National Haemophilia Database (NHD)

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

Objective for processing

The UK Haemophilia Centre Doctors Doctors’ Organisation (UKHCDO) requires mortality access to NHS England data for the purposes purpose of maintaining the National Haemophilia Database (NHD) and reusing that database for both following research and non-research purposes. programme: The NHD is a registry of more than 30,000 patients with bleeding disorders registered since 1968. National Haemophilia Database (NHD) The UKHCDO, a registered charity since 1991, is an association of medical practitioners who work within the Haemophilia Centres of England, Scotland, Northern Ireland, and Wales which has an interest in the care of people with Haemophilia or other inherited bleeding disorders. The UKHCDO was established in 1968 to improve haemophilia care, research into bleeding disorders, their treatment epidemiology, and complications and to facilitate healthcare planning through managing the database. The following is a summary of the aims of the research programme provided by UKHCDO: The UKHCDO established UKHCDO Ltd as the commercial arm of the organisation to employ substantive staff, administer and process data on its behalf and undertake commercial activity outside of the NHS. UKHCDO’s objectives are to: Since its inception, the database has monitored treatment trends and morbidity and mortality associated with bleeding disorders and changes in life expectancy. UKHCDO has published extensively on the epidemiology of bleeding disorders, life-expectancy and causes of death. The database is essentially conducting an open-ended cohort study. UKHCDO also reports regularly to the Department of Health and Social Care, NHS England, Scotland and Wales, and Public Health England to facilitate disease monitoring and healthcare planning. UKHCDO processes personal data, in accordance with GDPR Article(6)(1)(f), for the purposes of its legitimate interests as described above. UKHCDO’s objectives are to: [3 paragraphs unchanged] Where UKHCDO processes special categories of personal data, for these purposes the legal basis is: The following NHS England Data will be accessed: Article 9(2)(j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. • Civil Registration Mortality – necessary because the UK Haemophilia Centre Doctors Organisation (UKHCDO) requires mortality data for the purposes of maintaining the National Haemophilia Database (NHD) and reusing that database for both research and non research purposes. UKHCDO envisions the mortality data will contribute to safety (provision of care and treatment), cost reduction (management of health and social care services), improved knowledge and therefore care (provision of care and treatment), and provision of a firmer evidence base to inform public policy (Serve the wider public interest). UKHCDO uses the information in the NHD to analyse and study longitudinal morbidity and mortality in bleeding disorders and link these to patient and treatment related risk factors for death and/or disability. The UKHCDO has published extensively on the epidemiology of bleeding disorders, life-expectancy and causes of death. Other areas of research include the interaction between bleeding disorder and comorbidities such as ischaemic heart disease. The level of the Data will be: Haemophilia Centres report known deaths to the database, but the information supplied is not always complete. UKHCDO requires mortality reports from NHS Digital to mitigate the risk of incomplete reporting and reporting bias. UKHCDO needs to know the causes of death of the complete cohort so that treatment groups may be reliably compared with non-interventional epidemiological studies. • Identifiable – necessary to enable linkage and match and update patients’ data that UKHCDO hold on the database. UKHCDO envisions the mortality data will contribute to safety (provision of care and treatment), cost reduction (management of health and social care services), improved knowledge and therefore care (provision of care and treatment), and provision of a firmer evidence base to inform public policy (Serve the wider public interest). The Data will be minimised as follows: UKHCDO has multiple core functions for which the database is used: • Limited to a study cohort of 40,000 participants with the following conditions - Haemophilia and other inherited bleeding disorders. 1) MANAGEMENT OF PATIENT CARE AND HEALTH CARE PLANNING (Non-Research): UKHCDO is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. For the purposes of management of patient care and health care planning all patients with bleeding disorders are registered and data collected on total treatment issued, side effects in relation to the treatment and other complications of bleeding such as joint scores. This information is linked to the patient’s name and NHS number. The name is necessary so that the NHD can issue individuals with a Bleeding Disorder Card which states the patient’s name, diagnosis, usually treatment and haemophilia centre. Patients can show this card to any health care provider as required. The lawful basis for processing personal data under the UK GDPR is: Haemophilia Centres submit data to UKHCDO for all patients with bleeding disorders on a quarterly basis and in real time for cases of new diagnoses and adverse events. The data points collected may be reviewed on www.UKHCDO.org and include demographic details, details of treatment, bleeding side effects and infections and pharmacovigilance data . No patient identifiable data can be viewed on the UKHCDO website. Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party. Although deaths are reported, this data may be incomplete and has over the years been supplemented and cross-referenced with death certification data provided by ONS until June 2014. This enabled UKHCDO to study mortality and causes of death and relate these to changing treatment practice and with infections such as Human Immuno Deficiency Virus (HIV) and Hepatitis C Virus (HCV). UKHCDO has determined the processing is necessary for its legitimate interests in being able to provide tools and services that will benefit healthcare organisations. 2) RESEARCH DATABASE AND UK NATIONAL HAEMOPHILIA RESEARCH REGISTRY: The lawful basis for processing special category data under the UK GDPR is: UKHCDO has established the NHD as a research database to be used for research purposes to further the understanding of bleeding disorders and management. Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. Research conducted on data held by NHD has the important aim of understanding disease natural history, mechanisms, epidemiology, current treatment options and outcomes, complications, and health economics. This processing is in the public interest because UKHCDO envisions the mortality data will contribute to safety (provision of care and treatment), cost reduction (management of health and social care services), improved knowledge and therefore care (provision of care and treatment), and provision of a firmer evidence base to inform public policy (Serve the wider public interest). Patients who are registered on the NHD will be offered the opportunity to opt out of their data being used for research if they wish. All patients who do not choose to opt out are registered onto the UK National Haemophilia Research Registry (UK-NHR) a subsection of the NHD. The funding comes from multiple sources. Current funders include: The UK-NHR can be used for observational research in which the outcomes of treatment agreed between the patients and the haemophilia centre is analysed. • NHS England The data subjects are all patients with bleeding disorders seen by a Haemophilia Centre since 1968. UKHCDO will submit the details of all patients in the NHD whose deaths have not previously been reported by NHS Digital or predecessors to NHS Digital and will receive notifications of subsequent deaths or exits from registration with the NHS. A group of around 2,000 individuals who were contacted and invited to consent between August 2019 to January 2020 will be excluded from the cohort shared with NHS Digital because this is not covered by the HRA CAG approval. • NHS Scotland UKHCDO has support under section 251 of the NHS Act 2006 permitting it to share the data of all participants in the database except for the ~2,000 individuals, without informed consent. No data is flowing for those who declined to give consent. The consented cohort are not part of this Agreement. This Agreement is restricted to individuals covered under s251 support only. • NHS Wales UKHCDO is the sole Data Controller for the data under this Agreement. The UKHCDO originally set up the National Haemophilia Database (NHD) and UKHCDO Ltd is the entity that administers the processing and management of the data held within the database. • Companies who make treatments for bleeding disorders Medical Data Solutions and Services (MDSAS) is the UKHCDO’s IT service provider which hosts and maintains the UKHCDO’s servers. • Commercial sponsorship from the industry at the present time The National Haemophilia Database strategy is to position itself with a mixed economy of funding streams. UKHCDO Ltd has service level agreements with NHS England, NHS Scotland, and NHS Wales but UKHCDO also receives grants from companies that make treatments for bleeding disorders, and from commercial sponsorship from Industry at the present time. Funding to continue the work described will be sought on an ongoing basis. The funders will have no ability to suppress or otherwise limit the publication of findings. NHS England has confirmed it is not a data controller for the data in the NHD nor for any data processed under this Data Sharing Agreement. If there was any change to this assessment or to NHS England’s role in respect of the data, an amendment to this Agreement would be necessary and the UKHCDO would be required to submit an application for that amendment as soon as reasonably possible. Medical Data Solutions and Services (MDSAS) provides IT hosting services to UKHCDO. The database containing NHD data (but not NHS Digital data) is sponsored (in regard to Information Governance and not financially) by Manchester University NHS Foundation Trust. NHD systems are located on the internal Health and Social Care Network (HSCN previously known as N3) network. They are securely hosted in an Microsoft Azure data centre (UK South) with no external access. Physical access to the data centre is restricted, and only accessible via a request and approval process, external building security measures including Perimeter fences, CCTV, alarms, and full-time security gates and search facilities. The systems, PC’s and servers are protected by passwords and firewalls restricting IP, port, and application access. All data communications are paperless and protected within the NHS HSCN network using a 256-bit Advanced Encryption Standard. No other organisations are involved but not accessing data, including acting in an advisory capacity. Researchers can request aggregated data from the NHD. The researchers would all be doctors, usually members of the UKHCDO. The application process requires them to complete a request form outlining their hypothesis and reason for requesting the data. The data itself would never be released outside of UKHCDO Ltd. The data would only be processed by substantive employees of UKHCDO Ltd and the outputs, which would always be aggregated data with small numbers suppressed, would be delivered to the requesting researcher. All requests are subject to an approvals process involving review by the Data Analysis Group (DAG), which has delegated powers from the Data Management Working Party (DMWP). The DAG consists of Clinicians, Commissioners, Patient representatives, NHD analysts, whom meet monthly to review these requests. Data will only be accessed by individuals who are substantively employed by UKHCDO. As part of UKHCDO’s work with NHS England, as UKHCDO control the database for information for people with bleeding disorders, it was deemed that it would be helpful to the UK Health and Security Agency (UKHSA) if UKHCDO could contribute to its preparation of the annual report called ‘Monitoring individuals at risk of CJD’, it was agreed with both NHS England and UKHSA that UKHCDO would do what UKHCDO can to contribute to this report. It was not mandatory that UKHCDO do so. This contribution consists of providing a summary of all those ‘at increased risk’ groups on which data is collected and the current status of groups of patients with increased CJD risk. The report is on a page, consists of high level, aggregated data. One line of figures for the summary and several lines for the current status. Due to the constraints of the data base, these are minimum numbers only. This contribution is provided voluntarily. The UKHCDO has a long history of patient engagement and involvement in the oversight of the database and the uses to which the data are put. Patients are involved in the Data Management Working Party and the Data Analysis Group which are internal governance committees for the running of the database. Patient representatives provided extensive input on the protocol and patient information, which was crucial for ensuring that the content was ethical, clear, and written in plain English. This input helped align the practices with patient experiences and reduce jargon. The final version was circulated to the Advisory Committee for approval. For clarity, the data supplied via NHS Digital is not stored on Cloud. Should the data controller wish to store NHS Digital data on Cloud in the future, this will be subject to a new application with NHS Digital.

