National Joint Registry - renewal

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

Objective for processing

​​The Data will be used for the purpose of a research programme: the National Joint Registry [1 paragraph unchanged] This agreement has a Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. [1 paragraph unchanged] The following NHS England data will be accessed: Hospital Episodes Statistics (HES) • Admitted Patient Care – necessary to monitor compliance with the mandatory requirement for NHS England Trusts to submit details of hip, knee, shoulder, elbow, and ankle joint replacement procedures. The HES data also enables the NJR to be able to identify outsourced procedures and then calculate and report accurate rates of compliance for each Trust and hospital The level of the data will be: • Pseudonymised The data will be minimised as follows: • Limited to the specific conditions or related conditions to the joint conditions of interest. • Limited to conditions relevant to the audit identified by specific OPCS4 codes related to the joint replacement procedures recorded by the NJR. This includes the method of admission, the episode end and start date, the date that the operation took place, and the provider and site codes. The procedure codes (OPCS4) are limited to those primary and revision hip, knee, ankle, elbow, and shoulder joint replacement procedures recorded by the NJR. NHS England and Healthcare Quality Improvement Partnership (HQIP) are joint controllers as the organisations responsible for ensuring that the data will only be processed for the purpose described above. The HES data will only contain data for those patients treated in England. [2 paragraphs unchanged] The data is updated quarterly with a fifth ‘cleaned’ annual data file provided six months after the end of the preceding financial year. 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. . HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance. The NJR is funded by a subscription on NHS trusts and health boards, independent sector healthcare providers, and the suppliers and manufacturers of orthopaedic devices. Funding is specifically for the audit described. NEC Software Solution s is a processor acting under the instructions of HQIP. NECSWS role is limited to data collection, data management and reporting services. [1 paragraph unchanged] Data will be accessed by- • NEC Software Solutions • NHSE Trust staff

Processing activities

[1 paragraph unchanged] NHS England data will provide the relevant records from the HES APC to NECSWS. The data will contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient. · contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient. [3 paragraphs unchanged] The data Data will be accessed by authorised personnel via remote access. The data will remain on the servers at NTT Global Data Centers at all times. The data will not leave England at any time. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. Access is restricted to employees or agents of NECSWS who have authorisation from HQIP. For remote access: All personnel accessing the data have been appropriately trained in data protection and confidentiality. • Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA. The data will not be linked with any other data. • Access controls granting users the minimum level of access required are in place. There will be no requirement and no attempt to reidentify individuals when using the data. • Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data. Analysts from NECSWS will analyse the data for the purposes described above. • Multifactor authentication (MFA) is required for remote access. In order to accurately determine the outcomes of joint replacement surgery it is necessary to ensure that rates of compliance with the NJR remains as high as possible (95% target rate). The HES data provided enables the NJR to monitor the compliance rates of Trusts and hospitals within NHS England. High compliance rates give greater confidence in the calculation of outcomes of joint replacement surgery, both nationally and by Trusts. • Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access. Best Practice Tariff indicators relate to the rates of compliance for primary joint replacement procedures and unknown consent. A new indicator was introduced in 2019 relating to the rate of cemented and hybrid total hip replacements in patients over 70 years of age. • All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. Any historical flows of NHS England data that were approved under earlier versions of this agreement have been destroyed. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). The Data will not be linked with any other data outside of this agreement.

Expected output

The NJR is an ongoing clinical audit that has no planned end date. Compliance rates are published in a number of places at different times of the year. These include: The expected outputs of the processing will be: [8 paragraphs unchanged] All The outputs from use of the data will be based on not contain NHS England Data and will only contain aggregated data and any information with small numbers will be suppressed as appropriate in line with the HES analysis guide. relevant disclosure rules for the dataset(s) from which the information was derived.

