Cegedim Rx Ltd 2022

Cegedim Rx Ltd requires access to HES, ECDS and mortality data to maintain a secondary healthcare large scale data resource which will be used to provide services and insights to healthcare authorities at a local, regional, and national level. enable research providing insight in important disease areas, with national coverage over patient population, to understand the patient healthcare clinical experience.

Cegedim Rx Ltd will use the data resource to provide services to clients. The services provided are limited to undertaking research on behalf of the client and validating research outcomes produced by third parties.

Cegedim Rx Ltd may also use the data resource to undertake research without a client involvement.

The types of studies that will be conducted using the HES, ECDS and mortality data will take the form of disease epidemiology, risk prediction, medication safety, healthcare utilisation and health economics. The aforementioned activities will form parts of commercial activities undertaken for academia, life science researchers, pharmaceutical companies and governmental organisations.

All purposes for which the data are used are reviewed by a group of independent researchers and analysts with extensive experience in the areas of primary and secondary care data for research. The data will not be used for any purpose without a favourable recommendation from the Cegedim Scientific Review Committee.

Only substantive employees of Cegedim Rx Ltd will have access to the NHS Digital Data. Clients will only receive an analysis based on HES, ECDS and Mortality data, not the actual HES, ECDS and Mortality data itself.

Cegedim Rx Ltd will provide services to clients from the following industries:

- Academia,

- Independent researchers/epidemiologists,

- Pharmaceutical companies,

- Management consulting companies,

-Public health bodies,

- Medical Charities.

Cegedim Rx Ltd will not provide services to insurance companies and will not provide services for solely commercial purposes.

All uses of the data shall be with the aim of benefiting patient and public health. The ability to perform this data processing will enable outputs to key decision makers in healthcare to understand patient outcomes/treatments and pathways taking into consideration the entire patient journey through the healthcare system and to understand if there are any differences in care based on patient locality and geography in the UK health and care system. Benefits to patients will include a range of research projects that aim to understand more about disease risks and causes, improved diagnosis, developing new treatments, preventing diseases, planning NHS services and improved patient safety. The impact of the result of the outputs will range from national level, when informing public health policy and clinical patient management, to local communities when the evidence will serve to optimise the delivery of care at ICS provider level.

Cegedim Rx Ltd is part of the Cegedim Group of Companies. The Cegedim group of companies include: Cegedim Rx Ltd, The Health Improvement Network Ltd, In Practice Systems Ltd, Bluebay medical systems Ltd. The activities if the group companies are described below:

Cegedim Rx Ltd is a limited company incorporated in 1993, which is owned by a holding company (ALLIADIS EUROPE LTD) which in turn is owned and directed by Cegedim SA (France). Cegedim Rx Ltd has an ISO accreditation issued in its name that spans all the shared services across the Cegedim SA (France) Businesses in the UK

The Health Improvement Network (THIN) Ltd is a limited company directly owned by Cegedim SA (France), with a separate legal entity within the Cegedim Group with its own data environment.

IN PRACTICE SYSTEMS (INPS) Ltd is a limited company incorporated in 1984, owned by Cegedim SA (France). The trading name of INPS is VISION, which provides healthcare IT services to GP practices, shared-care services for different healthcare providers, population health information services, online patient services, and community support services.

Bluebay Medical Systems has been absorbed by INPS Ltd. This was purchased by the holding company (ALLIADIS Europe Ltd) and then the business, employees, assets and liabilities were transferred to INPS Ltd at the start of 2019.

For the purpose of gaining access to NHS Digital data, the only entity of concern with respect to this application is Cegedim Rx Ltd. At no point will NHS Digital data supplied under this data sharing agreement be shared with IN PRACTICE SYSTEMS (INPS) Ltd, Bluebay Medical Systems, Cegedim SA (France) or The Health Improvement Network (THIN) Ltd in any form other than aggregated with small number suppression applied as per the HES Analysis Guide

NHS Digital Data:

The specific datasets requested in relation to this application are:

- Civil Registration (deaths) - Secondary Care Cut linked to:

- Emergency Care Dataset (ECDS)

- HES A&E

- HES Admitted patient Care

- HES Critical Care

- HES Outpatients

Cegedim Rx Ltd requires access to record-level pseudonymised data from the above datasets. The data will be pseudonymised using a HES specific pseudo-identifier provided by NHS Digital.

DATA MINIMISATION:

Data Minimisation will be applied by only requesting the fields which are required to do the minimum level of analysis at an individual patient record level with the data set request limited to the last 6 complete years only.

Cegedim Rx Ltd require quarterly renewal for all data sets to the end of the current agreement. This is because Cegedim Rx Ltd expect the analysis of disease areas of interest to be impacted by changes in clinical coding guidelines and clinical best practices over the requested period of time. To enrich the understanding of the effect of such changes in epidemiological and ecological studies, Cegedim Rx Ltd anticipate to perform pre-change and post-change separate analyses and also to implement models with inclusion of time interaction effects.

Cegedim Rx Ltd have made every effort to ensure that data requested is adequate, relevant but at the same time limited to what is essentially required, in terms of data sets (e.g. Admitted Patient Care, etc.) and period of time included, taking into consideration the changes in clinical coding and clinical best practice over the period of interest. Cegedim Rx Ltd have also included only the required level of data in terms of spells and episodes, ensuring that no identifiable or sensitive fields have been selected. Finally, the linkages requested are only those required to fulfil our work (i.e. with Mortality data only).

Outputs will be aggregated and not presented at a patient record level. All analysis will be conducted as per the HES analysis guide.

Hospital admissions, outpatients care, Critical Care, A&E and mortality are fundamental data sets to achieve the objectives of this work. To achieve this aim while ensuring that the data set is accurate, relevant and limited to what is necessary for any particular project or research, Cegedim Rx Ltd will ensure that no single variable can be directly related to a group of less than 6 patients, including diagnosis code (e.g. rare diseases) and year of birth.

The data should underpin epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring, performed by academic bodies, government and regulatory agencies, and industry. The linked HES, ECDS and Mortality data resource will be used in a standardised manner, fully complaint to the ethical, regulatory and data protection current legal frameworks, thus enabling trustworthy, standard-based, quality assured and scale-able approach to research.

The secondary healthcare large scale data resource will enable research providing insight in important disease areas, with national coverage over patient population, that is fundamental for the understanding of the patient healthcare clinical experience. This type of research will underpin decision-making in the continual improvement of clinical management of patients and service delivery at national and local levels. The geographical coverage of the data set will also provide the actionable evidence required to drive equity in the provision of care and optimise the utilisation of resources. This resource will offer new opportunities to ascertain the strength of previous evidence, providing a test bed for validation of public health, epidemiological and clinical research. It will also aim to measure and improve the quality of the research data stock in the United Kingdom. This processing will be used to perform epidemiological, clinical and health economics research, supporting improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring, using statistical, epidemiological and computational methods.

Examples of how the aggregated and suppressed data will be useful for analysis include scenarios such as:

- A view of the referring organisation for a patient and which speciality/organisation they have been referred into and then aggregated up to ICS

- Practices treat patients like X have an outcome of X, and practice treat patient like Y have outcome Y analysis may provide instances where care sits outside of NICE guidelines or in relation to Quality Outcome Framework (QOF) performance

Further examples of specific projects that Cegedim Rx Ltd have previously been requested to perform by the above permitted clients include:

1. Venous Thromboembolism (VTE) and Surgeries: to describe the clinical journey of patients of patients experiencing VTE after surgeries (low and high risk), comparing standard with fast-track surgery designs with a view to gather evidence to inform patient recommendations and best clinical practice.

