NHS Digital Data Release Register - reformatted

Renal Registry projects

2 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).


Commissioning through Evaluation (CtE) Rituximab for Idiopathic Membranous Nephropathy (IMN) — DARS-NIC-386376-Z1H5J

Opt outs honoured: Anonymised - ICO Code Compliant (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: (Charity)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2021-09-20 — 2024-09-19

Access method: One-Off

Data-controller type: NHS ENGLAND (QUARRY HOUSE), THE RENAL ASSOCIATION

Sublicensing allowed: No

Datasets:

  1. Civil Registration (Deaths) - Secondary Care Cut
  2. Emergency Care Data Set (ECDS)
  3. HES:Civil Registration (Deaths) bridge
  4. Hospital Episode Statistics Accident and Emergency
  5. Hospital Episode Statistics Admitted Patient Care
  6. Hospital Episode Statistics Critical Care
  7. Hospital Episode Statistics Outpatients

Objectives:

The Commissioning through Evaluation (CtE) programme ‘Rituximab for the treatment of idiopathic membranous nephropathy (IMN) in adults’ has been commissioned to help NHS England (NHSE) decide whether to routinely commission rituximab and its biosimilars for the treatment of IMN. Currently in the UK, rituximab is only prescribed for IMN patients for whom all other options of immunosuppressive treatment have failed, or there is a contraindication for prescribing them.

Membranous nephropathy (MN) occurs when the small blood vessels in the kidney, which filter wastes from the blood, become damaged and thickened, this causes proteins to leak from the damaged blood vessels into the urine. MN has been identified as a leading cause of nephrotic syndrome (NS) in adults, these are a group of symptoms that signify that the kidneys are not functioning properly. If an underlying cause is not identified, the disorder is termed idiopathic (a term used for diseases with an unknown cause). The traditional treatment of MN has been shown to increase rates of remission from the disease and slow kidney function loss in patients with persistent NS. However, the side effects, which include increased risk of cancer, are severe. Data from clinical trials on the effectiveness of rituximab for patients with IMN is so far limited, although several trials are currently underway (GEMRITUX, MENTOR and STARMEN), with some promising initial results.

- Gemritux: High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy | American Society of Nephrology (asnjournals.org)
- Mentor: A Multicenter Randomized Controlled Trial of Rituximab versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (MENTOR) - PubMed (nih.gov)
- Starmen: The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy - Kidney International (kidney-international.org)

Clinical outcome data for the IMN patients recruited to the rituximab CtE programme will be collected by the Renal Association through its National Registry of Rare Kidney Diseases (RaDaR). RaDaR is an initiative designed to pull together information from patients with certain rare kidney diseases to develop a better understanding of how these illnesses affect people and to support research into these diseases. RaDaR is operated and governed by the Renal Association, a not for profit organisation registered with the Charity Commission as a membership organisation for healthcare professionals caring for people with kidney disease.

All analyses and the evaluation report will be undertaken by the King’s Technology Evaluation Centre (KiTEC), a NICE external assessment centre (EAC) based at King’s College London.

The Renal Association is applying for Hospital Episode Statistics (HES), ECDS Data (an extension of HES Accident and Emergency Data) and Civil Registration data (hereafter, for ease, collectively referred to as HES/ECDS/CRD) to enable KiTEC to answer the following 4 questions so that NHSE can make its commissioning decision:

1. How often is re-treatment with rituximab and its biosimilars necessary for people with IMN to maintain partial or complete remission and what is the timing of the treatment, when needed?
2. Does treatment of people with IMN with rituximab and its biosimilars for the clinical indication covered by the CtE rituximab protocol result in fewer hospitalisations in comparison with best supportive care?
3. Does the use of rituximab and its biosimilars for people with IMN for the clinical indication covered by the CtE rituximab protocol present different safety issues from their established uses?
4. What is the actual cost and relative cost effectiveness of treatment of people with IMN with rituximab and its biosimilars for the clinical indication covered by the CtE rituximab protocol?

