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.
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 the individual explicit consent of the patient. It is used to support medical purposes that are in the public interest where consent is not practicable but anonymised information will not suffice. It is reviewed annually.
Patient identifiable information is required by all UK anomaly registers to avoid duplication of cases and for validation of case information. Notifications are 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 support for the collection of personal information without consent. This exemption was initially granted by PIAG (Patient Information Advisory Group) and was first enacted under Section 60 of the Health and Social Care Act 2001, and subsequently under Section 251 of the NHS Act 2006. PIAG had been established to provide advice on issues of national significance involving the use of patient information (data) and to oversee arrangements for its use. Its responsibility for administering Section 251 powers transferred to the National Information Governance Board for Health and Social Care (NIGB) from 1 January 2009, and has since transferred again to the Health Research Authority’s Confidentiality Advisory Group (CAG) since 1 April 2013. For further information about CAG, please see http://www.hra.nhs.uk/resources/confidentiality-advisory-group/. BINOCAR registers have continued to be granted Section 251 support by CAG.
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 (2.9MB)
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.
Section 251 Application (160K)