2. Natural History of Parkinson’s Disease: to study the incidence, morbidity, mortality and clinical journey of Parkinson’s Disease patients in secondary care to inform clinical decision making around adjuvant therapy and enrich understanding of patterns of utilisation of therapies.

3. Acute Respiratory Distress Syndrome: to study the incidence, morbidity, mortality associated with patient that experience Acute Respiratory Syndrome, including a descriptive analysis of the disease trajectory leading up to the event and patterns of care.

Cegedim Rx Ltd also want to be able to add secondary care analysis as part of its services. Cegedim Rx Ltd's researcher base are moving more into secondary care analysis, Cegedim Rx Ltd having access to the above stated level of HES data will enable them to provide assistance to these organisations.

HES, ECDS and Mortality data from NHS Digital will be used to conduct such analysis for various regions. This also provides potential to identify areas of unwarranted variation of care e.g. length of time to diagnosis and referral to secondary care.

Patients with rare diseases and in general any patient with very specific clinical circumstances would be excluded from any analysis to reduce the risks of re-identification. All outputs will be conducted as per the HES Analysis Guide.

Processing of the data requested under this agreement will be conducted under the legal basis set out by the UK General Data Protection Regulation (UK GDPR). 'Processing is necessary for the purposes of the legitimate interests pursued by the controller...' [Article 6(1)(f)]. The NHS Digital data sought will be used to support epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring that are complementary to the work performed and products supplied by Cegedim Health Data. The pseudonymised NHS Digital data will be processed internally by Cegedim Rx Ltd for the purpose of producing aggregated tabulations/analysis with small number suppressed as per the HES analysis guide for specific projects for members form the aforementioned industry sectors.

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)

In 2021, Cegedim Rx Ltd refined the data structure in its data warehouse to ensure the data is easily usable, hence the following proposed outputs are expected to be released in 2022/early 2023.

The output will consist of secondary care data studies looking at understanding actual clinical pathways aimed at supporting epidemiological, treatment and clinical research. The outputs will be in the form of reports, submissions to peer reviewed journals, presentations, papers for conferences, tabulations, and analysis. All outputs will conform to the current NHD Digital HES Analysis guide rules.

Cegedim Rx Ltd Dissemination and Communication Strategy will prioritize key disease areas based on their clinical importance and service delivery demand. They are Cardiovascular Disease, Neurodegenerative diseases, Cancer, Upper and Lower Respiratory Diseases, Diabetes, Kidney Disease and other diseases of the Urinary system, COVID-19. For each area Cegedim Rx Ltd will perform a study extracting data-driven clinical pathways based on well-established methodologies, identifying clinical phenotypes at each pathway stage.

By the end of 2022/early 2023 Cegedim Rx Ltd will create the first technical report of the project for all priority disease areas and produce a dynamic infographic (tabulations) publicly available directed to relevant stakeholders. By the end of the third year, they will produce the data-driven clinical phenotypes for at each stage of the clinical pathways and produce the corresponding technical report. The dynamic infographics (tabulations) will be updated to display such clinical phenotypes and disseminated to key stakeholders. The outputs of each stage on the development will be published in relevant international conference first (years one and two), and then evolved into scientific publications during the second and third year.

All the above-mentioned outputs will be made available to those interested at ICB (Integrated Care Board) level.

Frequently Cegedim Rx Ltd is approached regarding studies that are designed to provide a more complete picture of the patient healthcare journey for the purpose of identifying opportunities and intervention points for improving patient outcomes. However, there is a pervading misunderstanding of how different UK datasets fit together and how they can be used to provide an overall picture. Whilst occasionally this linkage is critical for the deep insights that can be gained, it is not always the case that primary care data needs to be joined with data from HES. Cegedim Rx Ltd wishes to support a greater understanding within the community of how different data sources can be used appropriately together and to offer a much-needed perspective for when a single data source is sufficient to provide the requested answer. The importance of doing so is to help minimize access to data sets to the minimum needed, but clarity about when this is needed, and when it is not still needs to be developed.

To support this, Cegedim Rx Ltd plans to develop a white paper that focuses in on a single disease area that will help to demonstrate the landscape of data sets. Cegedim Rx Ltd propose to focus on lung cancer patients and demonstrate how information from both the THIN database (Primary care Dataset) and from HES contribute to understanding disease and patient journeys. Importantly Cegedim Rx Ltd shall set out to debunk some commonly held misconceptions about what data types are held and in doing so aid the research community into constructing more appropriately framed studies.

Cegedim Rx Ltd look to run a set of independent analyses from HES and from THIN to develop an approachable features table that can provide a visual aid for understanding the novelty and overlap, of each of the different data source within Cegedim Rx Ltd, including but not limited to:

1. High level counts and coverage (e.g., demographics, characteristics, such as age, gender, ethnicities of lung cancer patients in 1) THIN AND 2) HES.

2. Insights derived from the Free text from primary care, including referral and specialist notes: high level statistics of capture for adjuvant therapy, adverse events, mutational status, TMN cancer staging, duration of treatment?

3. Capture the high-level methodologies necessary for appropriate analysis to be included for each of the key results sections, e.g., THIN analysis, free-text, HES.

4. Conclusions and Perspectives – provide insights to clients for understanding the epidemiology of diseases and possible aetiology and how it can be applied for use in clinical trial design.

Additionally, Cegedim Rx Ltd consider that the proposed work will showcase how such questions can be tackled to offer a greater understanding of patients in oncology treatment from primary care records, and that can complement information typically derived from structured clinical trials. Cegedim Rx Ltd expect will be helpful to focus questions to be more specific and will provide the clarity needed for improving clinical trial design and support.

The aim of the Dissemination and Communication Strategy is to reach the relevant stakeholder groups effectively and efficiently in the use of the research outputs, namely, public health agencies, academic community, patients and the public at large, industry, government decision makers, non-profit organizations and strategic partners. For each stakeholder group, an issue or problem-oriented mission approach will be implemented, making the communication relevant to the stakeholder group. Once the target audience and issue are identified, a series of targeted vehicles of communication and dissemination will be implemented, appropriate for the target audience, such as short-films, peer reviewed publication, conference posters, presentations, press releases, seminars, and demonstration events. Following the Cegedim Rx Ltd dissemination and communication plan, there will be a quarterly delivery of dissemination and communication artefacts targeting different stakeholder groups.

Finally, researchers will agree by contractual agreement to publish the result of their research in open access publications and deposit code list of implementing their results in public repositories, in order to foster transparency and reproduce-ability of research (applicable to permitted clients where research and discovery are the main aims of their function).

Cegedim were unable to produce any yielded benefits to date because the data was received in May 2021 and the team then needed to manipulate the data formats to ensure they were able to be queried in an efficient manor within our data environments, ensuring they were in a research ready format.

Cegedim Rx Ltd requires access to HES, ECDS and mortality data to maintain a secondary healthcare large scale data resource which will be used to provide services and insights to healthcare authorities at a local, regional, and national level. enable research providing insight in important disease areas, with national coverage over patient population, to understand the patient healthcare clinical experience.

Cegedim Rx Ltd will use the data resource to provide services to clients. The services provided are limited to undertaking research on behalf of the client and validating research outcomes produced by third parties.

Cegedim Rx Ltd may also use the data resource to undertake research without a client involvement.

The types of studies that will be conducted using the HES, ECDS and mortality data will take the form of disease epidemiology, risk prediction, medication safety, healthcare utilisation and health economics. The aforementioned activities will form parts of commercial activities undertaken for academia, life science researchers, pharmaceutical companies and governmental organisations.

All purposes for which the data are used are reviewed by a group of independent researchers and analysts with extensive experience in the areas of primary and secondary care data for research. The data will not be used for any purpose without a favourable recommendation from the Cegedim Scientific Review Committee.

