SDE - NICE

The National Institute for Health and Care Excellence (NICE) requires access to the Secure Data Environment (SDE) at NHS England.

The National Institute for Health and Care Excellence (NICE) was established in 1999 and then as a non-departmental public body in the Health and Social Care Act in 2012. The statutory role and responsibilities are set out in the 2013 Regulations of the Health and Social Care Act.

Over the past 22 years NICE has established itself as an international leader in technology evaluation, guideline development and evidence synthesis. The work today spans three ecosystems (life sciences, guidelines, and information) that involve close working with partners to ensure patients have access to the latest technologies, advice and guidance. In 2021, NICE published a new strategy that sets out its strategic priorities for the next 5 years. This strategy sets out how NICE will:

a. Be at the forefront of anticipating and rapidly evaluating new and existing technologies to provide independent, world-leading assessments of value for the system and improved access for patients.

b. Provide dynamic, living guideline recommendations that are useful, useable and rapidly updated. NICE will incorporate the latest evidence and newly recommended technologies to maximise uptake and access for patients.

c. Drive the implementation of NICEs guidance, forming key strategic partnerships to make sure it’s used. NICE will make sure it delivers improvements and contributes to reducing inequalities, with measures to routinely track adoption.

d. Be scientific leaders, driving the research agenda and developing innovative and data-driven methods. NICE will use real-world data to resolve issues of uncertainty and improve access to new innovations for patients (though research is not the subject of this agreement).

e. Transform NICEs organisation to make sure NICE have the infrastructure, skills and capacity to deliver their strategy. NICE will leverage the use of technology to maximise efficiency and impact.

As the responsible organisation for collecting, transporting, storing, analysing and disseminating the nation’s health and social care data; NHS England can help NICE to achieve their goals. This draws on the strengths of both organisations and enhances the contribution each make for the benefit of NICEs users. Part of this agreement included a joint strategic objective to work in partnership to drive relevant and timely access to NHS England’s Secure Data Environment (SDE). This supports NICEs strategy by providing data that is linked, covers the full care pathway, involves new collections, has sufficient coverage and is of good quality.

The following NHS England Data will be accessed:

- Hospital Episodes Statistics

These data are needed to provide information on admissions to hospital (inpatient, outpatient, critical care and accident and emergency). This data will be used across NICE products to understand secondary care activity. For example, it can be used in the development of NICE’s economic model parameters, which will ultimately help NICE to establish if an intervention is effective and cost effective. In addition, it can be used in resource impact tools to understand the financial cost to the system to implement a particular guideline.

All available years of data are requested from HES to ensure that trends can be monitored over longer reporting periods, for example assessing the impact of a NICE guideline published in the early 2000s. While all reporting years for HES will be available in the SDE, only those years required for each piece of analysis will be used, adhering to the aforementioned minimisation rules.

- Civil registrations - Deaths

These data are needed to provide information on dates and contributing causes of deaths, which will help to inform the development of NICEs guidance. Using mortality data from this source is more accurate than using data from secondary or primary care services. One example of how this will be used is to inform the parameters of NICEs health economic models. These economic models help to establish whether different interventions are cost-effective, for example using quality adjusted life years (QALYs). Using accurate death data ensures the QALYs are as accurate as possible enabling NICE to make the best recommendations possible.

- Medicines dispensed in Primary Care (NHSBSA data)

These data are needed to provide up to date information on the dispensing of medication in primary care. When assessing new medicines where there could be gaps in evidence, NICE will need to understand the use of a technology across services. For example, in managed access, when assessing whether an innovative medicine is safe and effective, NICE will need to use dispensing data, to see which patients received a medication, along with relevant activity data, to track the appropriate outcomes, such as hospital admission. If there are uncertainties in effectiveness of a medication NICE may recommend that further evidence generation is required, through a managed access scheme. This enables patients to get early access to promising treatments, while also ensuring NICE has the most up to date evidence on its use. Dispensing data is then used to generate additional evidence which is presented back to NICE. NICE will then use this data to update their recommendations from managed access to a medication being provided routinely in the NHS or, in some cases, for them to say that a medication should not be used routinely.

- NHSBSA 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:

· 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.

Any use of the Medicines dispensed in Primary Care NHS BSA data must be within the parameters of the relevant Direction authorising that collection, that is to drive the linkage of medicines data with other data sets to provide intelligence about the safety and effectiveness of medicines.

- Maternity Services Data Set - These data are needed to provide the most accurate and up to date data source on maternity service care in England. This will help NICE access maternity data for a number of cases, but specifically, for the suite of maternity guidelines. Trials that focus on maternity services are notoriously difficult to conduct, given the multiple ethical considerations. Having access to real-world data in this area will help NICE to assess areas where a trial would not be ethical or feasible, for example what is the best place for someone to give birth based on their risk factors.

- Mental Health Services Dataset (MHSDS) and Improving Access to Psychological Therapies (IAPT) - These data are needed to provide the most accurate and up to date data source on mental health service care in England. Both MHSDS and IAPT are required given the range of mental health conditions they treat, such as more common mental health conditions in IAPT to sever mental illness in MHSDS. This will help NICE access mental health data for a number of cases, but specifically, for the suite of mental health guidelines and the early value assessment programme. The early value assessment programme will focus on new digital and medical technologies which require an additional evidence base, with a focus on common mental health conditions like depression and anxiety, and more severe mental illness like schizophrenia and bipolar disorder. Having access to real-world data in this area will help NICE to assess areas where a trial data is not available, given the innovative nature of the medical and digital technologies.

- NDRS Cancer Consolidated Dataset - enable a thorough analysis of overall survival rates, treatment effectiveness, and demographic trends among patients undergoing treatment for metastatic cancer. This information would allow NICE to identify patterns and correlations that may not be apparent in smaller datasets like clinical trials, whose population may not be fully representative of all cancer patients. This, in turn, would allow NICE to make more informed recommendations to NICE committees, ensuring that their decisions are based on the most accurate and up-to-date evidence available. As NICE is commissioned throughout the year to undertake studies into any type of cancer the full consolidated cancer dataset is required

The data accessed under this agreement will be used by NICE:

- during the scoping, development and review of guidance, standards and indicators;

- to resolve issues of uncertainty and improve access to new innovations for patients;

- assess the impact of NICE's products

- to develop guidance tools.

- Emergency Care Data Set (ECDS) - required to enable NICE to carry out analyses providing real-world data evidence that supports NICE's ongoing work. This includes evidence to support guideline development, technology appraisals, as well as evaluation and assessment of health technology or guideline implementation, for example. The ECDS will provide valuable data on health resource utilisation and acute events. The team have the HES A&E data in the DSA already but the team need the ECDS to be able to cover more recent emergency care events.

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

~ Only querying the relevant reporting years.

~ Filter on the relevant geography, patient demographics and clinical factors.

~ Only querying the relevant episodes of care.

~ Only querying the relevant fields from the dataset.

~ Ensure the most appropriate groupings (e.g., diagnoses) and linkage are used.

NICE is the 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)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller

The lawful 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.

The processing of data for this study is a task of public interest as it may help to inform NICEs evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance.

NHS England are listed as a data processor as NHS England substantive employees can access the data in the same way as NICE users to ensure they can assist users (data wranglers).

SDE is a data storage and access platform that enables approved users to access de-identified data and analytical tools for approved projects. Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this Agreement. Users can request that aggregated outputs are exported from the system following approval by trained NHSE staff. The access and use of the system is fully auditable, and all users must comply with the use of the data as specified in this Agreement.

Work using data from the SDE will be continuous, and the exact data that is required will be dependent on referrals to NICE. The data will not be used for research purposes and will instead be used for service evaluation as described in the HRA toolkit:

- Designed and conducted solely to define or judge current care.

- Designed to answer: “What standard does this service achieve?”

- Measures current service without reference to a standard.

- Involves an intervention in use only. The choice of treatment, care or services is that of the care professional and patient/service user according to guidance, professional standards and/or patient/ service user preference.

-Usually involves analysis of existing data but may also include administration of interview(s) or questionnaire(s).

- No allocation to intervention: the care professional and patient/ service user have chosen intervention before service evaluation.

- No randomisation

For the duration of this agreement there are expected to be several different outputs. What these outputs will be depends on referrals to NICE as well as company submissions in the case of medicines. However, NICE will always publish how data has been used on their website, and how evidence sources are used (such as data from the SDE) will be listed alongside their guidelines.

In 2023/24, NICE undertook 6 significant projects using the national secure data environment as well as other data requests to support the development of their products. These projects focused on sepsis, cirrhosis, otitis, revascularisation and respiratory infections. Using the SDE ensured NICE were able to use real-world data to support the development of their products, which means that their guidance is reflecting what is happening to patients in the NHS, rather than on the specific sub populations found in clinical trials. In addition, and in the case of sepsis, NICE were able to use the data to track what is happening with their guidance once published, which aids their implementation activities, as well as helping us to decide whether to update guidance.

For the year 2024/25 NICE will continue to do this work using data from the national secure data environment. As NICE now have a data flow of mental health and IAPT data this will include a focus on how NICE can ensure their guidance on mental health conditions supports an underserved population.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

NICE have completed 8 projects using the national SDE with a further 2 ongoing. Examples below demonstrate the yielded benefits from accessing the SDE in 2024/25:

• Using the Maternity Services Data Set (MSDS) to measure the uptake of the quality statement in the NICE quality standard on antenatal care, focusing on booking appointments, risk assessments at booking, mental health referrals an assessment for smoking. This helped to drive conversations with national and system bodies and produce tools to improve the implementation of NICE’s antenatal care guidance.

• Looking at dispensing datasets to explore the uptake and health inequalities in the usage of weight management medicines wegovy and saxenda. This was used to inform the implementation plan for tirzepatide.

• Using HES Admitted Patient Care and Outpatient datasets to explore tic disorder activity in hospitals. This was used to inform the resource impact tool alongside a NICE highly specialised technology guidance on tic disorders.

• Analysis of length of stay for health failure hospital spells. This calculated the average LOS by elective and non-elective admissions. This was used to inform parameters of economic models in NICE diagnostic guidance.

Data made available under this agreement informs NICE evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance.

The impact of NICE guidance can be found here: https://www.nice.org.uk/about/what-we-do/intopractice/measuring-the-uptake-of-nice-guidance.

For 2025/2026 period, NICE will continue to develop their products using real-world data, expanding to areas such as cancer services. These areas will ensure NICE are able to track the uptake of guidance produced, and update it where required, as well as make innovate products available to patients as quickly as possible.

The National Institute for Health and Care Excellence (NICE) requires access to the Secure Data Environment (SDE) at NHS England.

The National Institute for Health and Care Excellence (NICE) was established in 1999 and then as a non-departmental public body in the Health and Social Care Act in 2012. The statutory role and responsibilities are set out in the 2013 Regulations of the Health and Social Care Act.

Over the past 22 years NICE has established itself as an international leader in technology evaluation, guideline development and evidence synthesis. The work today spans three ecosystems (life sciences, guidelines, and information) that involve close working with partners to ensure patients have access to the latest technologies, advice and guidance. In 2021, NICE published a new strategy that sets out its strategic priorities for the next 5 years. This strategy sets out how NICE will:

a. Be at the forefront of anticipating and rapidly evaluating new and existing technologies to provide independent, world-leading assessments of value for the system and improved access for patients.

b. Provide dynamic, living guideline recommendations that are useful, useable and rapidly updated. NICE will incorporate the latest evidence and newly recommended technologies to maximise uptake and access for patients.

c. Drive the implementation of NICEs guidance, forming key strategic partnerships to make sure it’s used. NICE will make sure it delivers improvements and contributes to reducing inequalities, with measures to routinely track adoption.

d. Be scientific leaders, driving the research agenda and developing innovative and data-driven methods. NICE will use real-world data to resolve issues of uncertainty and improve access to new innovations for patients (though research is not the subject of this agreement).

e. Transform NICEs organisation to make sure NICE have the infrastructure, skills and capacity to deliver their strategy. NICE will leverage the use of technology to maximise efficiency and impact.

