NHS Digital Data Release Register - reformatted

Uk Health Security Agency projects

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


Opt outs honoured: Y, No - flow to PHE under a memorandum of understanding, Identifiable, No (Statutory exemption to flow confidential data without consent)

Legal basis: Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7)

Purposes: (Agency/Public Body)

Sensitive: Sensitive

When:2016.04 — 2019.12. DSA runs 2019-03-01 — 2020-02-29

Access method: Ongoing, One-Off

Data-controller type: PUBLIC HEALTH ENGLAND (PHE), DEPARTMENT OF HEALTH AND SOCIAL CARE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report
  5. Cancer Registration Data
  6. Civil Registration - Deaths

Objectives:

To describe the current biochemical, histological and clinically apparent liver disturbance in cases of HCV infection, and to relate current status to the interval since presumed infection and other potential prognostic factors.

Yielded Benefits:

Regarding yielded benefits, these data are critical for PHE's modelling of the HCV epidemic in England. Public Health England employ a Bayesian back-calculation approach, combining data on severe HCV-related liver disease and disease progression, to reconstruct historic HCV incidence and estimate current prevalence. PHE use these data to define disease progression rates to inform their modelling of the HCV disease burden in England and the UK. Modelling results are presented in a variety of papers and reports, including the annual national HCV in England reports that are available via this link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk In addition to the recent publications in the above link, past publications are also listed below, but it is important to note that most of the publications currently in preparation are being held up until this DSA is renewed, so PHE cannot currently update the survival analyses or respond to any requests in this area that are likely to come PHE's way from the government’s ongoing Infected Blood Enquiry. Ross J. Harris HH, Sema Mandal, Mary Ramsay, Peter Vickerman, Matthew Hickman, Daniela De Angelis. Monitoring the hepatitis C epidemic in England and evaluating intervention scale-up using routinely collected data. Journal of Viral Hep.2019;00:1-12. Hepatitis C: Estimating Disease Burden. Updated November 2018. https://www.gov.uk/government/publications/hepatitis-c-commissioning-template-for-estimating-disease-prevalence Harris RJ, Martin, N. K., Rand E, Mandal S, Mutimer D, Vickerman P, Ramsay ME, et al. New treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission in England. Journal of Viral Hepatitis. 2016(8):631-43. Increased uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease in England: Modelling the predicted impact of treatment under different scenarios. Journal of Hepatology 2014; 61: 530-7. Hepatitis C in England/the UK, annual reports from 2005-2019 (https://www.gov.uk/government/publications/hepatitisc-in-the-uk) Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; 2012 Oct;140(10):1830-7 The impact of mode of acquisition on biological markers of paediatric hepatitis C virus infection. Journal of Viral Hepatitis. 2011; 18: 533-541. Spontaneous loss of hepatitis C virus RNA from serum is associated with genotype 1 and younger age at exposure. Journal of Medical Virology 2011; 83: 1338-1344. Harris HE, Costella A, Amirthalingam G, Alexander G, Ramsay ME, Andrews N; the UK HCV National Register Collaborators. Improved hepatitis C treatment response in younger patients: findings from the UK HCV National Register cohort study. Epidemiology and Infection 2011; Nov 29:1-8. The burden of Hepatitis C in England. Journal of Viral Hepatitis 2007; 14 (8): 570􀍴576. Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis 2007; 14: 213-220. Harris HE, Mieli-Vergani G, Kelly D, Davison S, Gibb D and Ramsay ME. A national sample of individuals who acquired their hepatitis C virus infections in childhood/adolescence – risk factors for advanced disease. Journal of Paediatric Gastroenterology and Nutrition 2007; 45 (3); 335-341. H.E. Harris, K.P. Eldridge, S. Harbour, G. Alexander, C.-G. Teo, M.E. Ramsay and The HCV National Register Steering Group. Does the clinical outcome of hepatitis C infection vary with the infecting hepatitis C virus type? Journal of Viral Hepatitis March 2007; 14 (3):213-20. Survival of a national cohort of hepatitis C virus infected patients, 16 years after exposure Epidemiology and Infection 2006; 134: 472-477. Estimated progression rates in three United Kingdom hepatitis C cohorts differed according to method of recruitment. Journal of Clinical Epidemiology 2006; 59: 144-152. Sweeting MJ, De Angelis D, Neal KR, Ramsay ME, Wright M, Brant L, Harris HE and the Trent HCV Study Group. Estimating progression to cirrhosis in three UK hepatitis C cohorts: the effect of recruitment bias. Journal of Clinical Epidemiology 2006; 59: 144-152. Pathways of care and resource utilization in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-626. Harris HE, Ramsay ME, Andrews NJ. Survival of a national UK cohort of hepatitis C virus infected patients 16 years after exposure. Epidemiology and Infection 2006; 134: 472-7. Harris HE, Ramsay ME, Andrews NJ - Epidemiology and Infection 2006; 134: 472-7 (PDF, 98 KB) © Cambridge University Press 2005 Cambridge Journals Online - Epidemiology and Infection Brant L, Harris HE, Ramsay ME, Grieve, R, Roberts J on behalf of the HCV national register steering group. Pathways of care and resource utilisation in a national cohort of patients with transfusion-acquired hepatitis C. Journal of Viral Hepatitis 2005; 12 (6): 618-26. Helen E Harris, Mary E Ramsay, Nick Andrews, Keith P Eldridge on behalf of the HCV National Register Steering Group. Clinical course of hepatitis C virus during the first decade of infection: cohort study. BMJ 2002; 324:1-6. H. E. Harris, M. E. Ramsay, J. Heptonstall, K. Soldan, K. P. Eldridge, on behalf of the HCV National Register Steering Group. The HCV National Register: towards informing the natural history of hepatitis C infection in the UK. Journal of Viral Hepatitis November 2000; 7 (6): 420-7.