Only substantive employees of Cegedim Rx Ltd will have access to the NHS Digital Data. Clients will only receive an analysis based on HES, ECDS and Mortality data, not the actual HES, ECDS and Mortality data itself.

Cegedim Rx Ltd will provide services to clients from the following industries:

- Academia,

- Independent researchers/epidemiologists,

- Pharmaceutical companies,

- Management consulting companies,

-Public health bodies,

- Medical Charities.

Cegedim Rx Ltd will not provide services to insurance companies and will not provide services for solely commercial purposes.

All uses of the data shall be with the aim of benefiting patient and public health. The ability to perform this data processing will enable outputs to key decision makers in healthcare to understand patient outcomes/treatments and pathways taking into consideration the entire patient journey through the healthcare system and to understand if there are any differences in care based on patient locality and geography in the UK health and care system. Benefits to patients will include a range of research projects that aim to understand more about disease risks and causes, improved diagnosis, developing new treatments, preventing diseases, planning NHS services and improved patient safety. The impact of the result of the outputs will range from national level, when informing public health policy and clinical patient management, to local communities when the evidence will serve to optimise the delivery of care at ICS provider level.

Cegedim Rx Ltd is part of the Cegedim Group of Companies. The Cegedim group of companies include: Cegedim Rx Ltd, The Health Improvement Network Ltd, In Practice Systems Ltd, Bluebay medical systems Ltd. The activities if the group companies are described below:

Cegedim Rx Ltd is a limited company incorporated in 1993, which is owned by a holding company (ALLIADIS EUROPE LTD) which in turn is owned and directed by Cegedim SA (France). Cegedim Rx Ltd has an ISO accreditation issued in its name that spans all the shared services across the Cegedim SA (France) Businesses in the UK

The Health Improvement Network (THIN) Ltd is a limited company directly owned by Cegedim SA (France), with a separate legal entity within the Cegedim Group with its own data environment.

IN PRACTICE SYSTEMS (INPS) Ltd is a limited company incorporated in 1984, owned by Cegedim SA (France). The trading name of INPS is VISION, which provides healthcare IT services to GP practices, shared-care services for different healthcare providers, population health information services, online patient services, and community support services.

Bluebay Medical Systems has been absorbed by INPS Ltd. This was purchased by the holding company (ALLIADIS Europe Ltd) and then the business, employees, assets and liabilities were transferred to INPS Ltd at the start of 2019.

For the purpose of gaining access to NHS Digital data, the only entity of concern with respect to this application is Cegedim Rx Ltd. At no point will NHS Digital data supplied under this data sharing agreement be shared with IN PRACTICE SYSTEMS (INPS) Ltd, Bluebay Medical Systems, Cegedim SA (France) or The Health Improvement Network (THIN) Ltd in any form other than aggregated with small number suppression applied as per the HES Analysis Guide

NHS Digital Data:

The specific datasets requested in relation to this application are:

- Civil Registration (deaths) - Secondary Care Cut linked to:

- Emergency Care Dataset (ECDS)

- HES A&E

- HES Admitted patient Care

- HES Critical Care

- HES Outpatients

Cegedim Rx Ltd requires access to record-level pseudonymised data from the above datasets. The data will be pseudonymised using a HES specific pseudo-identifier provided by NHS Digital.

DATA MINIMISATION:

Data Minimisation will be applied by only requesting the fields which are required to do the minimum level of analysis at an individual patient record level with the data set request limited to the last 6 complete years only.

Cegedim Rx Ltd require quarterly renewal for all data sets to the end of the current agreement. This is because Cegedim Rx Ltd expect the analysis of disease areas of interest to be impacted by changes in clinical coding guidelines and clinical best practices over the requested period of time. To enrich the understanding of the effect of such changes in epidemiological and ecological studies, Cegedim Rx Ltd anticipate to perform pre-change and post-change separate analyses and also to implement models with inclusion of time interaction effects.

Cegedim Rx Ltd have made every effort to ensure that data requested is adequate, relevant but at the same time limited to what is essentially required, in terms of data sets (e.g. Admitted Patient Care, etc.) and period of time included, taking into consideration the changes in clinical coding and clinical best practice over the period of interest. Cegedim Rx Ltd have also included only the required level of data in terms of spells and episodes, ensuring that no identifiable or sensitive fields have been selected. Finally, the linkages requested are only those required to fulfil our work (i.e. with Mortality data only).

Outputs will be aggregated and not presented at a patient record level. All analysis will be conducted as per the HES analysis guide.

Hospital admissions, outpatients care, Critical Care, A&E and mortality are fundamental data sets to achieve the objectives of this work. To achieve this aim while ensuring that the data set is accurate, relevant and limited to what is necessary for any particular project or research, Cegedim Rx Ltd will ensure that no single variable can be directly related to a group of less than 6 patients, including diagnosis code (e.g. rare diseases) and year of birth.

The data should underpin epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring, performed by academic bodies, government and regulatory agencies, and industry. The linked HES, ECDS and Mortality data resource will be used in a standardised manner, fully complaint to the ethical, regulatory and data protection current legal frameworks, thus enabling trustworthy, standard-based, quality assured and scale-able approach to research.

The secondary healthcare large scale data resource will enable research providing insight in important disease areas, with national coverage over patient population, that is fundamental for the understanding of the patient healthcare clinical experience. This type of research will underpin decision-making in the continual improvement of clinical management of patients and service delivery at national and local levels. The geographical coverage of the data set will also provide the actionable evidence required to drive equity in the provision of care and optimise the utilisation of resources. This resource will offer new opportunities to ascertain the strength of previous evidence, providing a test bed for validation of public health, epidemiological and clinical research. It will also aim to measure and improve the quality of the research data stock in the United Kingdom. This processing will be used to perform epidemiological, clinical and health economics research, supporting improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring, using statistical, epidemiological and computational methods.

Examples of how the aggregated and suppressed data will be useful for analysis include scenarios such as:

- A view of the referring organisation for a patient and which speciality/organisation they have been referred into and then aggregated up to ICS

- Practices treat patients like X have an outcome of X, and practice treat patient like Y have outcome Y analysis may provide instances where care sits outside of NICE guidelines or in relation to Quality Outcome Framework (QOF) performance

Further examples of specific projects that Cegedim Rx Ltd have previously been requested to perform by the above permitted clients include:

1. Venous Thromboembolism (VTE) and Surgeries: to describe the clinical journey of patients of patients experiencing VTE after surgeries (low and high risk), comparing standard with fast-track surgery designs with a view to gather evidence to inform patient recommendations and best clinical practice.

2. Natural History of Parkinson’s Disease: to study the incidence, morbidity, mortality and clinical journey of Parkinson’s Disease patients in secondary care to inform clinical decision making around adjuvant therapy and enrich understanding of patterns of utilisation of therapies.

3. Acute Respiratory Distress Syndrome: to study the incidence, morbidity, mortality associated with patient that experience Acute Respiratory Syndrome, including a descriptive analysis of the disease trajectory leading up to the event and patterns of care.

Cegedim Rx Ltd also want to be able to add secondary care analysis as part of its services. Cegedim Rx Ltd's researcher base are moving more into secondary care analysis, Cegedim Rx Ltd having access to the above stated level of HES data will enable them to provide assistance to these organisations.

HES, ECDS and Mortality data from NHS Digital will be used to conduct such analysis for various regions. This also provides potential to identify areas of unwarranted variation of care e.g. length of time to diagnosis and referral to secondary care.

Patients with rare diseases and in general any patient with very specific clinical circumstances would be excluded from any analysis to reduce the risks of re-identification. All outputs will be conducted as per the HES Analysis Guide.