Processing activities

This Data Sharing Agreement authorises the retention and continued use of mortality data supplied by NHS Digital or predecessor data providers and held within the NHD for the purposes described above. UKHCDO will transfer data to NHS England. The data will consist of identifying details (specifically NHD Registration Number, NHS Number, Forename, Surname and Date of Birth) for the cohort to be linked with NHS England data. Under this Agreement, the following data flows are permitted: NHS England will provide the relevant records from the Civil Registration of Death datasets to UKHCDO. The Data will a) UKHCDO Ltd provides NHS Digital, securely, with the following identifiers for NHD registrants with bleeding disorders covered by section 251 support: • contain directly identifying data items including: Names, NHS Number and Date of Birth which are required to analyse and study longitudinal morbidity and mortality in bleeding disorders and link these to patient and treatment related risk factors for death and/or disability. • NHD registration number - Unique identifier to enable linkage between a patient The Data will not be transferred to any other location. • NHS number (to identify patient and perform linkage) The Data will be stored on servers internally on the Health and Social Care Network (previously N3). • Forename ʹto confirm identity of patient (complementary to or in absence of NHS number) UKHCDO Ltd uses offsite back-up services provided by [organisation] Azure Data Centre (UK South). These are also replicated across mirrored servers held in separate data centres at 15 minute intervals. • Surname ʹto confirm identity of patient (complementary to or in absence of NHS number) The Data will be accessed by authorised personnel via remote access. • Date of Birth ʹ(to calculate age at diagnosis and age at death) 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. b) NHS Digital traces patients using the supplied identifiers and provides UKHCDO Ltd with mortality data for patients where an instance of mortality has been recorded since the previous quarterly drop. For remote access: c) NHS Digital data is transferred to UKHCDO Ltd via secure file transfer and stored on N3 servers hosted at Leigh NHS Data Centre operated by Greater Manchester Shared Services . At this point NHS Digital data is linked to the data on the database. - 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; Leigh NHS Data Centre is within Leigh Infirmary. This is part of the N3 network. - Access controls granting users the minimum level of access required are in place; All access to NHS Digital data will be performed by substantive employees of UKHCDO Ltd. Access to data held on servers is restricted to authorised personnel who undergo information governance training in accordance with the NHS Data Security and Protection Toolkit (DSPT). This is reviewed and reassessed on an annual basis as required by the DSPT. - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; Staff are trained on access to data and backups are kept in the event of an error occurring. - Multifactor authentication (MFA) is required for remote access; d) The data is pseudonymised using NHD registration number prior to it being presented to statisticians for analysis. Access to the pseudonymised data is by named individuals within NHD and all are substantive employees of the UKHCDO Ltd. Once the data has been pseudonymised, no attempt will be made by UKHCDO to reidentify any patients. - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; e) Once pseudonymised, factors influencing mortality are studied using statistical methods. Death rates from specific causes are compared with national mortality rates (derived from World Health Organization data) using standardised mortality ratios. - 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. Necessary steps have been taken with the identifiable data being released by NHS Digital to minimise the risk of identification. Prior to NHS Digital releasing the identifiable data it has been minimised to cohort participants and data periods. Once the data is released to the NHD it is pseudonymised prior to presentation to statisticians for analysis and only fully anonymised aggregate with small numbers supressed reports are disseminated or published. NHD and NHS Digital data is not accessed by the Regional Health Authority at Leigh Infirmary and is only held on their systems to be accessed by UKHCDO Ltd staff. 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). Any data requests from researchers external to UKHCDO Ltd, once approved by the Data Management Working Party (DMWP) , are strictly processed by substantive employees of the UKHCDO Ltd and outputs are returned to the researcher as aggregated data with small numbers suppressed. The Data will not leave England/Wales at any time. This Data Sharing Agreement does not permit sharing of the data with third parties except in the form of aggregated anonymised outputs with small numbers suppressed. Access is restricted to substantive employees of UKHCDO Ltd who have authorisation from the Principal Investigator. NHS Digital reminds all organisations party to this agreement of the need to 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). All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The aggregated information derived from the Data will be combined with aggregated data from other sources The National Haemophilia Database. There will be no requirement and no attempt to reidentify individuals when using the Data. Analysts/researchers from the UKHCDO Ltd will process the Data. Researchers can request aggregated data from the NHD. The researchers would all be doctors, usually members of the UKHCDO. The application process requires them to complete a request form outlining their hypothesis and reason for requesting the data. The data itself would never be released outside of UKHCDO Ltd. The data would only be processed by substantive employees of UKHCDO Ltd and the outputs, which would always be aggregated data with small numbers suppressed, would be delivered to the requesting researcher. All requests are subject to an approvals process involving review by the Data Analysis Group (DAG), which has delegated powers from the Data Management Working Party (DMWP). The DAG consists of Clinicians, Commissioners, Patient representatives, NHD analysts, whom meet monthly to review these requests.

Expected output

Over the course of this Data Sharing Agreement, UKHCDO will continue to provide reports to the Department of Health and Social Care, NHS England, Scotland and Wales, and UK Health Security Agency (UKHSA) on mortality and causes of death for patients with bleeding disorders. The expected outputs of the processing will be: All reports contain only anonymised aggregate data (with small numbers suppressed in line with the HES Analysis Guide). • A report of findings to the Department of Health and Social Care, NHS England, Scotland and Wales produced quarterly and annual report and through Dashboards. Throughout this three -year Agreement UKHCDO Ltd will continue to provide reports to stakeholders as detailed below. • A report of findings to the UK Health Security Agency (UKHSA) produced every 6 months. Reports to UK Health Security Agency (UKHSA) are produced every six months. Reports submitted to NHS England, Scotland and Wales are produced quarterly in our annual report and through Dashboards. • Academic studies UKHCDO continue to be able to analyse and report in peer review journals the effect of new therapeutic developments on the natural history, life expectancy and causes of death. Examples of these new developments are as follows: - The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. a. Introduction of intensive factor VIII and IX prophylaxis. The outputs will be communicated to relevant recipients through the following dissemination channels: b. Introduction of extended half-life factor VIII and IX products. • Dashboards c. Introduction of effective antiviral therapy for hepatitis C. • Reports d. Introduction of Emicizumab, factor VIII mimetic haemophilia A prophylaxis. • Peer review journals e. The introduction of gene therapy. • Public reports In summary, there are several outputs which include reports and academic studies that will provide direct benefit to patients and those clinicians that are treating them, in meeting their objective to identify groups at risk. These reports and studies will also show which treatments are most beneficial to patients and cost effective. The benefits will be measured in terms of reduced morbidity, mortality and treatment costs but may take two or more years to show up. • Briefing documents The Database has a website open to the public, which enables them to review UKHSCDO’s activities, see UKHSCDO’s annual aggregated anonymised published statistics and download any publications derived from the data: http://www.ukhcdo.org/’ • Co-hosted events • Public events such as the Infected Blood Enquiry • Posters displayed at [ISTH, EHAD (Bleeding Disorder Conferences) • Reports aimed at participants/patients The target date for dissemination of the outputs is every quarter.

Expected measurable benefits

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study. The use of the data could: • Show which treatments are most beneficial to patients. This would be measured in terms of reduced morbidity and mortality. • To show which are cost effective treatments. This would be measured in terms of treatment costs. There are several outputs which include reports and academic studies that will provide direct benefit to patients and those clinicians that are treating them, in meeting their objective to identify groups at risk. These reports and studies will also show which treatments are most beneficial to patients and cost effective. The benefits will be measured in terms of reduced morbidity, mortality, and treatment costs. The death certification data allows UKHCDO to study trends in causes of death and in life expectancy as improvements in treatment are introduced. This would help to evaluate and justify therapeutic developments. Death is also an important endpoint in pharmacovigilance since some treatments, for example, Emicizumab, currently being widely introduced as prophylaxis against bleeding in Haemophilia A, may increase deaths from heart attack and stroke whilst reducing the risk of death from haemorrhage. Further, UK Health Security Agency (UKHSA) requests UKHCDO to provide a report to them every six months. The information provided by the NHD helps patient care by assisting continuity of care and monitoring safety through the provision of accurate data and this information informs and shapes national policy. [5 paragraphs unchanged] Now that the Infected Blood Inquiry has reported and the infected blood compensation authority compensation scheme has been set up, we are working directly with IBCA to support claims made by people who are infected and affected by the scandal. [3 paragraphs unchanged]

Benefits reported

NHS Digital has England (and predecessor organisations) provided UKHCDO with death certification data up to August 2022. This has [106 words unchanged] history of hepatitis C and HIV and the effect on life expectancy. [3 paragraphs unchanged] There are several ways that UKHCDO present this data at a granular [24 words unchanged] http://www.ukhcdo.org/home-2/annual-reports/ . UKHCDO are in the process of finalising all reports for 21/22, 24/25, which will be uploaded when complete.