As the responsible organisation for collecting, transporting, storing, analysing and disseminating the nation’s health and social care data; NHS England can help NICE to achieve their goals. This draws on the strengths of both organisations and enhances the contribution each make for the benefit of NICEs users. Part of this agreement included a joint strategic objective to work in partnership to drive relevant and timely access to NHS England’s Secure Data Environment (SDE). This supports NICEs strategy by providing data that is linked, covers the full care pathway, involves new collections, has sufficient coverage and is of good quality.

The following NHS England Data will be accessed:

- Hospital Episodes Statistics

These data are needed to provide information on admissions to hospital (inpatient, outpatient, critical care and accident and emergency). This data will be used across NICE products to understand secondary care activity. For example, it can be used in the development of NICE’s economic model parameters, which will ultimately help NICE to establish if an intervention is effective and cost effective. In addition, it can be used in resource impact tools to understand the financial cost to the system to implement a particular guideline.

All available years of data are requested from HES to ensure that trends can be monitored over longer reporting periods, for example assessing the impact of a NICE guideline published in the early 2000s. While all reporting years for HES will be available in the SDE, only those years required for each piece of analysis will be used, adhering to the aforementioned minimisation rules.

- Civil registrations - Deaths

These data are needed to provide information on dates and contributing causes of deaths, which will help to inform the development of NICEs guidance. Using mortality data from this source is more accurate than using data from secondary or primary care services. One example of how this will be used is to inform the parameters of NICEs health economic models. These economic models help to establish whether different interventions are cost-effective, for example using quality adjusted life years (QALYs). Using accurate death data ensures the QALYs are as accurate as possible enabling NICE to make the best recommendations possible.

- Medicines dispensed in Primary Care (NHSBSA data)

These data are needed to provide up to date information on the dispensing of medication in primary care. When assessing new medicines where there could be gaps in evidence, NICE will need to understand the use of a technology across services. For example, in managed access, when assessing whether an innovative medicine is safe and effective, NICE will need to use dispensing data, to see which patients received a medication, along with relevant activity data, to track the appropriate outcomes, such as hospital admission. If there are uncertainties in effectiveness of a medication NICE may recommend that further evidence generation is required, through a managed access scheme. This enables patients to get early access to promising treatments, while also ensuring NICE has the most up to date evidence on its use. Dispensing data is then used to generate additional evidence which is presented back to NICE. NICE will then use this data to update their recommendations from managed access to a medication being provided routinely in the NHS or, in some cases, for them to say that a medication should not be used routinely.

- NHSBSA 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:

· 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.

Any use of the Medicines dispensed in Primary Care NHS BSA data must be within the parameters of the relevant Direction authorising that collection, that is to drive the linkage of medicines data with other data sets to provide intelligence about the safety and effectiveness of medicines.

- Maternity Services Data Set - These data are needed to provide the most accurate and up to date data source on maternity service care in England. This will help NICE access maternity data for a number of cases, but specifically, for the suite of maternity guidelines. Trials that focus on maternity services are notoriously difficult to conduct, given the multiple ethical considerations. Having access to real-world data in this area will help NICE to assess areas where a trial would not be ethical or feasible, for example what is the best place for someone to give birth based on their risk factors.

- Mental Health Services Dataset (MHSDS) and Improving Access to Psychological Therapies (IAPT) - These data are needed to provide the most accurate and up to date data source on mental health service care in England. Both MHSDS and IAPT are required given the range of mental health conditions they treat, such as more common mental health conditions in IAPT to sever mental illness in MHSDS. This will help NICE access mental health data for a number of cases, but specifically, for the suite of mental health guidelines and the early value assessment programme. The early value assessment programme will focus on new digital and medical technologies which require an additional evidence base, with a focus on common mental health conditions like depression and anxiety, and more severe mental illness like schizophrenia and bipolar disorder. Having access to real-world data in this area will help NICE to assess areas where a trial data is not available, given the innovative nature of the medical and digital technologies.

- NDRS Cancer Consolidated Dataset - enable a thorough analysis of overall survival rates, treatment effectiveness, and demographic trends among patients undergoing treatment for metastatic cancer. This information would allow NICE to identify patterns and correlations that may not be apparent in smaller datasets like clinical trials, whose population may not be fully representative of all cancer patients. This, in turn, would allow NICE to make more informed recommendations to NICE committees, ensuring that their decisions are based on the most accurate and up-to-date evidence available. As NICE is commissioned throughout the year to undertake studies into any type of cancer the full consolidated cancer dataset is required

The data accessed under this agreement will be used by NICE:

- during the scoping, development and review of guidance, standards and indicators;

- to resolve issues of uncertainty and improve access to new innovations for patients;

- assess the impact of NICE's products

- to develop guidance tools.

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

~ Only querying the relevant reporting years.

~ Filter on the relevant geography, patient demographics and clinical factors.

~ Only querying the relevant episodes of care.

~ Only querying the relevant fields from the dataset.

~ Ensure the most appropriate groupings (e.g., diagnoses) and linkage are used.

NICE is the 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)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller

The lawful 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.

The processing of data for this study is a task of public interest as it may help to inform NICEs evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance.

NHS England are listed as a data processor as NHS England substantive employees can access the data in the same way as NICE users to ensure they can assist users (data wranglers).

SDE is a data storage and access platform that enables approved users to access de-identified data and analytical tools for approved projects. Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this Agreement. Users can request that aggregated outputs are exported from the system following approval by trained NHSE staff. The access and use of the system is fully auditable, and all users must comply with the use of the data as specified in this Agreement.

Work using data from the SDE will be continuous, and the exact data that is required will be dependent on referrals to NICE. The data will not be used for research purposes and will instead be used for service evaluation as described in the HRA toolkit:

- Designed and conducted solely to define or judge current care.

- Designed to answer: “What standard does this service achieve?”

- Measures current service without reference to a standard.

- Involves an intervention in use only. The choice of treatment, care or services is that of the care professional and patient/service user according to guidance, professional standards and/or patient/ service user preference.