For processing of general categories of personal data, the CtE rituximab programme relies on article 6(1)(f) legitimate interests – the legitimate interests of the rare kidney health and social care services in England to provide high standards of care to patients with IMN. Some patients with IMN are not suitable or do not respond to conventional treatments. In the UK, rituximab is not currently licensed for use for people with IMN. If the CtE programme for rituximab can provide evidence of the effectiveness of rituximab and its biosimilars and that it’s safe to use, NHS England may routinely fund rituximab for patients with IMN. This will open up another treatment against IMN, which would be especially important for those people with IMN who do not respond well to currently available treatments.

For processing of special category personal data, the CtE rituximab programme relies on article 9(2)(j) archiving, research, and statistics – processing for scientific evaluation purposes in the public interest. For the purposes of the evaluation function, CtE rituximab relies primarily on the ‘statistical analysis’ portion of the article, because the analysis of the data received from RaDaR is a vital component of the project.

Only aggregate data will be published in the evaluation report and other outputs, with small numbers (cells equalling or less than 5) suppressed where it has been formally assessed by the data processors that the potential risk of re-identification of patients outweighs the potential benefits of publishing the information. This means that there are no moral or ethical issues involved with publishing these data. The risk of harm to the public by the dissemination is negligible. There has been recent research indicating the relationship of rituximab to adverse outcomes in COVID-19 and reduced vaccine efficacy.

Linking the CtE rituximab data to HES/ECDS/CRD data will enable KiTEC to answer the following 4 evaluation questions on behalf of NICE and NHSE:
1. How often is re-treatment with rituximab and its biosimilars necessary for people with IMN to maintain partial or complete remission and what is the timing of the treatment, when needed? – Linkage with HES Outpatients for appointment dates, diagnosis, main speciality etc. is needed to answer this question.
2. Does treatment of people with IMN with rituximab and its biosimilars for the clinical indication covered by the CtE rituximab protocol result in fewer hospitalisations in comparison with best supportive care? – Hospitalisations will be accessed through linkage with HES APC and AE / ECDS datasets.
3. Does the use of rituximab and its biosimilars for people with IMN for the clinical indication covered by the CtE rituximab protocol present different safety issues from their established uses? – Linkage of the Civil Registration data for date and cause of death will assist in providing answers to this question.
4. What is the actual cost and relative cost effectiveness of treatment of people with IMN with rituximab and its biosimilars for the clinical indication covered by the CtE rituximab protocol? – Answering this question requires linkage with HES OP/AE/APC and ACC and ECDS datasets.

The CtE programme was launched in September 2013 and provides funding for a limited number of patients to access medical treatments and technologies not routinely commissioned within the NHS (National Health Service England 2014). Rituximab is one such treatment and the programme spans 2018-2021.

The data for patients recruited to the rituximab CtE programme are collected in the Renal Association’s RaDaR database (until 2021). These data, plus the HES/ECDS/CRD data, will be shared with KiTEC who will link the datasets and then conduct the analyses and write the evaluation report, which will assist NHSE in making its commissioning decision.

The number of patients receiving rituximab as part of the CtE programme was fixed and dependent on the funding available from NHSE.
A total of 52 sites were selected by NHSE to provide rituximab treatment and 190 patients with IMN were recruited to participate in the CtE. All 190 patients were recruited in 39 kidney centres across all regions in England.
The 190 people participating in the rituximab CtE programme are all adults, who are eligible to receive rituximab for the treatment of their IMN at one of the 52 participating kidney centres in England. They have either native or transplanted kidneys.
All consented for their data to be entered onto the CtE register within RaDaR for inclusion in the analyses and evaluation report.

The purpose of the linkage with RaDaR is to enable KiTEC to answer the 4 evaluation questions so that NHSE can decide whether rituximab and its biosimilars should be routinely prescribed to people with IMN.

Data about the patients treated with rituximab in the CtE programme is required, i.e. the 190 adult patients with IMN in England recruited at one of the 52 participating kidney centres in England.