Expected measurable benefits

[1 paragraph unchanged] The use of the data could- could: [5 paragraphs unchanged]

Benefits reported

Monitoring The use of the data to monitor and reporting report on compliance with the NJR ensures NJR, a mandatory data collection for NHS England providers, continues to ensure that case ascertainment levels remain high and high. This has ensured that the NJR can has the necessary quality of data to accurately measure the outcomes of joint replacement surgery. Measuring The measurement of the outcomes of joint replacement surgery improves is essential for providing continuous improvement to both patient safety and patient outcomes. The NJR has also provides continued to provide information to NHS NJR trusts to enable them so that they are able to monitor compliance with Best Practice Tariff targets for primary hip and knee joint replacement surgery and for the rates of patient consent. This reporting ensures report has not only ensured that trusts are do not remain financially disadvantaged. disadvantaged, but has also improved the quality of HES submissions in some trusts, particularly with regard to actual location of where the surgery took place. In many cases, the location of sub-contracted surgery was not recorded and the NJR would report low rates of compliance for the trust. This has led to an improvement in the quality of data available in HES.

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

Objective for processing

The National Joint Registry (NJR) is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England (NHSE) as part of the Clinical Audit and Patient Outcomes Programme (NCAPOP). (NHSE). The purpose of the National Joint Registry for England, Wales, Northern Ireland, [18 words unchanged] order to provide an early warning of issues relating to patient safety. This agreement has a Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. The NCAPOP is a large programme of circa 35 projects consisting of National Clinical Audits. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP jointly with HQIP as together both organisations determine the purposes and means of processing. The aim of the programme is to improve the quality of outcomes and ensure the quality and cost effectiveness of joint replacement surgery., The NJR monitors and reports on outcomes, and supports and enables related research. The NJR has collected data continuously since 1 April 2003 and has no planned end date. NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs. The following NHS England data will be accessed: NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties. Hospital Episodes Statistics (HES) Legal Basis Justification: • Admitted Patient Care – necessary to monitor compliance with the mandatory requirement for NHS England Trusts to submit details of hip, knee, shoulder, elbow, and ankle joint replacement procedures. The HES data also enables the NJR to be able to identify outsourced procedures and then calculate and report accurate rates of compliance for each Trust and hospital HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "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". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services. The level of the data will be: • Pseudonymised The data will be minimised as follows: • Limited to the specific conditions or related conditions to the joint conditions of interest. • Limited to conditions relevant to the audit identified by specific OPCS4 codes related to the joint replacement procedures recorded by the NJR. This includes the method of admission, the episode end and start date, the date that the operation took place, and the provider and site codes. The procedure codes (OPCS4) are limited to those primary and revision hip, knee, ankle, elbow, and shoulder joint replacement procedures recorded by the NJR. NHS England and Healthcare Quality Improvement Partnership (HQIP) are joint controllers as the organisations responsible for ensuring that the data will only be processed for the purpose described above. The HES data will only contain data for those patients treated in England. Apart from reporting on case ascertainment (measuring levels of submission from NHS Trusts) and being able to monitor data quality, the NJR also provides quarterly reports to the Quality, Improvement, Production, and Prevention (QIPP) programme that are for the Orthopaedic Best Practice Tariff (BPT). These reports are available to both QIPP and Trusts in NHS England. The data also enables the Identification of Contracted out Procedures. Many acute Trusts contract out joint replacement surgery to the independent sector and details of these procedures will be submitted to the NJR by the independent hospital undertaking the surgery. Because details of these procedures will still be submitted to HES for financial recovery, it leads to higher HES submissions than NJR submissions from Trusts resulting in inaccurate, lower rates of compliance with the NJR. The data is updated quarterly with a fifth ‘cleaned’ annual data file provided six months after the end of the preceding financial year. 