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

Objective for processing

The UK Haemophilia Centre Doctors Organisation (UKHCDO) requires mortality data for the purposes of maintaining the National Haemophilia Database (NHD) and reusing that database for both research and non-research purposes. [12 paragraphs unchanged] UKHCDO envisions the mortality data will contribute to safety (provision of care and treatment), cost reduction (management of health and social care services), improved knowledge and therefore care (provision of care and treatment), and provision of a firmer evidence base to inform public policy (Serve the wider public interest). [3 paragraphs unchanged] Haemophilia Centres submit data to UKHCDO for all patients with bleeding disorders [27 words unchanged] demographic details, details of treatment, bleeding side effects and infections and pharmacovigilance data. data . No patient identifiable data can be viewed on the UKHCDO website. [6 paragraphs unchanged] The data subjects are all patients with bleeding disorders seen by a [60 words unchanged] to January 2020 will be excluded from the cohort shared with NHS Digital. Digital because this is not covered by the HRA CAG approval. UKHCDO has support under section 251 of the NHS Act 2006 permitting [7 words unchanged] participants in the database except for the ~2,000 individuals, without informed consent. No data is flowing for those who declined to give consent. The consented cohort are not part of this Agreement. This Agreement is restricted to individuals covered under s251 support only. [4 paragraphs unchanged] The database is sponsored by at Manchester University NHS Foundation Trust (MFT) which also provides an Information Governance function to support UKHCDO Ltd. UKHCDO Ltd has an agreement with the Information Governance Department at MFT to inspect the registry every two years to ensure compliance with data protection legislation and adhering to the principle of fair data handling (Caldicott Principles). MFT does not have access to, nor any role in controlling or manipulating the data within the database including NHS Digital data. The database containing NHD data (but not NHS Digital data) is sponsored (in regard to Information Governance and not financially) by Manchester University NHS Foundation Trust. NHD systems are located on the internal Health and Social Care Network (HSCN previously known as N3) network. They are securely hosted in an Microsoft Azure data centre (UK South) with no external access. Physical access to the data centre is restricted, and only accessible via a request and approval process, external building security measures including Perimeter fences, CCTV, alarms, and full-time security gates and search facilities. The systems, PC’s and servers are protected by passwords and firewalls restricting IP, port, and application access. All data communications are paperless and protected within the NHS HSCN network using a 256-bit Advanced Encryption Standard. Researchers can request aggregated data from the NHD. The researchers would all be doctors, usually members of the UKHCDO. The application process requires them to complete a request form outlining their hypothesis and reason for requesting the data. The data itself would never be released outside of UKHCDO Ltd. The data would only be processed by substantive employees of UKHCDO Ltd and the outputs, which would always be aggregated data with small numbers suppressed, would be delivered to the requesting researcher. All requests are subject to an approvals process involving review by the Data Analysis Group (DAG), which has delegated powers from the Data Management Working Party (DMWP). The DAG consists of Clinicians, Commissioners, Patient representatives, NHD analysts, whom meet monthly to review these requests. As part of UKHCDO’s work with NHS England, as UKHCDO control the database for information for people with bleeding disorders, it was deemed that it would be helpful to the UK Health and Security Agency (UKHSA) if UKHCDO could contribute to its preparation of the annual report called ‘Monitoring individuals at risk of CJD’, it was agreed with both NHS England and UKHSA that UKHCDO would do what UKHCDO can to contribute to this report. It was not mandatory that UKHCDO do so. This contribution consists of providing a summary of all those ‘at increased risk’ groups on which data is collected and the current status of groups of patients with increased CJD risk. The report is on a page, consists of high level, aggregated data. One line of figures for the summary and several lines for the current status. Due to the constraints of the data base, these are minimum numbers only. This contribution is provided voluntarily. For clarity, the data supplied via NHS Digital is not stored on Cloud. Should the data controller wish to store NHS Digital data on Cloud in the future, this will be subject to a new application with NHS Digital.

Processing activities

[9 paragraphs unchanged] c) NHS Digital data is transferred to UKHCDO Ltd via secure file [5 words unchanged] servers hosted at Leigh NHS Data Centre operated by Greater Manchester Shared Services. Services . At this point NHS Digital data is linked to the data on the database. [1 paragraph unchanged] All access to NHS Digital data will be performed by substantive employees [32 words unchanged] reviewed and reassessed on an annual basis as required by the DSPT. A Caldicott inspection of the database and its security arrangements is regularly carried out. [1 paragraph unchanged] d) The data is pseudonymised using NHD registration number prior to it [8 words unchanged] the pseudonymised data is by named individuals within NHD and all are substantive employees of the UKHCDO Ltd. Once the data has been pseudonymised, no attempt will be made by UKHCDO to reidentify any patients. [1 paragraph unchanged] Necessary steps have been taken with the identifiable data being released by [37 words unchanged] prior to presentation to statisticians for analysis and only fully anonymised aggregate with small numbers supressed reports are disseminated or published. NHD and NHS Digital data is not [11 words unchanged] only held on their systems to be accessed by UKHCDO Ltd staff. Any data requests from researchers external to UKHCDO Ltd, once approved by the DMWP, Data Management Working Party (DMWP) , are strictly processed by substantive employees of the UKHCDO Ltd and outputs are returned to the researcher as aggregated data with small numbers suppressed. [2 paragraphs unchanged]

Expected output

Over the course of this Data Sharing Agreement, UKHCDO will continue to report provide reports to the Department of Health and Social Care, NHS England, Scotland and Wales, and Public UK Health England (PHE) Security Agency (UKHSA) on mortality and causes of death for patients with bleeding disorders. [1 paragraph unchanged] Throughout this one-year three -year Agreement UKHCDO Ltd will continue to provide reports to stakeholders as detailed below. Reports to PHE UK Health Security Agency (UKHSA) are produced every six months. Reports submitted to NHS England, Scotland and Wales are produced quarterly in our annual report and through Dashboards. UKHCDO expect continue to be able to analyse and report in peer review journals the [12 words unchanged] causes of death. Examples of these new developments are as follows: - [5 paragraphs unchanged] In summary, there are several outputs which include reports and academic studies that will provide direct benefit to patients and those clinicians that are treating them, in meeting their objective to identify groups at risk. These reports and studies will also show which treatments are most beneficial to patients and cost effective. The benefits will be measured in terms of reduced morbidity, mortality and treatment costs but may take two or more years to show up. The Database has a website open to the public, which enables them to review UKHSCDO’s activities, see UKHSCDO’s annual aggregated anonymised published statistics and download any publications derived from the data: http://www.ukhcdo.org/’

Expected measurable benefits

In adherence with UKHCDO's service level agreement with NHS England, Scotland, and Wales (policy makers), UKHCDO is required has agreed to provide annual cyclical reporting on mortality data to assist these organisations with national strategic healthcare planning and disease monitoring. [2 paragraphs unchanged] Further, PHE expects UK Health Security Agency (UKHSA) requests UKHCDO to provide a report to them every six months on any [38 words unchanged] England, various Public Inquiries and publish this data in anonymised aggregate form. The NHD has provided information to the Infected Blood Inquiry investigating morbidity and mortality due to HIV and hepatitis C in patients treated with certain blood products. products as well as to Parliament and the NHS. The NHD helps patient care by assisting continuity of care and monitoring safety through the provision of accurate data. [2 paragraphs unchanged] The information provided by the NHD helps patient care by assisting continuity of care and monitoring safety through the provision of accurate data and this information informs and shapes national policy.

Benefits reported

NHS Digital has provided UKHCDO with death certification data up to June 2014 this August 2022. This has enabled UKHCDO to report to NHS England, Scotland, and Wales to facilitate [5 words unchanged] the Annual Reports and several other requested ad - hoc reports. UKHCDO Ltd was has also been able to monitor the effect of improving healthcare on life expectancy and causes of death in patients with haemophilia and other bleeding disorders. UKHCDO was also has been able to describe the effect of blood born infections, principally hepatitis C [6 words unchanged] causes of death and describe the interaction between those two viruses. UKHCDO was then has been able to observe the effect that the introduction of effective antiviral treatment had on the natural history of hepatitis C and HIV and the effect on life expectancy. [2 paragraphs unchanged] As there has been no flow of Mortality data to UKHCDO since June 2014 there are no further yielded benefits to report at this time. The continuation of these activities relies on the continued collection of complete and accurate data, including reliable mortality data. There are several ways that UKHCDO present this data at a granular level, but probably, one of the best ways to comprehensively do this is with UKHCDO’s UK Annual Report and other working party reports - http://www.ukhcdo.org/home-2/annual-reports/ . UKHCDO are in the process of finalising all reports for 21/22, which will be uploaded when complete.

