Explanatory note

These Regulations make provision about the procedure to be followed in connection with the preparation and publication of an information standard under section 250 of the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”).

An information standard is a standard in relation to the processing of information and may be prepared by the Secretary of State, NHS England or both (“the responsible authority”).

An information standard may apply to the Secretary of State, NHS England, a public body which exercises functions in connection with the provision of health care or of adult social care in England or any person, other than a public body, who is required to be registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 in respect of the carrying out of a regulated activity (within the meaning of Part 1 of that Act).

These Regulations set out what must be included in information standards and the procedures that must be followed when preparing and publishing them. They also set out that the duties to seek advice, involve persons and have regard to certain matters also apply to information standards intended to replace a previously published information standard, other than when the responsible authority is satisfied that replacement of that information standard will not have a significant effect on those to whom it applies, or to the extent that it is required to be published in discharge of a legal obligation.

The Regulations also make provision for the review and revocation of information standards, as well as requiring each responsible authority to maintain a list of information standards and for NHS England to publish each list.

A full impact assessment has been prepared in relation to section 95 of the 2022 Act, and a copy is available at www.legislation.gov.uk. A hard copy can be obtained by writing to the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU.