The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
UK Statutory Instrument 2014 No. 2936 — creates 5 criminal offences.
- Made
- 6 November 2014
- In force from
- Not determined
- Extent
- Not stated
- Subject
- Alcohol licensing, gambling, smoke-free and public health
- Made under
- England Public Health, England The Health and Social Care Act 2008, Health and Social Care Act 2008
Explanatory note
(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.
These Regulations prescribe the kinds of activities that are regulated activities for the purposes of Part 1 of the Health and Social Care Act 2008 (“the Act”) and requirements that apply in relation to the way in which those activities are carried on. Regulation 3 deals with the activities that are regulated activities for the purposes of section 8(1) of the Act. The activities are set out in Schedule 1 to the Regulations together with certain activity specific exemptions. An activity is only a regulated activity if it is carried on in England (regulation 3(3)). Regulation 3(4) provides that the activities listed in Schedule 2 (general exceptions) are not to be regulated activities for the purposes of section 8(1) of the Act and these Regulations. In Part 3, regulations 4 to 7, and Schedules 3 and 4, contain requirements in relation to persons registered in respect of the carrying on or management of a regulated activity (“registered persons”), and require certain information to be available in relation to those persons. Where a regulated activity is carried on by a body other than a partnership, that body must nominate an individual (“the nominated individual”) who must meet certain requirements (regulation 6). Regulation 7 lays down requirements in relation to registered managers. Regulation 5 lays down a new fit and proper person requirement that must be met by directors of an NHS trust, an NHS foundation trust or a Special Health Authority that carries on a regulated activity. The requirement lays down criteria to be met by such directors, including that they are of good character and that none of the grounds of unfitness specified in Part 1 of Schedule 4 apply. A person must not perform the relevant role if they fail the fit and proper person requirement. A health service body that fails to comply with this requirement could have a condition imposed on its registration with the Care Quality Commission, requiring it to comply with the requirement, under section 12(5)(b) of the Act. Regulations 8 to 19 lay down fundamental standards to be met by registered persons. Regulation 20 lays down a further fundamental standard to be met by health service bodies. The fundamental standards provide that: a care and treatment must be appropriate and reflect service users needs and preferences (regulation 9); b service users must be treated with dignity and respect (regulation 10); c care and treatment must only be provided with consent (regulation 11) d care and treatment must be provided in a safe way (regulation 12); e service users must be protected from abuse and improper treatment (regulation 13); f service users’ nutritional and hydration needs must be met (regulation 14); g all premises and equipment used must be clean, secure, suitable and used properly (regulation 15); h complaints must be appropriately investigated and appropriate action taken in response (regulation 16); i systems and processes must be established to ensure compliance with the fundamental standards (regulation 17); j sufficient numbers of suitably qualified, competent, skilled and experienced staff must be deployed (regulation 18); k persons employed must be of good character, have the necessary qualifications, skills and experience, and be able to perform the work for which they are employed (regulation 19); l health service bodies must be open and transparent with service users about their care and treatment (regulation 20). Regulation 8(2) deals with who is responsible for complying with the Regulations in circumstances where there is more than one registered person in respect of a regulated activity. Regulation 21 states that, for the purposes of compliance with the Regulations, a registered person must take account of guidance issued by the Care Quality Commission under section 23 of the Act and the code of practice issued by the Secretary of State under section 21 of the Act in relation to the prevention or control of health care associated infections. The guidance issued by the Care Quality Commission is available from the Care Quality Commission, Citygate, Gallowgate, Newcastle upon Tyne, NE1 4PA (www.cqc.org.uk). The code of practice issued by the Secretary of State is available from the Department of Health, Richmond House, 79 Whitehall, London SW1A 2NS (www.gov.uk/government/organisations/department-of-health). Regulation 22 creates offences in relation to breaches of requirements in regulation 11, 12, 13(1) to (4), 14, 16(3), 17(3) or 20(2)(a) and (3) and also includes a due diligence defence relating to any proceedings for such a breach. Regulation 23 imposes penalties for those who commit such offences. Regulation 24 and Schedule 5 prescribe fixed penalty offences for the purposes of section 86 of the Act and the amount of the penalty, and make provision about the time by which a fixed penalty must be paid and the method by which the payment may be made, the period during which proceedings cannot be instituted for the offence to which the penalty notice relates, the content of the penalty notice and when a penalty notice can be withdrawn. Regulation 25 revokes the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 (“the 2010 Regulations”), together with other enactments which amended those Regulations. Regulation 26 makes transitional and transitory provision in consequence of these Regulations coming into force. It provides that where enforcement action has been taken in relation to a continuing breach of the 2010 Regulations, and the person or body concerned has been given a specified time by which it must secure compliance with the 2010 Regulations, no criminal proceedings may be taken under these Regulations in relation to the breach in so far as it occurred before that specified time. Regulation 27 requires the Secretary of State to review the operation and effect of these Regulations and lay a report before Parliament within five years after 1st April 2015 and within every five years after that. Following a review it will fall to the Secretary of State to consider whether the Regulations should remain as they are, or be revoked or be amended. A further instrument would be needed to revoke the Regulations or to amend them. A full impact assessment of the costs and benefits of this instrument is available from the Department of Health, Richmond House, 79 Whitehall, London SW1A 2NS (www.gov.uk/government/organisations/department-of-health) and is published alongside this instrument and its Explanatory Memorandum at www.legislation.gov.uk.
