Good TREs work
National Institute For Health And Care Excellence (nice) projects
- TRE - NICE (partially via "system access")
- Access to NHS Digital Portal (formerly HDIS) (partially via "system access")
282 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
TRE - NICE — DARS-NIC-610798-N0G8Z
Type of data: information not disclosed for TRE projects
Opt outs honoured: Anonymised - ICO Code Compliant, Identifiable (Does not include the flow of confidential data)
Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 - s261(5)(d), Health and Social Care Act 2012 s261(2)(a)
Purposes: No (Agency/Public Body)
Sensitive: Non-Sensitive
When:DSA runs 2022-04-01 — 2023-03-31 2022.12 — 2024.11.
Access method: System Access, Ongoing, One-Off
(System access exclusively means data was not disseminated, but was accessed under supervision on NHS Digital's systems)
Data-controller type: NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE (NICE)
Sublicensing allowed: No
Datasets:
- Civil Registration - Deaths
- Electronic Prescribing and Medicines Administration (EPMA) data in Secondary Care for COVID-19
- GPES Data for Pandemic Planning and Research (COVID-19)
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Admitted Patient Care
- Hospital Episode Statistics Critical Care
- Hospital Episode Statistics Outpatients
- Medicines dispensed in Primary Care (NHSBSA data)
- MSDS (Maternity Services Data Set) v2.0
- Civil Registrations of Death
- COVID-19 Electronic Prescribing and Medicines Administration (ePMA) in Secondary Care
- COVID-19 General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR)
- Hospital Episode Statistics Accident and Emergency (HES A and E)
- Hospital Episode Statistics Admitted Patient Care (HES APC)
- Hospital Episode Statistics Critical Care (HES Critical Care)
- Hospital Episode Statistics Outpatients (HES OP)
- Maternity Services Data Set (MSDS) v2
- Improving Access to Psychological Therapies (IAPT) v2
- Mental Health Services Data Set (MHSDS)
Objectives:
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 its 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 nations 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 Digitals 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.
Yielded Benefits:
Expected Benefits:
Data made available for the TRE 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 will be able to achieve our 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. Theyll incorporate the latest evidence and newly recommended technologies to maximise uptake and access for patients.
c. Drive the implementation of our guidance, forming key strategic partnerships to make sure its used. Well 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. Well 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 our organisation to make sure we have the infrastructure, skills and capacity to deliver our strategy. Well leverage the use of technology to maximise our efficiency and impact.
The impact of NICE guidance can be found here: https://www.nice.org.uk/about/what-we-do/into-practice/measuring-the-uptake-of-nice-guidance.
Outputs:
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.
Access to NHS Digital Portal (formerly HDIS) — DARS-NIC-11302-Q1L1F
Type of data: information not disclosed for TRE projects
Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant (Does not include the flow of confidential data)
Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 s261(2)(b)(ii)
Purposes: No (Agency/Public Body)
Sensitive: Non Sensitive, and Non-Sensitive
When:DSA runs 2019-08-01 — 2020-07-31 2017.09 — 2024.11.
Access method: Ongoing, System Access
(System access exclusively means data was not disseminated, but was accessed under supervision on NHS Digital's systems)
Data-controller type: NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE (NICE)
Sublicensing allowed: No
Datasets:
- Hospital Episode Statistics Admitted Patient Care
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Outpatients
- Hospital Episode Statistics Critical Care
- Hospital Episode Statistics Accident and Emergency (HES A and E)
- Hospital Episode Statistics Admitted Patient Care (HES APC)
- Hospital Episode Statistics Critical Care (HES Critical Care)
- Hospital Episode Statistics Outpatients (HES OP)
Objectives:
The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing evidence-based guidance on health and social care. NICE guidance, standards and other resources help health, public health and social care professionals deliver the best possible care within the resources available.
Hospital Episode Statistics (HES) are used for the following:
- during the scoping of guidance and standards;
- at review; and
- to develop resource impact assessment tools for commissioners/and providers.
The data is used to evaluate activity both prior to and following publication of guidance/standards e.g. when developing guidance or deciding if it should be reviewed.
