Evidence submitted by Diabetes UK (EPR
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
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
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 www.dataprotection.gov.uk/dpr/dpdoc.nsf. 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, www.doh.gov.uk/ipu/confiden).
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 (www.hmso.gov.uk/acts/acts2001/20010015.htm).
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 www.doh.gov.uk/ipu/confident.
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
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
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 www.show.scot.nhs.uk/csags/).
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
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
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.
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
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