Data Protection: confidentiality and consent

Data Protection and Confidentiality

SWCAR has a responsibility to maintain the confidentiality and security of all data held on the register. The collection and management of SWCAR data meets the requirements of the following guidelines and regulations:

Data Protection Act 1998
NHS Act 2006
Caldicott Guardian Principles 1997
The NHS Confidentiality Code of Practice
Information Sharing Agreement, Avon IM&T Consortium
SWCAR Code of Practice

We comply with the above by ensuring that:

all staff are trained in confidentiality and consent issues and are bound by a confidentiality agreement covering storage and transfer of information
all computer systems have controlled access
database and electronic storage of data are always password protected
data collection is relevant, not excessive and is used for legitimate medical purposes in the public interest.
data is stored for a limited period
policies on security and confidentiality are regularly reviewed
access to data is strictly controlled and on a need to know basis and all requests for patient identifiable information are referred to the SWCAR data controller
any research making use of SWCAR data requires independent ethical approval
patients have access to information about SWCAR and are able to obtain copies of their data on request.

In July 2004 BINOCAR gained MREC ethics approval on behalf of all UK Registers. See below for details.

Full details of our policies on confidentiality, data security and disclosure of information can be found in the SWCAR Code of Practice. See below for details.

Consent

All UK anomaly registers currently collect data without explicit patient consent under Section 251 of the NHS Act 2006.

Section 251 provides a power to ensure that patient identifiable information needed to support essential NHS activity can be used without obtaining explicit consent of the patient. It is used to support medical purposes that are in the public interest where consent is not practicable and anonymised information will not suffice. It is intended as a transitional measure and is reviewed annually.

Patient Identifiable Information is required by all UK anomaly registers to avoid duplication and for validation of case information. Notification is received from multiple sources and it is essential that new information is matched to the correct case and that each case appears only once in the data.

In June 2002, on behalf of all UK anomaly registers, BINOCAR (British Isles Network of Congenital Anomaly Registers) submitted an application for the support for the collection of personal information without 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 and then under Section 251 of the NHS Act 2006.

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.

Responsibility for administering Section 251 powers transferred to the NIGB on 1 January 2009. For further information about the NIGB, please see www.nigb.nhs.uk.

All UK Anomaly Registers have taken steps to ensure that information about congenital anomalies registers is in the public domain. Leaflets and posters are available in health care settings used by pregnant women and parents: antenatal clinics, GP surgeries, ultrasound departments, maternity wards, neonatal units, paediatric wards and clinics. Contact information is included so that parents can request the removal of identifiable information about their pregnancy/child or request a copy of information held.

SWCAR Code of Practice and Approvals

Help with downloads page

SWCAR Code of Practice (main text only) - being updated

SWCAR Code of Practice (includes all appendicees) - being updated

Multi-Centre Research Ethics Committee (MREC) Approval (260K)
MREC approval letter covers for all British Isles National Network of Congenital Anomaly Registers (BINOCAR) registers. SWCAR is a BINOCAR Member.

Patient Information Advisory Group (PIAG) Section 60 Approval (110K)

Section 60 Application (50K)

SWCAR Patient Information leaflet (50K)

Related web sites

Patient Information Advisory Group (PIAG) web site

The NHS Confidentiality Code of Practice web site

The Information Commission web site

NHS Act 2006: Section 251