This data allows NICE to establish current activity levels in the NHS and enables the resource impact of implementing guidance to be established with increased precision.
NICE uses HES data during the development of general practice and CCG level indicators. This is work jointly completed by NICE and NHS Digital on behalf of NHS England. These indicators provide clear, comparative information about the quality of health services and may be included in national frameworks such as the QOF, CCGOIS and CCGIAF.
Extract data at a national level but may need local level data for highly specialised technologies (small numbers of people) or for work associated with the cancer drugs fund.
Data will only 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.
Yielded Benefits:
1. Use of data to support implementation tools for NICE guideline: Heavy menstrual bleeding: assessment and management (NG73) Benefits: NICE produces reports, templates and statements alongside guidance. They detail the potential impact of implementing guidance on NHS finances and other resources (workforce, capacity and demand, infrastructure and training and education). The resource impact statement sets out the implementation of this guidance has the potential to generate costs savings through reduced emergency department admissions. 2. Use of data to support implementation tools for NICE guideline: Pancreatic cancer in adults: diagnosis and management (NG85) Benefits: NICE produces reports, templates and statements alongside guidance. They detail the potential impact of guidance on finances and other resources (workforce, capacity and demand, infrastructure and training and education). The resource impact statement sets out the implementation of this guidance has the potential to generate costs savings through reduced number of pancreatectomies.
Expected Benefits:
Evidence based guidance has clear benefits for the Health and Social Care sectors and for patients. The benefits of using the data extend beyond the term of the proposed contract.
The uptake and impact of NICE guidance can be found here: https://www.nice.org.uk/About/What-we-do/Into-practice/Measuring-the-uptake-of-NICE-guidance. Measuring the impact of NICE guidance is complicated as many other factors also contribute to patient outcomes.
Examples of benefits achieved using HDIS
NICE uses HDIS HES data to support the development and implementation of NICE Guidance and Quality Standards in the following ways:-
HES data are used to provide the NHS with information to help them understand the resource impact of implementing NICE guidance. NICE also uses the data to develop evidence based guidance. The data are used to understand the population likely to benefit from the introduction of new medicines and technologies.
The following are two specific examples to illustrate how NICE uses this data:
1. Use of data to support implementation tools (NICE guidelines [NG59])
Output: Resource impact statement published November 2016
https://www.nice.org.uk/guidance/ng59/resources/resource-impact-statement-2726444413
The number of finished consultant episodes (FCEs), by age and gender, was extracted to establish how many spinal fusion procedures were completed for people with a diagnosis of lower back pain. The data were used to confirm low levels of activity and consequently the associated cost impact would not be significant.
Summary statistics:
At a national level the data were used to estimate the number of people undergoing a spinal fusion with a diagnosis of lower back pain. The number of FCEs by age and gender were used by NICE’s resource impact assessment team to calculate the population likely to be affected by the guideline.
Published:
The resource impact statement has been published on the NICE website and does not contain any data. The statement is freely available (see link above).
Benefits:
NICE produces reports, templates and statements alongside our guidance. They detail the potential impact of guidance on finances and other resources (workforce, capacity and demand, infrastructure and training and education. Health and care organisations (NHS trusts and commissioners) will be aware that implementation of this guidance has the potential to generate costs savings, although they are not expected to be significant.
2. Use of data to support the development of a quality standard statement (NICE quality standard [QS152])
Output: Minutes October 2016, advisory committee decisions: https://www.nice.org.uk/guidance/qs152/documents/minutes
Aggregated data taken from the resource impact assessment tool for NG50, originally extracted from HDIS, were used to estimate the number of people who had an unplanned admission related to cirrhosis/fibrosis of the liver, excluding alcoholic fibrosis or cirrhosis, and who underwent a procedure (OPCS codes extracted).
Summary statistics:
At a national level the data were used to estimate the number of admissions for cirrhosis/fibrosis and of those the number expected to undergo a procedure. The data were used to confirm a low level of activity relative to the potential number of people who might be screened in primary care for liver disease.