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. . [2 paragraphs unchanged] The NJR was established in 2002 by the Department of Health following a National Audit Office (NAO) report into the higher than expected failure rate of the 3M hip replacement device. The NAO report concluded that, had a national register of hip replacements been in existence, the failure rate would have been detected earlier. Earlier identification would have meant less patients were affected and the costs of revision surgery for the NHS would have been considerably less. The NJR went live in April 2003. Since its establishment, the responsibility for delivering the NJR has passed to HQIP who are contracted by the Department of Health to deliver the National Joint Registry. The NJR is funded by a subscription on NHS trusts and health boards, independent sector healthcare providers, and the suppliers and manufacturers of orthopaedic devices. Funding is specifically for the audit described. Under this Agreement a limited set of HES data is used for two purposes: NEC Software Solution s is a processor acting under the instructions of HQIP. NECSWS role is limited to data collection, data management and reporting services. • The monitoring of compliance with the NJR by comparing the number of procedures recorded in HES to the number of procedures submitted to the NJR. The compliance rate is reported internally to the NJR Steering Committee. The NJR is managed by the Healthcare Quality Improvement Partnership and overseen by a Steering Committee which is an Expert Group. The Steering Committee reports to NHS England. • To enable Trusts to report against Best Practice Tariff indicators. The indicators are related to the rate of primary procedures submitted and the rate of unknown consent. The HES data for a Trust is compared to the number of procedures submitted to the NJR and the compliance, or case ascertainment, rate calculated. This information is made available to Trusts via the NJR website. Data will be accessed by- The data requested contains neither sensitive nor identifiable fields and includes data fields for a defined set of OPCS4 codes related to the joint replacement procedures recorded by the NJR. This includes the method of admission, the episode end and start date, the date that the operation took place, and the provider and site codes. • NEC Software Solutions The data is updated quarterly with a fifth ‘cleaned’ annual data file provided six months after the end of the preceding financial year. • NHSE Trust staff The National Joint Registry for England, Wales, Northern Ireland, and the Isle of Man (NJR) requires access to non-identifiable record level Hospital Episodes Statistics (HES) data in order to be able to monitor compliance with the mandatory requirement for NHS England Trusts to submit details of hip, knee, shoulder, elbow, and ankle joint replacement procedures. The HES data will only contain data for those patients treated in England. Apart from reporting on case ascertainment (measuring levels of submission from NHS Trusts) and being able to monitor data quality, the NJR also provides quarterly reports to the Quality, Improvement, Production, and Prevention (QIPP) programme that are for the Orthopaedic Best Practice Tariff (BPT). These reports are available to both QIPP and Trusts in NHS England and an example output is included with this application. a) The NJR was established in 2002 by the Department of Health following a National Audit Office (NAO) report into the higher than expected failure rate of the 3M hip replacement device. The NAO report concluded that, had a national register of hip replacements been in existence, the failure rate would have been detected earlier. Earlier identification would have meant fewer patients being affected and the subsequent costs of revision surgery for the NHS would have been considerably less. The NJR started to collect data in April 2003. Since its establishment, the responsibility for delivering the NJR has passed to HQIP who are contracted by the Department of Health to deliver the National Clinical Audit and Outcomes Programme (NCAPOP). The NJR is an audit within NCAPOP. b) HQIP acts as the data controller for the NJR and contracts to Northgate Public