHS Trusts and commissioners to demonstrate the co-morbidities, flow of patients and additional healthcare resource use that has resulted in a further review of the Stable Angina pathway. These reviews have led to further exploration of SA patients that are having falls or hospitalised for ulcerations due to the varying treatment pathways, with further objectives over the next 2 years to ensure that these unnecessary side effects or treatment are further stabilised and managed.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Emergency Care Data Set (ECDS); + HES-ID to MPS-ID HES Accident and Emergency; + HES-ID to MPS-ID HES Admitted Patient Care; + HES-ID to MPS-ID HES Outpatients · − Mental Health Services Data Set (MHSDS)

Objective for processing

Harvey Walsh Ltd (Harvey Walsh) is an IT solutions, NHS Data and Health Informatics Consultancy which provides services to the NHS, Academic Health Science Networks (AHSNs) Pharmaceutical and Device Industry, Patient Groups and Healthcare Charities and other NHS organisations. OPEN HEALTH is a business comprising of several legal entities which provide health economic and outcomes research, information, technology and services to healthcare. Harvey Walsh Limited is a legal entity which is part of the OPEN HEALTH group. Harvey Walsh uses pseudonymised, monthly refreshed Hospital Episode Statistic (HES) data to undertake analysis, develop services and provide solutions to support commissioning, analytical support and outcomes analysis for NHS organisations, which include NHS England, the NHS Board, GP Practices, GP Federations, CCGs, Regional Teams, Academic Health Science Networks, Health and Well-Being Boards, Provider Trusts, Ambulance Trusts, CSUs and Sustainability and Transformation Partnerships (STPs) and Accountable Care Organisations (ACOs). Integrated Care Systems (ACS), Primary Care Networks and Digital Innovation Hubs. The services and solutions provided include analysis and outputs for the purposes of informing commissioners, healthcare professionals and clinical networks on uptake on innovation national policy guidelines, including NICE, patient pathways, benchmarking and disease burden analytics. The insights and analysis may be on a national level or down to individual practice level. Harvey Walsh use pseudonymised, monthly refreshed Hospital Episode Statistics Data comprising of Admitted Patient Care, Outpatients, Critical Care, A&E (ECDS) and Civil Registry Data to undertake analysis, develop services and provide solutions to providers of Healthcare and life sciences services such as: In addition to HES data being used to carry out this processing, Harvey Walsh also utilise data in civil registration mortality data, Summary Hospital Mortality Indicators (SHMI) and Mental Health (MHSDS) for these same purposes. • Clinical Commissioning Groups (CCGs) • Commissioning Support Units (CSU’s) • Hospital Trusts • NHS England • Public Health England • Sustainability and Transformation Partnerships (STPs) • NHS Trusts • Clinical teams • Health and Wellbeing Boards • Universities • Life science industry • Pharmaceutical companies • Medical Device companies • Academic Heath Science Networks (AHSNs) • Patient Groups and Charities • Other NHS organisations The services and solutions provided include analysis and outputs for the purposes of informing commissioners, healthcare professionals and clinical networks on uptake on innovation national policy guidelines, including NICE, patient pathways, benchmarking and disease burden analytics. The insights and analysis may be on a national level or down to individual practice level. [1 paragraph unchanged] Dependent upon the purpose of processing as outlined above the HES data [124 words unchanged] the national opt out policy therefore opt outs will not be applied. For clarity, Harvey Walsh is the sole Data Controller for the data from NHS Digital and therefore all other organisations under the OPEN Health Group hold no influence over the data, nor are they data processors on behalf of Harvey Walsh. Harvey Walsh are a separate legal, geographical and financial entity to Open Health (the parent). For clarity, Harvey Walsh is the sole Data Controller for the data from NHS Digital and therefore all other organisations under the OPEN Health Group hold no influence over the data, nor are they data processors on behalf of Harvey Walsh. Harvey Walsh are a separate legal, geographical and financial entity to Open Health (the parent). [3 paragraphs unchanged] The data available via civil registration mortality data, Summary Hospital Mortality Indicators (SHMI) and Mental Health (MHSDS) is used to support existing work and also to develop new analysis. These additional datasets will not be available in the Axon tool. The existing projects that require mortality data include collaborative projects with NHS bodies including ICHP (Suspicion of Sepsis Programme, ten year temporal trends and outcomes in AF, and The Right Care AF Toolkit) In addition there are a number of existing projects which require the mortality data for determining overall survival in Renal Cell Cancer, Breast Cancer, MDS, Sickle Cell Disease, Liver Cancer. The MHSDS data set is being requested to support a pan London Programme with Imperial College Health Partners (ICHP) The linked HES MHSDS will be used to analyse historic trends for patient across primary, acute and community care services for patients under the Mental Health Act 1983. On behalf of Mental Health Transformation for London, Harvey Walsh will be undertaking the analysis to allow ICHP to perform an evaluation which answers the following questions: • What are the drivers/ predictors / influencers /factors that underpin current bed based activity? • How many MH acute beds will be required to meet future demand? • How much of this demand could be met by community services and what would be the downstream effects of configuring MH services this way? • and provide a regional overview of the issues driving bed based care It will be used as part of a service capacity assessment and improvement programme to ensure that they have an appropriate number of beds as well as sufficient resources in their crisis resolution and home treatment teams to meet the need for rapid access to high quality care’. As part of the Five Year Forward View requirement for all out of area placements to be eliminated by 2021. The MHSDS is also used for analysis on the burden of mental illness and to support service redesign. The request for additional data sources namely Mortality Data and SHMI are required to undertake existing projects in a variety of disease areas which include longitudinal analysis of oncology pathways to determine variation, outcomes and access to treatment between providers. Mortality data will be used to supplement existing projects in AF/Stroke where survival rates and cause of death are required to show outcomes of NHS Policy. SHMI will assist in benchmarking organisations with regards outcomes and allow accurate reflection of outcomes.