The datasets and data items requested are aligned with the CtE programme's aims and evaluation questions. Recruiting for CtE rituximab patients started in 2018 and finished in 2019, allowing up to 2 years of follow-up (to 2021). The date of IMN diagnosis varies between patients and obtaining hospital information prior to recruitment to the programme is very important to understand hospitalisations and outpatient appointments prior to inclusion in the programme.

• HES Admitted Patient Care, period 2016/17-2020/21. Hospitalisation data will be used to answer the questions about (1) whether treatment with rituximab results in fewer hospitalisations compared with best supportive care (question 2) and (2) actual and relative cost effectiveness of treatment with rituximab (question 4).

• HES Critical Care, period 2016/17-2020/21. Data will be used to answer the question about actual and relative cost effectiveness of treatment with rituximab (question 4).

• HES Outpatients, period 2016/17-2020/21. Outpatient appointments will be used to answer the questions about (1) re-treatment to maintain partial or complete remission and the timing when needed (question 1) and (2) actual and relative cost effectiveness of treatment with rituximab (question 4).

• HES Accident & Emergency Care/ECDS data, period 2016/17-2020/21. Data will also be used to answer the questions about (1) whether treatment with rituximab results in fewer hospitalisations compared with best supportive care (question 2) and (2) actual and relative cost effectiveness of treatment with rituximab (question 4).

• Civil Registration (Deaths) Secondary Care Cut. Data will be used to answer the question about whether rituximab presents different safety issues from its established uses

The HES/ECDS/CRD linkage is required at a patient level so that the cohort of patients can be evaluated for hospitalisations, outpatient appointments, accident & emergencies, death information and critical care.
Patient identifiers that will be shared with NHS Digital for linkage are NHS number, date of birth, sex and postcode. Data returned to the Renal Association from HES/ECDS/CRD will be pseudonymised and will include a HES ID and a study ID.

Recruiting for the CtE rituximab programme started in 2018 and finished in 2019. Patients will be followed-up for up to 2 years. The date of IMN diagnosis varies between patients and getting hospital information prior to recruitment to the CtE rituximab programme that started in 2018 is very important to understand hospitalisations and outpatient appointments prior to recruitment. Data are therefore requested from 2016/17 to 2020/21.

NHS England wants to prospectively evaluate the efficacy of Rituximab in patients with idiopathic membranous nephropathy across renal units nationally, therefore all 52 kidney centres in England were invited by NHS England to take part and recruit patients for the CtE Rituximab programme. 190 patients were recruited in 39 kidney centres across all regions in England.

The CtE rituximab data collection through RaDaR is the most efficient, least intrusive, and most cost-effective way of collecting the data. A linkage with HES/ECDS/CRD is necessary to answer the four evaluation questions because centres recruiting patients are unable to provide the required detailed hospital and death information. Obtaining these data through HES/ECDS/CRD is the least intrusive way to achieve the aims of the CtE rituximab programme.

The cohort of 190 patients recruited for the CtE Rituximab programme will be linked to the HES/ECDS/CRD data. There were strict clinical criteria for patients to be recruited to the CtE and the cohort of 190 recruited patients is from a wide range of age groups. Recruitment for the CtE started in September 2018 and HES data are only requested for 2 years before recruitment to capture prior hospitalisations and relapses to the most recent data at time of linkage.

All data items requested in the HES/ECDS/CRD linkage have been specifically chosen to answer the four evaluation questions described above. The Renal Association have not requested any data items that is not needed. Only pseudonymised Civil registration data relating to the 190 patients has been requested. The fields selected from the Civil Registrations datasets have been limited to only the fields required to meet the objectives of this research such as date of death, place of death, cause of death etc.