Processing of the data requested under this agreement will be conducted under the legal basis set out by the UK General Data Protection Regulation (UK GDPR). 'Processing is necessary for the purposes of the legitimate interests pursued by the controller...' [Article 6(1)(f)]. The NHS Digital data sought will be used to support epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring that are complementary to the work performed and products supplied by Cegedim Health Data. The pseudonymised NHS Digital data will be processed internally by Cegedim Rx Ltd for the purpose of producing aggregated tabulations/analysis with small number suppressed as per the HES analysis guide for specific projects for members form the aforementioned industry sectors.

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)

In 2021, Cegedim Rx Ltd refined the data structure in its data warehouse to ensure the data is easily usable, hence the following proposed outputs are expected to be released in 2022/early 2023.

The output will consist of secondary care data studies looking at understanding actual clinical pathways aimed at supporting epidemiological, treatment and clinical research. The outputs will be in the form of reports, submissions to peer reviewed journals, presentations, papers for conferences, tabulations, and analysis. All outputs will conform to the current NHD Digital HES Analysis guide rules.

Cegedim Rx Ltd Dissemination and Communication Strategy will prioritize key disease areas based on their clinical importance and service delivery demand. They are Cardiovascular Disease, Neurodegenerative diseases, Cancer, Upper and Lower Respiratory Diseases, Diabetes, Kidney Disease and other diseases of the Urinary system, COVID-19. For each area Cegedim Rx Ltd will perform a study extracting data-driven clinical pathways based on well-established methodologies, identifying clinical phenotypes at each pathway stage.

By the end of 2022/early 2023 Cegedim Rx Ltd will create the first technical report of the project for all priority disease areas and produce a dynamic infographic (tabulations) publicly available directed to relevant stakeholders. By the end of the third year, they will produce the data-driven clinical phenotypes for at each stage of the clinical pathways and produce the corresponding technical report. The dynamic infographics (tabulations) will be updated to display such clinical phenotypes and disseminated to key stakeholders. The outputs of each stage on the development will be published in relevant international conference first (years one and two), and then evolved into scientific publications during the second and third year.

All the above-mentioned outputs will be made available to those interested at ICB (Integrated Care Board) level.

Frequently Cegedim Rx Ltd is approached regarding studies that are designed to provide a more complete picture of the patient healthcare journey for the purpose of identifying opportunities and intervention points for improving patient outcomes. However, there is a pervading misunderstanding of how different UK datasets fit together and how they can be used to provide an overall picture. Whilst occasionally this linkage is critical for the deep insights that can be gained, it is not always the case that primary care data needs to be joined with data from HES. Cegedim Rx Ltd wishes to support a greater understanding within the community of how different data sources can be used appropriately together and to offer a much-needed perspective for when a single data source is sufficient to provide the requested answer. The importance of doing so is to help minimize access to data sets to the minimum needed, but clarity about when this is needed, and when it is not still needs to be developed.

To support this, Cegedim Rx Ltd plans to develop a white paper that focuses in on a single disease area that will help to demonstrate the landscape of data sets. Cegedim Rx Ltd propose to focus on lung cancer patients and demonstrate how information from both the THIN database (Primary care Dataset) and from HES contribute to understanding disease and patient journeys. Importantly Cegedim Rx Ltd shall set out to debunk some commonly held misconceptions about what data types are held and in doing so aid the research community into constructing more appropriately framed studies.

Cegedim Rx Ltd look to run a set of independent analyses from HES and from THIN to develop an approachable features table that can provide a visual aid for understanding the novelty and overlap, of each of the different data source within Cegedim Rx Ltd, including but not limited to:

1. High level counts and coverage (e.g., demographics, characteristics, such as age, gender, ethnicities of lung cancer patients in 1) THIN AND 2) HES.

2. Insights derived from the Free text from primary care, including referral and specialist notes: high level statistics of capture for adjuvant therapy, adverse events, mutational status, TMN cancer staging, duration of treatment?

3. Capture the high-level methodologies necessary for appropriate analysis to be included for each of the key results sections, e.g., THIN analysis, free-text, HES.

4. Conclusions and Perspectives – provide insights to clients for understanding the epidemiology of diseases and possible aetiology and how it can be applied for use in clinical trial design.

Additionally, Cegedim Rx Ltd consider that the proposed work will showcase how such questions can be tackled to offer a greater understanding of patients in oncology treatment from primary care records, and that can complement information typically derived from structured clinical trials. Cegedim Rx Ltd expect will be helpful to focus questions to be more specific and will provide the clarity needed for improving clinical trial design and support.

The aim of the Dissemination and Communication Strategy is to reach the relevant stakeholder groups effectively and efficiently in the use of the research outputs, namely, public health agencies, academic community, patients and the public at large, industry, government decision makers, non-profit organizations and strategic partners. For each stakeholder group, an issue or problem-oriented mission approach will be implemented, making the communication relevant to the stakeholder group. Once the target audience and issue are identified, a series of targeted vehicles of communication and dissemination will be implemented, appropriate for the target audience, such as short-films, peer reviewed publication, conference posters, presentations, press releases, seminars, and demonstration events. Following the Cegedim Rx Ltd dissemination and communication plan, there will be a quarterly delivery of dissemination and communication artefacts targeting different stakeholder groups.

Finally, researchers will agree by contractual agreement to publish the result of their research in open access publications and deposit code list of implementing their results in public repositories, in order to foster transparency and reproduce-ability of research (applicable to permitted clients where research and discovery are the main aims of their function).

Cegedim were unable to produce any yielded benefits to date because the data was received in May 2021 and the team then needed to manipulate the data formats to ensure they were able to be queried in an efficient manor within our data environments, ensuring they were in a research ready format.

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling the Cegedim Rx Ltd to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).

The following provides background information on the purpose of the original study:

This data sharing agreement requests the use of Hospital Episode Statistics (HES) and Mortality data to support essential public health, epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring that are complementary to the work performed and products supplied by Cegedim Health Data.

Cegedim Rx Ltd wish to obtain HES and mortality data to create a secondary healthcare large scale data resource that will enable research providing insight in important disease areas, with national coverage over patient population, time and space to understand the patient healthcare clinical experience. The objective of the data analysis is to provide a deeper understanding of actual clinical pathways as seen implemented in the data for all disease areas with a view to elicit the clinical phenotypes (categories) of patients as they traverse their care pathway and support understanding the variations in the delivery of care. Cegedim Rx Ltd will be providing researchers an opportunity to validate their research at a regional level (e.g. CCG/Primary Care Network/Integrated Care System levels). Validation will occur based on Cegedim Rx Ltd performing internal analysis on the various HES data sets to provide supporting evidence for researcher studies.

Only substantive employees of Cegedim Rx Ltd will have access to the record level, pseudonymised NHS Digital Data. Researchers will only receive an analysis based on HES and Mortality data, not the actual HES and Mortality data itself.

Cegedim Rx Ltd is part of the Cegedim Group, a major supplier of healthcare technology and information services across Europe and is the market leading supplier of software solutions and computer services to UK pharmacies. Cegedim Rx Ltd is a leading supplier of innovative healthcare technology, pharmacy software and data services offering integrated end-to-end service solutions to healthcare professionals, healthcare industries and life science companies.

Cegedim Health Data is a brand of Cegedim Rx Ltd in the UK. Cegedim Health Data provides Real World Data and Evidence (RWD-E) to drive cutting edge improvements in patient outcomes. With a data history of over 25 years and millions of anonymised patient records immediately accessible from the THIN (The Health Improvement Network) European database, Cegedim Health Data is the partner for RWD-E and Advanced Analytics in Europe.

Driving standards across the industry, Cegedim Rx Ltd's expertise in IT solutions for healthcare providers and in data management provides; precise, ethical and actionable, fully anonymised patient data. Cegedim Rx Ltd support their customers to deliver the application of data, intelligence and reason. This enables vastly improved business, society and patient outcomes.

