NIGB

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NIGB
Using confidential patient information for
research and other purposes the role of PIAG
NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH
AND SOCIAL CARE
Professor Dame Joan Higgins, Chair of PIAG/ECC
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NIGB
The creation of PIAG

• PIAG created under S61 of Health and Social Care
  Act 2001.
• It administered powers under S60 of the Act
  (later S251 of the National Health Service Act
  2006).
• Abolished by Health and Social Care Act 2008, but
  S251 powers transferred to NIGB (and its Ethics
  and Confidentiality Committee)

NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH
AND SOCIAL CARE
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NIGB
Why was PIAG established?

• Registries without informed consent
• Lack of clarity amongst researchers about use of
  patient information.
• Increase in use of secondary data. Huge volume
  of data being exchanged in the NHS.
• Poor or careless consent procedures

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NIGB
Terms of reference

• To advise the SoS on the use of powers provided
  by S60
• To advise the SoS on key issues, particularly
  those of national significance, relating to the
  use of patient information

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NIGB
Context

• Section 60 followed
• - the principles of Common Law on informed
  consent, the Data Protection Act, 1998 which
  requires appropriate data handling and the Human
  Rights Act, 1998, which is concerned (inter alia)
  with the invasion of privacy. Also Caldicott.
• Section 60 introduced to allow the regulated use
  of information by organisations wishing to obtain
  patient identifiable data, for medical purposes,
  where it was impracticable to obtain informed
  consent.

NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH
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NIGB
Hazel Blears MP,launching PIAG

• The Group will play a crucial role in ensuring
  that patient-centred consent practice
  continuesThose organisations, which obtain
  support under Section 60 to use information about
  patients without their consent, will in future be
  expected to demonstrate that they are developing
  mechanisms to either obtain informed consent of
  the patients involved or to develop ways of
  anonymising data

NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH
AND SOCIAL CARE
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NIGB
What ispatient information?

• S.60(8)
• (a) information (however recorded) which relates
  to the physical or mental health or condition of
  an individual, to the diagnosis of his condition
  or to his care and treatment and
• (b) information (however recorded) which is to
  any extent derived, directly or indirectly, from
  such information.

NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH
AND SOCIAL CARE
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NIGB
What isconfidential patient information?

• S.60(9)
• the identity of the individual in question is
  ascertainable either from the information, or
  from the information and other information in the
  possession of, or likely to come into the
  possession of, the person processing that
  information and
• that information was obtained or generated by
  someone who owed an obligation of confidence to
  the individual

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NIGB
Key features

• Designed to protect the interests of patients and
  to promote greater privacy and confidentiality,
  whilst facilitating high quality research and
  other essential activities.
• Expected to be a temporary/transitional measure
• Plan was to abolish PIAG when consent and/or
  anonymisation and/or pseudonymisation are
  satisfactorily achieved (e.g through SUS).

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NIGB
PIAG PrinciplesAsk or Anonymise

• Organisations which have a direct relationship
  with patients should normally seek consent.
• Third party organisations should normally seek
  anonymised/ pseudonymised data.
• Organisations with Section 60 support should not
  rely on it indefinitely and must have an exit
  strategy.

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AND SOCIAL CARE
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NIGB
Principles continued

• Organisations should provide information to
  patients about the data they use and why they
  need it. They should always aim to involve
  patients in the project or policies.
• PIAG is not convinced that all research studies
  demand 100 coverage.
• Research carried out with S60 support must be
  significant, in terms of subject matter and
  scale, and must be likely to benefit the patients
  concerned or the wider public.

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NIGB
Examples of applications

• HPA support for obtaining patient information
  for communicable disease surveillance and control
• Cancer Registries support for obtaining patient
  info for use on cancer registry database
• Applications from individual clinical researchers

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NIGB
Examples cont

• Use of large national NHS databases
• UK Biobank (to select and contact patients to
  gain their consent)
• Longitudinal research projects going back many
  years where patients are uncontactable or have
  died.
• Access to chaplains for Section 60 support to use
  patient identifiable information

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NIGB
2 types of support

• Specific support and class support.
• Specific supportis required for controversial
  or complex cases, which need detailed description
  within the regulations (e.g. communicable disease
  control or use of cancer registries). These will
  be debated in Parliament and may or may not be
  approved.