-Usually involves analysis of existing data but may also include administration of interview(s) or questionnaire(s).

- No allocation to intervention: the care professional and patient/ service user have chosen intervention before service evaluation.

- No randomisation

For the duration of this agreement there are expected to be several different outputs. What these outputs will be depends on referrals to NICE as well as company submissions in the case of medicines. However, NICE will always publish how data has been used on their website, and how evidence sources are used (such as data from the SDE) will be listed alongside their guidelines.

In 2023/24, NICE undertook 6 significant projects using the national secure data environment as well as other data requests to support the development of their products. These projects focused on sepsis, cirrhosis, otitis, revascularisation and respiratory infections. Using the SDE ensured NICE were able to use real-world data to support the development of their products, which means that their guidance is reflecting what is happening to patients in the NHS, rather than on the specific sub populations found in clinical trials. In addition, and in the case of sepsis, NICE were able to use the data to track what is happening with their guidance once published, which aids their implementation activities, as well as helping us to decide whether to update guidance.

For the year 2024/25 NICE will continue to do this work using data from the national secure data environment. As NICE now have a data flow of mental health and IAPT data this will include a focus on how NICE can ensure their guidance on mental health conditions supports an underserved population.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

We have completed 8 projects using the national SDE with a further 2 ongoing. Examples below demonstrate the yielded benefits from accessing the SDE in 2024/25:

• Using the Maternity Services Data Set (MSDS) to measure the uptake of the quality statement in the NICE quality standard on antenatal care, focusing on booking appointments, risk assessments at booking, mental health referrals an assessment for smoking. This helped to drive conversations with national and system bodies and produce tools to improve the implementation of NICE’s antenatal care guidance.

• Looking at dispensing datasets to explore the uptake and health inequalities in the usage of weight management medicines wegovy and saxenda. This was used to inform the implementation plan for tirzepatide.

• Using HES Admitted Patient Care and Outpatient datasets to explore tic disorder activity in hospitals. This was used to inform the resource impact tool alongside a NICE highly specialised technology guidance on tic disorders.

• Analysis of length of stay for health failure hospital spells. This calculated the average LOS by elective and non-elective admissions. This was used to inform parameters of economic models in NICE diagnostic guidance.

Data made available under this agreement informs NICE evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance.

The impact of NICE guidance can be found here: https://www.nice.org.uk/about/what-we-do/intopractice/measuring-the-uptake-of-nice-guidance.

For 2025/2026 period, NICE will continue to develop their products using real-world data, expanding to areas such as cancer services. These areas will ensure NICE are able to track the uptake of guidance produced, and update it where required, as well as make innovate products available to patients as quickly as possible.

The National Institute for Health and Care Excellence (NICE) was established in 1999 and then as a non-departmental public body in the Health and Social Care Act in 2012. The statutory role and responsibilities are set out in the 2013 Regulations of the Health and Social Care Act.

Over the past 22 years NICE has established itself as an international leader in technology evaluation, guideline development and evidence synthesis. The work today spans three ecosystems (life sciences, guidelines, and information) that involve close working with partners to ensure patients have access to the latest technologies, advice and guidance. In 2021, NICE published a new strategy that sets out its strategic priorities for the next 5 years. This strategy sets out how NICE will:

a. Be at the forefront of anticipating and rapidly evaluating new and existing technologies to provide independent, world-leading assessments of value for the system and improved access for patients.

b. Provide dynamic, living guideline recommendations that are useful, useable and rapidly updated. NICE will incorporate the latest evidence and newly recommended technologies to maximise uptake and access for patients.

c. Drive the implementation of NICEs guidance, forming key strategic partnerships to make sure it’s used. NICE will make sure it delivers improvements and contributes to reducing inequalities, with measures to routinely track adoption.

d. Be scientific leaders, driving the research agenda and developing innovative and data-driven methods. NICE will use real-world data to resolve issues of uncertainty and improve access to new innovations for patients (though research is not the subject of this agreement).

e. Transform NICEs organisation to make sure NICE have the infrastructure, skills and capacity to deliver their strategy. NICE will leverage the use of technology to maximise efficiency and impact.

As the responsible organisation for collecting, transporting, storing, analysing and disseminating the nation’s health and social care data; NHS England can help NICE to achieve their goals. This draws on the strengths of both organisations and enhances the contribution each make for the benefit of NICEs users. Part of this agreement included a joint strategic objective to work in partnership to drive relevant and timely access to NHS England’s Secure Data Environment (SDE). This supports NICEs strategy by providing data that is linked, covers the full care pathway, involves new collections, has sufficient coverage and is of good quality.

Any data accessed under the arrangements of this agreement will be used for purposes relating to the provision of healthcare or the promotion of health in line with the requirements of the Health and Social Care Act 2012 as amended by the Care Act 2014.

The legal basis for processing personal data for this purpose data at NICE falls under Article 6(1)(e) of the General Data Protection Regulations (GDPR), i.e., “a task carried out in the public interest”. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”. The processing of data for this study is a task of public interest as it may help to inform NICEs evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance.

NICE are the sole data controller for this work and will also process data, NHS England are listed as a data processor as NHS England substantive employees can access the data in the same way as NICE users to ensure they can assist users (data wranglers). Data will be accessed by substantive employees of the Data Controller.

SDE is a data storage and access platform that enables approved users to access de-identified data and analytical tools for approved projects. Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this Agreement. Users can request that aggregated outputs are exported from the system following approval by trained NHSE staff. The access and use of the system is fully auditable, and all users must comply with the use of the data as specified in this Agreement.

Work using data from the SDE will be continuous, and the exact data that is required will be dependent on referrals to NICE. The data will not be used for research purposes and will instead be used for service evaluation as described in the HRA toolkit:

- Designed and conducted solely to define or judge current care.

- Designed to answer: “What standard does this service achieve?”

- Measures current service without reference to a standard.

- Involves an intervention in use only. The choice of treatment, care or services is that of the care professional and patient/service user according to guidance, professional standards and/or patient/ service user preference.

-Usually involves analysis of existing data but may also include administration of interview(s) or questionnaire(s).

