The Health and Care Act 2022 (Commencement No. 10 and Transitional and Saving Provision) Regulations 2025
These regulations, effective July 7th, 2025, bring into force section 95 of the Health and Care Act 2022, establishing updated information standards in the health and social care sector.
They also include transitional provisions to ensure a smooth transition from existing standards under the Health and Social Care Act 2012, preventing disruption to ongoing processes.
The regulations apply to England and Wales.
Arguments For
Intended Benefit: The commencement of section 95 of the 2022 Act aims to improve information standards within the health and social care system, leading to better data management and potentially improved patient care.
Evidence Cited: The Explanatory Note references the Health and Care Act 2022 and the Health and Social Care Act 2012, implying a need for updated regulations based on existing legislation and assessment.
Implementation Methods: The regulations directly put into force section 95 of the 2022 Act, employing a clear commencement date and transitional provisions to manage the shift from previous regulations.
Legal/Historical Basis: The regulations are explicitly made under the powers granted by section 186 of the Health and Care Act 2022, providing a clear legal foundation for their implementation.
Arguments Against
Potential Impacts: The changes to information standards could potentially impose new burdens on healthcare providers and lead to disruptions during the transition period.
Implementation Challenges: Ensuring compliance with the new information standards across the entire health and social care system may require substantial resources and training.
Alternative Approaches: Alternative approaches might have focused on a more gradual implementation of section 95 of the 2022 Act, potentially allowing for a smoother transition and mitigation of potential negative impacts.
Unintended Effects: The introduction of stricter data standards could create unintended consequences if the regulations are not adequately implemented or if their impact on different aspects of the system were not adequately considered beforehand.
- Citation, extent and interpretation (1) These Regulations may be cited as the Health and Care Act 2022 (Commencement No. 10 and Transitional and Saving Provision) Regulations 2025. (2) These Regulations extend to England and Wales. (3) In these Regulations— “the 2012 Act” means the Health and Social Care Act 20122; “the 2022 Act” means the Health and Care Act 2022.
This section details the title, geographic scope, and definitions used within the regulations.
The regulations are officially known as the 'Health and Care Act 2022 (Commencement No. 10 and Transitional and Saving Provision) Regulations 2025' and apply to England and Wales.
It defines 'the 2012 Act' as the Health and Social Care Act 2012 and 'the 2022 Act' as the Health and Care Act 2022 for clarity throughout the document.
- Commencement of section 95 of the 2022 Act Subject to regulation 3, section 95 of the 2022 Act (information standards) comes into force on 7th July 2025.
This section states that section 95 of the Health and Care Act 2022 (relating to information standards) will come into effect on July 7th, 2025.
This is contingent on the provisions outlined in regulation 3, which addresses transitional matters.
- Transitional and saving provision (1) This regulation applies to any information standard prepared and published under section 2503 of the 2012 Act which has effect immediately before 7th July 2025. (2) For the purposes of an information standard to which this regulation applies, the 2012 Act has effect as if the amendments made by section 95 of the 2022 Act had not been brought into force.
This regulation handles the transition period before the new information standards take effect.
Any information standards created under the older 2012 Act and effective before July 7th, 2025, will continue to function as if the 2022 Act's amendments hadn't been implemented.
This ensures a smoother transition and avoids sudden disruptions during the changeover.
Signed by authority of the Secretary of State for Health and Social Care Karin Smyth Minister of State 7th July 2025
This section provides the official signature and title of the Minister of State who authorized these regulations, along with the date of signing.
Explanatory Note (This note is not part of the Regulations) These Regulations bring into force section 95 (information standards) of the Health and Care Act 2022 (c. 31) (“the 2022 Act”) on 7th July 2025 (regulation 2). The Regulations are the 10th set of commencement regulations to be made under the 2022 Act. These Regulations also make transitional and saving provision in connection with the coming into force of section 95 of the 2022 Act. Section 95 of the 2022 Act makes certain amendments to the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”). This includes an amendment to section 250 of the 2012 Act to make information standards prepared and published under that section applicable to any person who is carrying out a regulated activity as defined in Chapter 2 of Part 1 of the Health and Social Care Act 2008 (c. 14), as well as to require persons to whom information standards apply to comply with them. Section 95 of the 2022 Act also substitutes section 251 of the 2012 Act to require the Secretary of State to make regulations about the procedure to be followed in connection with the preparation and publication of information standards. Section 95 of the 2022 Act also introduces a new section 251ZA into the 2012 Act to enable the Secretary of State to require persons to provide information to enable the Secretary of State to monitor compliance with information standards. Regulation 3 makes transitional and saving provision to ensure that, for the purposes of any information standard published under section 250 of the 2012 Act and in effect before 7th July 2025 the 2012 Act continues to have effect as if it had not been amended by section 95 of the 2022 Act. This includes the continued application of section 250(6) of the 2012 Act which requires certain persons to have regard to information standards. A full impact assessment has been prepared in relation to the 2022 Act, and a copy is available at https://www.gov.uk/government/publications/health-and-care-bill-combined-impact-assessments. A hard copy can be obtained by writing to the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU.
The explanatory note summarizes the regulations' purpose, providing context and clarifying the legal amendments.
It explains that these regulations are the tenth set implementing the 2022 Act, specifically focusing on enacting section 95, which updates information standards.
The note highlights the transitional arrangements ensuring that existing standards remain valid until the new ones take effect.
It also notifies the public of the availability of a full impact assessment.
NOTE AS TO EARLIER COMMENCEMENT REGULATIONS (This note is not part of the Regulations) The following provisions of the Health and Care Act 2022 (c. 31) have been brought into force by commencement Regulations made before the date of these Regulations. [Table of previously commenced sections and related information]
This note lists other sections of the Health and Care Act 2022 that were previously brought into force through earlier commencement regulations.
It serves as a record of the progression of implementation of the Act.