Processing activities

[59 paragraphs unchanged] Mental Health suppression rules: For data from the Mental Health (MHSDS, MHLDDS, MHMDS) data sets, and any Mental Health data linked to HES or SUS, the following disclosure control rules must be applied: • National-level figures only may be presented unrounded, without small number suppression • Suppress all numbers between 0 and 5 • Round all other numbers to the nearest 5 • Percentages can be calculated based on unrounded values, but need to be rounded to the nearest integer in any outputs • In addition for Learning Disability data in Mental Health (MHSDS, MHLDDS, MHMDS), the England-level data also must apply the suppression of all numbers between 0 and 5, and rounding of other numbers to the nearest 5. [1 paragraph unchanged]

Expected output

Harvey Walsh undertake numerous projects utilizing HES on a yearly basis, approximately 120 150 distinct projects were completed in 2017/18. 2019/20. The outputs produced as a result of the data processing may include (but are not limited to) the following: [20 paragraphs unchanged] Harvey Walsh have a number of rolling contracts and expect to produce these outputs up until at least 2024 2025 and have a produced a large number of historic outputs which are recorded in the data output register.

Expected measurable benefits

Harvey Walsh has held a data sharing agreement for over 8 10 years and has provided services to the NHS (NHS England, the NHS [18 words unchanged] Charities) during this time. Harvey Walsh have contracts which run through to 2019 2022 and beyond and would expect to provide HES outputs through to this time. The solutions and projects that Harvey Walsh undertake have utilized cohort data from 2006 2009 to date, and have been used for numerous different projects. The benefits that are provided from the analysis and insights of the HES data are direct and indirect to the patient and health and social care environment. The benefits that are provided from the analysis and insights of the HES data are direct and indirect to the patient and health and social care environment. Below are examples of publications with direct benefits to patients and the NHS: The provision of the additional data sets e.g. Mortality/Mental Health will provide additional benefits in the following ways. 1: Analysis of HES to demonstrate the secondary care treatment pathways and outcomes for patients with cutaneous t-cell lymphoma in England 2020 Mortality data will allow for enhanced analysis and outcomes evaluation meaning that variation which results in more deaths may be prevented. Understanding death rates and causes will strengthen the types of analysis that can be undertaken and make the outputs more robust and statistically significant. 2: A Cohort Study Comparing Clinical Outcomes and Healthcare Resource Utilisation In Patients Undergoing Surgery For Osteomyelitis In England: A Case For Reorganising Orthopaedic Infection Services 2020 The mental health data sets will allow for enhanced pathway analysis across population based health and for the burden of mental illness to be quantified and potential pathway improvements or interventions to be identified thus improving outcomes for patients and health and social care. 3: Radical Cystectomy (Open, Laparoscopic and Robotic) in 12,625 patients in England: National trends, Peri-operative outcomes and Cost analysis from Hospital Episode Statistics data Below are examples example of other outputs which have direct benefits to patients and the NHS: NHS 1: NHS England issued Clinical Commissioning Policy: 1: Variation and access to specialist epilepsy services in England. Vagal Nerve Stimulation for Epilepsy April 2013 Reference: NHSCB/D04/P/d. This project is a collaboration between a device company, patient group, academic unit and healthcare professionals. Longitudinal HES data and mortality data has been analysed to determine outcomes for patients from different geographical areas and their referral and management at specialist tertiary centres. This project has now been running for 5 years and it has encompassed HES analysis, study publication, dashboard development, healthcare resource use and modelling. Vagal Nerve Stimulation is used in refractory and drug resistant Epilepsy. Working with a device company and in collaboration with a Neurology Clinical Guidelines group analysis using HES has been undertaken to