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

Datasets: + Civil Registrations of Death

Objective for processing

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling UK Haemophilia Centre Doctors Organisation to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). The UK Haemophilia Centre Doctors Organisation (UKHCDO) requires data for the purposes of maintaining the National Haemophilia Database (NHD) and reusing that database for both research and non-research purposes. Background: The NHD is a registry of more than 30,000 patients with bleeding disorders registered since 1968. The UK Haemophilia Database (NHD), managed by the UK Haemophilia Centre Doctors Organisation (UKHCDO), was established in 1968 as UKHCDO, a registry of patients with bleeding disorders. UKHCDO (NHD) now have more than 30,000 patients with bleeding disorders registered with the database. The aim of the database is to study the complete national cohort of patients with these conditions. Haemophilia centres were first designated by the UK Ministry of Health in 1968. The directors of the then 36 haemophilia centres first met in 1968 and subsequently agreed in 1969 to establish a register of all patients with bleeding disorders, managed by UKHCDO. The UKHCDO charity since 1991, is an association of medical practitioners who work within the Haemophilia Centre’s Centres of England, Scotland, Northern Ireland, or and Wales and have which has an interest in the care of people with Haemophilia or other inherited bleeding disorders. The UKHCDO was established in 1968 to improve haemophilia care, research into bleeding disorders, their treatment epidemiology, and complications and to facilitate healthcare planning through managing the database. UKHCDO is registered with the charity commission under registration number 1032606. Since its inception, the database has monitored treatment trends and morbidity and mortality associated with bleeding disorders and changes in life expectancy. UKHCDO have published extensively on the epidemiology of bleeding disorders, life-expectancy and causes of death. The database is essentially conducting an open-ended cohort study. UKHCDO also report regularly to the Department of Health, NHS England, Scotland and Wales, and the Health Protection Agency to facilitate disease monitoring and healthcare planning. The UKHCDO established UKHCDO Ltd as the commercial arm of the organisation to employ substantive staff, administer and process data on its behalf and undertake commercial activity outside of the NHS. Data Summary: Since its inception, the database has monitored treatment trends and morbidity and mortality associated with bleeding disorders and changes in life expectancy. UKHCDO has published extensively on the epidemiology of bleeding disorders, life-expectancy and causes of death. The database is essentially conducting an open-ended cohort study. UKHCDO also reports regularly to the Department of Health and Social Care, NHS England, Scotland and Wales, and Public Health England to facilitate disease monitoring and healthcare planning. The UKHCDO Mortality Study was supported by death certification data provided by NHS Digital between about 1990 and June 2013. UKHCDO wish to re-establish this data exchange also obtaining retrospective data. All patients registered with a bleeding disorder and have provided consent will be included. This is a longitudinal study. The control group to be used in each analysis will vary with the parameter or outcome being studied. UKHCDO processes personal data, in accordance with GDPR Article(6)(1)(f), for the purposes of its legitimate interests as described above. UKHCDO’s objectives are to: To date, UKHCDO has received quarterly disseminations record-level identifiable data under the following MRIS reports against their cohort of patients who have consented to be included in the database: a) preserve, protect, and relieve persons suffering from haemophilia and other inherited bleeding disorders MRIS – Cause of Death report b) advance the education of the medical profession, the nursing profession, professions allied to healthcare and the public in the knowledge of haemophilia and other inherited bleeding disorders and their treatment MRIS – Members and Postings Report c) assist in the promotion of audit and research into the causes, prevention, alleviation and management of haemophilia and other inherited bleeding disorders and to disseminate the useful results of such research. MRIS – Flagging Current Status Report Where UKHCDO processes special categories of personal data, for these purposes the legal basis is: MRIS – Cohort Event Notification Report Article 9(2)(j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. UKHCDO received disseminations of the above data until July 2013. UKHCDO uses the information in the NHD to analyse and study longitudinal morbidity and mortality in bleeding disorders and link these to patient and treatment related risk factors for death and/or disability. The UKHCDO has published extensively on the epidemiology of bleeding disorders, life-expectancy and causes of death. Other areas of research include the interaction between bleeding disorder and comorbidities such as ischaemic heart disease. Aims: Haemophilia Centres report known deaths to the database, but the information supplied is not always complete. UKHCDO requires mortality reports from NHS Digital to mitigate the risk of incomplete reporting and reporting bias. UKHCDO needs to know the causes of death of the complete cohort so that treatment groups may be reliably compared with non-interventional epidemiological studies. Establish and develop the UK‐NHR as a resource for research and to further understanding of coagulation disorders and management. UKHCDO has multiple core functions for which the database is used: Research conducted on data held by NHD has the important aim of understanding disease natural history, mechanisms, epidemiology, current treatment options and outcomes, complications, and health economics. The NHD and UKHCDO do not undertake interventional studies and studies of this type are run through individual haemophilia centres. The NHD undertakes observational research in which the outcomes of treatment agreed between the patients and the haemophilia centre is analysed. 1) MANAGEMENT OF PATIENT CARE AND HEALTH CARE PLANNING (Non-Research): UKHCDO objectives: For the purposes of management of patient care and health care planning all patients with bleeding disorders are registered and data collected on total treatment issued, side effects in relation to the treatment and other complications of bleeding such as joint scores. This information is linked to the patient’s name and NHS number. The name is necessary so that the NHD can issue individuals with a Bleeding Disorder Card which states the patient’s name, diagnosis, usually treatment and haemophilia centre. Patients can show this card to any health care provider as required. a) to preserve, protect and relieve persons suffering from haemophilia and other inherited bleeding disorders Haemophilia Centres submit data to UKHCDO for all patients with bleeding disorders on a quarterly basis and in real time for cases of new diagnoses and adverse events. The data points collected may be reviewed on www.UKHCDO.org and include demographic details, details of treatment, bleeding side effects and infections and pharmacovigilance data. b) to advance the education of the medical profession, the nursing profession, professions allied to medicine and the public in the knowledge of haemophilia and other inherited bleeding disorders and their treatment Although deaths are reported, this data may be incomplete and has over the years been supplemented and cross-referenced with death certification data provided by ONS until June 2014. This enabled UKHCDO to study mortality and causes of death and relate these to changing treatment practice and with infections such as Human Immuno Deficiency Virus (HIV) and Hepatitis C Virus (HCV). c) to promote or assist in the promotion of audit and research into the causes, prevention, alleviation and management of haemophilia and other inherited bleeding disorders and to disseminate the useful results of such research. 2) RESEARCH DATABASE AND UK NATIONAL HAEMOPHILIA RESEARCH REGISTRY: NHD has multiple core functions which outline the purposes of the database. These functions include: UKHCDO has established the NHD as a research database to be used for research purposes to further the understanding of bleeding disorders and management. - DIRECT PATIENT CARE AND HEALTH CARE PLANNING: Research conducted on data held by NHD has the important aim of understanding disease natural history, mechanisms, epidemiology, current treatment options and outcomes, complications, and health economics. For the purposes of direct patient care and health care planning all patients are registered and data are submitted on total treatment issued, side effects in relation to the treatment and other complications of bleeding such as joint scores. This information is linked to the patient’s name and NHS number. The name is necessary so that the NHD can issue individuals with a Bleeding Disorder Card which the states the patients name, diagnosis, usually treatment and haemophilia centre. Patients can show this card to any health care provider as required. Patients who are registered on the NHD will be offered the opportunity to opt out of their data being used for research if they wish. All patients who do not choose to opt out are registered onto the UK National Haemophilia Research Registry (UK-NHR) a subsection of the NHD. Haemophilia Centres and patients submit data to UKHCDO for all patients with bleeding disorders on a quarterly basis, and in real time for cases of new diagnoses and adverse events. All data is securely submitted electronically, encrypted and within the NHS N3 network. The data points collected may be reviewed on www.UKHCDO.org but include demographic details, details of treatment, bleeding side effects and infections and pharmacovigilance data. Although deaths are reported, this data may be incomplete and has over the years been supplemented and cross-referenced with death certification data provided originally by ONS from the late nineteen eighties. This has enabled UKHCDO to study mortality and causes of death and relate these to changing treatment practice and with infections such as HIV and HCV. The UK-NHR can be used for observational research in which the outcomes of treatment agreed between the patients and the haemophilia centre is analysed. In addition, patients give informed signed consent at their local haemophilia centre to have genetic information uploaded under Haemtrack. Haemtrack is a secure therapy recording system developed by MDSAS, connecting patients and clinicians through the Haemtrack phone apps and website. When a patient signs up to Haemtrack they agree to their data being included in the NHD. This consent for genetic data and Haemtrack covers direct patient care and health care planning. Patients are informed about the NHD and the use of their data by the NHD is covered in the NHD patient information leaflet. In this leaflet they are informed of their right to opt out of the having some or all their data held on the NHD. Patients are provided the leaflet at the time of registration onto NHD. No NHS Digital data disseminated under this agreement will be shared on Haemtrack. The data subjects are all patients with bleeding disorders seen by a Haemophilia Centre since 1968. UKHCDO will submit the details of all patients in the NHD whose deaths have not previously been reported by NHS Digital or predecessors to NHS Digital and will receive notifications of subsequent deaths or exits from registration with the NHS. A group of around 2,000 individuals who were contacted and invited to consent between August 2019 to January 2020 will be excluded from the cohort shared with NHS Digital. - RESEARCH DATABASE AND UK NATIONAL HAEMOPHILIA RESEARCH REGISTRY: UKHCDO has support under section 251 of the NHS Act 2006 permitting it to share the data of all participants in the database except for the ~2,000 individuals, without informed consent. Establishing the NHD as a research database allows the data held by the NHD to be used for research purposes and ensures that the conduct of this research is in line with current principles on management of personal information. Patients who are registered on the NHD will be offered the opportunity to participate in research. Patients will be provided with a research information sheet and given the opportunity to ask questions. If they wish to have their data used for research, they will be asked to sign a consent form. Age appropriate procedures will be used for children. UKHCDO is the sole Data Controller for the data under this Agreement. The UKHCDO originally set up the National Haemophilia Database (NHD) and UKHCDO Ltd is the entity that administers the processing and management of the data held within the database. Patients who consent to participation into research will be registered onto the UK National Haemophilia Research Registry (UK – NHR) a subsection of the NHD. Medical Data Solutions and Services (MDSAS) is the UKHCDO’s IT service provider which hosts and maintains the UKHCDO’s servers. In addition to conduct of research on existing data, it will allow new data collections additional to routine patient care. The National Haemophilia Database strategy is to position itself with a mixed economy of funding streams. UKHCDO Ltd has service level agreements with NHS England, NHS Scotland, and NHS Wales but UKHCDO also receives grants from companies that make treatments for bleeding disorders, and from commercial sponsorship from Industry at the present time. Consent: NHS England has confirmed it is not a data controller for the data in the NHD nor for any data processed under this Data Sharing Agreement. If there was any change to this assessment or to NHS England’s role in respect of the data, an amendment to this Agreement would be necessary and the UKHCDO would be required to submit an application for that amendment as soon as reasonably possible. The NHD is a named database in that UKHCDO hold data on fully identifiable patients. The UK National Haemophilia Research Registry was given national ethical approval for a period of five years in April 2019 and following consultation with the NHS HRA Confidentiality Advisory Group in 2019, UKHCDO are in the process of obtaining written informed consent from the Haemophilia Research Registry population. The database is sponsored by at Manchester University NHS Foundation Trust (MFT) which also provides an Information Governance function to support UKHCDO Ltd. UKHCDO Ltd has an agreement with the Information Governance Department at MFT to inspect the registry every two years to ensure compliance with data protection legislation and adhering to the principle of fair data handling (Caldicott Principles). MFT does not have access to, nor any role in controlling or manipulating the data within the database including NHS Digital data. The original process in place was a system of informed implied consent. This process has been used since data started to be collected from people during treatment in NHS hospitals. Following NHD’s application for Ethical approval of the research registry from the HRA (CAG) and with the implementation of GDPR, NHD moved to a process of written informed (explicit) consent for data to be used specifically for research purposes and not for the purposes of collecting data for reasons in the public interest, for example NHD procured services to provide bleeding disorder data to regional health care commissioners. The new process was started in 2019 where the first consent was received on 13 August 2019. This is a rolling programme of acquiring consent from all patients, where NHD expect to have a mature embedded model of explicit consent in the next three to five years from the implementation day. The NHS functions of the database do not require consent. Before the introduction of this consent process, UKHCDO informed patients about the database using a patient information leaflet and offered them an opt-out. This process has been implemented in line with GDPR and as mentioned previously following our successful ethical approval with HRA (CAG) Patients in NHD will be allocated to one of three groups based on their consent for research and participation in the UK‐NHR. Depending upon the consent for research. a. Patients registered and consented for UK‐NHR b. Patients registered and declined consent for UK‐NHR c. Patients registered and with no data available on consent for UK‐NHR. Typically, the patient is not in regular contact with the centre and the opportunity to seek consent has not presented. UKHCDO accessed death certification data on patients registered with the database to perform longitudinal study of the natural history of bleeding disorders and the effect of evolving treatment modalities and treatment regimens on life expectancy and the causes of death of those conditions. The pre-treatment life-expectancy of severe haemophilia was 10-15 years and had only improved to about 40 years by 1960. Actuarial methods suggest that current life expectancy is still reduced by 2-4 years compared with the general population but UKHCDO hope that recently introduced changes in treatment may improve this. Until recently, bleeding and especially intracranial haemorrhage was the most common cause of death in severe haemophilia but, again, improved and intensified replacement therapy strategies will hopefully reduce this risk and extend life expectancy. This may be especially true in patients with factor VIII inhibitors, a group previously resistant to replacement therapy who suffer far more morbidity and have a far greater risk of haemorrhagic death. The aim of UK Haemophilia Database is to analyse morbidity and mortality in bleeding disorders and link these to patient and treatment related risk factors for death and/or disability. Although Haemophilia Centres reporting to the database report deaths that they know about, if UKHCDO rely on such reports, there is a risk of incomplete reporting and reporting bias. UKHCDO need to know the causes of death of the complete cohort so that treatment groups may validly be compared in non-interventional epidemiological studies. The National Haemophilia Database is funded by NHS England. UKHCDO have provided a signed copy of the Service Level Agreement for 2017 – 2019, under the Evidence section. NHD has received payment for 2019 -20 but UKHCDO currently awaiting signed confirmation for the 2019/20 Service Level Agreement from NHS England. Data Controllership: UKHCDO are the Data Controller for this agreement and manage the NHS Digital data currently held and will manage the data being requested. NHD's handling of information about patients is based upon statutory powers which underpin the legal bases that apply for the purposes of the GDPR. The legal bases for NHD’s data processing are based on improving patient care and serve the wider public interest. The details are: Article 6(1)(f) – processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. Where UKHCDO process special categories of data, for example data concerning health, racial or ethnic origin, genetic information, and gender, UKHCDO need to meet an additional condition in the GDPR. Where UKHCDO are processing special categories of personal data for purposes related to the commissioning and provision of health services the condition is: Article 9(2)( j ) – processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The examples below, coupled with the Legitimate Interest Assessment (LIA) completed by UKHCDO outline the wider legitimate and public interests and serve to describe why the processing of this data is required: • In adherence with UKHCDO Ltd service level agreement with NHS England, Scotland and Wales (policy makers) the NHD is required to provide annual cyclical reporting on mortality data to assist these organisations with national strategic healthcare planning and disease monitoring. • There are several outputs which include reports and academic studies that will provide direct benefit to patients and those clinicians that are treating them, in meeting their objective to identify groups at risk. These reports and studies will also show which treatments are most beneficial to patients and cost effective. The benefits will be measured in terms of reduced morbidity, mortality and treatment costs but may take two or more years to show up • The death certification data allows NHD analysts to study trends in causes of death and in life expectancy as improvements in treatment are introduced. This would help UKHCDO to evaluate and justify therapeutic developments. Death is also an important end-point in pharmacovigilance since some treatments, for example, Emicizumab, currently being widely introduced as prophylaxis against bleeding in Haemophilia A, may increase deaths from heart attack and stroke whilst reducing the risk of death from haemorrhage. • Further, the Health Protection Agency expect UKHCDO to provide a report to them every six months on any cases of Jacob Kreuzfeld Disease or variant Jacob Kreutzfeld disease. Furthermore, NHD are required to collate data on deaths from complications of other blood born viruses such as hepatitis B and C and HIV and report these to NHS England, various public Inquiries and publish this data in anonymised aggregate form. • The NHD has provided information to the Infected Blood Inquiry investigating morbidity and mortality due to HIV and hepatitis C in patients treated with certain blood products.as well as to Parliament and the NHS. The NHD helps patient care by assisting continuity of care and monitoring safety through the provision of accurate data. • Products to treat bleeding disorders are amongst the most expensive in the NHS so potential savings are extremely significant. UKHCDO Ltd. / NHD has an SLA with NHS England through the Clinical Reference Group (CRG) for Haemophilia. In collaboration with the CRG and the Commercial Medicines Unit (CMU), NHD have been successful in providing evidence to the CMU to allowing them to achieve savings in excess of £100M when securing national contracts for factor concentrates. The NHD can provide detailed surveillance of patients who have been switched to a lower cost product which in turn leads to significant savings in the medication costs. • The information provided by the NHD helps patient care by assisting continuity of care and monitoring safety through the provision of accurate data and this information informs and shapes national policy. • For the mortality data, this will contribute to safety (provision of care and treatment), cost reduction (management of health and social care services), improved knowledge and therefore care (provision of care and treatment), and provision of a firmer evidence base to inform public policy (Serve the wider public interest).