Proprietary data is used for healthcare research and analysis by healthcare authorities, academics, pharmaceutical companies, and research organisations. More than 1000 scientific papers have been published as a result of evidence derived from their THIN database. Cegedim Health Data provides access to anonymised datasets through a variety of mediums, including analytical dashboards.

Cegedim Rx Ltd

Cegedim Rx Ltd is a limited company incorporated in 1993, which is owned by a holding company (ALLIADIS EUROPE LTD) which in turn is owned and directed by Cegedim SA (France). Cegedim Rx Ltd has an ISO accreditation issued in its name that spans all the shared services across the Cegedim SA Businesses in the UK

The Health Improvement Network (THIN) Ltd

THIN is a limited company directly owned by Cegedim SA (France), with a separate legal entity within the Cegedim Group with its own data environment.

IN PRACTICE SYSTEMS (INPS) Ltd

INPS Ltd is a limited company incorporated in 1984, owned by Cegedim SA. The trading name of INPS is VISION, which provides healthcare IT services to GP practices, shared-care services for different healthcare providers, population health information services, online patient services, and community support services. INPS Ltd is directly owned by Cegedim SA (France) and whose trading name is ‘Vision’

Bluebay Medical Systems

Bluebay Medical Systems has been absorbed by INPS Ltd. This was purchased by the holding company (ALLIADIS Europe Ltd) and then the business, employees, assets and liabilities were transferred to INPS Ltd at the start of 2019.

For the purpose of gaining access to NHS Digital data, the only entity of concern with respect to this application is Cegedim Rx Ltd. At no point will NHS Digital data supplied under this data sharing agreement be shared with IN PRACTICE SYSTEMS (INPS) Ltd, Bluebay Medical Systems, Cegedim SA or The Health Improvement Network (THIN) Ltd in any form other than aggregated with small number suppression applied as per the HES Analysis Guide

NHS Digital Data:

The specific datasets requested in relation to this application are:

- Civil Registration (deaths) - Secondary Care Cut linked to:

- Emergency Care Dataset (ECDS)

- HES A&E

- HES Admitted patient Care

- HES Critical Care

- HES Outpatients

Cegedim Rx Ltd requires access to record-level pseudonymised data from the above datasets. The data will be pseudonymised using a HES specific pseudo-identifier provided by NHS Digital.

DATA MINIMISATION:

Data Minimisation will be applied by only requesting the fields which are required to do the minimum level of analysis at an individual patient record level. In addition no data fields have been requested that could potentially lead to patient re-identification with the data set request limited to the last 6 years only.

Cegedim Rx Ltd are asking for 6 years of historic data (2014/15 to 2019/20) and current data to the end of the current agreement. This is because Cegedim Rx Ltd expect the analysis of disease areas of interest to be impacted by changes in clinical coding guidelines and clinical best practices over the requested period of time. To enrich their understanding of the effect of such changes in epidemiological and ecological studies, Cegedim Rx Ltd anticipate to perform pre-change and post-change separate analyses and also to implement models with inclusion of time interaction effects. Examples of the changes and updates Cegedim Rx Ltd are seeking to investigate are in the management of Psychosis and Schizophrenia in adults (2015), Metastatic Breast cancer (2016), Non-small-cell Lung cancer that has progressed after/prior chemotherapy (2015), and Dementia (2015 and 2018).

Cegedim Rx Ltd have made every effort to ensure that data requested is adequate, relevant but at the same time limited to what is essentially required, in terms of data sets (e.g. Admitted Patient Care, etc.) and period of time included, taking into consideration the changes in clinical coding and clinical best practice over the period of interest. Cegedim Rx Ltd have also included only the required level of data in terms of spells and episodes, ensuring that no identifiable or sensitive fields have been selected. Finally, the linkages requested are only those required to fulfil our work (i.e. with Mortality data only).

Also in any outputs will be aggregated and not presented at a patient record level. Any analysis that yields patient numbers of less than 8 will be masked in analysis presentations with an asterix (*) as per the HES analysis guide.

In addition no data fields have been requested that could potentially lead to patient re-identification with the data set:

HES CC

• The data requested has been limited to the last 6 years only.

• Any fields associated with a specific time have not been requested to ensure that specific patients could not be re-identified.

HES APC

• Limited to 6 years historic data

• No Method of admission

• No Source of admission

• No Electoral ward

• IMD limited to Index of Multiple deprivation, Decile Group and overall rank

HES A&E

• Only 6 years requested

• No fields that are identified as high risk* or identifiable have been selected.

• Times of admissions and discharges not selected, only dates

• Location of incident leading to admission not requested

HES OP

• ensuring only the last 6 years worth of data is requested, to ensure any potential outputs are relevant to today's healthcare climate

• Patient's marital status not requested

• IMD has been limited to : Index of multiple deprivation ; IMD decile group and IMD overall ranking.

• No fields that are identified as high risk* or identifiable have been selected.

ECDS

• All fields relating to any specific time of admission or treatment for the patient, limited to date only

• All fields relating to location of the patient's injury (geographical).

• No fields that are identified as high risk* or identifiable have been selected.

• Any reference to a patients preferred language has not been requested

Civil Registrations (Deaths) - Summary Care Record

• Data minimisation will be implemented by ensuring that the data fields requested are limited to the locality of a Strategic Health Authority.

• No fields that are identified as high risk* or identifiable have been selected.

* HIGH RISK is as defined in the field selection criteria through DARS, deemed sensitive data.

Hospital admissions, outpatients care, Critical Care, A&E and mortality are fundamental data sets to achieve the objectives of this work. To achieve this aim while ensuring that the data set is accurate, relevant and limited to what is necessary for any particular project or research; Cegedim Rx Ltd will ensure that no single variable can be directly related to a group of less than 6 patients, including diagnosis code (e.g. rare diseases) and year of birth .

The requested data will underpin essential public health, epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring, performed by academic bodies, government and regulatory agencies, and industry. The linked HES and Mortality data resource will be used in a standardised manner, fully complaint to the ethical, regulatory and data protection current legal frameworks, thus enabling trustworthy, standard-based, quality assured and scale-able approach to research.

Cegedim Rx Ltd are asking for 6 years of historic data (2014/15 to 2019/20) and current data to the end of the current agreement. This is because Cegedim Rx Ltd expect the analysis of disease areas of interest to be impacted by changes in clinical coding guidelines and clinical best practices over the requested period of time. To enrich their understanding of the effect of such changes in epidemiological and ecological studies, Cegedim Rx Ltd anticipate to perform pre-change and post-change separate analyses and also to implement models with inclusion of time interaction effects. Examples of the changes and updates Cegedim Rx Ltd are seeking to investigate are in the management of Psychosis and Schizophrenia in adults (2015), Metastatic Breast cancer (2016), Non-small-cell Lung cancer that has progressed after/prior chemotherapy (2015), and Dementia (2015 and 2018).

The secondary healthcare large scale data resource will enable research providing insight in important disease areas, with national coverage over patient population, time and space that is fundamental for the understanding of the patient healthcare clinical experience. This type of research will underpin decision-making in the continual improvement of clinical management of patients and service delivery at national and local levels. The geographical coverage of the data set will also provide the actionable evidence required to drive equity in the provision of care and optimise the utilisation of resources. This resource will offer new opportunities to ascertain the strength of previous evidence, providing a test bed for validation of public health, epidemiological and clinical research. It will also aim to measure and improve the quality of the research data stock in the United Kingdom. This processing will be used to perform essential public health, epidemiological, clinical and health economics research, supporting improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring, using statistical, epidemiological and computational methods.

