# The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

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Statutory Instruments

# 2014 No. 2936

National Health Service, England

Social Care, England

Public Health, England

# The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

Made

6th November 2014

Coming into force in accordance with regulation 1

The Secretary of State makes the following 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 2008 F1.                        

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 a resolution of each House of Parliament.                        

F12008 c. 14. Section 20 of the Health and Social Care Act 2008 (“the 2008 Act”) was amended by section 81 of the Care Act 2014 (c. 23). Section 161(3) of the 2008 Act was amended by section 294(4) of the Health and Social Care Act 2012 (c. 7).

## **PART 1**E+WGeneral

### Citation and commencementE+W

1.—(1) These Regulations may be cited as the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.                  

(2) This regulation and regulation 2 come into force on the day after the day on which these Regulations are made.

(3) The provisions to which this paragraph applies come into force at the end of the period of 21 days beginning with the day                     on which these Regulations are made.                  

(4) Paragraph (3) applies to—

(a)regulation 5, and Schedule 3 insofar as it relates to regulation 5;                  

(b)regulation 20;                  

(c)regulation 21, only insofar as it relates to regulations 5 and 20;                  

(d)regulation 22(3);                  

(e)regulation 22(4), only insofar as it relates to a breach of regulation 20(2)(a) and (3);                  

(f)regulation 23(6);                  

(g)regulation 24 and Schedule 5, only insofar as they relate to a contravention of, or a failure to comply with, requirements                        in regulation 20(2)(a) and (3);                  

(h)regulation 26(2);                  

(i)Schedule 4.                  

(5) All other provisions of these Regulations come into force on 1st April 2015.

### InterpretationE+W

2.—(1) In these Regulations—                  

“16 to 19 Academy” has the same meaning as in section 1B of the Academies Act 2010 F2;                  

“the Act” means the Health and Social Care Act 2008;                  

“the 1983 Act” means the Mental Health Act 1983 F3;                  

“the 2005 Act” means the Mental Capacity Act 2005 F4;                  

“the 2006 Act” means the National Health Service Act 2006 F5;                  

“the 2001 Order” means the Health and Social Work Professions Order 2001 F6;                  

“the 2010 Regulations” means the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 F7;                  

“employment” means—                  

employment under a contract of service, an apprenticeship, a contract for services or otherwise than under a contract, and

the grant of practising privileges by a service provider to a medical practitioner, giving permission to practice as a medical                              practitioner in a hospital managed by the service provider,                           

and “employed” and “employer” is to be construed accordingly;                  

“employment agency” and “employment business” have the same meaning as in section 13 (interpretation) of the Employment Agencies Act 1973 F8;                  

“equipment” includes—                  

a medical device (as defined in regulation 2(1) (interpretation) of the Medical Devices Regulations 2002) F9, and                           

materials used in, or used by persons employed in, the carrying on of a regulated activity;

“health care professional”, except in paragraph 4 of Schedule 1, means a person who is registered as a member of any profession                     to which section 60(2) of the Health Act 1999 F10 (regulation of health professions, social workers, other care workers, etc) applies;                  

“health service body” means—                  

an NHS trust established under section 25 of the 2006 Act,

an NHS foundation trust, or

a Special Health Authority;

“hospital”, except in paragraphs 1(3)(d) and 5 of Schedule 1, has the same meaning as in section 275 (interpretation) of the                     2006 Act;                  

“institution within the further education sector” has the same meaning as in section 91 (interpretation of Education Acts) of the Further and Higher Education Act 1992 F11;                  

“local anaesthesia” means any anaesthesia other than general, spinal or epidural anaesthesia, and also excludes the administration of a regional                     nerve block;                  

“medical practitioner” means a registered medical practitioner;                  

“nominated individual” must be construed in accordance with regulation 6(2);

“nurse” means a registered nurse;                  

“nursing care” means any services provided by a nurse and involving—                  

the provision of care, or

the planning, supervision or delegation of the provision of care,

other than any services which, having regard to their nature and the circumstances in which they are provided, do not need                     to be provided by a nurse;                  

“partnership” does not include a limited liability partnership;                  

“personal care” means—                  

physical assistance given to a person in connection with—

eating or drinking (including the maintenance of established parenteral nutrition),

toileting (including in relation to the process of menstruation),

washing or bathing,

dressing,

oral care, or

the care of skin, hair and nails (with the exception of nail care provided by a person registered with the Health and Care                                       Professions Council as a chiropodist or podiatrist pursuant to article 5 of the 2001 Order), or                                    

the prompting, together with supervision, of a person, in relation to the performance of any of the activities listed in paragraph                              (a), where that person is unable to make a decision for themselves in relation to performing such an activity without such                              prompting and supervision;                           

