The Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025

Published: Mon 3rd Mar 25

These regulations amend the 2014 Health and Social Care Act regulations, removing their expiry date and implementing a five-year review process.

The amendments ensure ongoing regulatory oversight of health and social care activities in England and Wales, with the next review due by July 13, 2028, and subsequent reviews every five years thereafter.

Arguments For

  • Extension of Regulatory Framework: Removing the expiry date from the 2014 Regulations ensures the continued regulation of health and social care activities in England and Wales, providing ongoing legal certainty for providers and enhancing patient safety.

  • Structured Review Process: Establishing a five-year review cycle for the regulations ensures their ongoing relevance and effectiveness, allowing for updates and improvements based on experience and emerging needs.

  • Efficient Regulatory Oversight: The established review process promotes accountability and transparency in the sector, fostering continuous improvement in health and social care delivery.

  • Legal Basis: The regulations are made under the powers conferred by the Health and Social Care Act 2008, providing a strong legal foundation for their enactment and enforcement.

Arguments Against

  • Regulatory Burden: Could impose unnecessary administrative burdens on health and social care providers, potentially diverting time and resources away from direct patient care.

  • Unforeseen Consequences: The extension and changes to the review process may lead to unintended consequences which are hard to predict without detailed impact assessments.

  • Alternative Approaches: Alternative methods of regulatory oversight could achieve similar goals with less bureaucratic effort, such as relying on more flexible guidance documents rather than rigid regulations.

  • Limited Impact Assessment: The lack of a full impact assessment might lead to oversight of potential negative consequences on different sectors.

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8, 20(1) to (5A), 35, 86(2) and (4), 87(1) and (2) and 161(3) and (4) of the Health and Social Care Act 20081. In accordance with section 20(8) of that Act, the Secretary of State has consulted such persons as the Secretary of State considers appropriate. A draft of these Regulations was laid before Parliament in accordance with section 162(3) of the Health and Social Care Act 2008 and was approved by resolution of each House of Parliament.

These Regulations may be cited as the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2025 and come into force on 30th March 2025.

These Regulations extend to England and Wales.

The Health and Social Care Act 2008 (Regulated Activities) Regulations 20142 are amended as follows.

In regulation 1 (citation and commencement), omit paragraph (6)3.

In regulation 27 (review)—

in paragraph (1)4, for “1st April 2020” substitute “the end of each review period”;

after paragraph (2) insert—

“(3)

Subject to paragraph (4), in this regulation, “review period” means—

(a)

the period beginning on 13th July 2023 and ending five years after that date;

(b)

each subsequent period of five years beginning on the day after the date on which the immediately preceding review period came to an end.

(4)

Where a report under paragraph (1)(c) is published before the end of the review period referred to in paragraph (3)(a) or (b), as the case may be, the next review period will commence on the day after the date of publication.”.

Signed by the authority of the Secretary of State for Health and Social Care. Merron Parliamentary Under-Secretary of State Department of Health and Social Care 25th February 2025

These Regulations amend the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (“the 2014 Regulations”). Regulation 3(2) removes the expiry date, to ensure the 2014 Regulations continue to have effect after 31 March 2025. Regulation 3(3) amends the review clause in the 2014 Regulations so the next review and report is due by 13 July 2028 (which is 5 years after the previous review report of the 2014 Regulations was laid before Parliament on 13 July 2023). It also inserts a requirement for there to be 5 yearly reviews following this date. A full impact assessment has not been produced by this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.