Service UK Limited (NPS) for the data collection, aggregation and reporting services. NPS is a data processor for the NJR. HQIP do not have access to the data. c) The work undertaken by the NJR is to monitor the outcomes of hip, knee, shoulder, ankle, and elbow joint replacement surgery with regards to the performance of devices, surgical teams, and Trusts and hospitals. The monitoring is necessary to ensure patient safety, improve patient outcomes. d) The overall purpose of the NJR is summarised in its mission statement: ‘The purpose of the National Joint Registry for England, Wales, Northern Ireland, and the Isle of Man is to collect high quality and relevant data about joint replacement surgery in order to provide an early warning of issues relating to patient safety. In a continuous drive to improve the quality of outcomes and ensure the quality and cost effectiveness of joint replacement surgery, the NJR will monitor and report on outcomes, and support and enable related research.’ The strategic goals of the NJR are as follows: • To monitor in real time the outcomes achieved by brand of prosthesis, hospital and surgeon, and highlight where these fall below an expected performance in order to allow prompt investigation and to support follow-up action. • To inform patients, clinicians, providers and commissioners of healthcare, regulators and implant suppliers of the outcomes achieved in joint replacement surgery. • To evidence variations in outcome achieved across surgical practice in order to inform best practice. • To enhance patient awareness of joint replacement outcomes to better inform patient choice and patients’ quality of experience through engagement with patients and patient organisations. • To support evidence-based purchasing of joint replacement implants for healthcare providers to support quality and cost effectiveness. • To support suppliers in the routine post-market surveillance of implants and provide information to clinicians, patients, hospital management and the regulatory authorities (this goal is met using NJR data only). e) The NJR has been collecting data since 2002 and is an ongoing audit with no planned end date. The NJR’s Steering Committee reviews the NJR’s mission statement and strategic goals annually to ensure that they remain relevant to existing stakeholder priorities, clinical guidance, and legislation. g) NPS has had ongoing access to pseudonymised HES data since 2006. h) In order to monitor the performance of joint replacement surgery, the NJR needs to ensure high levels of case ascertainment, i.e. there must be high levels of compliance for what is a mandatory collection service for both the NHS and independent centre in England and Wales. In its calculation of outcomes, it is necessary to be able to link a patient's first, or primary procedure, to any subsequent, or revision, procedures on the same joint. It is vitally important, therefore, that the reporting of both primary and revision procedures is as high as possible. The data is used for the following purposes: • Monitoring Compliance with the NJR. The data provided is the only way in which the NJR can monitor submission rates by Trusts and Hospitals in the NHS in England and calculate compliance rates. The compliance rate is the key indicator of data quality and high rates are essential if the NJR is to achieve its mission and strategic goals. It is known that data completeness is lower for revision procedures than for primary procedures and this can only be quantified with the use of the data provided through HES. The identification of low compliance rates by an organisation is vital if remedial action is to be taken to ensure that the missing data is provided. • Best Practice Tariff. Compliance with the NJR forms part of the Best Practice Tariff (BPT) and the data provided through HES enables the NJR to report Trust compliance rates as part of the Quality, Innovation, Productivity, and Prevention (QIPP) programme. There are significant financial penalties to Trusts if they fail to meet the BPT requirements for NJR submissions. • Identifying Contracted out Procedures. Many acute Trusts contract out joint replacement surgery to the independent sector and details of these procedures will be submitted to the NJR by the hospital undertaking the surgery. Because details of these procedures will still be submitted to HES for financial recovery, it leads to higher HES submissions than NJR submissions from Trusts resulting in inaccurate, lower rates of compliance with the NJR. The HES data enables the NJR to be able to identify outsourced procedures and then calculate and report accurate rates of compliance for each Trust and hospital.