determine the: The objective of these projects is to drive awareness of unmet need in the severe epilepsy patient cohort, reduce inequalities, improve survival and reduce time to specialist interventions. • Burden of Epilepsy and Variance across England demonstrating the patient pathways into specialist care 2: COVID-19 Impact Reports • Modelled the capacity and potential requirements of surgical units so that patients who are suitable for treatment gain earlier access to treatment These reports are provided to demonstrate the impact of COVID-19 on other disease cohorts and treatments. The aim of these reports is to support NHS organisations in capacity planning around elective surgery and treatments and for them to model the impact on delayed activity and outcomes. A health economic evaluation was undertaken on the healthcare utilisation pre and post implant to provide evidence to commissioners and NHS England on the benefits for patients as unplanned activity reduces as does cost to the NHS. 3: Multiple Sclerosis Resource Utilisation Toolkit This evaluation has been published Burke T, Hughes D, Forsey J, Bunker M, Bhattacharya D, Smithson WH, A Study of the Impact of VNS on Health Care Utilisation in England, SEIZURE: European Journal of Epilepsy (2015), http://dx.doi.org/10.1016/j.seizure.2015.11.002 This toolkit was developed for use with healthcare professionals and commissioners, the objective is to provide a quantification in terms of hospitalisations for patients with MS, demonstrating the burden of non-elective activity and infusion capacity. The aim was to support hospitals in reviewing their service provision and management of MS so that patients develop less infections thus requiring less admissions to hospital. 2: Idiopathic Pulmonary Fibrosis Pathway Analysis: . This project was undertaken with a commercial client for use in collaborative working with the NHS. Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized by a progressive decline in lung function. The term pulmonary fibrosis means scarring of lung tissue and is the cause of worsening dyspnoea (shortness of breath). Fibrosis is usually associated with a poor prognosis. In its earlier stages IPF mimics many routine chest conditions and requires specialist diagnostics to make a definitive diagnosis. Once diagnosed it is managed under specialist commissioning arrangements at key specialist centres such as the Royal Brompton. It is quite possible for a patient to have many hospital admissions to local Hospital Trusts then specialist Chest Units before receiving a final diagnosis and referral to the appropriate Tertiary Specialist Centres. This makes determining a patient pathway difficult and the planning and commissioning of IPF services complicated. Tertiary referral trusts and their clinicians face challenges in planning and optimising capacity of IPF services due to the paucity of service data for this rare condition and the wide geographical distribution of patients. The IPF Pathway Analysis and Dashboard output supports the NHS to identify the current resource management of patients who may be identified as Idiopathic Pulmonary Fibrosis (IPF) patients in England. The dashboard provides a comprehensive Health Episode Statistic (HES) patient pathway and outcomes analysis from 2009 – 2014 across different co-morbidities and organisations. The data is displayed as reports and bespoke dashboards in order to support the NHS to plan for future patient and resource management requirements, for patients who may have IPF. In addition, by determining IPF records in 2014 to go back through the HES record for those patients to the first admission for a chest related condition and calculate two factors: • The Time from first Chest Condition Admission to diagnosis of IPF • To determine any patterns of Chest Conditions admissions that could be used as a marker for patients at risk of developing IPF to speed referral to the appropriate Tertiary Referral Specialist Trust for definitive diagnostics with aim of diagnosing and treating IPF earlier. The numbers of patients in England has been static around 5250 for the last 5 years accounting for approximately 7000 spells per year and costing on average £15m per year. For the first time it has been possible to say that the average time from first presentation with a chest condition to diagnosis with IPF is between 400 and 600 days. The top 5 chest