Cegedim Rx Ltd will be providing researchers an opportunity to validate their research at a regional level (e.g. CCG/PCN/ICS levels). Validation will occur based on Cegedim Rx Ltd performing internal analysis on the various HES and mortality data sets to provide supporting evidence for researcher studies. Researchers will only receive an analysis based on HES and mortality and not the actual HES and mortality data itself. Cegedim Rx Ltd expect the following industries to be recipients of any HES and mortality data outputs as described in an aggregated and suppressed form:

- Academia,

- Independent researchers/epidemiologists,

- Pharmaceutical companies,

- Management consulting companies,

-Public health bodies,

- Medical Charities.

N.B: Cegedim Rx Ltd does not engage with Insurance companies.

Examples of how the aggregated and suppressed data will be useful for analysis include scenarios such as:

- A view of the referring organisation for a patient and which speciality/organisation they have been referred into and then aggregated up to CCG/PCN/ICS

- Practices treat patients like X have an outcome of X, and practice treat patient like Y have outcome Y analysis may provide instances where care sits outside of NICE guidelines or in relation to Quality Outcome Framework (QOF) performance

Further examples of specific projects that Cegedim have previously been requested to perform by the above permitted clients include:

1. Venous Thromboembolism (VTE) and Surgeries: to describe the clinical journey of patients of patients experiencing VTE after surgeries (low and high risk), comparing standard with fast-track surgery designs with a view to gather evidence to inform patient recommendations and best clinical practice.

2. Natural History of Parkinson’s Disease: to study the incidence, morbidity, mortality and clinical journey of Parkinson’s Disease patients in secondary care to inform clinical decision making around adjuvant therapy and enrich understanding of patterns of utilisation of therapies.

3. Acute Respiratory Distress Syndrome: to study the incidence, morbidity, mortality associated with patient that experience Acute Respiratory Syndrome, including a descriptive analysis of the disease trajectory leading up to the event and patterns of care.

Cegedim Rx Ltd also want to be able to add secondary care analysis as part of its services. Cegedim Rx Ltd's researcher base are moving more into secondary care analysis, Cegedim Rx Ltd having access to the above stated level of HES data will enable them to provide assistance to these organisations.

HES and Mortality data from NHS Digital will still be required to be provided to Cegedim Rx Ltd at the patient level to be able to conduct such analysis for various regions. This also provides potential to identify areas of unwarranted variation of care e.g. length of time to diagnosis and referral to secondary care.

Patients with rare diseases and in general any patient with very specific clinical circumstances would be excluded from any analysis to reduce the risks of re-identification. In addition patients who present in any given CCG and where the total of that diagnosis or disease area count is <8, these figures and patients will be masked and not be available for analysis, as per the HES Analysis Guide.

Processing of the data requested under this agreement will be conducted under the legal basis set out by the General Data Protection Regulation (GDPR). 'Processing is necessary for the purposes of the legitimate interests pursued by the controller...' [Article 6(1)(f)]. Cegedim Rx Ltd shared a copy of its Legitimate Interests Assessment (LIA) with NHS Digital. NHS Digital have assessed this response against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met. The NHS Digital data sought will be used to support essential public health, epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring that are complementary to the work performed and products supplied by Cegedim Health Data. The pseudonymised NHS digital data will be processed internally by Cegedim Rx Ltd for the purpose of producing aggregated tabulations/analysis with small number suppressed as per the HES analysis guide for specific projects for members form the aforementioned industry sectors.

Processing of special category data will be carried out in line with Article 9(2)(j) of GDPR - '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.

There will be no further outputs during the course of this Short Term Extension.

The following provides background on the outputs expected prior to this Agreement:

The output will consist of secondary care data studies looking at understanding actual clinical pathways aimed at supporting essential public health, epidemiological, treatment and clinical research. The outputs will be in the form of reports, submissions to peer reviewed journals, presentations, papers for conferences, tabulations and analysis. Any aggregations resulting in small numbers will be appropriately suppressed using current NHS Digital HES Analysis guide rules for suppressing small numbers i.e. any numbers smaller than 8 replaced with '*'.

Cegedim Rx Ltd's Dissemination and Communication Strategy will prioritise key disease areas based on their clinical importance and service delivery demand. They are Cardiovascular Disease, Neurodegenerative diseases, Cancer, Upper and Lower Respiratory Diseases, Diabetes, Kidney Disease and other diseases of the Urinary system, COVID-19. For each area Cegedim Rx Ltd will perform a study extracting data-driven clinical pathways based on well-established methodologies, identifying clinical phenotypes at each pathway stage.

Examples of potential projects/Studies include:

1. Venous Thromboembolism (VTE) and Surgeries: to describe the clinical journey of patients of patients experiencing VTE after surgeries (low and high risk), comparing standard with fast-track surgery designs with a view to gather evidence to inform patient recommendations and best clinical practice.

2. Natural History of Parkinson’s Disease: to study the incidence, morbidity, mortality and clinical journey of Parkinson’s Disease patients in secondary care to inform clinical decision making around adjuvant therapy and enrich understanding of patterns of utilisation of therapies.

3. Acute Respiratory Distress Syndrome: to study the incidence, morbidity, mortality associated with patient that experience Acute Respiratory Syndrome, including a descriptive analysis of the disease trajectory leading up to the event and patterns of care.

By the end of the first year Cegedim Rx Ltd will create the first technical report of the project for all priority disease areas and produce an dynamic info-graphics (tabulations) publicly available directed to relevant stakeholders. By the end of the second year, they will produce the data-driven clinical phenotypes for at each stage of the clinical pathways and produce the corresponding technical report. The dynamic info-graphics (tabulations) will be updated to display such clinical phenotypes and disseminated to key stakeholders. The outputs of each stage on the development will be published in relevant international conference first (years one and two), and then evolved into scientific publications during the second and third year.

All of the above mentioned outputs will be made available to those interested at CCG level.

The aim of the Dissemination and Communication Strategy is to effectively and efficiently reach the relevant stakeholder groups in the use of the research outputs, namely, public health agencies, academic community, patients and the public at large, industry, government decision makers, non-profit organisations and strategic partners. For each stakeholder group, an issue or problem-oriented mission approach will be implemented, making the communication relevant to the stakeholder group. Once the target audience and issue are identified, a series of targeted vehicles of communication and dissemination will be implemented, appropriate for the target audience, such as short-films, peer reviewed publication, conference posters, presentations, press releases, seminars, and demonstration events. Following the Cegedim Rx Ltd dissemination and communication plan, there will be a quarterly delivery of dissemination and communication artefacts targeting different stakeholder groups.

Finally, researches will agree by contractual agreement to publish the result of their research in open access publications and deposit code list of implementing their results in public repositories, in order to foster transparency and reproduce-ability of research (applicable to permitted clients where research and discovery are the main aims of their function).

This data sharing agreement requests the use of Hospital Episode Statistics (HES) and Mortality data to support essential public health, epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring that are complementary to the work performed and products supplied by Cegedim Health Data.

Cegedim RX Ltd wish to obtain HES and mortality data to create a secondary healthcare large scale data resource that will enable research providing insight in important disease areas, with national coverage over patient population, time and space to understand the patient healthcare clinical experience. The objective of the data analysis is to provide a deeper understanding of actual clinical pathways as seen implemented in the data for all disease areas with a view to elicit the clinical phenotypes (categories) of patients as they traverse their care pathway and support understanding the variations in the delivery of care. Cegedim RX Ltd will be providing researchers an opportunity to validate their research at a regional level (e.g. CCG/Primary Care Network/Integrated Care System levels). Validation will occur based on Cegedim RX Ltd performing internal analysis on the various HES data sets to provide supporting evidence for researcher studies.