Published:
A high level summary of the committee discussion was published. The minutes of the meeting do not reference the use of HES data but are freely available.
Benefits:
NICE quality standards set out the priority areas for quality improvement in health and social care. They cover areas where there is variation in care. Each standard gives a set of statements to help improve quality and information on how to measure progress. NICE quality standards are used by primary and secondary care providers, local authorities and social care providers. The identification of liver disease in primary care was not selected as priority area for quality improvement. Specifically, for adults, the committee felt that there was a lack of specific guideline recommendations to support a quality statement and it was therefore reluctantly agreed that there could not be a quality statement about identifying NAFLD in higher-risk groups. The data helped to explain the resource impact of testing for liver disease in primary care relative to those who would require an intervention.
Outputs:
The data is being used for the development of guidance/standards that: are independent and authoritative, are based on the best available evidence and set out the best ways to prevent, diagnose and treat disease and ill health, promote healthy living, and care for vulnerable people.
The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. HES data are used during guidance development and to produce tools to support its implementation.
Users of HDIS are able to produce outputs from the system in a number of formats. The system has the ability to be able to produce small row count extracts for local analysis in Excel or other local analysis software.
Users are also able to produce tabulations, aggregations, reports, charts, graphs and statistical outputs for viewing on screen or export to a local system. Any outputs that are produced from the system that are to be published or shared will be small number suppressed outputs in line with the HES analysis guide. Users are not permitted to link data extracted from the system to any other data items which make the data identifiable.
The results are provided to teams within NICE responsible for guidance/standard/indicator development. They are also discussed by guidance/indicator developing committees. Key documents used during the development of guidance/standards are published on NICE’s website. Only data in a format suitable for publication will be presented. These documents are available free of charge to the public.
Outputs will contain only aggregate level of data and small numbers suppressed in line with the HES analysis guide/ small numbers policy.
NICE publishes new guidance throughout the year and so this work is on-going.
HES data is also used by NICE’s indicator development team during the development phase of QOF and CCG OIS indicators. This is work jointly undertaken by NICE and the NHS Digital, and is funded by NHS England. The data are discussed at indicator development committees but only once the small numbers policy has been applied (see above).
Processing:
The data will be extracted from HDIS in an aggregated form and shared with guidance, guideline, indicator and tool developing teams within NICE. The data is shared using a secure distribution method (NICE Share is a HTTPS file sharing application based on Microsoft IIS. All communication is encrypted using HTTPS and authentication is required for any file access).
The data will be used to: assess current activity levels in the NHS, in cost effectiveness analysis (economic modelling) and to cost the implementation (resource impact assessment) of NICE guidance.
All data extracted from HDIS which includes small number are stored in network folders which have restricted access. The HDIS database and any extracted aggregate data which includes small numbers will only be access using the NICE network through desktop PCs. Any data held temporarily on portable equipment must be supported by a business case and must be encrypted to a minimum of AES25.
To complete trend analysis NICE require access to the last five years of data. Analysis of the last full five years data enables patterns and trends to be established and allows NICE to assess the level of need/cost with increased precision.
The data extracted from HDIS is compared to other datasets at a national level (England) e.g. prescribing data in the Innovation Scorecard. No data will be linked to record level patient data.
The majority of the data extracted from HDIS is at a national level (England) however access to local level data (CCG or trust) is sometimes needed when developing resource impact assessment tools or during the scoping of guidance to establish if there is variation in practice across the country (England).
Access to pseudonymised record level data is essential when considering guidance for rare conditions/diseases, as they often affect very small numbers of people.
NICE has offices in Manchester and London, and the data extracted from HDIS will be stored and accessed using servers based onsite in these locations; each server is a mirror of the other. The security arrangements and policies are the same for both locations. HDIS is only accessed by Manchester based staff.
Record level data will not be extracted from the database. All extracts taken from the database will be aggregate level which may contain small numbers.
Data in format suitable for publication, after the small numbers policy has been applied (in line with the HES analysis guide) are shared with committee members. All committee members have signed confidentiality agreements.
Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guide.