The organisations involved with the management and storage of the RaDaR and HES/ECDS/CRD data are the Renal Association, AIMES Management Services and the King’s Technology Evaluation Centre (KiTEC). KiTEC is a collaboration between several King’s College London departments and the Medical Physics Department of Guy’s and St Thomas’ NHS Foundation Trust (GSTT). Their roles are explained below:

RaDaR falls under the Renal Association. Data are processed by the Renal Association and KiTEC. The CtE rituximab data are collected in RaDaR and these data are stored on servers at AIMES Management Services (see processing activities below for the detail). The HES/ECDS/CRD data will also be stored on the Renal Association server at AIMES Management Services prior to secure sharing with KiTEC.

Pseudonymised RaDaR and HES/ECDS/CRD data will be shared securely with KiTEC and the data will be stored on servers at King’s College London. Once transferred, the HES/ECDS/CRD data will be deleted from the Renal Association’s server.

The Renal Association (the legal entity under which RaDaR sits) is the data controller for the RaDaR database and the CtE rituximab data collection. There are 2 processors for the CtE rituximab data collection: RaDaR that falls under the Renal Association and KiTEC. The Renal Association and KiTEC are both data processors for the HES/ECDS/CRD data.

The CtE rituximab programme data will be collected by RaDaR (IMN is one of the rare kidney diseases on RaDaR). Once follow-up is completed, the RaDaR data will be pseudonymised and shared securely with KiTEC. The HES/ECDS/CRD data will also be shared securely with KiTEC. KiTEC will link the 2 datasets and will then be responsible for the analysis and publication of results.

The RaDaR CtE rituximab data are stored on the Renal Association’s server at AIMES Management Services. The HES/ECDS/CRD data will be also be stored at AIMES, albeit on a temporary basis – once they have been sent securely to KiTEC for statistical analysis and evaluation, the HES/ECDS/CRD data will be deleted from AIMES.

The data will not be shared with any other organisation not named in this agreement and the linked RaDaR-HES/ECDS/CRD dataset will not leave the secure servers at KiTEC. Only substantive employees of both organisations (Renal Association and KiTEC) will have access to the data.

The HES/ECDS/CRD data will be stored temporarily at AIMES Management Services until they are sent securely to KiTEC. They will then be deleted and held solely by KiTEC.
CtE rituximab is commissioned by NICE to support NHSE in its CtE programme and summary results will be shared with NHSE and NICE.

The CtE rituximab programme is funded by NHS England and they are a joint data controller but will not process the data. Kidney centres in England were invited by NHSE to participate in the CtE rituximab programme. Those centres that contracted with NHSE to participate in the CtE are funded by NHSE to recruit patients, administer rituximab and provide data of a high completeness and quality to the RaDaR CtE rituximab group. NHSE also provides the funding to RaDaR for the administration of the RaDaR CtE rituximab data. NHSE and commissioners funded this work with the aim of prospectively evaluating the clinical effectiveness of rituximab and its biosimilars in patients with idiopathic membranous nephropathy across kidney units nationally and to assist NHSE in making its commissioning decisions.

Expected Benefits:

Membranous nephritis remains a leading cause of nephrotic syndrome in adults. About one quarter of cases are felt to be secondary to a pre-disposing disease, an infection, or medical therapy. In most other cases, an underlying reason for the lesion is idiopathic (IMN). There are established treatments for IMN. However, none are completely effective, and all have side-effects, some severe, such as increased risk of cancer. Recently, rituximab has surfaced as a potential treatment option for IMN. There is some emerging evidence showing there may be benefit in the use of rituximab for the treatment of IMN. However, there is currently insufficient evidence for NHSE to commission the treatment for the NHS. The key objective of KiTEC is to analyse clinical outcomes data related with rituximab treatment for patients participating to the CtE. It is hoped that this analysis will provide results regarding the clinical effectiveness of rituximab (as well as other outcomes of interest), which will assist NHSE in making its commissioning decision.

NHS England/NICE: It is hoped that the outputs from the rituximab CtE will help NHS England make future commissioning decisions for IMN care and rituximab treatment for IMN across the country and for NICE to consider guidelines for IMN treatment with rituximab.

