SECTION 251 (FORMERLY SECTION 60)

The National Breast and Cervical Cancer Screening Programmes have been operating since the late 1980s with the Bowel Cancer Screening Programme having recently commenced in 2007.   Each of these programmes have a requirement to use patient identifiable data in order to identify eligible women and men, to invite them to participate in the national programmes and in order to record and evaluate the outcomes of screening.

In 2001, the Health & Social Care Act acknowledged the need to seek patients’ explicit consent before their details were passed from agency to agency. It was deemed impractical to obtain consent from those involved within the Cancer Screening Programmes.  Therefore since 2003, the NHS Cancer Screening Programme applied for and was given exemption by the Patient Information Advisory Group (PIAG) under Section 60 of the Health and Social Care Act 2001.   In 2006, Section 60 of Health and Social Care Act 2001 was replaced by Section 251 of the NHS Act 2006. In 2008, the Health and Social Care Act was revised and the National Information Governance Board for Health and Social Care (NIGB) was established.  This replaces PIAG as the statutory body responsible for Section 251 of the NHS Act 2006 (formerly Section 60 of the Health and Social Care Act 2001). 

Section 251 (formerly Section 60) allows the NHS Cancer Screening Programme to access patient identifiable information without patients’ consent.  Under Section 251 (formerly Section 60), exemption was conditional and subject to the programme’s implementation and sign-up to the following national policies.These policies are currently being updated by the National Screening Office. All relevant cancer screening personnel are still required to sign up to the following policies on an annual basis until the updated policies are published:

·      NHS Cancer Screening Programme – Confidentiality & Disclosure Policy (September 2003)

·      NHS Cancer Screening Programme – Information Security Policy (September 2003)

·      NHS Cancer Screening Programme – System Level Security Policy for the NHAIS (June 2005)

·      NHS Cancer Screening Programmes - System Level Security Policy for the NBSS System (January 2006)

·      NHS Cancer Screening Programmes – System Level Security Policy for the NBCSS System (March 2006)

These national policies have been implemented within the London Cancer Screening Quality Assurance Reference Centre and have been disseminated to all screening units, acute trusts, primary care trusts and primary care agencies involved in the screening programmes in the local region. These policies ensure that very high standards of confidentiality and data security are maintained across all parts of the screening programmes.  

It is imperative that all relevant cancer screening personnel including data controllers and IT departments comply with these national policies and that all declaration forms are appropriately signed and retained by the organisation.  Should non-compliance become evident then it is possible for NIGB exemption to be withdrawn.  This would mean the Cancer Screening Programme would no longer be able to operate.

To ensure compliance has been met, annual confirmation will be requested by the London QARC to PCT screening commissioners, call/recall screening managers, breast and bowel screening unit leads and acute trust hospital based programme co-ordinators as well as Caldicott Guardians and Directors of IT.  This includes confirmation that all departments are compliant to the above national policies, that information has been cascaded to all relevant personnel and documentary evidence (i.e. a signed declaration form) retained and that GPs/smear takers, radiographers and colonoscopists/specialist screening practitioners in the local area are aware and in compliance with the national policies. Additional checks will be undertaken at bowel, breast and cervical programme QA visits.