“premises” means—                  

any building or other structure, including any machinery, engineering systems or other objects which are physically affixed                              and integral to such building or structure, and any surrounding grounds, or                           

a vehicle,

but in regulations 12, 14 and 15 does not include the service user's accommodation where such accommodation is not provided                     as part of the service user's care or treatment;                  

“reasonable adjustments” means such reasonable adjustments as would be required under the Equality Act 2010 F12;                  

“registered manager” means, in respect of a regulated activity, a person registered with the Commission F13 under Chapter 2 of Part 1 of the Act as a manager in respect of that activity;                  

“registered person” means, in respect of a regulated activity, a person who is the service provider or registered manager in respect of that                     activity;                  

“relevant person”, except in regulation 20, means the service user or, where the service user is under 16 and not competent                     to make a decision in relation to their care or treatment, a person lawfully acting on their behalf;                  

“school” has the same meaning as in section 4 of the Education Act 1996 F14;                  

“service provider” means, in respect of a regulated activity, a person registered with the Commission under Chapter 2 of Part 1 of the Act                     as a service provider in respect of that activity;                  

“service user” means a person who receives services provided in the carrying on of a regulated activity;                  

“shared lives agreement” means an agreement entered into between a person carrying on a shared lives scheme and an individual for the provision,                     by that individual, of personal care to a service user together with, where necessary, accommodation in the individual's home;                  

“shared lives carer” means an individual who, under the terms of a shared lives agreement, provides, or intends to provide, personal care for                     service users together with, where necessary, accommodation in the individual's home;                  

“shared lives scheme” means a scheme carried on (whether or not for profit) by a local authority or other person for the purposes of—                  

recruiting and training shared lives carers,

making arrangements for the placing of service users with shared lives carers, and

supporting and monitoring placements;

“social worker” means a person who is registered as such in Part 16 of the register maintained by the Health and Care Professions Council                     under article 5 of the 2001 Order;                  

“treatment”, except in paragraph 5 of Schedule 1, includes—

a diagnostic or screening procedure carried out for medical purposes,

the ongoing assessment of a service user's mental or physical state,

nursing, personal and palliative care, and

the giving of vaccinations and immunisations;

“vulnerable adult” has the same meaning as in section 60(1) (interpretation) of the Safeguarding Vulnerable Groups Act 2006 F15.                  

(2) In the definition of “employment” in paragraph (1), the reference to otherwise than under a contract includes—

(a)under a shared lives agreement;                  

(b)under an agreement between the service provider and a temporary work agency for the supply of an agency worker to the service                        provider;                  

(c)under arrangements for persons to provide their services voluntarily.                  

(3) In paragraph (2)—

“agency worker” and “temporary work agency” have the same meaning as in the Agency Workers Regulations 2010 F16.                     

F22010 c. 32. Section 1B was inserted by section 53(7) of the Education Act 2011 (c. 21).

F31983 c. 20.

F42005 c. 9. Relevant amendments were made by the Mental Health Act 2007 (c. 12), **sections 50** and 55 and Part 10 of Schedule 11.

F52006 c. 41.

F6S.I. 2002/254. Relevant amendments were made by sections 213 and 214 of the Health and Social Care Act 2012 (c. 7) and S.I. 2004/2033, 2009/1182 and 2009/1357.

F7S.I. 2010/781, as amended by S.I. 2011/2711, 2012/921, 2012/979, 2012/1479, 2012/1513, 2013/235 and 2013/472.

F81973 c. 35. Relevant amendments were made by the Employment Relations Act 1999 (c. 26), **section 31** and paragraphs 1 and 7 of Schedule7.

F9S.I. 2002/618. Relevant amendments were made by S.I. 2008/2986.

F101999 c. 21. Relevant amendments were made by the Health and Social Care Act 2008, sections 111 and 116, paragraph 1 of Schedule 8 and                              Part 2 of Schedule 15, the Health and Social Care Act 2012, sections 209 and 213, and S.I. 2002/253 and 2010/231.

F111992 c. 13. Relevant amendments were made by the Apprenticeships, Skills, Children and Learning Act 2009 (c. 22), **section 125** and paragraphs 1 and 13(1) and (2) of Schedule 8.