Expected Benefits:

The HCV National Register population is one of the largest cohorts of patients in Europe who acquired their HCV infections on a known date and so the information on progression of their liver disease post-infection, and their clinical outcomes, are invaluable. Now that it is virtually impossible to acquire hepatitis C via blood transfusion in the UK due to screening, the possibility of recruiting such a large group of individuals who acquired their HCV infection on a known date (in who statistically reliable findings are possible) is now virtually impossible.

The HCV Register is supported by clinicians and patients throughout the country and response rates to clinical follow-up have never fallen below 90% to date (well above usual levels). Because the natural history/clinical course is long and many of the patients in the Register have now been infected for more than 20-30 years, the Register contains a wealth of data that is becoming increasingly valuable as the years go by.

The objective for processing of the data has been to describe the current biochemical, histological and clinically apparent liver disturbance in cases of HCV infection, and to relate current status to the interval since presumed infection and other potential prognostic factors. The HCV National Register uses all of the collected data to address these questions and to assess the burden of HCV-related disease. In addition, data are used to produce peer reviewed scientific publications, and to inform Public Health England modelling work on the future burden of HCV in the NHS. These data are used to inform national policy on how best to tackle hepatitis C infection in UK countries and help monitor the progress of HCV elimination strategies. The outputs help to determine the current and future burden of HCV-related disease on health care services and to assess the impact of currently available treatment as well as those that may become available in the future. This is important for the commissioning of treatment and care services, and for monitoring the progress of the WHO Global Health Sector Strategy to eliminate hepatitis C as a major public health threat by 2030, that the UK government is signed up to.

It is also key that PHE follow this group as they largely comprise transfusion recipients who received HCV infected blood from National Health services prior to the introduction of HCV screening of the blood supply. These individuals are subject to the ongoing government Infected Blood Enquiry, and information on disease in this cohort helps to inform compensation payments.