- No allocation to intervention: the care professional and patient/ service user have chosen intervention before service evaluation.

- No randomisation.

The data accessed under this agreement will be used by NICE:

- during the scoping, development and review of guidance, standards and indicators;

- to resolve issues of uncertainty and improve access to new innovations for patients;

- assess the impact of NICE's products

- to develop guidance tools.

For the duration of this agreement there are expected to be several different outputs. What these outputs will be depends on referrals to NICE as well as company submissions in the case of medicines. However, NICE will always publish how data has been used on their website, and how evidence sources are used (such as data from the SDE) will be listed alongside our guidelines.

In 2023/24, NICE undertook 6 significant projects using the national secure data environment as well as other data requests to support the development of our products. These projects focused on sepsis, cirrhosis, otitis, revascularisation and respiratory infections. Using the SDE ensured we were able to use real-world data to support the development of our products, which means that our guidance is reflecting what is happening to patients in the NHS, rather than on the specific sub populations found in clinical trials. In addition, and in the case of sepsis, we were able to use the data to track what is happening with our guidance once published, which aids our implementation activities, as well as helping us to decide whether to update guidance.

For the year 2024/25 we will continue to do this work using data from the national secure data environment. As we now have a data flow of mental health and IAPT data this will include a focus on how we can ensure our guidance on mental health conditions supports an underserved population.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The following benefits have already been realised from accessing the SDE.

Understanding the patterns in recording of revascularisations associated with CVD admissions and in particular, how often are revascularisations recorded within the same spells as a CVD admission and how often are they instead recorded in separate subsequent spells/admissions within the 30 days following the initial CVD spell. This analysis is to support work NICE's lipids guidance. This led to the guideline being updated with lower lipid levels meaning more patients would receive medication to prevent CVD.

Establishing the number to people admitted for respiratory conditions. This helps to support early value assessment work on the development virtual wards products to ensure we knew the correct patient population.

Data on the total number of admissions, deaths and attendances in A&E for sepsis. This was to understand the impact of NICE guidance in sepsis care and whether since publishing there had been any changes in this outcome. This enabled us to demonstrate NICE's impact.

In addition to these we have used data to support our resource impact assessments, to understand the cost impact of implementing our guidance as well as indicator development to ensure we can feasibility test indicators in development.

Yielded benefits as provided by National Institute for Health and Care Excellence (NICE) on 27/02/2024.

Data made available under this agreement may help to inform NICE evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance. By using the data sources listed NICE hope to be able to achieve their 5-year strategy and:

a. Be at the forefront of anticipating and rapidly evaluating new and existing technologies to provide independent, world-leading assessments of value for the system and improved access for patients.

b. Provide dynamic, living guideline recommendations that are useful, useable and rapidly updated. They’ll incorporate the latest evidence and newly recommended technologies to maximise uptake and access for patients.

c. Drive the implementation of their guidance, forming key strategic partnerships to make sure it’s used. NICE will make sure it delivers improvements and contributes to reducing inequalities, with measures to routinely track adoption.

d. Be scientific leaders, driving the research agenda and developing innovative and data-driven methods. NICE will use real-world data to resolve issues of uncertainty and improve access to new innovations for patients (though research is not the subject of this agreement).

e. Transform their organisation to make sure they have the infrastructure, skills and capacity to deliver the strategy. NICE will leverage the use of technology to maximise their efficiency and impact.

The impact of NICE guidance can be found here: https://www.nice.org.uk/about/what-we-do/intopractice/measuring-the-uptake-of-nice-guidance.

For 2024/2025 period, NICE will continue to develop our products using real-world data, expanding to areas such as in mental health services. NICE will also continue to develop the NICE Early Value Assessment (EVA) programme, with a large focus on mental health. These areas will ensure NICE are able to track the uptake of guidance produced, and update it where required, as well as make innovate products available to patients as quickly as possible.

The National Institute for Health and Care Excellence (NICE) was established in 1999 and then as a non-departmental public body in the Health and Social Care Act in 2012. The statutory role and responsibilities are set out in the 2013 Regulations of the Health and Social Care Act.

Over the past 22 years NICE has established itself as an international leader in technology evaluation, guideline development and evidence synthesis. The work today spans three ecosystems (life sciences, guidelines, and information) that involve close working with partners to ensure patients have access to the latest technologies, advice and guidance. In 2021, NICE published a new strategy that sets out its strategic priorities for the next 5 years. This strategy sets out how NICE will:

a. Be at the forefront of anticipating and rapidly evaluating new and existing technologies to provide independent, world-leading assessments of value for the system and improved access for patients.

b. Provide dynamic, living guideline recommendations that are useful, useable and rapidly updated. NICE will incorporate the latest evidence and newly recommended technologies to maximise uptake and access for patients.

c. Drive the implementation of NICEs guidance, forming key strategic partnerships to make sure it’s used. NICE will make sure it delivers improvements and contributes to reducing inequalities, with measures to routinely track adoption.

d. Be scientific leaders, driving the research agenda and developing innovative and data-driven methods. NICE will use real-world data to resolve issues of uncertainty and improve access to new innovations for patients (though research is not the subject of this agreement).

e. Transform NICEs organisation to make sure NICE have the infrastructure, skills and capacity to deliver their strategy. NICE will leverage the use of technology to maximise efficiency and impact.

As the responsible organisation for collecting, transporting, storing, analysing and disseminating the nation’s health and social care data; NHS England can help NICE to achieve their goals. This draws on the strengths of both organisations and enhances the contribution each make for the benefit of NICEs users. Part of this agreement included a joint strategic objective to work in partnership to drive relevant and timely access to NHS England’s Secure Data Environment (SDE). This supports NICEs strategy by providing data that is linked, covers the full care pathway, involves new collections, has sufficient coverage and is of good quality.

Any data accessed under the arrangements of this agreement will be used for purposes relating to the provision of healthcare or the promotion of health in line with the requirements of the Health and Social Care Act 2012 as amended by the Care Act 2014. In addition, COVID-19 datasets and HES/deaths/NHSBSA datasets will also be accessed for specific COVID-19 purposes, such as the development of COVID-19 guidelines.