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NIGB
6 types of class support

• For the process of extracting and anonymising
  information
• To select and contact patients and gain their
  consent
• To obtain and use information about past or
  present geographical location
• To link patient identifiable information obtained
  from more than one source
• For auditing, monitoring and analysing patient
  care and treatment
• To allow access to an authorised user for one or
  more of the above purposes

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NIGB
Requirements

• Applicants for S251 are asked
• Why consent cannot be obtained?
• How the use of patient information will improve
  patient care or serve the wider public interest
  and how patients have been involved in the
  project?
• Will the data will be held securely and will it
  be destroyed when it is not longer needed?
• How are the requirements of the DPA being met?
• What is your exit strategy from S251?

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NIGB
Some recent issues

• The Redfern Enquiry (deceased persons records and
  medical purposes)
• UK Biobank
• The legal basis for honest brokers and safe
  havens
• Consent for consent
• Improving consent practice

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AND SOCIAL CARE
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NIGB
Redfern Enquiry

• Enquiry into the removal, without consent, of
  organs of people who worked in the nuclear
  industry 1961-92.
• Could PIAG provide legal support to Doctor at AWE
  who was asked to disclose medical records to the
  Enquiry?
• PIAG said that, although the law was unclear on
  whether confidentiality survived death, it was
  appropriate to act as if it did.
• Gave S251 support because disclosure was in the
  public interest

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NIGB
Foskett J 18.8.08

• Arguable that the duty of confidentiality
  survives death of pt, so it was necessary to
  obtain the Courts authority. No established
  authorities in domestic law but Plon v France
  (Mitterand) argues it should.
• Disclosure was not for a medical purpose in the
  meaning of the Act, but it would clearly help the
  Enquiry.
• However, Foskett supported disclosure (as PIAG
  had done) in the public interest.

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NIGB
UK Biobank

• Wanted access to demographic info (address, DoB,
  NHS No, GP practice) in order to approach 5m
  people to invite them to participate in Biobank.
• PIAG took the view that, although this was not
  clinical info, it was info which patients had
  given to their GP in the expectation of
  confidentiality.

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NIGB
Biobank continued

• PIAG supported application on the grounds that
  consent was not feasible for such a large cohort
  (although Biobank would seek consent for
  participation in the study itself). Dissent would
  be honoured, complaints would be handled
  effectively, patient information and involvement
  would be improved.

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AND SOCIAL CARE
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NIGB
Honest brokers and safe havens

• Lack of clarity over definitions
• RCP the aim is to reduce the burden on
  researchers by granting class approvals for
  the use of pt data.
• SUS and IC already have this role (but have S251
  support for some of their activities)

NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH
AND SOCIAL CARE
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NIGB
RCP wants brokers/havens to

• Anonymise data
• Pseudonymise and reverse
• Derive geographical attributes (eg from
  postcodes)
• Undertake data linkage
• Recruit to trials
• Data analysis
• Provide advice to researchers

NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH
AND SOCIAL CARE
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NIGB
Legal basis for these activities

• Some currently have S251 support
• Specific support and regulations probably the
  answer
• Alternatively, new legislation needed

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AND SOCIAL CARE
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NIGB
Consent for consent

• More accurately disclosure for consent
• Frustration in research community that it is not
  legal for researchers to trawl databases (e.g. GP
  records) to identify cohorts to be invited to
  participate in clinical trials and other
  research.
• PIAG/ECC can provide class support for such
  activity and has done (e.g. Biobank)

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NIGB
Consent and Trust

• PIAGs view has been that patients share personal
  information with their direct care team in the
  expectation that it will be held in confidence.
• Implied consent for this information to be used
  for other purposes (eg research) cannot be
  assumed.
• It is vital to maintain trust between health
  professional and patients.

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AND SOCIAL CARE
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NIGB
Reasons given to PIAG for not seeking consent

• Too expensive/time consuming
• Could cause distress
• Too difficult/sensitive
• Lack of mental capacity
• Language
• PIAG/ECC takes the view that some (not all) of
  these problems can be overcome

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AND SOCIAL CARE
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NIGB
Finally PIAG becomes the ECC

• Health and Social Care Act 2008 formally
  abolished PIAG, but S251 powers transferred to
  NIGB and exercised by Ethics and Confidentiality
  Committee (ECC). Most PIAG members have
  transferred to ECC and it is business as usual
• www.nigb.nhs.uk

NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH
AND SOCIAL CARE