These requirements apply to all business activities in this division.
registration
England
Ongoing
CQC registration for regulated activities
Enforced by:
CQC
Health and Social Care Act 2008; Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
Mandatory for all providers of regulated activities in England. Equivalent regulators: HIW (Wales), HIS (Scotland), RQIA (Northern Ireland).
registration
Scotland
Ongoing
HIS registration for independent healthcare services (Scotland)
Enforced by:
HEALTHCARE_IMPROVEMENT_SCOTLAND
National Health Service (Scotland) Act 1978; The Healthcare Improvement Scotland (Requirements as to Independent Health Care Services) Regulations 2011; The Healthcare Improvement Scotland (Applications and Registration) Regulations 2011
Scottish equivalent of CQC registration. Providers of independent hospitals and independent clinics (private practice by a medical or dental practitioner, registered nurse, midwife, pharmacist or dental care professional) must register with Healthcare Improvement Scotland (HIS) under s.10P before operating; providing an unregistered independent healthcare service is a criminal offence under s.10Z9. The Requirements Regulations 2011 set fitness-of-provider/manager/employee standards (regs 5-8) and a quality duty (reg 13); the Applications and Registration Regulations 2011 set the application and registration process. Note: unlike English NHS GP practices, NHS general practice, NHS dental and NHS ambulance services in Scotland are not registered with HIS in the same way — HIS registration here applies to genuinely independent/private providers only.
registration
Wales
Ongoing
HIW registration for independent healthcare services (Wales)
Enforced by:
HEALTHCARE_INSPECTORATE_WALES
Care Standards Act 2000; The Independent Health Care (Wales) Regulations 2011
Welsh equivalent of CQC registration. Independent hospitals, independent clinics and independent medical agencies in Wales must register with Healthcare Inspectorate Wales (HIW) under Part 2 of the Care Standards Act 2000; carrying on or managing an unregistered establishment or agency is an offence under s.11. The Independent Health Care (Wales) Regulations 2011 set the detailed operating requirements: policies and procedures (reg 9), fitness of the responsible individual and DBS checks (regs 10, 12, 21 and Schedule 2), and notifiable events such as death or unauthorised absence of a detained patient (regs 30-35). Note: unlike English NHS GP practices, NHS general practice, NHS dental and NHS ambulance services in Wales are not registered with HIW in the same way — HIW registration here applies to genuinely independent/private providers only.
certification
England_Wales
Ongoing
DBS checks for healthcare staff
Enforced by:
DBS
Safeguarding Vulnerable Groups Act 2006
Enhanced DBS with barred list check required for all staff in regulated activity with children or vulnerable adults. Recheck recommended every 3 years. Access NI equivalent in Northern Ireland; Disclosure Scotland (PVG scheme) in Scotland.
certification
Scotland
Ongoing
PVG scheme membership (Scotland)
Enforced by:
DISCLOSURE_SCOTLAND
Protection of Vulnerable Groups (Scotland) Act 2007
Scottish equivalent of enhanced DBS. Staff doing regulated work with children or protected adults must be PVG scheme members; Disclosure Scotland carries out ongoing monitoring and issues updated records when new information arises.
certification
Ni
Ongoing
AccessNI checks (Northern Ireland)
Enforced by:
ACCESSNI
Safeguarding Vulnerable Groups (Northern Ireland) Order 2007
Northern Ireland equivalent of enhanced DBS. Staff in regulated activity with children or vulnerable adults require an enhanced AccessNI check with barred list information.
insurance
Uk
Annual
Professional indemnity insurance
Enforced by:
CQC
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014; The Health Care and Associated Professions (Indemnity Arrangements) Order 2014
CQC-registered providers in England must have appropriate indemnity arrangements as a fundamental standard (reg 12, HSCA 2008 (Regulated Activities) Regulations 2014). Separately, individual practitioners registered with GMC, GDC, NMC, HCPC, GOC or GPhC must hold suitable indemnity cover as a condition of registration under the Health Care and Associated Professions (Indemnity Arrangements) Order 2014, which applies across the whole UK (so covers Scotland, Wales and Northern Ireland practitioners too) — cover may be via professional body membership (e.g. MDU, MPS) or a separate policy.
registration
England
Ongoing
Clinical waste disposal duty of care
Enforced by:
ENVIRONMENT_AGENCY
Environmental Protection Act 1990; Hazardous Waste (England and Wales) Regulations 2005
Clinical waste is controlled waste. Must use licensed waste carriers and maintain consignment notes for hazardous waste. Separate regimes: SEPA (Scotland), NRW (Wales), DAERA (Northern Ireland).
registration
Uk
Annual
Health data protection (special category data)
Enforced by:
ICO
Data Protection Act 2018
Health data is special category data under UK GDPR Article 9. Requires explicit consent or other lawful basis. Data Protection Impact Assessment required for high-risk processing.
inspection
England
Ongoing
Safeguarding duties (children and adults)
Enforced by:
CQC
Children Act 2004; Care Act 2014
Duty to safeguard and promote welfare of children (s11 Children Act 2004). Duty to report safeguarding concerns for adults at risk (Care Act 2014). Must have designated safeguarding lead and policies.
inspection
Scotland
Ongoing
Adult support and protection duties (Scotland)
Enforced by:
LOCAL_AUTHORITY
Adult Support and Protection (Scotland) Act 2007
Duty to co-operate with the local authority's Adult Protection Committee and report concerns about adults at risk of harm in Scotland. Must have a designated safeguarding lead and policies.
inspection
Wales
Ongoing
Safeguarding and adult protection duties (Wales)
Enforced by:
LOCAL_AUTHORITY
Social Services and Well-being (Wales) Act 2014
Duty to report and co-operate with the local authority on safeguarding of children and adults at risk in Wales. Must have a designated safeguarding lead and policies.
inspection
England
Ongoing
Infection prevention and control
Enforced by:
CQC
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014; Health and Safety at Work etc. Act 1974
CQC Regulation 12 requires safe care including IPC measures. Must have IPC policy, designated IPC lead, hand hygiene protocols, and environmental cleanliness standards.
inspection
Scotland
Ongoing
Infection prevention and control (Scotland)
Enforced by:
HEALTHCARE_IMPROVEMENT_SCOTLAND
The Healthcare Improvement Scotland (Requirements as to Independent Health Care Services) Regulations 2011
Regulation 2 requires an independent healthcare service to be provided in a manner which promotes quality and safety of service users, which HIS's operating standards frame to include infection prevention and control. Must have an IPC policy, designated IPC lead, hand hygiene protocols, and environmental cleanliness standards.
inspection
Wales
Ongoing
Infection prevention and control (Wales)
Enforced by:
HEALTHCARE_INSPECTORATE_WALES
The Independent Health Care (Wales) Regulations 2011
Regulation 9 requires the registered person to have written policies and procedures for the management and treatment of service users, reviewed at least every 3 years, which HIW's operating standards frame to include infection prevention and control. Must have an IPC policy, designated IPC lead, hand hygiene protocols, and environmental cleanliness standards.
insurance
Great_Britain
Annual
Employers' liability insurance
Enforced by:
HSE
Employers' Liability (Compulsory Insurance) Act 1969
Required for all employers. Sole practitioners with no employees exempt.