- Status
- Amended (in force with amendments)
- Penalty ceiling
- Prosecution 2 of 18 obligations carry an unlimited fine. 3 carry different penalties and 13 have no criminal penalty — flagged in the list below.
Does it bind you?
Business-side roles with duties under this instrument.
Plus 2 duties on the regulator, Crown ministers and public bodies — folded into the section list below.
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Operator — also bound by 746 other Acts
Any Person — also bound by 2340 other Acts
Licence Holder — also bound by 225 other Acts
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
General
0 of 2 sections shown2 other sections in this Part — procedural and definitional
Regulated Activities
0 of 1 section shown1 other section in this Part — procedural and definitional
Requirements in relation to Regulated Activities
12 of 19 sections shown- Ensure fitness and competence to provide health or social care servicesOperator
- Ensure directors and senior leaders are 'fit and proper' personsOperator
- Ensure registered managers are fit and qualified for their rolesAny Person
- Comply with fundamental standards and assess mental capacityLicence Holder
- Treat service users with dignity and respectLicence Holder
- Obtain valid consent before providing care or treatmentLicence Holder
Fine up to £4,000
- Provide safe care and treatment to service usersLicence Holder
Unlimited fine
- Protect service users from abuse and improper treatmentOperator
- Maintain safe, clean, and suitable premises and equipmentOperator
- Establish and operate a system for handling complaintsLicence Holder
- Ensure sufficient, trained and competent staffingOperator
- Ensure staff are fit and proper for regulated care activitiesAny Person
7 other sections in this Part — procedural and definitional
Compliance and Offences
2 of 3 sections shown- Fail to comply with regulated activity requirementsAny Person
Fine up to £2,500
- Breach of regulation 11Any Person
Unlimited fine
1 other section in this Part — procedural and definitional
Penalty Notices
1 of 1 section shown- Pay a fixed penalty notice to avoid prosecutionAny Person
Miscellaneous
2 of 3 sections shownOther duties (1) — Crown / regulator
- CQC cannot prosecute for past failures covered by a valid Warning NoticeStatutory regulator
Other duties (1) — Crown / regulator
- Secretary of State must review the healthcare regulations every five yearsCrown / Minister / Government department
1 other section in this Part — procedural and definitional
Schedules
1 of 48 shown- Complete prescribed pre-employment checks for regulated activity staffOperator
47 other schedules
Help complying
Guvnor’s practical routes through this instrument.
Start a healthcare business
Launch a healthcare or social care business with CQC registration
Run a healthcare business
Ongoing compliance for CQC-registered healthcare providers covering inspections, professional registration, safeguarding, clinical governance, medicines management, and staff obligations
Healthcare compliance quick check
Quick compliance check for experienced healthcare providers. Covers CQC registration, professional registrations, DBS checks, medicines audit, controlled drugs register, IPC audit, fire …
Start a social care provider business
End-to-end learning path for starting a social care business. Covers which regulator applies, CQC registration, registered manager requirements, workforce qualifications (Care Certificate, …
Respond to a medicines or controlled drugs incident
What to do when a medicines incident occurs: medication error, controlled drug discrepancy, or CD theft/loss. Covers securing the patient and evidence, …
Respond to a CQC investigation or enforcement action
What to do if your healthcare or social care service faces CQC enforcement action. Covers understanding the type and severity of action, …
Clinical governance and quality improvement
Clinical governance framework for healthcare providers covering patient safety culture, clinical audit, incident investigation, duty of candour, complaints handling, and continuous quality …
Healthcare and social care regulation (CQC)
CQC registration requirements for health and social care providers in England, including detailed guidance on regulated activities, costs, and devolved nation alternatives.
Healthcare provider annual compliance checklist
Annual checklist of recurring compliance obligations for CQC-registered healthcare providers covering registration, workforce, clinical governance, premises, data protection, and policy reviews.
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, annual fees, fit and proper person …
6 more guides that reference this instrument
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.