conditions that account for the majority of hospital admissions prior to a diagnosis with IPF are: 1. Lobar Pneumonia Unspecified 2. Chronic Obstructive pulmonary disease with acute lower respiratory infection 3. Abnormal findings on diagnostic imaging of lung 4. Pneumonia unspecified 5. Interstitial Pulmonary disease unspecified Which presents an opportunity for the NHS to work to identify the types of patients with this pattern of admissions for definitive IPF diagnostics so reducing the time from presentation to diagnosis and treatment. Therefore directly improving outcomes for patients and reducing costs for the NHS. 3: Analysis of TURPS Patient Pathways for England: This work was undertaken with a commercial client to support NICE submission and to provide data to NHS England on innovative surgical techniques. Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH). During TURP, a combined visual and surgical instrument (resectoscope) is inserted through the tip of the penis and into the (urethra). The urethra is surrounded by the prostate. Using the resectoscope, excess prostate tissue is removed that's blocking urine flow and increases the size urethra that allows the patient to empty their bladder. Current surgical approaches like TURP can leave permanent side effects such as urinary incontinence and erectile dysfunction. The aim of this project was to understand how many Patients had BPH, the number of TURPs undertaken for BPH and the complications associated with those TURPs and the long term impact of those complications on patient hospital admissions. This would indicate the real costs and patient impact of TURP as a baseline against which alternative less invasive procedures might be evaluated. A longitudinal analysis was performed on the HES Data Set for England and all records with a recorded diagnosis of BPH in 2013 who had within the same year undergone TURP. Harvey Walsh then identified subsequent admissions over the following year for the complications associated with TURP for those patients with a diagnosis of BPH also having a TURP in 2013. This data was presented nationally, and by CCG and hospital trust. Summary Post-operative complications add approximately 23% to the actual costs of performing TURP procedures and have a significant impact on patients’ lives. It is clear that clinically patients who undergo TURP and subsequently are admitted for a TURP complication will have that recorded in their notes. However, as the admissions for complication do not generally coincide with the spell during which the procedure is performed it may be very difficult for commissioners to see the impact in terms on subsequent hospitals admissions LOS and costs for patient undergoing TURP without investing scarce time and resource for data analysis for a procedure that is routine for this condition. Further as expected the peak in complication numbers & costs occurs in the year following procedure. However, in the 5 years following surgery many of the complications persist in reoccurring spells. TURP remains the standard procedure to relieve moderate to severe urinary symptoms caused by an enlarged prostate. In reviewing alternative procedures to TURP those that are less invasive but preclude the complications from TURP could have an impact on service cost and efficiency but potentially patient outcome not just in year but in the longer term. It was on the basis of this data analysis that the client was able to secure a meeting with the Office of Life Sciences to discuss complications of TURP as part of their remit to look for opportunities for innovation in patient care. This has now spread to NICE and there are on-going meetings to discuss the management pathways for these patients providing a direct benefit to patients by offering innovative procedures with less chance of complications whilst saving money for the NHS. 4. Renal Cancer Commissioning Insights Dashboard. (Commissioned by Pfizer) A quarterly refreshed insights tool that provides aggregated metrics to Providers and CCGs on: • Numbers of patients/growth/decline • Time to referral • Pathway of treatment • Healthcare utilisation • Variation and comparison The Pathways for Renal Cancer vary across the country. The objective of this project was to provide information and insights on current referral and management pathways for Renal Cancer to Commissioners and Clinicians. So that gaps