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. This Data Sharing Agreement authorises the retention and continued use of mortality data supplied by NHS Digital or predecessor data providers and held within the NHD for the purposes described above. The study data, including data provided by NHS Digital under previous agreements, are currently held by UK Haemophilia Centre Doctors' Organisation. Under this Agreement, the following data flows are permitted: UKHCDO have previously received flows of mortality data for patients held within NHD where consent has been received for the collection of this data. UKHCDO have received this data under the dataflows described below on a quarterly basis: a) UKHCDO Ltd provides NHS Digital, securely, with the following identifiers for NHD registrants with bleeding disorders covered by section 251 support: a) UKHCDO provide NHS Digital, securely, with the following identifiers for all consented NHD registrants with bleeding disorders: [1 paragraph unchanged] • NHS number or CHI (Scotland NHS equivalent) number (to identify patient and perform linkage) • Forename – to ʹto confirm identity of patient (complementary to or in absence of NHS number) • Surname – to ʹto confirm identity of patient (complementary to or in absence of NHS number) • Date of Birth – (to ʹ(to calculate age at diagnosis and age at death) b) NHS Digital traced traces patients using UKHCDO the supplied identifiers and provide provides UKHCDO Ltd with mortality data for patients where an instance of mortality has been recorded since the previous quarterly drop. c) NHS Digital data was is transferred to UKHCDO Ltd via secure file transfer and stored on N3 servers hosted at Leigh NHS Data Centre operated by Greater Manchester Shared Services. • There are four levels of security before reaching the servers: Leigh NHS Data Centre is within Leigh Infirmary. This is part of the N3 network. o Secured Perimeter All access to NHS Digital data will be performed by substantive employees of UKHCDO Ltd. Access to data held on servers is restricted to authorised personnel who undergo information governance training in accordance with the NHS Data Security and Protection Toolkit (DSPT). This is reviewed and reassessed on an annual basis as required by the DSPT. A Caldicott inspection of the database and its security arrangements is regularly carried out. o Facility Building Access Control Staff are trained on access to data and backups are kept in the event of an error occurring. o Computer Rooms with secured access d) The data is pseudonymised using NHD registration number prior to it being presented to statisticians for analysis. Access to the pseudonymised data is by named individuals within NHD and all are employees of the UKHCDO Ltd. Once the data has been pseudonymised, no attempt will be made by UKHCDO to reidentify any patients. o Secured server cabinets e) Once pseudonymised, factors influencing mortality are studied using statistical methods. Death rates from specific causes are compared with national mortality rates (derived from World Health Organization data) using standardised mortality ratios. • All access to NHS Digital data was performed by substantive employees of the Data Controller via restricted access to approved processors and will be for data requested under this agreement. Necessary steps have been taken with the identifiable data being released by NHS Digital to minimise the risk of identification. Prior to NHS Digital releasing the identifiable data it has been minimised to cohort participants and data periods. Once the data is released to the NHD it is pseudonymised prior to presentation to statisticians for analysis and only fully anonymised aggregate reports are disseminated or published. NHD and NHS Digital data is not accessed by the Regional Health Authority at Leigh Infirmary and is only held on their systems to be accessed by UKHCDO Ltd staff. • VPN restricted access control with all data transferred from sites encrypted using industry standard SSL 4096-bit encryption Any data requests from researchers external to UKHCDO Ltd, once approved by the DMWP, are strictly processed by substantive employees of the UKHCDO Ltd and outputs are returned to the researcher as aggregated data with small numbers suppressed. • Access to data held on servers is restricted to authorised personnel who undergo information governance training in accordance with the NHS DSPT toolkit. This is reviewed and reassessed on an annual basis as required by the DSPT toolkit. Caldecott inspection of the database and its security arrangements is regularly carried out see UKHCDO website for details. • Restricted VPN access for authorised personnel only. High entropy password protected and only accessible via the NHS network (N3) • Data is only accessed directly from the N3 servers and is not transferred • Staff are trained on access to data and backups are kept in the event of an error occurring • All systems and operating systems automatically patched with the latest windows updates incorporating inbuilt virus protection • Systems and their databases (Inc. updates) are replicated across mirrored servers held in separate data centres at 15-minute intervals. In addition to this full SQL database backups are carried out nightly and these are also mirrored across the servers d. The data is pseudonymised using NHD registration number prior to it being presented to statisticians for analysis. Access to the pseudonymised data is by named individuals within NHD and all are employees of the UKHCDO. Once the data has been pseudonymised, no attempt will be made by UKHCDO to re-identify any patients using the data. e. Once pseudonymised, factors influencing mortality are studied using incident rate ratios estimated using Poisson regression. Death rates from specific causes are compared with national mortality rates (derived from World Health Organization data) using standardised mortality ratios. Necessary steps have been taken with the identifiable data being released by NHS Digital to minimise the risk of identification. Prior to NHS Digital releasing the identifiable data it has been minimised to cohort participants and data periods. Once the data is released to the NHD, it is pseudonymised prior to presentation to our statisticians for analysis and only fully anonymised aggregate reports are disseminated or published. NHD and NHS Digital data is not accessed by the Regional Health Authority at Leigh Infirmary and is only held on their systems to be accessed by UKHCDO staff. [1 paragraph unchanged] NHS Digital reminds all organisations party to this agreement of the need [17 words unchanged] that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: – i.e. employees, agents and contractors of the Data Recipient who may have access to that data).

