Select Committee on Health Written Evidence

Evidence submitted by Diabetes UK (EPR 54)

  Diabetes UK is one of Europe's largest patient organisations. Our mission is to improve the lives of people with diabetes and to work towards a future without diabetes through care, research and campaigning. With a membership of over 170,000, including over 6,000 health care professionals, Diabetes UK is an active and representative voice of people living with diabetes in the UK.


  1.1  Diabetes UK welcomes the opportunity to submit evidence to this inquiry. Diabetes UK supports moves to develop the process of storing patient information and develop the level of information stored.

2.   What patient information will be held on the new local and national electronic record systems, including whether patients may prevent their personal data being placed on systems

  2.1  Diabetes UK believes that population based registers are an essential component of the delivery and monitoring of diabetes services at primary care organisation or managed diabetes network level. They form the basis of inter-agency communication within the NHS, and are currently the best method for maintaining a diabetes electronic health care record between primary, secondary, and community care. Registers have a central role to play in the implementation of clinical governance, and in ensuring a seamless, quality service for all people with diabetes.

3.   Who will have access to locally and nationally held information and under what circumstances and whether patient confidentiality can be adequately protected

  3.1  Diabetes UK takes the position that the use of data on registers requires the informed consent of people with diabetes. Ideally this should be supported with written consent, but this is not a substitute for discussion and ensuring that the consent is informed. The topic should be revisited periodically and people should be informed that they can withdraw their consent at any time. There is no consensus on how frequently consent should be sought. Diabetes UK suggests every three years, as being a reasonable interval.

  3.2  People with diabetes should be told how their information will be used, in particular less obvious uses such as clinical audit and financial checks and explanation of any potential implications from this, such as being approached to allow their information to be used for research. People are often concerned about inappropriate and non-consensual disclosure to third parties such as insurers or employers. In general consent should be sought when information is used in an identifiable form. People with diabetes should also be informed about the systems in place to ensure confidentiality, in line with the spirit and requirements of the Data Protection Act 1998.

  3.3  The Information Commissioner has issued guidance on the use and disclosure of health data, which can be found at Health data systems within the NHS should follow the recommendations of the Caldicott report (The Caldicott Committee: Report on the review of patient-identifiable information, December 1997, This requires that Trusts/PCOs have a monitoring system in place to ensure that confidentiality is respected for all identifiable health data. Most feedback to Diabetes UK indicates that few people with diabetes would choose to opt out from a register when these requirements are adhered to.

  3.4  The legal position regarding the use of all health data within the NHS has changed in England and Wales with the passing of the Health and Social Care Act 2001 ( The relevant sections of the Act (60 and 61), grant the Secretary of State for Health powers to determine how patient data can be used in the NHS. The Secretary of State must, nevertheless, comply with the requirements of the Data Protection and Human Rights Acts. Section 60 includes a process that permits application for patient data to be used without consent, under particular circumstances. Section 61 of the Act prescribed that an expert Patient Information Advisory Group (PIAG), be set up to advise the Secretary of State and the Department of Health on applications under Section 60. The use of this application process is to be reviewed annually, until such time as the infrastructure necessary, either to seek and record individual consent is established, or for data to be acceptably anonymised for uses other than direct care of the patient. The Patient Information Advisory Group and application process for Section 60 is now in use. Further information on the group and application process can be found on their website at

  3.5  The Department of Health is not concerned about identifiable information collected at practice level, for the direct care of patients ie for call and recall, provided that patients are appropriately informed and due attention is paid to confidentiality. Information gathered for the direct care of the patient is deemed to have consent through the normal activities of a patient consultation. Local clinical audit is included in this as it has a direct impact on the quality of care a patient receives, although this is a use which is less obvious to most people with diabetes.

  3.6  In Northern Ireland, the Task Force on Diabetes has identified Information Management and Diabetes Registers to be one of the key areas for early action. It has recommended that integrated diabetes care must be supported by a Northern Ireland wide information system supporting diabetes care delivery in primary and secondary care and linking general practice and hospital information. The Task Force has emphasized that good information systems are central to planning and delivering high quality services and that the availability of a Diabetes Register would facilitate regular monitoring and screening systems to be put in place.

  3.7  The Northern Ireland Health Service has stated that it does not have the capacity currently to fully comply with the fair and lawful processing requirements of the DPA 1998 and the Common Law requirement of confidentiality. They have and continue to rely on the implied consent of service users for the processing of personal identifiable information. There is a recognition that this is no longer sustainable and that in the future:

    —  provision of more information to the public and service users about how the health service uses personal information, must be made;

    —  personal information should be acceptably anonymised wherever possible for uses other than clinical care;

    —  where anonymisation is not possible the aim is to gain user consent for the use of their personal information; and

    —  new legislation should be considered to address this situation.