Only substantive employees of Cegedim RX Ltd will have access to the record level, pseudonymised NHS Digital Data. Researchers will only receive an analysis based on HES and Mortality data, not the actual HES and Mortality data itself.

Cegedim Rx Ltd is part of the Cegedim Group, a major supplier of healthcare technology and information services across Europe and is the market leading supplier of software solutions and computer services to UK pharmacies. Cegedim Rx Ltd is a leading supplier of innovative healthcare technology, pharmacy software and data services offering integrated end-to-end service solutions to healthcare professionals, healthcare industries and life science companies.

Cegedim Health Data is a brand of Cegedim Rx Ltd in the UK. Cegedim Health Data provides Real World Data and Evidence (RWD-E) to drive cutting edge improvements in patient outcomes. With a data history of over 25 years and millions of anonymised patient records immediately accessible from the THIN (The Health Improvement Network) European database, Cegedim Health Data is the partner for RWD-E and Advanced Analytics in Europe.

Driving standards across the industry, Cegedim RX Ltd's expertise in IT solutions for healthcare providers and in data management provides; precise, ethical and actionable, fully anonymised patient data. Cegedim RX Ltd support their customers to deliver the application of data, intelligence and reason. This enables vastly improved business, society and patient outcomes.

Proprietary data is used for healthcare research and analysis by healthcare authorities, academics, pharmaceutical companies, and research organisations. More than 1000 scientific papers have been published as a result of evidence derived from their THIN database. Cegedim Health Data provides access to anonymised datasets through a variety of mediums, including analytical dashboards.

Cegedim Rx Ltd

Cegedim Rx Ltd is a limited company incorporated in 1993, which is owned by a holding company (ALLIADIS EUROPE LTD) which in turn is owned and directed by Cegedim SA (France). Cegedim Rx Ltd has an ISO accreditation issued in its name that spans all the shared services across the Cegedim SA Businesses in the UK

The Health Improvement Network (THIN) Ltd

THIN is a limited company directly owned by Cegedim SA (France), with a separate legal entity within the Cegedim Group with its own data environment.

IN PRACTICE SYSTEMS (INPS) Ltd

INPS Ltd is a limited company incorporated in 1984, owned by Cegedim SA. The trading name of INPS is VISION, which provides healthcare IT services to GP practices, shared-care services for different healthcare providers, population health information services, online patient services, and community support services. INPS Ltd is directly owned by Cegedim SA (France) and whose trading name is ‘Vision’

Bluebay Medical Systems

Bluebay Medical Systems has been absorbed by INPS Ltd. This was purchased by the holding company (ALLIADIS Europe Ltd) and then the business, employees, assets and liabilities were transferred to INPS Ltd at the start of 2019.

For the purpose of gaining access to NHS Digital data, the only entity of concern with respect to this application is Cegedim Rx Ltd. At no point will NHS Digital data supplied under this data sharing agreement be shared with IN PRACTICE SYSTEMS (INPS) Ltd, Bluebay Medical Systems, Cegedim SA or The Health Improvement Network (THIN) Ltd in any form other than aggregated with small number suppression applied as per the HES Analysis Guide

NHS Digital Data:

The specific datasets requested in relation to this application are:

- Civil Registration (deaths) - Secondary Care Cut linked to:

- Emergency Care Dataset (ECDS)

- HES A&E

- HES Admitted patient Care

- HES Critical Care

- HES Outpatients

Cegedim RX Ltd requires access to record-level pseudonymised data from the above datasets. The data will be pseudonymised using a HES specific pseudo-identifier provided by NHS Digital.

DATA MINIMISATION:

Data Minimisation will be applied by only requesting the fields which are required to do the minimum level of analysis at an individual patient record level. In addition no data fields have been requested that could potentially lead to patient re-identification with the data set request limited to the last 6 years only.

Cegedim RX Ltd are asking for 6 years of historic data (2014/15 to 2019/20) and current data to the end of the current agreement. This is because Cegedim RX Ltd expect the analysis of disease areas of interest to be impacted by changes in clinical coding guidelines and clinical best practices over the requested period of time. To enrich their understanding of the effect of such changes in epidemiological and ecological studies, Cegedim RX Ltd anticipate to perform pre-change and post-change separate analyses and also to implement models with inclusion of time interaction effects. Examples of the changes and updates Cegedim RX Ltd are seeking to investigate are in the management of Psychosis and Schizophrenia in adults (2015), Metastatic Breast cancer (2016), Non-small-cell Lung cancer that has progressed after/prior chemotherapy (2015), and Dementia (2015 and 2018).

Cegedim RX Ltd have made every effort to ensure that data requested is adequate, relevant but at the same time limited to what is essentially required, in terms of data sets (e.g. Admitted Patient Care, etc.) and period of time included, taking into consideration the changes in clinical coding and clinical best practice over the period of interest. Cegedim RX Ltd have also included only the required level of data in terms of spells and episodes, ensuring that no identifiable or sensitive fields have been selected. Finally, the linkages requested are only those required to fulfil our work (i.e. with Mortality data only).

Also in any outputs will be aggregated and not presented at a patient record level. Any analysis that yields patient numbers of less than 8 will be masked in analysis presentations with an asterix (*) as per the HES analysis guide.

In addition no data fields have been requested that could potentially lead to patient re-identification with the data set:

HES CC

• The data requested has been limited to the last 6 years only.

• Any fields associated with a specific time have not been requested to ensure that specific patients could not be re-identified.

HES APC

• Limited to 6 years historic data

• No Method of admission

• No Source of admission

• No Electoral ward

• IMD limited to Index of Multiple deprivation, Decile Group and overall rank

HES A&E

• Only 6 years requested

• No fields that are identified as high risk* or identifiable have been selected.

• Times of admissions and discharges not selected, only dates

• Location of incident leading to admission not requested

HES OP

• ensuring only the last 6 years worth of data is requested, to ensure any potential outputs are relevant to today's healthcare climate

• Patient's marital status not requested

• IMD has been limited to : Index of multiple deprivation ; IMD decile group and IMD overall ranking.

• No fields that are identified as high risk* or identifiable have been selected.

ECDS

• All fields relating to any specific time of admission or treatment for the patient, limited to date only

• All fields relating to location of the patient's injury (geographical).

• No fields that are identified as high risk* or identifiable have been selected.

• Any reference to a patients preferred language has not been requested

Civil Registrations (Deaths) - Summary Care Record

• Data minimisation will be implemented by ensuring that the data fields requested are limited to the locality of a Strategic Health Authority.

• No fields that are identified as high risk* or identifiable have been selected.

* HIGH RISK is as defined in the field selection criteria through DARS, deemed sensitive data.

Hospital admissions, outpatients care, Critical Care, A&E and mortality are fundamental data sets to achieve the objectives of this work. To achieve this aim while ensuring that the data set is accurate, relevant and limited to what is necessary for any particular project or research; Cegedim RX Ltd will ensure that no single variable can be directly related to a group of less than 6 patients, including diagnosis code (e.g. rare diseases) and year of birth .

The requested data will underpin essential public health, epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring, performed by academic bodies, government and regulatory agencies, and industry. The linked HES and Mortality data resource will be used in a standardised manner, fully complaint to the ethical, regulatory and data protection current legal frameworks, thus enabling trustworthy, standard-based, quality assured and scale-able approach to research.

Cegedim RX Ltd are asking for 6 years of historic data (2014/15 to 2019/20) and current data to the end of the current agreement. This is because Cegedim RX Ltd expect the analysis of disease areas of interest to be impacted by changes in clinical coding guidelines and clinical best practices over the requested period of time. To enrich their understanding of the effect of such changes in epidemiological and ecological studies, Cegedim RX Ltd anticipate to perform pre-change and post-change separate analyses and also to implement models with inclusion of time interaction effects. Examples of the changes and updates Cegedim RX Ltd are seeking to investigate are in the management of Psychosis and Schizophrenia in adults (2015), Metastatic Breast cancer (2016), Non-small-cell Lung cancer that has progressed after/prior chemotherapy (2015), and Dementia (2015 and 2018).

