About Section 251
Section 251 of the NHS Act 2006
Section 251 of the NHS Act 2006 re-enacted Section 60 of the Health and Social Care Act 2001. The terms Section 60 and Section 251, when used in relation to use of patient information therefore refer to the same powers. These powers allow the Secretary of State for Health to make regulations to set aside the common law duty of confidentiality for medical purposes where it is not possible to use anonymised information and where seeking individual consent is not practicable. Under the Health and Social Care Act 2008, responsibility for administering these powers was transferred from the Patient Information Advisory Group to the National Information Governance Board.
Why was Section 251 created?
Section 251 came about because it was recognised that there were essential activities of the NHS, and important medical research, that required use of identifiable patient information but because patient consent had not been obtained to use people's personal and confidential information for these other purposes, there was no secure basis in law for these uses. [NB. There are a few exceptions where there is a legal basis for disclosure e.g. reporting of notifiable diseases]. Section 251 was established to provide a secure legal basis for disclosure of confidential patient information for medical purposes, where it was not possible to use anonymised information and where seeking consent was not practicable, having regard to the cost and technology available.
It was anticipated when Section 251 powers were originally established that the NHS would develop mechanisms to seek, record and implement consent. Also that the NHS would endeavour to improve data quality and develop processes to link data in pseudonymised form, reducing the need for identifiable data to be used. These mechanisms are still being developed. It has since been acknowledged that there will continue to be a need for Section 251 powers, for some uses, on a more long-term basis.
How is Section 251 administered?
The Health Service (Control of Patient Information) Regulations 2002 (SI 1438) were made under Section 60 of the Health and Social Care Act 2001 and continue to have effect under Section 251 of the NHS Act 2006. These regulations established a class support mechanism whereby Section 251 powers could be used by the Secretary of State without needing to lay regulations before Parliament for each use of the powers. The classes of support are:
- To reduce the identifiability of data.
- For the past or present geographical location of patients for medical research.
- To identify and contact patients with a view to inviting them to participate in medical research or to allow their data or tissue to be used for medical research or to allow their tissue to be used for other medical purposes.
- To link information from more than one source or to validate the quality and completeness of confidential patient information or information derived from patient data.
- For the audit, monitoring and analysing of the provision made by the health service for patient care and treatment.
- To allow access to confidential patient information for one or more of the above purposes.
[Paraphrased from Schedule 1 of the 2002 Regulations]
Additionally, these regulations provided specific support under Section 251 for the Health Protection Agency and other public health staff to collect data relating to communicable disease surveillance and for surveillance of other risks to public health. They also provided specific support for Cancer Registries to collect data relating to cancer.
The National Information Governance Board and its Ethics and Confidentiality Committee do not have statutorily delegated authority from the Secretary of State but rather advise the Secretary of State on the use of Section 251 powers and make recommendations about applications for approval under Section 251. The NIGB has agreed to delegate its responsibility for administering Section 251 powers to its Ethics and Confidentiality Committee.
As and when the above regulations need revision, Section 251 requires that the Secretary of State consults the NIGB prior to revised regulations being laid before Parliament.