Offences created by this instrument
- SCHEDULE 4 SCHEDULE 4 · Status not determined · Strict liability
- Safeguarding service users from abuse and improper treatment regulation 13(6) · Status not determined · Strict liability
- It is an offence for a registered person to fail to comply with any of the requirements in the following regulations,… regulation 22(1) · Status not determined · Strict liability
- A registered person commits an offence if the registered person fails to comply with a requirement of regulation 12,… regulation 22(2) · Status not determined · Strict liability
- It is an offence for a health service body to fail to comply with regulation 20(2)(a) and (3) regulation 22(3) · Status not determined · Strict liability
What Parliament said about it
Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Lords · Lords Chamber · 5 November 2014
- Making Vaccination a Condition of Deployment: Consultation Response
Commons · Written Statements · 17 June 2021 · The Minister for Care (Helen Whately)
On 14 April, we informed the House of our intention to consult on a proposal to amend regulations to require care home providers, with at least one resident over the age of 65, to deploy only those workers who have received both doses of their covid-19 vaccination (or have a legitimate medical exemption from vaccination). An extensive six-week consultation, addressing both whether this change should be made and how, has now been completed. We have seen a substantial level of engagement with the consultation with care home staff, providers, wider stakeholders, residents and their families, in…
- Visiting in Care Homes, Hospitals and Hospices Consultation
Commons · Written Statements · 21 June 2023 · The Minister for Social Care (Helen Whately)
In collaboration with my hon. Friend the Minister of State for Health and Secondary Care (Will Quince), and my hon. Friend the Minister for Mental Health and Women’s Health Strategy (Maria Caulfield), I am making this statement for the benefit of all members of Parliament to bring their attention to the Government consultation on visiting in care homes, hospitals and hospices. Ensuring that care home residents and hospital and hospice patients maintain contact with loved ones is vital to the health and wellbeing of people receiving care or treatment. Friends and family also provide…
- Health and Care Settings: Duty of Candour
Commons · Written Statements · 6 December 2023 · The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)
I wish to inform the House that the Department of Health and Social Care will lead a review into the effectiveness of the statutory duty of candour for health and social care providers in England. The review will formally commence early in the new year. The duty of candour is set out in regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. It has been in place for NHS trusts and NHS foundation trusts since 2014 and for all other providers regulated by the Care Quality Commission since 2015. The duty of candour is about people’s right to openness and…
- Duty of Candour in Health and Social Care: Review
Commons · Written Statements · 16 April 2024 · The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)
On 6 December 2023, I informed the House that the Department of Health and Social Care will lead a review into the effectiveness of the statutory duty of candour for health and social care providers in England. The duty of candour is set out in regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. It has been in place for NHS trusts and NHS foundation trusts since 2014 and for all other providers regulated by the Care Quality Commission since 2015. The duty of candour is a crucial instrument for promoting an open and transparent culture in health and…
- Mental Health Bill [HL]
Lords · Lords Chamber · 2 April 2025 · Baroness Merron (Lab)
My Lords, I am grateful for all the contributions and considerations this evening, to which I have listened closely. I first turn to Amendment 50 in the name of the noble Baroness, Lady Tyler. Workforce is absolutely a critical factor in enabling these reforms and we have committed to recruiting 8,500 more mental health staff over the course of this Parliament. The impact assessment sets out our expectations for the additional workforce that is required to deliver the Bill. However, there are already various mechanisms in place to monitor and address concerns about the mental health…
- Care Settings: Right to Maintain Contact
Commons · Westminster Hall · 24 June 2025 · Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
It is a pleasure to serve under your chairmanship, Ms Butler. I declare my interest, as an NHS consultant. I know from my own professional experience that hospitals and other care settings can be distressing places for patients and their relatives. Even with our excellent NHS staff on hand, patients want more assurance and familiarity while they undergo care and treatment. For many, that support comes from the family and friends who visit them during their hospital stay, or while they are in a hospice or receiving care in a care home. I pay tribute to the very many excellent staff who work…
- Down’s Syndrome Regression Disorder
Commons · Westminster Hall · 8 July 2025 · Stephen Kinnock
As the Government have made clear throughout the debate on reforming the welfare system, those who need to be supported and protected will be supported and protected, so I can reassure the hon. Gentleman on that point. There is clearly a lot of work to do through the review that will be led by the Minister for Social Security and Disability, my right hon. Friend the Member for East Ham (Sir Stephen Timms). This will be an important part of his work. Through the implementation of the Down Syndrome Act 2022, we will improve awareness and understanding of the needs of people with Down’s…
- Draft Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2026
Commons · General Committees · 15 April 2026 · The Parliamentary Under-Secretary of State for Health and Social Care (Dr Zubir Ahmed)
I beg to move, That the Committee has considered the draft Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2026. It is a pleasure to serve under your chairmanship, Mr Stringer. This statutory instrument makes an important change. It will amend the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 so that the treatment of disease, disorder or injury—TDDI—is brought within the regulatory scope of the Care Quality Commission. The change will be for TDDI provided in sports grounds and gymnasiums or under temporary arrangements at sporting or…
How Parliament handled it
Parliament's Statutory Instruments service records procedure from May 2017 onwards, and this instrument predates it. That is a limit of the source, not a statement that nothing happened.
Check the source
- This instrument on legislation.gov.uk The authoritative text, including amendments made since
- Other instruments from 2014