Use of Patient Information
Section 251 of the Health and Social Care Act 2008 enables the Secretary of State to support and regulate the use of confidential patient information in the interest of patients or the wider public good. Parliament agreed to the creation of this power to ensure that patient identifiable information currently needed to support essential NHS activity can be used, without the consent that should normally be obtained, where there is no reasonably practicable alternative. The process is administered by the Ethics and Confidentiality Committee (ECC) of the National Information Governance Board for Health and Social Care (NIGB). This committee was formerly known as the Patient Information Advisory group.
Regulations made under Section 251 can provide a basis in law for patient identifiable information to be disclosed to specified bodies, (e.g. cancer registries), for specific purposes.
Parliament has also agreed to the establishment of 'class support' that will provide a lawful basis for using and disclosing patient identifiable information to support relatively uncontroversial processing, for limited and defined purposes, without the need for dedicated Parliamentary consideration. The approval of the Secretary of State, advised where appropriate by the ECC, is required in these circumstances.
Section 251 requires an annual review of the regulations. The Secretary of State, supported by the ECC, will keep under review the need for support and aim to revoke it as soon as it is practicable. Support under Section 251 is intended as a transitory measure. That said, there might be a small number of uses for which informed consent or anonymisation will never be practicable. Through transparent and robust annual review, Section 251 will be used to determine whether or not this is the case. In these instances, specific and permanent legislation may be the solution.
Section 251 support is not unconditional. A number of requirements impact upon those who receive support, with the twin goals of ensuring that there are adequate safeguards for patients and that options for improving consent practice and/or introducing anonymisation techniques are actively pursued. Those applying for ECC support must therefore develop and practice policies of confidentiality and information security.
Section 251 class support has been granted to the NHS Cancer Screening Programmes subject to annual review.
For more information see http://www.nigb.nhs.uk.