Citation, commencement, interpretation and extent

1.—(1) These Regulations may be cited as the Health and Social Care Information Standards (Procedure) Regulations 2025 and come into force 28 days after the day on which they are made.

(2) In these Regulations, “ the responsible authority ” means the Secretary of State, NHS England or both acting jointly (as the case may be).

(3) These Regulations extend to England and Wales.

Procedures in connection with information standards

2.—(1) Subject to paragraph (2), when preparing or publishing an information standard under section 250 of the Health and Social Care Act 2012 (powers to publish information standards) (3), the responsible authority must follow the requirements set out in regulations 3 to 9.

(2) Regulations 3 to 5 do not apply to the preparation of an information standard that is intended to replace a previously published information standard—

(a)where the responsible authority is satisfied that the replacement of that information standard will not have a significant effect on those to whom it applies; or

(b)to the extent that the new information standard is required in order to discharge a legal obligation.

Seeking advice

3. Where the responsible authority considers that there is a person with expertise relevant to the subject matter or content of an information standard, the responsible authority must seek advice from that person during the preparation of that information standard.

Involvement of persons

4.—(1) Where the responsible authority considers that it is appropriate to involve a person, having regard to the subject matter or content of an information standard, the responsible authority must involve that person in the preparation of that standard.

(2) For the purposes of paragraph (1), involving a person may include consulting a person or providing a person with information on the effect of that standard.

Having regard to matters

5. The responsible authority must have regard to the following matters during the preparation of an information standard—

(a)any advice received under regulation 3;

(b)any views obtained under regulation 4;

(c)such other matters as the responsible authority considers appropriate.

Matters to include in published information standards

6. The responsible authority must include the following in an information standard—

(a)the title of the information standard;

(b)the identity of the responsible authority and their contact details;

(c)the date that the information standard takes effect;

(d)the date of publication of the information standard;

(e)a statement that the information standard must be complied with or had regard to (as the case may be);

(f)the consequences, if any, of failure to comply with the information standard(4);

(g) a statement that the Secretary of State may require a person to provide the Secretary of State with documents, records or other information for the purposes of monitoring the person’s compliance with the information standard (“monitoring purposes”)( 5 );

(h)the consequences of failure to comply with a requirement to provide information for monitoring purposes or the provision of information in response to such a requirement that is false or misleading to a material extent(6);

(i)information about any guidance issued by the responsible authority about implementation of the information standard;

(j)any significant revisions made to the information standard since it was last published;

(k)such other information as the responsible authority considers appropriate.

List of information standards

7.—(1) The responsible authority must—

(a)maintain a list of information standards that it has prepared and published; and

(b)where the responsible authority is the Secretary of State, provide that list to NHS England when requested by NHS England to do so.

(2) NHS England must—

(a)publish a list of the information standards prepared and published by each responsible authority; and

(b)ensure that list is kept up to date.

Review of information standards

8. The responsible authority must review an information standard at such intervals as the responsible authority considers appropriate.

Revocation of an information standard

9.—(1) Subject to paragraph (2), regulations 3 to 5 apply to the revocation of an information standard as they apply to the preparation of a standard.

(2) Regulations 3 to 5 do not apply to revocation of an information standard, to the extent that revocation of that standard is required in order to discharge a legal obligation.