  3.8  In Scotland, confidentiality issues have been subject to a major review through the Confidentiality and Security Advisory Group Scotland (CSAGS), an independent committee which produced its final report, Protecting Patient Confidentiality, in April 2002 (report can be found at CSAGS recommends that "patients must be informed about how information about them is used", "wherever possible, data must be anonymised" and if data cannot be anonymised to an acceptable degree, "the patient has a right to object to their use". CSAGS also rejects the introduction of new legislation similar to Section 60 of the Health & Social Care Act in England & Wales. It does so on the basis that "in a patient-centred service, the implications of any legislation which restricts rights of individual patients ... must be taken seriously". The report's recommendations are currently being considered by the Scottish Executive.

  3.9  As a general principle information should be de-identified as much as possible and only the minimum information necessary for the purpose should be disclosed to other authorised bodies.

  3.10  Diabetes UK will continue to monitor the situation and review its position in light of any changes.

4.   How data held on the new systems can and should be used for purposes other than the delivery of care eg clinical research

  4.1  Other uses such as service planning, audit above the level of individual care provider and research should be acceptably anonymised, or informed consent gained or support under Section 60 sought as appropriate. It is envisaged by PIAG that generally, audit should be done through anonymisation/pseudonymisation (see glossary). Given current technical constraints, and the need to integrate with other linked initiatives, like the Integrated Care Record Service, it is likely that it will take some time to implement pseudonymisation or consent fully. In such situations Section 60 support should be sought as an interim measure until pseudonymisation or consent can be achieved. Rarely Section 60 support may lead to regulations providing more permanent support where neither pseudonymisation nor consent is feasible.


  5.1  Diabetes UK believes the key issues are to ensure that people are made aware of confidentiality issues, that there is a dialogue and that it is made clear to them what the information is used for and who can access it.

Diabetes UK

March 2007


  Registers: A disease register is a list of patients with a given condition. Often register information is combined with clinical information from a number of sources to facilitate better quality of care for the individual. This information can be used for call/recall to ensure all patients receive regular check ups and also for non-clinical purposes such as audit, service planning and epidemiological health outcomes research.

Anonymisation: Where information, which might be used to identify the person, has been removed eg name, address, postcode, date of birth. Sometimes individual items of data would not identify a person if used on their own, such as date of birth but if used in combination with another item such as postcode would make the person identifiable. Acceptably anonymised therefore refers to records where the risk of identification through combined factors is very small.

  Pseudonymised: This is where data has been anonymised but which contains an identifier such as new NHS number, or Community Health Index (in Scotland). On its own this identifier does not identify the individual. It is only if the person looking at the data also has access to the key linking the identifier number with individual names that the data becomes identifiable again. This is called pseudonymisation or linked anonymisation. It is useful as it enables data from different episodes of care for the same individual to be linked, whilst protecting their identity. It also means that researchers can qury data that may have been wrongly recorded and the Trust holding the patient's record could track the information back to an individual and check the accuracy of the data. This therefore helps ensure data quality and consequently the reliability of research results.

  Informed Consent: This is an approval process in which the patient receives a full and understandable explanation of purpose, risks, benefits and rights of withdrawal of the approval. Explicit consent means that a patient is asked verbally or in writing to approve a particular procedure, or in the case of registers the transmission and storage of clinical information. Current practice often involves using posters in a surgery about certain policies or initiatives and it is assumed that the patient agrees with them unless they explicitly withdraw their consent. This has been called implied consent. The view of the Patient Information Advisory Group (PIAG) is that this is not adequate in terms of providing information to patients and therefore consent based on this is unlikely to be valid, legally or in terms of ethical practice.


1  Amos A F, McCarty D J, Zimmet P. The Rising Global Burden of Diabetes and its Complications: Estimates and Projections to the Year 2010. Diabetic Medicine. 5: Volume 14. 1997.

2  Chaturverdi N, Jarret J, Shipley M J, Fuller J H. Socio-economic gradient in morbidity and mortality in people with diabetes: Cohort study findings from the Whitehall Study and the WHO multinational study of vascular disease in diabetes. BMJ 1998; 316: 100-106.

3  Mather H M, Chaturverdi N, Fuyller J H. Mortality and morbidity from diabetes in South Asians and Europeans: 11 year follow-up of the Southall Diabetes Survey, London, UK. Diabetic Medicine 15: 53-59.

4  UK Prospective Study Group (UKPDS). Effect of intensive blood glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) The Lancet. Vol 352, 12 September 1998.

5  Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The New England Journal of Medicine. Vol 329: 14. 30 September 1993.

6  UK Prospective Diabetes Study Group (UKPDS). Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes (UKPDS 38). BMJ Volume 317, 12 September 1998.

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