Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
What this means for your business
- Applies to
- United Kingdom
- On this page
- 14 compliance obligations, 14 practical guides
What you must do
14 compliance obligations under this legislation.
Risk assessment 3
Confirm you and any partners are fit to carry out a regulated activity
If you run a health or social care service as a sole trader or a partnership, you must be able to show you are of good character, health‑fit (with reasonable adjustments), and have the right qualifications, skills and experience. You also need to supply the Commission with the personal information it requires. This assessment must be satisfied before you start the regulated activity and kept up to date.
Ensure registered manager is fit to manage regulated activity
If you run a health or social care service you must only appoint a registered manager who is fit to do the job. This means checking they have a good character, the right qualifications, competence, skills and experience, are healthy (or reasonable adjustments are in place), and can provide the information the regulator requires. You also need to assess their character against the specific factors set out in the regulations.
Obtain consent before providing care or treatment
If you run a health or social care service you must only give care or treatment once you have the person's consent. When the person is aged 16 or over but cannot give consent because they lack capacity, you must follow the Mental Capacity Act 2005. If mental health legislation (the 1983 Act) applies, you must follow that instead.
Management duties 8
Deploy sufficient qualified staff and provide ongoing training and support
You must make sure you have enough people with the right qualifications, skills and experience to carry out each regulated health or social care activity. In addition, you need to give those employees the training, supervision, appraisal and professional development they need, and support them to keep their professional registrations up to date.
Ensure directors are fit and proper and keep required records
You must only appoint people as directors (or anyone acting like a director) who are of good character, have the right qualifications, skills and health, and have not been involved in serious misconduct. You also need to keep the information the regulator requires about each director and be ready to replace any director who stops meeting these standards, informing the relevant professional regulator if the director is a health‑care or social‑care professional.
Handle complaints and report to CQC
You must set up a clear, easy‑to‑use system for receiving, recording and dealing with any complaints about your care service. Every complaint must be investigated and appropriate action taken, and you must give the Care Quality Commission a summary of complaints and how they were handled within 28 days of their request.
Hire and retain only fit‑and‑proper staff
If you provide a regulated health or social‑care service, you must make sure anyone you employ to carry out that activity is of good character, has the right qualifications, skills, experience and health (with reasonable adjustments) to do the job. You need recruitment processes to check this, keep the prescribed records for each employee, ensure any required professional registration, and act promptly if someone stops meeting the criteria.
Keep premises and equipment clean, secure and fit for purpose
You must every building and piece of equipment you use deliver health or social care services is clean, secure, suitable, correctly used, well‑maintained and placed in the right location. In addition, the registered person must maintain appropriate hygiene standards for those premises and equipment at all times.
Provide safe care and treatment for service users
Unlimited fineYou must make sure that any care or treatment you deliver is safe. This means checking for risks to the health and safety of the people you look after, reducing those risks where you can, having qualified staff, keeping premises and equipment safe, maintaining enough medicines and equipment, managing medicines correctly, stopping infections spreading, and coordinating with other providers to ensure timely care planning.
Safeguard service users from abuse and improper treatment
If you run a health or social care service, you must put in place effective systems to prevent abuse, investigate any allegations straight away, and ensure care is never discriminatory, degrading, overly restrictive or neglectful. This means having clear policies, training, reporting and monitoring arrangements that protect every service user.
Treat service users with dignity and respect
When you provide health or social care services you must treat every service user with dignity and respect. This means protecting their privacy, supporting their independence and involvement in the community, and taking into account any protected characteristics such as disability or ethnicity. Your everyday care practices and staff behaviour must reflect these requirements.
Other requirements 1
Comply with regulations 9‑20A while providing a regulated activity
If your business is a registered provider of health or social care services, you must follow every requirement set out in regulations 9 to 20A whenever you deliver those services. In practice this means having the right policies, procedures and records in place to meet each of those detailed rules.
Offences and prohibitions 2
Breach of regulation 11
Unlimited fineIf your organisation fails to comply with the requirements set out in regulation 11, you commit a criminal offence. On summary conviction in the Magistrates’ Court you face an unlimited fine.
Fail to comply with regulated activity requirements
Fine up to £2,500If your organisation is a registered health or social care provider and you do not meet the specific regulatory requirements set out in regulations 11, 12, 13, 14, 16(3), 17(3), 20(2)(a)&(3) or 20A, you commit a criminal offence. The offence also applies when such non‑compliance leads to avoidable harm, a serious risk of harm, or loss of money or property to a service user. Conviction can result in fines, imprisonment or other sanctions, although the exact penalties are detailed in the next section of the Regulations.
Penalties for non-compliance
3 penalties under this legislation. 2 carry an unlimited fine.
Provide safe care and treatment for service users
Unlimited fine
Breach of regulation 11
Unlimited fine
Fail to comply with regulated activity requirements
Fine up to £2,500
Practical guidance
Our guides explain how to comply with the requirements above.
Sector-Specific 14
Register with the Care Quality Commission (CQC)
Complete step-by-step guide to CQC registration for healthcare providers in England, including what activities require registration, application fees, …
Healthcare and social care regulation (CQC)
CQC registration requirements for health and social care providers in England, including detailed guidance on regulated activities, costs, …
Start and Register a Childcare Business
Complete guide to registering and launching a childcare business in England, from Ofsted registration to EYFS compliance. Covers …
Support Children with SEND in Early Years Settings
Legal requirements and practical guidance for identifying and supporting children with Special Educational Needs and Disabilities (SEND) in …
Nannies and Au Pairs: Regulations and Employment
Legal requirements, Ofsted registration rules, and employment obligations for nannies and au pairs. Covers when registration is required, …
Register as a Childminder in England
Complete guide to becoming a registered childminder, from pre-registration training and DBS checks to Ofsted registration and setting …
Comply with the EYFS Statutory Framework
How to implement the Early Years Foundation Stage (EYFS) framework in your childcare setting. Covers safeguarding, staff ratios, …
Start a clinical laboratory service
How to set up and operate a clinical laboratory in the UK. Covers UKAS accreditation, CQC registration, HTA …
Social care registration and regulators
Guide to registering as a social care provider across all four UK nations. Covers CQC registration in England, …
Healthcare premises and equipment requirements
CQC Regulation 15 premises and equipment requirements, radiation protection under IRR 2017, healthcare ventilation, medical gas systems, decontamination …
Healthcare regulation across the UK nations
Comparison reference for healthcare regulation in England (CQC), Scotland (HIS and Care Inspectorate), Wales (HIW and CIW), and …
Clinical governance and quality improvement
Clinical governance framework for healthcare providers covering patient safety culture, clinical audit, incident investigation, duty of candour, complaints …
Healthcare provider annual compliance checklist
Annual checklist of recurring compliance obligations for CQC-registered healthcare providers covering registration, workforce, clinical governance, premises, data protection, …
Infection prevention and control for healthcare providers
How to meet infection prevention and control (IPC) requirements under the Health and Social Care Act 2008 Code …
Sections and provisions
29 classified provisions from this legislation.
Duties 14
- s.4 Requirements where the service provider is an individual or partnership P
- s.5 Fit and proper persons: directors a service provider
- s.7 Requirements relating to registered managers
- s.8 General A registered person
- s.10 Dignity and respect
- s.11 Need for consent
- s.12 Safe care and treatment
- s.13 Safeguarding service users from abuse and improper treatment
- s.15 Premises and equipment
- s.16 Receiving and acting on complaints complaint received
- s.18 Staffing
- s.19 Fit and proper persons employed enactment
- s.26 Transitional and transitory provision
- s.27 Review