Processing activities

a) Data is provided by NHS Digital to NPS for a defined set of procedure codes related to hip, knee, shoulder, elbow, and ankle joint replacement surgery. This data is held by NPS in its secure data centre, provided by Gyron Internet Ltd on a dedicated server. IRON Mountain is a storage facility only. Analysis of the data is carried out by NPS. No data will flow to NHS England for the purposes of this Agreement. b) Access to the HES data for analysis purposes only is limited to three, full time NPS staff who are directly involved in the delivery of the NJR under NPS’ contract with HQIP. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). NHS England data will provide the relevant records from the HES APC to NECSWS. The data will c) The data will not be made available to third parties and will be used only for the purposes set out in this Agreement. All outputs from use of the data will be based on aggregated data and any small numbers will be suppressed in line with the HES analysis guide. The data will not be linked to any other data and the data under this agreement will be held separately to the data supplied under NIC-07289. · contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient. d) In order to accurately determine the outcomes of joint replacement surgery it is necessary to ensure that rates of compliance with the NJR remains as high as possible (95% target rate). The HES data provided enables the NJR to monitor the compliance rates of Trusts and hospitals within NHS England. High compliance rates give greater confidence in the calculation of outcomes of joint replacement surgery both nationally and by Trusts. The data will not be transferred to any other location. Best Practice Tariff indicators relate to the rates of compliance an unknown consent. A new indicator was introduced in 2019 relating to the rate of cemented and hybrid total hip replacements in patients over 70 years of age. The NHS England data is held by NECSWS in its secure data centre, provided by NTT Global Data Centers EMEA UK Ltd on a dedicated server. Only data related to specific joint replacements are requested and these do not include any patient identifiers or sensitive data items. NECSWS uses NTT Global Data Centers for the backup of data. Data is backed up to a second data centre. Any historical flows of NHS Digital data that were approved under earlier versions of this agreement have been destroyed. The data will be accessed by authorised personnel via remote access. The data will remain on the servers at NTT Global Data Centers at all times. The data will not leave England at any time. Access is restricted to employees or agents of NECSWS who have authorisation from HQIP. All personnel accessing the data have been appropriately trained in data protection and confidentiality. The data will not be linked with any other data. There will be no requirement and no attempt to reidentify individuals when using the data. Analysts from NECSWS will analyse the data for the purposes described above. In order to accurately determine the outcomes of joint replacement surgery it is necessary to ensure that rates of compliance with the NJR remains as high as possible (95% target rate). The HES data provided enables the NJR to monitor the compliance rates of Trusts and hospitals within NHS England. High compliance rates give greater confidence in the calculation of outcomes of joint replacement surgery, both nationally and by Trusts. Best Practice Tariff indicators relate to the rates of compliance for primary joint replacement procedures and unknown consent. A new indicator was introduced in 2019 relating to the rate of cemented and hybrid total hip replacements in patients over 70 years of age. Any historical flows of NHS England data that were approved under earlier versions of this agreement have been destroyed.

Expected output

All outputs are aggregated with small numbers suppressed in line with the HES analysis guide. [2 paragraphs unchanged] b) Quarterly reports to the QIPP programme. This information is also made available to Trusts via the NJR website (Best practice tariff - The National Joint Registry (njrcentre.org.uk)) so that they can monitor progress against BPT targets. targets can be monitored. c) Compliance rates are published on the NJR’s website via its NJR [13 words unchanged] targets and also provide patients with information about procedures undertaken in each Trust: Trust (Home - NJR Surgeon and Hospital Profile (njrcentre.org.uk). Http://www.njrcentre.org.uk/njrcentre/Healthcareproviders/Accessingthedata/StatsOnline/tabid/117/Default.aspx. [1 paragraph unchanged] e) HES data is used to publish trust level compliance for both primary and revision procedures on the NJR's Clinical Outcomes Programme (COP) website. COP is a mandatory reporting programme for a number of clinical audits surgeon and is designed hospital profile website which provides information specifically for patients. This programme is mandatory for patients . Data includes information about the practice of all consultants who have undertaken surgery in an NHS hospital during the [10 words unchanged] data submitted by a hospital which is compared to a national average. This information, as already states, is specifically designed for patients and is also shared with NHS Choices for publication on the NHS Choice website. The data is refreshed annually and the website can be found at: https://surgeonprofile.njrcentre.org.uk http://www.njrsurgeonhospitalprofile.org.uk/ f) Data completeness and quality is also included in the NJR’s Annual Report, published in September each year, which is available both online and as a hard copy document. Detailed information about data quality, at a Trust level, is provided within Part Four of the report. Access to further information about joint replacement procedures, including signposting to the COP website are also provided. The following website provides access to online reports and documents concerning the NJR, its works, and the outcomes of joint replacement surgery: Welcome to NJR (njrcentre.org.uk). f) Data completeness and quality is also included in the NJR’s Annual Report, published in September each year, which is available both online and as a hard copy document. Detailed information about data quality, at a Trust level, is provided within Part Four of the report. Access to further information about joint replacement procedures, including signposting to the COP website are also provided. The following website provides access to online reports and documents concerning the NJR, its works, and the outcomes of joint replacement surgery: Compliance rates, calculated using HES data, are also made available to CQC and included in local CQC audits. http://www.njrreports.org.uk/ Compliance rates, calculated using HES data are also made available to CQC and included in local CQC audits. [1 paragraph unchanged] All outputs from use of the data will be based on aggregated data and any small numbers will be suppressed in line with the HES analysis guide.