The legal basis for processing personal data for this purpose data at NICE falls under Article 6(1)(e) of the General Data Protection Regulations (GDPR), i.e., “a task carried out in the public interest”. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”. The processing of data for this study is a task of public interest as it may help to inform NICEs evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance.

The GPES Data for Pandemic Planning and Research (COVID-19) and Electronic Prescribing and Medicines Administration (EPMA) data in Secondary Care for COVID-19 datasets and any HES/mortality data/NHS BSA data they are linked to can only be used for COVID-19 purposes.

NICE are the sole data controller for this work and will also process data, NHS England are listed as a data processor as NHS England substantive employees can access the data in the same way as NICE users to ensure they can assist users (data wranglers). Data will be accessed by substantive employees of the Data Controller.

Existing TRE users will migrate to the Secure Data Environment (SDE). SDE is a data storage and access platform that enables approved users to access de-identified data and analytical tools for approved projects. Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this Agreement. Users can request that aggregated outputs are exported from the system following approval by trained NHSE staff. The access and use of the system is fully auditable, and all users must comply with the use of the data as specified in this Agreement.

Work using data from the SDE will be continuous, and the exact data that is required will be dependent on referrals to NICE. The data will not be used for research purposes and will instead be used for service evaluation as described in the HRA toolkit:

- Designed and conducted solely to define or judge current care.

- Designed to answer: “What standard does this service achieve?”

- Measures current service without reference to a standard.

- Involves an intervention in use only. The choice of treatment, care or services is that of the care professional and patient/service user according to guidance, professional standards and/or patient/ service user preference.

-Usually involves analysis of existing data but may also include administration of interview(s) or questionnaire(s).

- No allocation to intervention: the care professional and patient/ service user have chosen intervention before service evaluation.

- No randomisation.

The data accessed under this agreement will be used by NICE:

- during the scoping, development and review of guidance, standards and indicators;

- to resolve issues of uncertainty and improve access to new innovations for patients;

- assess the impact of NICE's products

- to develop guidance tools.

For the duration of this agreement there are expected to be several different outputs. What these outputs will be depends on referrals to NICE as well as company submissions in the case of medicines. However, NICE will always publish how data has been used on their website, and how evidence sources are used (such as data from the SDE) will be listed alongside their guidelines - https://www.nice.org.uk/about/what-we-do/into-practice/measuring-the-uptake-of-nice-guidance/impact-of-guidance

In 2021, NICE performed 40 data requests which informed NICE products. Since access to the data was established in June 2022, NICE have used data in the development of 4 prototypes for an automated measurement framework on breast cancer. These are long term projects which are expected to deliver an automated measurement framework for the NICE living guidelines in April 2023. NICE's automated measurement framework, will automatically provide uptake data to the digital living guidelines team, enabling them to rapidly update their guidelines on breast cancer by providing real world evidence. From April 2023 further development in this area will focus on new topics such as maternity services, which will be supported by access to MSDS data. This is especially important for maternity where it is difficult to recruit to and conduct trials.

In addition to the continued development of the automated measurement framework for 2023/24, NICE will begin continuing to develop evidence generation plans for its early value assessment programme, information available here: https://www.nice.org.uk/about/what-we-do/eva-for-medtech. This will include accessing data to address evidence gaps for innovative digital technologies. Many of these new technologies focus on unmet need in mental health, and therefore access to MHSDS and IAPT data will be vital.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The following benefits have already been realised from accessing HES data under DARS-NIC-11302-Q1L1F.

- Hospital Episodes Statistics

NICE has used HES data in development of its guidance tools and in particular resource impact assessment tools. These explore the costing of NICE recommendations to establish the financial impact on the NHS, Local Authorities and individual providers. These tools help the organisations involved to plan the implementation of evidence-based guidance which helps to improve health and social care. NICE used HES data to support an impact statement for NICE technology appraisal guidance: Avatrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure (TA626). By using the data to inform committee discussions NICE were able to come to the conclusion that NICE did not expect the guidance to have a significant impact on resources; that is, the resource impact of implementing the recommendations would be less than £5 million per year in England (or £9,0000 per 100,000 population).

Since access to the data was established in June 2022, NICE have used data in the development of 4 prototypes for an automated measurement framework on breast cancer. These prototypes are assessing the uptake of NICE's guideline on breast cancer. As these develop, they will inform NICE's automated measurement framework, which will automatically provide uptake data to their digital living guidelines team, enabling them to rapidly update their guidelines on breast cancer. So far the prototypes have focused on the following:

• Sentinel Node Biopsy

• Breast reconstruction

• Hormone replacement therapy

• Breast cancer prescribing

These prototypes were finalised by March 2023 and presented to the NICE board on digital living guidelines. They will now inform how NICE will develop an automated dashboard to understand how NICE can be part of a system that continually learns from data. While still to be decided these automated dashboards will likely focus on antenatal care and mental health care.

In addition to these larger scale projects there have been ad hoc requests on:

• Community dispensing data on prescribing of several classes of diabetes medicines. Medicine classes included: DPP4-Inhibitors, GLP-1 mimetics, SGLT2-inhibitors, Sulfonylureas, Metformin and pioglitazone. These supported the development of guideline on type 2 diabetes in adults: management

• A&E attendances for head injury to support the development of NICE guideline on head injury.

For 2023/24 NICE will continue to develop the NICE automated measurement framework expanding to areas like maternity as well as continue to develop the NICE EVA programme as outlined in the outputs section, with a large focus on mental health. These areas will ensure NICE track the uptake of NICE guidance, and update it where required, as well as make innovate products available to patients as quickly as possible.

The National Institute for Health and Care Excellence (NICE) was established in 1999 and then as a non-departmental public body in the Health and Social Care Act in 2012. The statutory role and responsibilities are set out in the 2013 Regulations of the Health and Social Care Act.