Expected output

This Agreement permits the secure retention of the data only and no other processing. Over the course of this Data Sharing Agreement, UKHCDO will continue to report to the Department of Health and Social Care, NHS England, Scotland and Wales, and Public Health England (PHE) on mortality and causes of death for patients with bleeding disorders. No new outputs will be produced under this Data Sharing Agreement. All reports contain only anonymised aggregate data (with small numbers suppressed in line with the HES Analysis Guide). UKHCDO plan to submit a full renewal to this agreement to receive further data once the application has been amended in line with the current NHS Digital DARS Standards. Over the course of this renewed agreement, NHD will continue to report to the Department of Health, Health Protection Agency, NHS England and NHS Scotland and Wales on mortality and causes of death for patients with bleeding disorders. Throughout this one-year Agreement UKHCDO Ltd will continue to provide reports to stakeholders as detailed below. Reports to Health Protection Agency PHE are produced every six months. Reports submitted to NHS England, Scotland and Wales are produced quarterly in our annual report and through Dashboards. All reports are on anonymised aggregate data (with censorship of low numbers in line with Caldicott guidelines). [6 paragraphs unchanged] See previous publications below References (Previous publications using Death Certification Data): 1. Darby SC, Kan SW, Spooner RJ, Giangrande PL, Hill FGH, Hay CRM, Lee, CA, Ludlam CA, Williams M. Mortality Rates, Life expectancy and causes of death in people with haemophilia A or B in the United Kingdom who were not infected with HIV. Blood 2007, 110 (3), 815-25. 2. Darby SC, Keeling DM, Spooner RJ, Wan Kan S, Giangrande PL, Collins PW, Hill FGH, Hay CRM. UK Haemophilia Centre Doctors Organisation. The incidence of factor VIII and Factor IX inhibitors in the haemophilia population of the UK and their effect on subsequent mortality 1977-99. J Thrombosis and Haemostasis 2004, 2 (7): 1047-54. 3. Darby SC et al. Multiple authors including Hay CRM. Mortality before and after HIV infection in the complete UK population of haemophiliacs. Nature 1995, 377 (6544) 79-82. 4. Darby SC et al. Incidence of AIDS and excess of mortality associated with HIV in haemophiliacs in the United Kingdom: report on behalf of the directors of haemophilia centres in the United Kingdom. BMJ 1989; 298: 1064-68.

Expected measurable benefits

This Agreement permits the secure retention of the data only and no other processing. In adherence with UKHCDO's service level agreement with NHS England, Scotland, and Wales (policy makers), UKHCDO is required to provide annual cyclical reporting on mortality data to assist these organisations with national strategic healthcare planning and disease monitoring. In adherence with UKHCDO's service level agreement with NHS England, Scotland and Wales (policy makers), UKHCDO/NHD is required to provide annual cyclical reporting on mortality data to assist these organisations with national strategic healthcare planning and disease monitoring. There are several outputs which include reports and academic studies that will provide direct benefit to patients and those clinicians that are treating them, in meeting their objective to identify groups at risk. These reports and studies will also show which treatments are most beneficial to patients and cost effective. The benefits will be measured in terms of reduced morbidity, mortality, and treatment costs. There are a number of outputs which include reports and academic studies that will provide direct benefit to patients and those clinicians that are treating them, in meeting their objective to identify groups at risk. These reports and studies will also show which treatments are most beneficial to patients and cost effective. The benefits will be measured in terms of reduced morbidity, mortality and treatment costs. The death certification data allows UKHCDO to study trends in causes of death and in life expectancy as improvements in treatment are introduced. This would help to evaluate and justify therapeutic developments. Death is also an important endpoint in pharmacovigilance since some treatments, for example, Emicizumab, currently being widely introduced as prophylaxis against bleeding in Haemophilia A, may increase deaths from heart attack and stroke whilst reducing the risk of death from haemorrhage. The death certification data allows UKHCDO to study trends in causes of death and in life expectancy as improvements in treatment are introduced. This would help to evaluate and justify therapeutic developments. Death is also an important end-point in pharmacovigilance since some treatments, for example, Emicizumab, currently being widely introduced as prophylaxis against bleeding in Haemophilia A, may increase deaths from heart attack and stroke whilst reducing the risk of death from haemorrhage. Further, PHE expects UKHCDO to provide a report to them every six months on any cases of Jacob Kreutzfeld Disease or variant Jacob Kreutzfeld disease. Furthermore, UKHCDO also must collate data on deaths from complications of other blood born viruses such as hepatitis B and C and HIV and report these to NHS England, various Public Inquiries and publish this data in anonymised aggregate form. Further, the Health Protection Agency expect UKHCDO to provide a report to them every six months on any cases of Jacob Kreuzfeld Disease or variant Jacob Kreutzfeld disease. Furthermore, UKHCDO also have to collate data on deaths from complications of other blood born viruses such as hepatitis B and C and HIV and report these to NHS England, various public Inquiries and publish this data in anonymised aggregate form. [3 paragraphs unchanged]