F122010 c. 15.

F13By section 1(1) of the 2008 Act, “the Commission” means the Care Quality Commission.

F141996 c. 56. Relevant amendments were made by the Education Act 1997 (c. 44), **sections 51** and 57, paragraph 10 of Schedule 7 and Schedule 8, the Education Act 2002 (c. 32), **section 215** and Part 3 of Schedule 22, the Childcare Act 2006 (c. 21), **section 95**, and the Education Act 2011 (c. 21), **section 54** and paragraph 9 of Schedule 13, and S.I. 2010/1080.

F152006 c. 47. Relevant amendments were made by section 65(2) of the Protection of Freedoms Act 2012 (c. 9).

F16S.I. 2010/93. Relevant amendments were made by S.I. 2011/1941.

## **PART 2**E+WRegulated Activities

### Prescribed activitiesE+W

## **PART 3**E+WRequirements in relation to Regulated Activities

### SECTION 1E+WRequirements relating to persons carrying on or managing a regulated activity

### SECTION 2E+WFundamental Standards

## **PART 4**E+WCompliance and Offences

### Guidance and CodeE+W

## **PART 5**E+WPenalty Notices

### Penalty noticesE+W

24.—(1) The offences under the provisions listed in the first column of Schedule 5 are prescribed as fixed penalty offences for the                     purposes of section 86 of the Act.                  

(2) The monetary amount of a penalty for each fixed penalty offence is prescribed in the third column of Schedule 5.

(3) The time by which the penalty specified in a penalty notice is to be paid is the end of the period of 28 days beginning with                     the date of receipt of the notice.                  

(4) Subject to paragraph (5), the methods by which a penalty notice may be paid are by cash, cheque, credit or debit card, postal                     order or electronic transfer of funds to the Commission's bank account.                  

(5) A penalty may only be paid by credit card from the date on which the Commission has in place arrangements to accept such payments.

(6) Where a person is given a penalty notice, proceedings for the offence to which the notice relates may not be instituted before                     the end of the period of 28 days beginning with the date of receipt of the notice.                  

(7) Section 93 of the Act applies to a penalty notice as it applies to a notice required to be given under Part 1 of the Act.

(8) If a penalty notice is given by being sent by an electronic communication, in accordance with section 94 of the Act, the notice                     is, unless the contrary is proved, to be taken to have been received on the next working day after the day on which it is                     sent.                  

(9) A penalty notice must give such particulars of the circumstances alleged to constitute the offence as seem to the Commission                     to be reasonably required to provide the person to whom the notice is given with information about it.                  

(10) A penalty notice must state—

(a)the name and address of the person to whom the notice is given,                  

(b)the amount of the penalty,                  

(c)the period during which proceedings will not be taken for the offence,                  

(d)that payment within that period will discharge any liability for the offence,                  

(e)the consequences of the penalty not being paid before the expiration of the period for paying it,                  

(f)the person to whom and the address at which the penalty may be paid and to which any correspondence about the penalty may                        be sent, and                  

(g)the means by which payment of the penalty may be made.                  

(11) The Commission may withdraw a penalty notice by giving written notice of the withdrawal to the person to whom the notice was                     given if—                  

(a)the Commission determines that it ought not to have been given or it ought not to have been given to the person to whom it                        was addressed, or                  

(b)it appears to the Commission that the notice contains material errors.                  

(12) A penalty notice may be withdrawn in accordance with paragraph (11) whether or not the period for payment referred to in paragraph                     (3) has expired, and whether or not the penalty has been paid.                  

(13) Where a penalty notice has been withdrawn in accordance with paragraph (11), the Commission must—

(a)repay any amount paid by way of penalty in pursuance of that notice to the person who paid it, within 14 days beginning with                        the day on which written notice of the withdrawal was given, and                  

(b)remove from publication any information about the payment of the penalty which has been published in accordance with regulations                        made under section 89 of the Act, within 7 days beginning with the day on which written notice of the withdrawal was given.                  

(14) Except as provided in paragraph (15), no proceedings may be instituted or continued against the person to whom a penalty notice                     was given for the offence to which the penalty notice relates where that notice has been withdrawn in accordance with paragraph                     (11).                  

(15) Where a penalty notice has been withdrawn under paragraph (11)(b), proceedings may be instituted or continued for the offence                     in connection with which that penalty notice was issued if a further penalty notice in respect of the offence has been given                     and the penalty has not been paid before the expiration of the period for payment referred to in paragraph (3).                  