Over the past 22 years NICE has established itself as an international leader in technology evaluation, guideline development and evidence synthesis. The work today spans three ecosystems (life sciences, guidelines, and information) that involve close working with partners to ensure patients have access to the latest technologies, advice and guidance. In 2021, NICE published a new strategy that sets out its strategic priorities for the next 5 years. This strategy sets out how NICE will:

a. Be at the forefront of anticipating and rapidly evaluating new and existing technologies to provide independent, world-leading assessments of value for the system and improved access for patients.

b. Provide dynamic, living guideline recommendations that are useful, useable and rapidly updated. NICE will incorporate the latest evidence and newly recommended technologies to maximise uptake and access for patients.

c. Drive the implementation of NICEs guidance, forming key strategic partnerships to make sure it’s used. NICE will make sure it delivers improvements and contributes to reducing inequalities, with measures to routinely track adoption.

d. Be scientific leaders, driving the research agenda and developing innovative and data-driven methods. NICE will use real-world data to resolve issues of uncertainty and improve access to new innovations for patients (though research is not the subject of this agreement).

e. Transform NICEs organisation to make sure NICE have the infrastructure, skills and capacity to deliver their strategy. NICE will leverage the use of technology to maximise our efficiency and impact.

As the responsible organisation for collecting, transporting, storing, analysing and disseminating the nation’s health and social care data; NHS Digital can help NICE to achieve their goals. This draws on the strengths of both organisations and enhances the contribution each make for the benefit of NICEs users. Part of this agreement included a joint strategic objective to work in partnership to drive relevant and timely access to NHS Digital’s Trusted Research Environment (TRE). This supports NICEs strategy by providing data that is linked, covers the full care pathway, involves new collections, has sufficient coverage and is of good quality.

Any data accessed under the arrangements of this agreement will be used for purposes relating to the provision of healthcare or the promotion of health in line with the requirements of the Health and Social Care Act 2012 as amended by the Care Act 2014. In addition, COVID-19 datasets and HES/deaths/NHSBSA datasets will also be accessed for specific COVID-19 purposes, such as the development of COVID-19 guidelines.

The legal basis for processing personal data for this purpose data at NICE falls under Article 6(1)(e) of the General Data Protection Regulations (GDPR), i.e., “a task carried out in the public interest”. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”. The processing of data for this study is a task of public interest as it may help to inform NICEs evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance.

The GPES Data for Pandemic Planning and Research (COVID-19) and Electronic Prescribing and Medicines Administration (EPMA) data in Secondary Care for COVID-19 datasets and any HES/mortality data/NHS BSA data they are linked to can only be used for COVID-19 purposes.

NICE are the sole data controller for this work and will also process data, NHS Digital are listed as a data processor as NHS Digital substantive employees can access the data in the same way as NICE users to ensure they can assist TRE users (data wranglers). Only substantive employees of NICE will have access to the data in the TRE shared under this agreement.

Existing TRE users will migrate to the Secure Data Environment (SDE). SDE is a data storage and access platform that enables approved users to access de-identified data and analytical tools for approved projects. Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this Agreement. Users can request that aggregated outputs are exported from the system following approval by trained NHSD staff. The access and use of the system is fully auditable, and all users must comply with the use of the data as specified in this Agreement.

Work using data from the TRE/SDE will be continuous, and the exact data that is required will be dependent on referrals to NICE. The data will not be used for research purposes and will instead be used for service evaluation as described in the HRA toolkit:

- Designed and conducted solely to define or judge current care.

- Designed to answer: “What standard does this service achieve?”

- Measures current service without reference to a standard.

- Involves an intervention in use only. The choice of treatment, care or services is that of the care professional and patient/service user according to guidance, professional standards and/or patient/ service user preference.

-Usually involves analysis of existing data but may also include administration of interview(s) or questionnaire(s).

- No allocation to intervention: the care professional and patient/ service user have chosen intervention before service evaluation.

- No randomisation.

The data accessed under this agreement will be used by NICE:

- during the scoping, development and review of guidance, standards and indicators;

- to resolve issues of uncertainty and improve access to new innovations for patients;

- assess the impact of NICE's products

- to develop guidance tools.

For the duration of this agreement there are expected to be several different outputs. What these outputs will be depends on referrals to NICE as well as company submissions in the case of medicines. However, NICE will always publish how data has been used on their website, and how evidence sources are used (such as data from the TRE/SDE) will be listed alongside their guidelines - https://www.nice.org.uk/about/what-we-do/into-practice/measuring-the-uptake-of-nice-guidance/impact-of-guidance

In 2021, NICE performed 40 data requests which informed NICE products. Since access to the TRE was established in June 2022, NICE have used data in the development of 4 prototypes for an automated measurement framework on breast cancer. These are long term projects which are expected to deliver am automated measurement framework for our living guidelines in April 2023. NICE's automated measurement framework, will automatically provide uptake data to the digital living guidelines team, enabling them to rapidly update their guidelines on breast cancer by providing real world evidence. From April 2023 further development in this area will focus on new topics such as maternity services, which will be supported by access to MSDS data. This is especially important for maternity where it is difficult to recruit to and conduct trials.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The following benefits have already been realised from accessing HES data within the NHS Digital DAE (under DARS-NIC-11302-Q1L1F).

- Hospital Episodes Statistics

NICE has used HES data in development of its guidance tools and in particular resource impact assessment tools. These explore the costing of NICE recommendations to establish the financial impact on the NHS, Local Authorities and individual providers. These tools help the organisations involved to plan the implementation of evidence-based guidance which helps to improve health and social care. NICE used HES data to support an impact statement for NICE technology appraisal guidance: Avatrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure (TA626). By using the data to inform committee discussions NICE were able to come to the conclusion that NICE did not expect the guidance to have a significant impact on resources; that is, the resource impact of implementing the recommendations would be less than £5 million per year in England (or £9,0000 per 100,000 population).

Since access to the TRE was established in June 2022, NICE have used data in the development of 4 prototypes for an automated measurement framework on breast cancer. These prototypes are assessing the uptake of NICE's guideline on breast cancer. As these develop, they will inform NICE's automated measurement framework, which will automatically provide uptake data to their digital living guidelines team, enabling them to rapidly update their guidelines on breast cancer. So far the prototypes have focused on the following:

• Sentinel Node Biopsy

• Breast reconstruction

• Hormone replacement therapy

• Breast cancer prescribing

These prototypes are due be finalised by March 2023.