in service provision and variation in care can be addressed by the development of local education and pathway support. This programme brings benefits to patients as it addresses service variation and supports improvement in quicker referral times to specialist centres for treatment and interventions 5. IBS Insights Tool (Commissioned by Allergan) A monthly refreshed dashboard that provides aggregated metrics to CCGs and Clinicians on the IBS Pathways showing: • Rates of scopes • Variation • Burden of IBS • Capacity mapping Irritable Bowel Syndrome (IBS) is often misdiagnosed and patients have unnecessary scopes which result in high costs for CCGs and capacity issues for Providers. The objective of this project was to show the current referral and management pathways for IBS to CCGs and provide the data and insights for service reviews and the development of local protocols to support appropriate referrals and reduce the numbers of referrals and thus reduce costs. This programme provides benefits to patients by reducing physical diagnostic scopes which are often not required and benefits to providers as capacity can be reduced and CCGs save money on scopes. 6. Atrial Fibrillation Insights Tool (Joint working Greater Manchester AHSN and Diatchi Sankyo) A monthly refreshed model with aggregated data (HES, QOF, Prescribing and GRASP) which maps the local impact and variation of AF across Greater Manchester Atrial Fibrillation is a ACS and QOF condition which is actively managed by GPs and CCGs. However significant numbers of patients still enter hospital as unplanned emergency admissions each month. The aim of this programme was to provide an in-depth analysis of AF across Greater Manchester, highlighting variance in care, uptake of NICE Guidance. Areas where performance and outcomes where not as good as expected were supported by educational and transformational programmes via the AHSN. This programme provides benefits to patients by improving how they are treated and aims to reduce admissions to hospital. This in turn benefits CCGs and Providers by reducing costs and unplanned admissions. 7. Saving Sight Campaign (commissioned by RNIB) Analysis of variation of Cataract Procedures across England by CCG to determine time to treatment. Originally commissioned in 2013, Harvey Walsh undertook a deep dive analysis on Cataract services in England to develop a publication Surgery Deferred Sight Denied Report 2013. This report showed significant variation in access to first and second eye surgery. This resulted in a number of interventions and educational support by the RNIB. In 2016 Harvey Walsh were asked by the RNIB to undertake a refreshed analysis based on the 2013 study. This analysis shows increases in treatment and a decrease in the variation of care with over 100,000 additional procedures taking place since the initial study. This programme has produced improvements in time to treatment and the treatment of second eye blindness resulting in benefits for patients and the wider healthcare arena. 8. Impact of Vaccination on the rates of Pneumococcal Disease in England since 2006 (Commissioned by Pfizer) Analysis of HES data to produce aggregated national analysis on the rates of Pneumococcal Disease over 10 years The complications of Pneumonia can lead to devastating outcomes such as death, meningitis and sepsis. The objective of this analysis was to determine whether vaccines have had an impact on these complications and the outputs will be used to provide evidence to NICE and other NHS bodies to support their decisions on future vaccine programmes. This work has provided benefits to patients by providing outputs to support further vaccine programmes which will result in less people developing the consequence of Pneumonia Infections. 9. AF/Stroke High Impact Intervention Programme with Imperial College Health Partners and NHS England This programme involves the development of a opportunity model to assist NHS Organisations is mapping the burden of AF/Stroke and their outcomes including mortality with the aim of reducing the overall death rate.

Benefits reported

Harvey Walsh has delivered numerous projects in 2017/18, 2019/20, below are 5 examples showing how HES data has been used with both the NHS and commercial clients to benefit patients and Health and Social Care: [10 paragraphs unchanged]

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.