Benefits reported

NHS Digital provided UKHCDO with death certification data up to 2013. As already mentioned above, June 2014 this enabled UKHCDO to report to NHS England, Scotland Scotland, and Wales to facilitate national strategic healthcare planning using the Annual reports Reports and a number of several other requested ad - hoc reports. UKHCDO were Ltd was also able to monitor the effect of improving healthcare on life expectancy and causes of death in patients with haemophilia and other bleeding disorders. UKHCDO were was also able to describe the effect of blood born infections, principally hepatitis [7 words unchanged] causes of death and describe the interaction between those two viruses. UKHCDO were was then able to observe the effect that the introduction of effective antiviral [5 words unchanged] history of hepatitis C and HIV and the effect on life expectancy. [1 paragraph unchanged] Similarly, it has helped justify allocation of resource to improve Joint HIV and joint Hepatology care for patients infected with HIV and hepatitis C such that hepatitis C has now been largely eradicated from this group. eradicated. As there has been no flow of Mortality data to UKHCDO since June 2014 there are no further yielded benefits to report at this time.

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

Objective for processing

This is a short-term extension to retain, but not otherwise process the data that is already held. This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling UK Haemophilia Centre Doctors Organisation to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). [1 paragraph unchanged] The UK Haemophilia Database (NHD), managed by the UK Haemophilia Centre Doctors [6 words unchanged] as a registry of patients with bleeding disorders. UKHCDO (NHD) now have in excess of more than 30,000 patients with bleeding disorders registered with the database. The aim of [64 words unchanged] medical practitioners who work within the Haemophilia Centre’s of England, Scotland, Northern Ireland Ireland, or Wales and have an interest in the care of people with [9 words unchanged] in 1968 to improve haemophilia care, research into bleeding disorders, their treatment epidemiology epidemiology, and complications and to facilitate healthcare planning through managing the database. UKHCDO is registered with the charity commission under registration number 1032606. Since its inception, the database has monitored treatment trends and morbidity and [28 words unchanged] essentially conducting an open-ended cohort study. UKHCDO also report regularly to the Dept. Department of Health, NHS England, Scotland and Wales, and the Health Protection Agency to facilitate disease monitoring and healthcare planning. Aims: Establish and develop the UK‐NHR as a resource for research, to further our understanding of coagulation disorders and their management. Research conducted on data held by NHD has the important aim of understanding disease natural history, mechanisms, epidemiology, current treatment options and outcomes, complications and health economics. The NHD and UKHCDO do not undertake interventional studies and studies of this type are run through individual haemophilia centres. The NHD undertakes observational research in which the outcomes of treatment agreed between the patients and the haemophilia centre is analysed. UKHCDO objectives: a) to preserve, protect and relieve persons suffering from haemophilia and other inherited bleeding disorders; b) to advance the education of the medical profession, the nursing profession, professions allied to medicine and the general public in the knowledge of haemophilia and other inherited bleeding disorders and their treatment c) to promote or assist in the promotion of audit and research into the causes, prevention, alleviation and management of haemophilia and other inherited bleeding disorders and to disseminate the useful results of such research. NHD has multiple core functions which outline the purposes of the database. These functions include: Direct patient care and health care planning – For the purposes of direct patient care and health care planning all patients are registered and data are submitted on total treatment issued, side effects in relation to the treatment and other complications of bleeding such as joint scores. This information is linked to the patients name and NHS number. The name is necessary so that the NHD can issue individuals with a Bleeding Disorder Card which the states the patients name, diagnosis, usually treatment and haemophilia centre. Patients can show this card to any health care provider as required. Haemophilia Centres and patients submit data to UKHCDO for all patients with bleeding disorders on a quarterly basis, and in real time for cases of new diagnoses and adverse events. All data is securely submitted electronically, encrypted and within the NHS N3 network. The data points collected may be reviewed on www.UKHCDO.org but include demographic details, details of treatment, bleeding side effects and infections and pharmacovigilance data. Although deaths are reported, this data may be incomplete and has over the years been supplemented and cross-referenced with death certification data provided originally by ONS from the late nineteen eighties. This has enabled UKHCDO to study mortality and causes of death and relate these to changing treatment practice and also with infections such as HIV and HCV. In addition, patients give informed signed consent at their local haemophilia centre to have genetic information uploaded under Haemtrack. When a patient signs up to Haemtrack they agree to their data being included in the NHD. This consent for genetic data and Haemtrack covers direct patient care and health care planning. Patients are informed about the NHD and the use of their data by the NHD is covered in the NHD patient information leaflet. In this leaflet they are informed of their right to opt out of the having some or all their data held on the NHD. Patients are provided the leaflet at the time of registration onto NHD. Research database and UK National Haemophilia Research Registry – Establishing the NHD as a research database allows the data held by the NHD to be used for research purposes and ensures that the conduct of this research is in line with current principles on management of personal information. Patients who are registered on the NHD will be offered the opportunity to participate in research. Patients will be provided with a research information sheet and given the opportunity to ask questions. If they wish to have their data used for research they will be asked to sign a consent form. Age appropriate procedures will be used for children. Patients who consent to participation into research will be registered onto the UK National Haemophilia Research Registry (UK – NHR) a subsection of the NHD. In addition to conduct of research on existing data, it will allow new data collections additional to routine patient care. Consent: The NHD is a named database in that UKHCDO hold data on fully identifiable patients. The UK National Haemophilia Research Registry was given national ethical approval for a period of five years in April 2019 and following consultation with the NHS HRA Confidentiality Advisory Group in 2019, UKHCDO are in the process of obtaining written informed consent from the Haemophilia Research Registry population. Our process of moving from a system of informed implied consent to written informed (explicit) consent is for data to be used for research for all patients registered with a bleeding disorder. The process was started in 2019 where the first consent was received on 13 August 2019. This is a rolling programme of acquiring consent from all patients, where we expect to have a mature embedded model of explicit consent in the next three to five years from the implementation day. Approximately 1300 patients have provided their consent to date. The NHS functions of the database do not require consent. Before the introduction of this consent process, UKHCDO informed patients about the database using a patient information leaflet and offered them an opt-out. This process is currently being updated in line with General Data Protection Regulation. Data security processes and processes of fair data handling are detailed elsewhere in this application. Patients in NHD will be allocated to one of three groups based on their consent for research and participation in the UK‐NHR. Depending upon the consent for research. a. Patients registered and consented for UK‐NHR b. Patients registered and declined consent for UK‐NHR c. Patients registered and with no data available on consent for UK‐NHR. Typically the patient is not in regular contact with the centre and the opportunity to seek consent has not presented. [7 paragraphs unchanged] UKHCDO received disseminations of the above data until July 2013. The purpose of this request is for the retention but not processing of the data already received from NHS Digital. UKHCDO plans to submit an amendment to this agreement once this extension has been approved to receive further mortality data against its cohort of database members. UKHCDO received disseminations of the above data until July 2013. Aims: Establish and develop the UK‐NHR as a resource for research and to further understanding of coagulation disorders and management. Research conducted on data held by NHD has the important aim of understanding disease natural history, mechanisms, epidemiology, current treatment options and outcomes, complications, and health economics. The NHD and UKHCDO do not undertake interventional studies and studies of this type are run through individual haemophilia centres. The NHD undertakes observational research in which the outcomes of treatment agreed between the patients and the haemophilia centre is analysed. UKHCDO objectives: a) to preserve, protect and relieve persons suffering from haemophilia and other inherited bleeding disorders b) to advance the education of the medical profession, the nursing profession, professions allied to medicine and the public in the knowledge of haemophilia and other inherited bleeding disorders and their treatment c) to promote or assist in the promotion of audit and research into the causes, prevention, alleviation and management of haemophilia and other inherited bleeding disorders and to disseminate the useful results of such research. NHD has multiple core functions which outline the purposes of the database. These functions include: - DIRECT PATIENT CARE AND HEALTH CARE PLANNING: For the purposes of direct patient care and health care planning all patients are registered and data are submitted on total treatment issued, side effects in relation to the treatment and other complications of bleeding such as joint scores. This information is linked to the patient’s name and NHS number. The name is necessary so that the NHD can issue individuals with a Bleeding Disorder Card which the states the patients name, diagnosis, usually treatment and haemophilia centre. Patients can show this card to any health care provider as required. Haemophilia Centres and patients submit data to UKHCDO for all patients with bleeding disorders on a quarterly basis, and in real time for cases of new diagnoses and adverse events. All data is securely submitted electronically, encrypted and within the NHS N3 network. The data points collected may be reviewed on www.UKHCDO.org but include demographic details, details of treatment, bleeding side effects and infections and pharmacovigilance data. Although deaths are reported, this data may be incomplete and has over the years been supplemented and cross-referenced with death certification data provided originally by ONS from the late nineteen eighties. This has enabled UKHCDO to study mortality and causes of death and relate these to changing treatment practice and with infections such as HIV and HCV. In addition, patients give informed signed consent at their local haemophilia centre to have genetic information uploaded under Haemtrack. Haemtrack is a secure therapy recording system developed by MDSAS, connecting patients and clinicians through the Haemtrack phone apps and website. When a patient signs up to Haemtrack they agree to their data being included in the NHD. This consent for genetic data and Haemtrack covers direct patient care and health care planning. Patients are informed about the NHD and the use of their data by the NHD is covered in the NHD patient information leaflet. In this leaflet they are informed of their right to opt out of the having some or all their data held on the NHD. Patients are provided the leaflet at the time of registration onto NHD. No NHS Digital data disseminated under this agreement will be shared on Haemtrack. - RESEARCH DATABASE AND UK NATIONAL HAEMOPHILIA RESEARCH REGISTRY: Establishing the NHD as a research database allows the data held by the NHD to be used for research purposes and ensures that the conduct of this research is in line with current principles on management of personal information. Patients who are registered on the NHD will be offered the opportunity to participate in research. Patients will be provided with a research information sheet and given the opportunity to ask questions. If they wish to have their data used for research, they will be asked to sign a consent form. Age appropriate procedures will be used for children. Patients who consent to participation into research will be registered onto the UK National Haemophilia Research Registry (UK – NHR) a subsection of the NHD. In addition to conduct of research on existing data, it will allow new data collections additional to routine patient care. Consent: The NHD is a named database in that UKHCDO hold data on fully identifiable patients. The UK National Haemophilia Research Registry was given national ethical approval for a period of five years in April 2019 and following consultation with the NHS HRA Confidentiality Advisory Group in 2019, UKHCDO are in the process of obtaining written informed consent from the Haemophilia Research Registry population. The original process in place was a system of informed implied consent. This process has been used since data started to be collected from people during treatment in NHS hospitals. Following NHD’s application for Ethical approval of the research registry from the HRA (CAG) and with the implementation of GDPR, NHD moved to a process of written informed (explicit) consent for data to be used specifically for research purposes and not for the purposes of collecting data for reasons in the public interest, for example NHD procured services to provide bleeding disorder data to regional health care commissioners. The new process was started in 2019 where the first consent was received on 13 August 2019. This is a rolling programme of acquiring consent from all patients, where NHD expect to have a mature embedded model of explicit consent in the next three to five years from the implementation day. The NHS functions of the database do not require consent. Before the introduction of this consent process, UKHCDO informed patients about the database using a patient information leaflet and offered them an opt-out. This process has been implemented in line with GDPR and as mentioned previously following our successful ethical approval with HRA (CAG) Patients in NHD will be allocated to one of three groups based on their consent for research and participation in the UK‐NHR. Depending upon the consent for research. a. Patients registered and consented for UK‐NHR b. Patients registered and declined consent for UK‐NHR c. Patients registered and with no data available on consent for UK‐NHR. Typically, the patient is not in regular contact with the centre and the opportunity to seek consent has not presented. [2 paragraphs unchanged] The National Haemophilia Database is funded by NHS England. UKHCDO have provided [25 words unchanged] currently awaiting signed confirmation for the 2019/20 Service Level Agreement from NHS England England. [1 paragraph unchanged] UKHCDO have been amended as the Data Controller for this agreement, the NHS Digital data currently held and the data being requested. The previous version of this agreement listed NHS Manchester CCG as the Data Controller for this agreement, however UKHCDO confirm that they are and have always been the Data Controller for the database including NHS Digital data already held. UKHCDO originally set up haemophilia database (NHD) and control the processing and management of the data held within the database, including NHS Digital data previously held and to be requested. UKHCDO are the Data Controller for this agreement and manage the NHS Digital data currently held and will manage the data being requested. The previous version of this agreement naming NHS Manchester CCG as the data controller had been based on a misunderstanding in that Manchester CCG housed the fileservers in the past, though they did not have any role in controlling or manipulating the data on the servers. Currently, the database is hosted by Central Manchester Healthcare Foundation Trust who provide Information Governance. Central Manchester Healthcare Foundation Trust undertakes regular inspection through a review by the hospital Caldicott Guardian. Neither NHS Manchester CCG or Central Manchester Healthcare Foundation Trust have access to, or any role in controlling or manipulating, the data within database including NHS Digital data. NHD's handling of information about patients is based upon statutory powers which underpin the legal bases that apply for the purposes of the GDPR. The legal bases for NHD’s data processing are based on improving patient care and serve the wider public interest. The details are: NHD's handling of information about patients is based upon statutory powers which underpin the legal bases that apply for the purposes of the GDPR. The legal bases for most of our data processing is based on improving patient care and serve the wider public interest. [1 paragraph unchanged] Where UKHCDO process special categories of data, for example data concerning health, racial or ethnic origin, genetic information information, and gender, UKHCDO need to meet an additional condition in the GDPR. [11 words unchanged] related to the commissioning and provision of health services the condition is: Article 9(2)(h) 9(2)( j ) – processing is necessary for archiving purposes in the public interest, scientific [43 words unchanged] to safeguard the fundamental rights and the interests of the data subject. The examples below, coupled with the Legitimate Interest Assessment (LIA) completed by UKHCDO under SD1, outline the wider legitimate and public interests and serve to describe why the processing of this data is required: • In adherence with our UKHCDO Ltd service level agreement with NHS England, Scotland and Wales (policy makers) the [11 words unchanged] to assist these organisations with national strategic healthcare planning and disease monitoring. • There are a number of several outputs which include reports and academic studies that will provide direct benefit [47 words unchanged] treatment costs but may take two or more years to show up [1 paragraph unchanged] • Further, the Health Protection Agency expect UKHCDO to provide a report [6 words unchanged] any cases of Jacob Kreuzfeld Disease or variant Jacob Kreutzfeld disease. Furthermore, we also have NHD are required to collate data on deaths from complications of other blood born viruses [13 words unchanged] England, various public Inquiries and publish this data in anonymised aggregate form. [1 paragraph unchanged] • Products to treat bleeding disorders are amongst the most expensive in [25 words unchanged] Haemophilia. In collaboration with the CRG and the Commercial Medicines Unit (CMU), we NHD have been successful in providing evidence to the CMU to allowing them [30 words unchanged] product which in turn leads to significant savings in the medication costs. [2 paragraphs unchanged]