Outputs:

Data on disease progression and clinical outcome from the HCV National Register are used by PHE’s statisticians in mathematical models that help predict numbers of patients with HCV infection and the burden this will place on NHS health services. This is important for local planning of treatment and care services and to inform commissioners of the need to provide these services to the population. Information from these analyses are also used to monitor progress against WHO targets, that UK governments are signed up to, to eliminate HCV by 2030.

Data are processed to produce peer reviewed scientific publications, presentations at scientific meetings on the natural history/outcome/burden of HCV infection. These results of these analyses will be published in the HCV in the UK 2019 report (published around September 2019) and the HCV in England 2020 report (published around March 2020). These are both annual reports which have been published since 2005 and can be seen at the following link: https://www.gov.uk/government/publications/hepatitis-c-in-the-uk

An updated survival analysis is planned once the data subject to this application are available, along with further analyses to inform HCV disease progression rates/outcomes (2019-2021).

Processing:

Data from NHS Digital include death notifications, such as full details of cause of death and date of death, and cancer events, including details of the type and site of cancer. In addition, Public Health England (PHE) also receives information from NHS Digital to contact Health Administration Centres to allow PHE to re-establish links via the participant's current general practitioner if they become lost to follow-up.

Each patient enrolled into the HCV National Register is given a unique identifier. This identifier is used to link data received from NHS Digital to existing clinical data for each patient. These data enable PHE to establish which patients in the HCV National Register have died and the cause of their death and whether they have been diagnosed with cancer (and whether any deaths or cancers might be related to their HCV infections). The HCV National Register does not contain patient names or addresses; the data contained in the Register are identifiable but anonymised. PHE do not request name or address of flagged patients from NHS Digital, therefore patient identifiers such as NHS number and date of birth sent to PHE by NHS digital are data PHE already has for each patient.

NHS Digital data are received via a secure file transfer system and downloaded into a secure folder on a secure PHE network. Only key authorized users can access this folder. The data are then imported into the HCV National Register which is held in a password protected Access database on a secure network drive at PHE’s Colindale site. Only key authorized personnel have access to the database. PHE encrypted laptops will be used to access and process the data. The data is never stored on local hard drives.

NHS Digital data are kept in separate tables within the register database i.e. one table for members and postings, one for deaths and one for cancer events; these tables are linked to other data within the Register via their unique register number. The data are not linked to any external data. Outputs from the Register, like presentations or papers in peer review journals, contain no information on individual patients or any information that could be linked by others to individual patients; only aggregated data are shared

Every 3-5 years, patients are followed-up. Letters are sent out to patients’ GP or consultant asking for an update on their patients’ health. If the GP or consultant no longer cares for the patient, PHE are informed. NHS Digital flagging data are then used to find the region in which the patient has currently registered with a GP. PHE are then able to contact the regional health administration centres to obtain details of the patient’s current GP. This process enables PHE to re-establish contact to obtain follow-up clinical information.

Authorised users of the HCV National Register, including the data received from NHS Digital, are obliged to fully comply with the Data Protection Act 2018, together with all other related and relevant legislation (as amended or replaced from time to time) and with Department of Health directives covering issues of data sharing. All staff authorised to access the HCV National Register data have completed mandatory Information Governance training (Public Health England, Civil Service learning – Responsible for Information Asset Owner (IOA) Including Government Security Classifications 2014 and NHS Health Education England, NHS Data security Awareness level 1). A System Level Security Policy has been produced which records processing activities specifically for the HCV National Register, along with a Risk Assessment and Privacy Impact Assessment; these are held in an Asset Register at PHE.

Electronic data are stored on secure PHE networks in folders that have restricted access to authorised personnel only. Any paper copies of forms are held in cupboards that are locked and held on a secure site. No data are given out that could lead to the identification of any individual patient either directly or via linkage to other data sources. These data are not shared with any third party in the format provided by the NHS Digital. Although no data are stored on the hard drive of computers at PHE, any computers that reach the end of their life are disposed of according to PHE policies which require hard disks to the erased or, where this is not possible, crushed by an official approved service provider.

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