In addition to these larger scale projects there have been ad hoc requests on:

• Community dispensing data on prescribing of several classes of diabetes medicines. Medicine classes included: DPP4-Inhibitors, GLP-1 mimetics, SGLT2-inhibitors, Sulfonylureas, Metformin and pioglitazone. These supported the development of guideline on type 2 diabetes in adults: management

• A&E attendances for head injury to support the development of NICE guideline on head injury.

The National Institute for Health and Care Excellence (NICE) was established in 1999 and then as a non-departmental public body in the Health and Social Care Act in 2012. The statutory role and responsibilities are set out in 2013 Regulations.

Over the past 22 years NICE has established itself as an international leader in technology evaluation, guideline development and evidence synthesis. The work today spans three ecosystems (life sciences, guidelines, and information) that involve close working with partners to ensure patients have access to the latest technologies, advice and guidance. In 2021, NICE published a new strategy that sets out its strategic priorities for the next 5 years. This strategy sets out how NICE will:

a. Be at the forefront of anticipating and rapidly evaluating new and existing technologies to provide independent, world-leading assessments of value for the system and improved access for patients.

b. Provide dynamic, living guideline recommendations that are useful, useable and rapidly updated. NICE will incorporate the latest evidence and newly recommended technologies to maximise uptake and access for patients.

c. Drive the implementation of NICEs guidance, forming key strategic partnerships to make sure it’s used. NICE will make sure it delivers improvements and contributes to reducing inequalities, with measures to routinely track adoption.

d. Be scientific leaders, driving the research agenda and developing innovative and data-driven methods. NICE will use real-world data to resolve issues of uncertainty and improve access to new innovations for patients (though research is not the subject of this agreement).

e. Transform NICEs organisation to make sure NICE have the infrastructure, skills and capacity to deliver their strategy. NICE will leverage the use of technology to maximise our efficiency and impact.

As the responsible organisation for collecting, transporting, storing, analysing and disseminating the nation’s health and social care data; NHS Digital can help NICE to achieve their goals. This draws on the strengths of both organisations and enhances the contribution each make for the benefit of NICEs users. Part of this agreement included a joint strategic objective to work in partnership to drive relevant and timely access to NHS Digital’s Trusted Research Environment (TRE). This supports NICEs strategy by providing data that is linked, covers the full care pathway, involves new collections, has sufficient coverage and is of good quality.

Any data accessed under the arrangements of this agreement will be used for purposes relating to the provision of healthcare or the promotion of health in line with the requirements of the Health and Social Care Act 2012 as amended by the Care Act 2014. In addition, COVID-19 datasets and HES/deaths/NHSBSA datasets will also be accessed for specific COVID-19 purposes, such as the development of COVID-19 guidelines.

The legal basis for processing personal data for this purpose data at NICE falls under Article 6(1)(e) of the General Data Protection Regulations (GDPR), i.e. “a task carried out in the public interest”. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”. The processing of data for this study is a task of public interest as it may help to inform NICEs evidence-based guidance that ensures the health and care system and more importantly patients have access to the latest technologies, advice, and guidance.

The GPES Data for Pandemic Planning and Research (COVID-19) and Electronic Prescribing and Medicines Administration (EPMA) data in Secondary Care for COVID-19 datasets and any HES/mortality data/NHS BSA data they are linked to can only be used for COVID-19 purposes.

NICE are the sole data controller for this work and will also process data, NHS Digital are listed as a data processor as NHS Digital substantive employees can access the data in the same way as NICE users to ensure they can assist TRE users (data wranglers). Only substantive employees of NICE will have access to the data in the TRE shared under this agreement.

Work using data from the TRE will be continuous, and the exact data that is required will be dependent on referrals to NICE. The data will not be used for research purposes and will instead be used for service evaluation as described in the HRA toolkit:

- Designed and conducted solely to define or judge current care.

- Designed to answer: “What standard does this service achieve?”

- Measures current service without reference to a standard.

- Involves an intervention in use only. The choice of treatment, care or services is that of the care professional and patient/service user according to guidance, professional standards and/or patient/ service user preference.

-Usually involves analysis of existing data but may also include administration of interview(s) or questionnaire(s).

- No allocation to intervention: the care professional and patient/ service user have chosen intervention before service evaluation.

- No randomisation.

The data accessed under this agreement will be used by NICE:

- during the scoping, development and review of guidance, standards and indicators;

- to resolve issues of uncertainty and improve access to new innovations for patients;

- assess the impact of NICE's products

- to develop guidance tools.

For the duration of this agreement there are expected to be several different outputs. What these outputs will be depends on referrals to NICE as well as company submissions in the case of medicines. However, NICE will always publish how data has been used on their website, and how evidence sources are used (such as data from the TRE) will be listed alongside their guidelines - https://www.nice.org.uk/about/what-we-do/into-practice/measuring-the-uptake-of-nice-guidance/impact-of-guidance

In 2021 NICE performed 40 data requests which informed NICE products. NICE expect this to increase in 2022 as key part of NICE's 5 year strategy is to use data in a more dynamic way, ensuring it is used more routinely in the development of our products, for example in the use of innovative medicines fund and access pathways, as well as being able to use new COVID data sources to inform our rapid COVID-19 guidelines.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The following benefits have already been realised from accessing HES data within the NHS Digital DAE (under DARS-NIC-11302-Q1L1F).

- Hospital Episodes Statistics

NICE has used HES data in development of its guidance tools and in particular resource impact assessment tools. These explore the costing of NICE recommendations to establish the financial impact on the NHS, Local Authorities and individual providers. These tools help the organisations involved to plan the implementation of evidence-based guidance which helps to improve health and social care. NICE used HES data to support an impact statement for NICE technology appraisal guidance: Avatrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure (TA626). By using the data to inform committee discussions NICE were able to come to the conclusion that NICE did not expect the guidance to have a significant impact on resources; that is, the resource impact of implementing the recommendations would be less than £5 million per year in England (or £9,0000 per 100,000 population).