Some patients with IMN are not suitable or do not respond to conventional treatments. In the UK, rituximab is not currently licensed for use for people with IMN. If the CtE programme for rituximab can provide evidence of the effectiveness of rituximab and its biosimilars and that it’s safe to use, NHS England may routinely fund rituximab for patients with IMN. It is hoped that this will open up another treatment against IMN, which would be especially important for those people with IMN who do not respond well to currently available treatments. It is hoped that by adding another treatment option (rituximab) for IMN would help to improve quality of life or life expectancy of those patients.

This is a prospective multi-centre national database (register) project to obtain the evidence related to rituximab that will address the gap in evidence. Outputs to be produced from the HES/ECDS and mortality linked data are to assist NHSE to evaluate the clinical effectiveness and safety of rituximab treatment and to assist NHSE in making a commissioning decision about rituximab treatment. Ultimately, the research aims to be instructive for clinicians treating IMN patients. The research may also help NICE to consider guidelines for IMN treatment and rituximab. Should the evaluation of rituximab show evidence of benefit to patients, making rituximab available earlier on in the treatment pathway will benefit patient outcome and health. The results of the final analysis are due to be reported and sent to NICE by February 2022.

Outputs:

Outputs to be produced from the HES and mortality linked data are a report to assist NHSE in evaluating the clinical effectiveness and safety of rituximab treatment for IMN patients. This will enable them to make a commissioning decision about rituximab treatment. This report will be made publicly available by NHSE (via their website) originally for public consultation and comments and afterwards as the final policy.

NICE will also use the findings to consider guidelines for IMN treatment and rituximab. NICE will evaluate the summary report produced by KiTEC to consider guidelines for IMN treatment and Rituximab'.

Other outputs are the submission of the summary results to a peer reviewed journal. An academic paper will be published in an open-access high impact nephrology journal on the methodology, analyses and results, including the impact of rituximab on the induction of remission (partial or complete) of nephrotic syndrome and on the decline of kidney function.

KiTEC intends to publish before the end of 2022. They do not plan to publish interim results.
For each paper published, a short presentation will be developed to summarise the findings for a range of stakeholders, including health technology assessment practitioners. Findings may be presented at relevant conferences such as the HTAi Annual Meeting. The KiTEC website will provide links to our open access papers and summaries of findings. Publications will also be listed on individuals’ King’s College London Pure pages.

All outputs will be at the aggregate level with small numbers (cells equalling or less than 5) suppressed. All reports to NHSE will be summary data and NHSE will not receive any patient level data from HES or RaDaR.

There is no scope to exploit the results and outputs beyond what has been described above as the purpose of this project does not result in further intellectual property development.

Processing:

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by "Personnel" (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

To enable linkage of the CtE rituximab patients from RaDaR with HES/ECDS/CRD, personal identifiers for patients in the CtE programme (English kidney patients with IMN) will be securely uploaded by RaDaR to NHS Digital’s Secure Electronic File Transfer (SEFT) data portal. Patient identifiers will be limited to date of birth, NHS number, sex and postcode. The CtE study ID will also be uploaded, but this is an anonymised study ID.

Upon receipt of the CtE rituximab programme patient identifiers, NHS Digital will send back to the Renal Association the agreed clinical and mortality data with patient identifiers removed and the CtE study ID included. The clinical data refers to the ‘Admitted Patient Care (APC)’, ‘Outpatient’, ‘Critical Care’ and ‘AE/ECDS datasets and mortality data to the NHS Digital ‘Civil Registration (deaths)’ dataset, all to be linked by NHS Digital to the cohort of 190 CtE rituximab patients.

Data for the CtE rituximab programme that are collected by RaDaR include demographic data, comorbidities, information about the IMN diagnosis and treatment, blood test results and adverse events. From this database, RaDaR will extract the NHS-number, date of birth, gender, postcode and study-id (anonymous number) for the cohort of 190 recruited patients to upload to NHS Digital’s SEFT platform for linkage. The HES/ECDS/CRD data to be downloaded from SEFT will be for the cohort of 190 patients matched with the requested HES/ECDS/CRD datasets and the CtE study-id, no other patient identifiers.

