BINOCAR Registers
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British and Irish Network of
Congenital Anomaly Researchers

Data Confidentiality

 

The legal position

 

BINOCAR is authorised under Section 251 of the NHS Act 2006 to collect personal information without individual consent. 

 

This exemption was initially granted by PIAG (the Patient Information Advisory Group), and was first enacted under Section 60 of the Health and Social Care Act 2001.  Section 251 of the 2006 Act permits the common law duty of confidentiality to be set aside in specific circumstances for medical purposes (see below).

 

PIAG was established to provide advice on issues of national significance involving the use of patient information (data) and to oversee arrangements for its use.  It was formally wound up on 31 December 2008, and replaced by the National Information Governance Board for Health and Social Care (NIGB) under Section 158 of the Health and Social Care Act 2008.  NIGB has now been replaced by the Confidentiality Advisory Group (CAG).

 

Responsibility for administering Section 251 powers transferred to CAG on 1 April 2013.

 

For further information about the CAG, please see:

http://www.hra.nhs.uk/resources/confidentiality-advisory-group/.

 

The background

 

Congenital anomaly registers achieve high levels of ascertainment and completeness by collecting information from multiple sources.  For data validation purposes, and to prevent cases being counted more than once, which is vitally important where rare anomalies and small numbers are involved, personal information about both the mother and baby is required.

 

Understanding the cases of anomalies and monitoring their occurrence requires data relating to geographical location, maternal age, birth weight, gestational age at delivery and so on.  Evaluating the success of screening programmes and auditing maternity care, and the planning for future care requirements, requires accurate outcome data together with knowledge about how and when anomalies were diagnosed.

 

NHS patients provide information about themselves in confidence and where information is held in confidence, informed consent from the patient is normally required for use of that information in a way that could identify the patient.  The Government recognises and is committed to the protection of patient rights regarding disclosure of their personal information and the Health and Social Care Act (2001), together with relevant Data Protection legislation, sets out this commitment very clearly.  However, there are certain situations where it is not possible to obtain informed consent from patients.  In recognition of this, Section 60 of the Health and Social Care Act 2001 was established to provide a means by which patient identifiable information needed to support essential NHS activity could be used without the consent of patients.  This can only be used in circumstances where the medical purpose is in the interests of patients or the wider public, where consent is not a practicable alternative, and where anonymised information is not available or cannot suffice.  Similar arrangements are in place for the national system of Cancer Registries.

 

The Registers' position

 

All BINOCAR registers aim to provide timely, accurate and easily accessible information for health professionals and parents, to help them make informed decisions about current and future pregnancies and the care of their children.  Ongoing surveillance and the monitoring of anomaly occurrence to check for varying trends or changing patterns of distribution are also very important public health activites.

 

Identifiers are required to avoid double counting and for the validation of cases, ensuring accurate matching between antenatally diagnosed anomalies and postnatal notifications.  Since it is currently impractical to obtain explicit parental consent for the inclusion of a case in a BINOCAR register, BINOCAR therefore applied for and was granted exemption under the terms of the 2001 Health and Social Care Act.  Permission has to be reviewed annually, and has been granted for the following reasons:

  1. Many reliable and valuable notification sources used by registers involve little or no contact with parents; for instance cytogenetic laboratories and pathology departments
  2. There would be unique and irreconcilable difficulties in matching anonymised antenatal diagnoses in a fetus with similarly anonymised postnatal notifications of a child, often received some months or even years after delivery
  3. Parents understandably become distressed when asked for consent from multiple notifiers
  4. Discussions of congenital anomaly notification may not be appropriate during the period when parents have first been informed about a potential problem, especially prenatally.  Assessing the likely outcome of an affected pregnancy is usually very difficult, and properly 'informed' consent is therefore impossible to obtain
  5. The potential for sensitivities surrounding terminations of pregnancy for congenital anomalies may prevent discussions for notification to a register
  6. Anonymisation is impossible in those cases where the fetus does not reach 24 weeks' gestation and therefore does not acquire an NHS number.  This includes almost all terminations of pregnancy for fetal anomaly reasons
  7. It is the experience of many studies that health professionals do not request consent for notification of congenital anomalies during consultation and that this leads to long delays in notification or failure to notify

Approval coverage

 

The BINOCAR registers have CAG approval for the following:

Separate approval will need to be sought from CAG for sending identifiable data between registers and matching with outcome datasets for non-surveillance purposes.

  

BINOCAR Patient Information Leaflet

 

We have taken steps to ensure that information about congenital anomaly registers are in the public domain, by producing leaflets and posters to inform all women about congenital anomaly registers when they book for antenatal care.  These leaflets and posters are available in health care settings used by pregnant women and parents e.g. antenatal clinics, ultrasound departments, maternity wards, neonatal units, paediatric wards and clinics etc.

 

Information provided on these leaflets and posters provide contact information so that parents can request that identifiable information about their pregnancy and/or child be removed from the register should they so wish.  It is our experience, however, that the vast majority of parents welcome the data generated from registers and wish their child's details to be included in order to maximise the information available to themselves and others.

 

PDF logoDownload the BINOCAR patient information leaflet (PDF | 88KB)

 

IT Security

 

All registers are sited in institutions with robust IT security policies.  All BINOCAR registers have to fulfil strict security and confidentiality requirements.  No named data is ever released to third parties, and no data are ever published which could potentially identify an individual or small group of individuals.

 

Small Numbers Policy

 

The BINOCAR Management Committee has carried out a risk assessment (download here) and decided on a small numbers policy (download here) to ensure the confidentiality of the babies and their mothers described in the BINOCAR reports and in online data tables in respect of small numbers.

 

The policy was made after considering the two reports:

1.  In 2006, the Office for National Statistics (ONS) published a paper on "Review of the Dissemination of Health Statistics: Confidentiality Guidance".  Its focus was the risk presented by the dissemination of data with small numbers.

2.  In 2009, the NHS Information Centre issued the "HES Protocol" section 4 of which deals with the risks presented by cell values for 1 to 5.

 

Policy summary:

In all tables contained data presented by register, cells containing less than five cases will be suppressed.  All rates based on such numbers will also be suppressed.  Secondary suppressions will also be applied as necessary to avoid the possibility of disclosure through differencing/subtraction.  In all tables containing data presented for all registers combined there will be no suppression.