Expected measurable benefits

[1 paragraph unchanged] It is difficult to accurately measure or quantify the benefits arising out of the work of the NJR, but there is evidence to show that its outputs do lead to changes in clinical practice for the benefit of all stakeholders, including patients, Trusts and hospitals, clinicians, suppliers, and the regulatory authorities such as CQC, NICE, and the MHRA. Whilst patient outcomes continue to improve, the NHS is making potential savings through a reduction in the need to undertake as many revision procedures in the future. The use of the data could- · lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience. · provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed. [1 paragraph unchanged] HES data has enabled the NJR to identify organisations where compliance does [15 words unchanged] using the HES data as the basis of an audit within a hospital. Audits hospital, audits have also improved the quality of data submitted by hospitals to HES. [1 paragraph unchanged] Reporting compliance to clinicians, patients, and trust management enables them to make an assessment of the quality of the data provided to the NJR. Ultimately, the quality and completeness of the data will affect all outcomes analyses.

Benefits reported

HES data has and continues to enable the NJR to identify organisations where compliance does not meet expected levels and to work with those organisations to improve submission rates. By using the HES data as the basis of an audit within a hospital, data missing from the NJR has been added retrospectively. Audits have also improved the quality of data submitted by hospitals to HES. Monitoring and reporting on compliance with the NJR ensures that case ascertainment levels remain high and that the NJR can accurately measure the outcomes of joint replacement surgery. Measuring the outcomes of joint replacement surgery improves patient safety and outcomes. The use of HES data to report compliance publicly has provided a clear focus on those organisations who are not reaching the required levels of compliance and, hence, the quality of outcomes reporting for those organisations will not be as reliable as it could be. This public visibility of compliance rates has led to an improvement in the submission of data to the NJR by a number of hospitals with previously poor rates of compliance. The NJR also provides information to NHS trusts to enable them to monitor compliance with Best Practice Tariff targets for primary hip and knee joint replacement and for rates of patient consent. This reporting ensures that trusts are not financially disadvantaged. Inclusion of NJR submissions (and patient consent rates) in the Best Practice Tariff (BPT) by Quality Innovation Productivity and Prevention (QIPP) has also improved compliance with the NJR. HES data is used to report compliance rates to QIPP.