Processing activities

This is a short-term extension to retain, but not otherwise process the data that is already held. The description of processing here covers historic processing. Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. UKHCDO received flows of mortality data for patients held within NHD where consent has been received for the collection of this data. UKHCDO have previously received this data under the dataflows described below on a quarterly basis: The study data, including data provided by NHS Digital under previous agreements, are currently held by UK Haemophilia Centre Doctors' Organisation. UKHCDO have previously received flows of mortality data for patients held within NHD where consent has been received for the collection of this data. UKHCDO have received this data under the dataflows described below on a quarterly basis: [8 paragraphs unchanged] • There are four levels of security before you can physically reach reaching the servers:- servers: [4 paragraphs unchanged] • All access to NHS Digital data was performed by substantive employees of the Data Controller via restricted access to approved processors. processors and will be for data requested under this agreement. • VPN restricted access control with all data transferred from sites encrypted using industry standard SSL 4096 bit 4096-bit encryption • Access to data held on servers is restricted to authorised personnel who undergo information governance training in accordance to with the NHS DSPT toolkit. This is reviewed and reassessed on an annual [13 words unchanged] its security arrangements is regularly carried out see UKHCDO website for details. [4 paragraphs unchanged] • Systems and their databases (Inc. updates) are replicated across mirrored servers held in separate data centres at 15 minute 15-minute intervals. In addition to this full SQL database backups are carried out nightly and these are also mirrored across the servers d. The data is pseudonymised using NHD registration number prior to it [26 words unchanged] data has been pseudonymised, no attempt will be made by UKHCDO to reidentify re-identify any patients using the data. [1 paragraph unchanged] Necessary steps have been taken with the identifiable data being released by [21 words unchanged] cohort participants and data periods. Once the data is released to the NHD NHD, it is pseudonymised prior to presentation to our statisticians for analysis and [26 words unchanged] is only held on their systems to be accessed by UKHCDO staff. Our This data sharing agreement does not permit sharing of the data with third parties except in the form of aggregated anonymised outputs with small numbers suppressed. Processing This agreement permits continued retention of the data only. The agreement does not permit any other processing of the data. UKHCDO must inform NHS Digital DARS team if, when the DSPT is reviewed by NHS Digital, it is deemed to have not passed or if any issues are raised with the submission. If, after a DSPT review by NHS Digital, UKHCDO are required to carry out improvements (as stipulated in the review) these will be carried out within 3 months of the review date. UKHCDO must subsequently maintain their DSPT (or subsequent versions / successors) during the period of this DSA. Meeting these security controls as set out within these special conditions is a requirement of this Data Sharing Agreement, and UKHCDO must inform NHS Digital if these criteria are not met [1 paragraph unchanged]

Expected output

This Agreement permits the secure retention of the data only and no other processing. No new outputs will be produced under this Data Sharing Agreement. [14 paragraphs unchanged]

Expected measurable benefits

This Agreement permits the secure retention of the data only and no other processing. [7 paragraphs unchanged]

Unchanged: Benefits reported.