The Health and Social Care Information Standards (Procedure) Regulations 2025
These regulations establish procedures for creating and publishing information standards in England and Wales under the Health and Social Care Act 2012.
The responsible authority (the Secretary of State, NHS England, or both) must follow specified steps, including seeking expert advice, involving relevant individuals, and including specific details in published standards.
The regulations also address the maintenance and publication of a list of information standards and procedures for review and revocation.
Arguments For
Improved Standardisation: The regulations promote consistency and clarity in health and social care data processing by establishing clear procedures for creating and publishing information standards.
Enhanced Transparency and Accountability: The requirement for public consultation and detailed record-keeping ensures transparency and accountability in the development of information standards.
Greater Efficiency and Interoperability: Standardized data formats facilitate better information sharing and interoperability between different health and social care systems, potentially leading to improved efficiency and patient care.
Legal Basis: The regulations are explicitly based on powers granted under the Health and Social Care Act 2012, providing a solid legal foundation for their implementation.
Evidence-Based Decision Making: The requirement to seek advice and consider various stakeholders’ views promotes a more evidence-based approach to standard setting.
Arguments Against
Potential Bureaucracy: The detailed procedures outlined in the regulations could create unnecessary bureaucracy and slow down the process of developing and implementing information standards.
Implementation Challenges: Ensuring consistent compliance with the regulations across all relevant organizations may prove challenging and require substantial resources.
Unintended consequences: The regulations might create unintended consequences like a reduction in flexibility and innovation in data processing.
Resource Constraints: Compliance with these regulations might place additional resource burdens on already-stretched health and social care organizations.
Alternative Approaches: Other approaches to achieving data standardization might be explored, such as market-driven solutions or voluntary adoption of industry best practices.
1. Citation, commencement, interpretation and extent (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.
Regulation 1 sets the title as the Health and Social Care Information Standards (Procedure) Regulations 2025 and specifies a 28-day commencement period.
It defines 'the responsible authority' as either the Secretary of State, NHS England, or both jointly.
Finally, it establishes that the regulations apply to both England and Wales.
2. Procedures in connection with information standards (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) , 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.
Regulation 2 outlines the general procedure for preparing and publishing information standards under the Health and Social Care Act 2012.
Regulations 3-9 detail these procedures; however, an exception is made for replacing existing standards if the responsible authority deems the replacement insignificant or if legally required.
3. Seeking advice 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.
Regulation 3 mandates that the responsible authority seek advice from relevant experts when preparing information standards.
4. Involvement of persons (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.
Regulation 4 requires the responsible authority to involve appropriate individuals in the preparation of information standards.
This may include consultation or providing information regarding the standard's impact.
5. Having regard to matters 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.
Regulation 5 requires the responsible authority to consider advice received (Regulation 3), views gathered (Regulation 4), and any other relevant matters during the preparation of an information standard.
6. Matters to include in published information standards 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; (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”); (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; (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.
Regulation 6 details the mandatory information to be included in published information standards.
This includes title, responsible authority details, effective and publication dates, compliance requirements, consequences of non-compliance, monitoring provisions, guidance information, revisions, and other relevant details as deemed necessary by the responsible authority.
7. List of information standards (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.
Regulation 7 mandates that the responsible authority maintains a list of published information standards.
If the Secretary of State is the responsible authority, this list must be provided to NHS England upon request.
NHS England is further responsible for publishing and maintaining an up-to-date list of all information standards.
8. Review of information standards The responsible authority must review an information standard at such intervals as the responsible authority considers appropriate.
Regulation 8 requires the responsible authority to periodically review information standards at intervals it deems appropriate.
9. Revocation of an information standard (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.
Regulation 9 states that regulations 3-5 regarding advice, stakeholder involvement, and consideration of relevant matters apply to the revocation of information standards, except where revocation is legally mandated.