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

Data controllers: + NHS ENGLAND

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

Objective for processing

The National Joint Registry (NJR) is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England (NHSE) as part of the Clinical Audit and Patient Outcomes Programme (NCAPOP). The purpose of the National Joint Registry for England, Wales, Northern Ireland, and the Isle of Man is to collect high quality and relevant data about joint replacement surgery in order to provide an early warning of issues relating to patient safety. This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. The NCAPOP is a large programme of circa 35 projects consisting of National Clinical Audits. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP jointly with HQIP as together both organisations determine the purposes and means of processing. NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs. NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties. Legal Basis Justification: HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "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". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services. HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance. The NJR was established in 2002 by the Department of Health following a National Audit Office (NAO) report into the higher than expected failure rate of the 3M hip replacement device. The NAO report concluded that, had a national register of hip replacements been in existence, the failure rate would have been detected earlier. Earlier identification would have meant less patients were affected and the costs of revision surgery for the NHS would have been considerably less. The NJR went live in April 2003. Since its establishment, the responsibility for delivering the NJR has passed to HQIP who are contracted by the Department of Health to deliver the National Joint Registry. Under this Agreement a limited set of HES data is used for two purposes: • The monitoring of compliance with the NJR by comparing the number of procedures recorded in HES to the number of procedures submitted to the NJR. The compliance rate is reported internally to the NJR Steering Committee. • To enable Trusts to report against Best Practice Tariff indicators. The indicators are related to the rate of primary procedures submitted and the rate of unknown consent. The HES data for a Trust is compared to the number of procedures submitted to the NJR and the compliance, or case ascertainment, rate calculated. This information is made available to Trusts via the NJR website. The data requested contains neither sensitive nor identifiable fields and includes data fields for a defined set of OPCS4 codes related to the joint replacement procedures recorded by the NJR. This includes the method of admission, the episode end and start date, the date that the operation took place, and the provider and site codes. The data is updated quarterly with a fifth ‘cleaned’ annual data file provided six months after the end of the preceding financial year. [1 paragraph unchanged] Apart from reporting on case ascertainment (measuring levels of submission from NHS [19 words unchanged] and Prevention (QIPP) programme that are for the Orthopaedic Best Practice Tariff (PBT). (BPT). These reports are available to both QIPP and Trusts in NHS England. England and an example output is included with this application. Each year, the NJR also applies for an annual update of patient identifiable HES/PROMs/ONS data. This data is linked to NJR data at the record level and is used for more detailed analyses and research by approved data processors. Such analyses have included, for example, an assessment of the increased risk of cancer following the implantation of metal-on-metal hip prostheses. The data under this agreement is using the same set of OPCS4 codes, does not provide the data necessary to undertake this work and is required only to provide monthly reports on Trust and hospital compliance with the NJR and for quarterly reports to QIPP for BPT. The patient identifiable data is not part of this agreement. [1 paragraph unchanged] b) HQIP acts as the data controller for the NJR and contracts [10 words unchanged] collection, aggregation and reporting services. NPS is a data processor for the NJR, data held at IRON Mountain is purely stored and not held for analysis: NJR. HQIP do not have access to the data. [11 paragraphs unchanged] g) NPS has had ongoing access to pseudonymised HES data for a number of years. since 2006. [4 paragraphs unchanged]

Processing activities

a) Data Flows. Data is provided by NHSD NHS Digital to NPS for a defined set of procedure codes related to hip, [6 words unchanged] replacement surgery. This data is held by NPS in its secure data centre centre, provided by Gyron Internet Ltd on a dedicated server. Data held at IRON Mountain is purely stored and not held for analysis, a storage facility only. Analysis of the analysis data is carried out by NPS. b) Access to the data. Access to the HES data for analysis purposes only is limited to [59 words unchanged] contractors of the Data Recipient who may have access to that data). The data will not be linked to any other data and the data disseminated under NIC-07289 will be held separately. NIC-07289 covers the dissemination of identifiable data. c) What will not happen to the data. The data will not be made available to third parties and will [52 words unchanged] this agreement will be held separately to the data supplied under NIC-07289. d) Justification for the data required. In order to accurately determine the outcomes of joint replacement surgery it [46 words unchanged] calculation of outcomes of joint replacement surgery both nationally and by Trusts. Best Practice Tariff indicators relate to the rates of compliance an unknown consent. A new indicator was introduced in 2019 relating to the rate of cemented and hybrid total hip replacements in patients over 70 years of age. [1 paragraph unchanged] Any historical flows of NHS Digital data that were approved under earlier versions of this agreement have been destroyed.

Expected measurable benefits

[3 paragraphs unchanged] HES data has enabled the NJR to identify organisations where compliance does [15 words unchanged] using the HES data as the basis of an audit within a hospital, data missing from the NJR has been added retrospectively. hospital. Audits have also improved the quality of data submitted by hospitals to HES. [2 paragraphs unchanged]

Benefits reported

HES data has enabled and continues to enable the NJR to identify organisations where compliance does not meet expected levels [34 words unchanged] have also improved the quality of data submitted by hospitals to HES. [1 paragraph unchanged] Inclusion of NJR submissions (and patient consent rates) in the BPT Best Practice Tariff (BPT) by QIPP Quality Innovation Productivity and Prevention (QIPP) has also improved compliance with the NJR. HES data is used to report compliance rates to QIPP.

Unchanged: Expected output.