The HES/ECDS/CRD data downloaded from SEFT by RaDaR will be stored securely on the Renal Association’s servers in the data centre at Aimes Management Services and HES/ECDS/CRD data will be securely transferred (using a secure file exchange platform) to KiTEC. Once KiTEC received the data from RaDaR and proceeded with the analysis, RaDaR will securely delete the HES/ECDS/CRD data from their server. There will be no onward flow of the HES/ECDS/CRD data from RaDaR to any other organisations. RaDaR will share the CtE rituximab RaDaR collected clinical data with KiTEC: all patient identifiers will be removed and the study id included. KiTEC will analyse the HES/ECDS/CRD data and will link it via the study-id with the clinical data collected and shared with them by RaDaR for the CtE rituximab programme. KiTEC will store the HES/ECDS/CRD data securely on King’s College London servers. There will be no onward flow of the HES/ECDS/CRD data from KiTEC to any other organisations.

As detailed above, the Renal Association will upload patient identifiers for those patients in the CtE rituximab programme (NHS number, date of birth, sex, postcode, study id) to NHS Digital. NHS Digital will return clinical information about each patient – the data will be pseudonymised with the study-id included.

The HES/ECDS/CRD data will be stored on the Renal Association’s server at the AIMES Management Services data centre. AIMES Management Services will process the data for backup and storage functions only.

The HES/ECDS/CRD data will then be securely transferred from the Renal Association to KiTEC for analysis. KiTEC will only receive pseudonymised data and all data received will be stored securely. Data will only be accessed by individuals within KiTEC who have authorisation to access the data for the purpose(s) described, all of whom are substantive employees of KiTEC within King’s College London. No HES/ECDS/CRD linked CtE rituximab data will leave the KiTEC servers. All analyses using the HES/ECDS/CRD data will be performed by substantive employees of KiTEC. The NHS Digital data will leave the RA servers when RaDaR securely shares the pseudonymised CtE-HES linked data with KiTEC who will perform the analyses and write the evaluation report

Patients were recruited for the CtE rituximab programme at English hospitals and registered on the RaDaR database by research nurses. Recruitment of CtE rituximab patients has been completed. Hospitals update the information on RaDaR for CtE rituximab with follow-up data. Substantive Renal Association employees validate the data and provide recruiting hospitals with regular reports on quality and completeness of the data at baseline and during follow-up visits. Once follow-up visits are completed and all data collected (estimated May 2021), the database will be closed.

The Renal Association will share RaDaR and HES/ECDS/CRD data with KiTEC who will analyse and produce summary results (aggregated) for the evaluation report which they will share with NHSE and NICE. They will also publish the results in a peer reviewed journal. All results will be checked for any risk for re-identification by ensuring that small numbers rules are adhered to and categories used for reporting don't pose a risk of re-identification of individuals.

To achieve the purpose stated in the previous section (‘Objective for processing’), HES, ECDS and Civil Registration data would be used by KiTEC for patients recruited to the CtE rituximab programme:
• HES Outpatients for appointment dates, diagnosis, main speciality etc. is needed to determine if retreatment is necessary to maintain partial or complete remission and what the timing is of that treatment when needed.
• HES APC and A&E and ECDS datasets will be used to assess if treatment with rituximab results in fewer hospitalisations in comparison with best supportive care.
• Civil Registration data for date and cause of death will be used to provide answers to the question of safety issues around rituximab.
• HES Outpatient, A&E, APC, CC and ECDS datasets will be used to determine the actual and relative cost effectiveness of the rituximab treatment.

The above analyses will be performed only by KiTEC.

Data collected by the Renal Association’s RaDaR for the CtE rituximab programme will be shared with KiTEC. Prior to sharing, the data will be pseudonymised with all patient identifiers removed.

KiTEC will link the CtE rituximab programme clinical data from RaDaR with the HES matched data to be able to answer the questions as detailed above.

Access to patient identifiers is limited to Renal Association staff working directly with the CtE rituximab programme, all of whom are substantive employees of the Renal Association and have been appropriately trained in data protection and confidentiality. KiTEC employees who will analyse the linked data will only have access to pseudonymised data with the study-id. The CtE rituximab programme clinical data from RaDaR will be shared with KiTEC, but this is also pseudonymised data with the study-id and no other patient identifiers.

NHS Digital data will never leave the servers of the Renal Association in the data centre at Aimes Management Services or KiTEC and will only be used in analyses conducted by substantive employees of KiTEC.

First and foremost, the Renal Association and KiTEC do not want to reidentify patients. All data available for analysis by KiTEC are pseudonymised. Results of the analysis by KiTEC will be in the form of aggregated outputs and will be completely anonymised, to be published in academic paper(s) in an open access journal, with small numbers suppressed in line with the HES Analysis Guide. Record level HES and Civil Registration Mortality data will not be released to any external organisation not listed in this application. These approaches and processes ensure that the inadvertent risk of reidentification of patients is extremely low. NHSE will not receive any patient level or any HES/ECDS/CRD data and only summary results in the final report from KiTEC will be shared with them.

The HES, ECDS, and Civil Registration Mortality data will not be matched to publicly available data.

There will be no requirement or attempt to re-identify individuals from HES/ECDS/CRD held data by employees of the Renal Association or KiTEC. The data from NHS Digital will not be used for any other purpose other than that outlined in this agreement.

Record level HES/ECDS mortality data will not be released to any external organisation not mentioned in this agreement.

Only substantive employees of the Renal Association working within RaDaR and who have been appropriately trained in data protection and confidentiality, have access to the data for processing. All analyses involving HES/mortality data will be undertaken by substantive employees of KiTEC who are appropriately trained in data protection and confidentiality.
Both organisations have completed and met the required standards of the Data Security and Protection Toolkit, including staff training.

All data processing will be carried out by substantive employees of KiTEC and RaDaR. All analyses involving HES, ECDS and Civil Registration Mortality data will only be undertaken by substantive employees of KiTEC.

All employees of the Renal Association and KiTEC complete annual training in data protection and confidentiality.

The HES/ECDS/CRD data will be stored on the Renal Association’s server at AIMES Management Servers in a protected folder on the server with the password known only to the Renal Association’s systems administrator.

KiTEC substantive employees will have access to the pseudonymised HES/ECDS/CRD data for analyses. They use a secure working environment. No data are ever stored on desktops or laptops. With the current working from home arrangements, members of the KiTEC team will use a virtual private network (VPN) to access the data on the King’s College London servers for processing. Access to folders is restricted to those members of staff who will do the statistical analysis using the data. All staff have unique log-on details to their laptop and desktop and laptops are encrypted.

All organisations where data is stored are named in the agreement and detailed as above.

The HES/ECDS/CRD data will be stored on the Renal Association’s server at the AIMES Management Services data centre. AIMES Management Services host the physical hardware in a Secure Data centre and provide connectivity. AIMES have ISO27001 certification (UK8000045), NHS IG Data Security and Protection Toolkit Compliance and are a G-Cloud Assured Supplier. The Virtual Machines are backed up to a backup server in a secondary location at the same address on a daily basis. These backups are encrypted with access to the keys limited to the Renal Association’s Systems Team. AIMES Management Services will process the data for backup and storage functions only.

The HES/ECDS/CRD data will also be securely transferred to KiTEC for analysis. KiTEC will only receive pseudonymised data and all data received will be stored securely. All university computers where data will be stored are password protected. The areas where the computers are located have restricted ID protected access. Data will only be accessed by individuals within KiTEC who have authorisation to access the data for the purpose(s) described, all of whom are substantive employees of KiTEC within King’s College London. No HES/ECDS/CRD linked CtE rituximab data will leave the KiTEC servers. All analyses using the data will be performed by substantive employees of KiTEC. NHSE will not receive any patient level or any HES/ECDS/CRD data and only summary results in the final report from KiTEC will be shared with them.