The secondary healthcare large scale data resource will enable research providing insight in important disease areas, with national coverage over patient population, time and space that is fundamental for the understanding of the patient healthcare clinical experience. This type of research will underpin decision-making in the continual improvement of clinical management of patients and service delivery at national and local levels. The geographical coverage of the data set will also provide the actionable evidence required to drive equity in the provision of care and optimise the utilisation of resources. This resource will offer new opportunities to ascertain the strength of previous evidence, providing a test bed for validation of public health, epidemiological and clinical research. It will also aim to measure and improve the quality of the research data stock in the United Kingdom. This processing will be used to perform essential public health, epidemiological, clinical and health economics research, supporting improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring, using statistical, epidemiological and computational methods.

Cegedim RX Ltd will be providing researchers an opportunity to validate their research at a regional level (e.g. CCG/PCN/ICS levels). Validation will occur based on Cegedim RX Ltd performing internal analysis on the various HES and mortality data sets to provide supporting evidence for researcher studies. Researchers will only receive an analysis based on HES and mortality and not the actual HES and mortality data itself. Cegedim RX Ltd expect the following industries to be recipients of any HES and mortality data outputs as described in an aggregated and suppressed form:

- Academia,

- Independent researchers/epidemiologists,

- Pharmaceutical companies,

- Management consulting companies,

-Public health bodies,

- Medical Charities.

N.B: Cegedim RX Ltd does not engage with Insurance companies.

Examples of how the aggregated and suppressed data will be useful for analysis include scenarios such as:

- A view of the referring organisation for a patient and which speciality/organisation they have been referred into and then aggregated up to CCG/PCN/ICS

- Practices treat patients like X have an outcome of X, and practice treat patient like Y have outcome Y analysis may provide instances where care sits outside of NICE guidelines or in relation to Quality Outcome Framework (QOF) performance

Further examples of specific projects that Cegedim have previously been requested to perform by the above permitted clients include:

1. Venous Thromboembolism (VTE) and Surgeries: to describe the clinical journey of patients of patients experiencing VTE after surgeries (low and high risk), comparing standard with fast-track surgery designs with a view to gather evidence to inform patient recommendations and best clinical practice.

2. Natural History of Parkinson’s Disease: to study the incidence, morbidity, mortality and clinical journey of Parkinson’s Disease patients in secondary care to inform clinical decision making around adjuvant therapy and enrich understanding of patterns of utilisation of therapies.

3. Acute Respiratory Distress Syndrome: to study the incidence, morbidity, mortality associated with patient that experience Acute Respiratory Syndrome, including a descriptive analysis of the disease trajectory leading up to the event and patterns of care.

Cegedim RX Ltd also want to be able to add secondary care analysis as part of its services. Cegedim RX Ltd's researcher base are moving more into secondary care analysis, Cegedim RX Ltd having access to the above stated level of HES data will enable them to provide assistance to these organisations.

HES and Mortality data from NHS Digital will still be required to be provided to Cegedim RX Ltd at the patient level to be able to conduct such analysis for various regions. This also provides potential to identify areas of unwarranted variation of care e.g. length of time to diagnosis and referral to secondary care.

Patients with rare diseases and in general any patient with very specific clinical circumstances would be excluded from any analysis to reduce the risks of re-identification. In addition patients who present in any given CCG and where the total of that diagnosis or disease area count is <8, these figures and patients will be masked and not be available for analysis, as per the HES Analysis Guide.

Processing of the data requested under this agreement will be conducted under the legal basis set out by the General Data Protection Regulation (GDPR). 'Processing is necessary for the purposes of the legitimate interests pursued by the controller...' [Article 6(1)(f)]. Cegedim RX Ltd shared a copy of its Legitimate Interests Assessment (LIA) with NHS Digital. NHS Digital have assessed this response against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met. The NHS Digital data sought will be used to support essential public health, epidemiological, clinical and health economics research, improvements in healthcare service delivery, treatment, technology appraisals and patient safety monitoring that are complementary to the work performed and products supplied by Cegedim Health Data. The pseudonymised NHS digital data will be processed internally by Cegedim RX Ltd for the purpose of producing aggregated tabulations/analysis with small number suppressed as per the HES analysis guide for specific projects for members form the aforementioned industry sectors.

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

The output will consist of secondary care data studies looking at understanding actual clinical pathways aimed at supporting essential public health, epidemiological, treatment and clinical research. The outputs will be in the form of reports, submissions to peer reviewed journals, presentations, papers for conferences, tabulations and analysis. Any aggregations resulting in small numbers will be appropriately suppressed using current NHS Digital HES Analysis guide rules for suppressing small numbers i.e. any numbers smaller than 8 replaced with '*'.

Cegedim RX Ltd's Dissemination and Communication Strategy will prioritise key disease areas based on their clinical importance and service delivery demand. They are Cardiovascular Disease, Neurodegenerative diseases, Cancer, Upper and Lower Respiratory Diseases, Diabetes, Kidney Disease and other diseases of the Urinary system, COVID-19. For each area Cegedim RX Ltd will perform a study extracting data-driven clinical pathways based on well-established methodologies, identifying clinical phenotypes at each pathway stage.

Examples of potential projects/Studies include:

1. Venous Thromboembolism (VTE) and Surgeries: to describe the clinical journey of patients of patients experiencing VTE after surgeries (low and high risk), comparing standard with fast-track surgery designs with a view to gather evidence to inform patient recommendations and best clinical practice.

2. Natural History of Parkinson’s Disease: to study the incidence, morbidity, mortality and clinical journey of Parkinson’s Disease patients in secondary care to inform clinical decision making around adjuvant therapy and enrich understanding of patterns of utilisation of therapies.

3. Acute Respiratory Distress Syndrome: to study the incidence, morbidity, mortality associated with patient that experience Acute Respiratory Syndrome, including a descriptive analysis of the disease trajectory leading up to the event and patterns of care.

By the end of the first year Cegedim RX Ltd will create the first technical report of the project for all priority disease areas and produce an dynamic info-graphics (tabulations) publicly available directed to relevant stakeholders. By the end of the second year, they will produce the data-driven clinical phenotypes for at each stage of the clinical pathways and produce the corresponding technical report. The dynamic info-graphics (tabulations) will be updated to display such clinical phenotypes and disseminated to key stakeholders. The outputs of each stage on the development will be published in relevant international conference first (years one and two), and then evolved into scientific publications during the second and third year.

All of the above mentioned outputs will be made available to those interested at CCG level.

The aim of the Dissemination and Communication Strategy is to effectively and efficiently reach the relevant stakeholder groups in the use of the research outputs, namely, public health agencies, academic community, patients and the public at large, industry, government decision makers, non-profit organisations and strategic partners. For each stakeholder group, an issue or problem-oriented mission approach will be implemented, making the communication relevant to the stakeholder group. Once the target audience and issue are identified, a series of targeted vehicles of communication and dissemination will be implemented, appropriate for the target audience, such as short-films, peer reviewed publication, conference posters, presentations, press releases, seminars, and demonstration events. Following the Cegedim RX Ltd dissemination and communication plan, there will be a quarterly delivery of dissemination and communication artefacts targeting different stakeholder groups.

Finally, researches will agree by contractual agreement to publish the result of their research in open access publications and deposit code list of implementing their results in public repositories, in order to foster transparency and reproduce-ability of research (applicable to permitted clients where research and discovery are the main aims of their function).

Yielded Benefits is not a requirement for new applications.