(16) In this regulation—

“debit card” means a card the use of which by its holder to make a payment results in a current account of the holder at a bank, or at                     any other institution providing banking services, being debited with the payment;                  

“credit card” means a card which is a credit-token within the meaning of section 14 of the Consumer Credit Act 1974 F19;                  

“electronic communication” has the same meaning as in the Electronic Communications Act 2000 F20;                  

“working day” means any day other than—                  

a Saturday or Sunday,

Christmas Day or Good Friday, or

a day which is a bank holiday in England and Wales under the Banking and Financial Dealings Act 1971 F21.                           

## **PART 6**E+WMiscellaneous

### RevocationsE+W

### ReviewE+W

Signed by the authority of the Secretary of State for Health.

Norman Lamb

 Minister of State,

 Department of Health

6th November 2014

 Regulation 3(1)

## SCHEDULE 1E+WRegulated Activities

### Personal careE+W

### Accommodation for persons who require nursing or personal careE+W

### Accommodation for persons who require treatment for substance misuseE+W

### Treatment of disease, disorder or injuryE+W

### Assessment or medical treatment for persons detained under the 1983 ActE+W

### Surgical proceduresE+W

### Diagnostic and screening proceduresE+W

### Management of supply of blood and blood derived products etcE+W

### Maternity and midwifery servicesE+W

### Termination of pregnanciesE+W

### Services in slimming clinicsE+W

### Nursing careE+W

### Family planning servicesE+W

 Regulation 3(4)

## SCHEDULE 2E+WRegulated Activities: General Exceptions

1.—(1) Any activity which is carried on—E+W

(a)in the course of a family or personal relationship, and

(b)for no commercial consideration.

(2) A family relationship includes a relationship between two persons who—

(a)live in the same household, and

(b)treat each other as though they were members of the same family.

(3) A personal relationship is a relationship between or among friends.

(4) A friend of a person (A) includes a person who is a friend of a member of A's family.

2.  Any activity which involved the carrying on of an establishment or agency within the meaning of the Care Standards Act 2000                     F34 for which Her Majesty's Chief Inspector of Education, Children's Services and Skills is the registration authority under                     that Act.E+W

3.—(1) Subject to paragraph 4, the provision of treatment in a surgery or consulting room by a medical practitioner who is (or a                     group of medical practitioners who are)—E+W

(a)a service provider in respect of a regulated activity specified in paragraph 4 of Schedule 1 (treatment of disease, disorder                        or injury) or employed by such a service provider, and

(b)either on the medical performers list for a designated body or employed by a service provider that is a designated body.

(2) In this paragraph, “designated body” means a body prescribed by regulation 4 of the Medical Profession (Responsible Officers) Regulations 2010 F35.                  

4.  Paragraph 3 does not apply in relation to—E+W

(a)treatment carried out under anaesthesia (other than local anaesthesia for the purposes of a procedure mentioned in paragraph                        6(2) of Schedule 1) or intravenously administered sedation,

(b)medical services provided in connection with childbirth,

(c)the termination of pregnancies,

(d)cosmetic surgery, with the exception of the procedures referred to in paragraph 6(4) of Schedule 1,

(e)haemodialysis or peritoneal dialysis,

(f)endoscopy other than using a device which does not have a lumen or other channel for the purpose or design of passing fluid                        or instruments through, or removing body tissue or fluid or any other item from, a person's body,

(g)the provision of hyperbaric therapy, being the administration of oxygen (whether or not combined with one or more other gases)                        to a person who is in a sealed chamber which is gradually pressurised with compressed air, where such therapy is carried out                        by or under the supervision or direction of a medical practitioner,

(h)intravenous, intrathecal or epidural administration of medicines or diagnostic agents,

(i)the therapeutic or diagnostic use of x-rays, radiation, protons or magnetic resonance imaging, or

(j)invasive cardiac physiology tests.

5.—(1) Medical or dental services provided (otherwise than in conjunction with the provision of accommodation in a hospital) only                     under arrangements made on behalf of service users by—E+W

(a)their employer,

(b)a government department, or

(c)an insurance provider with whom the service users hold an insurance policy, other than an insurance policy which is solely                        or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability                        or infirmity.

(2) In this paragraph, “insurance provider” means—                  

(a)a person regulated by the Financial Conduct Authority or the Prudential Regulation Authority who sells insurance, or underwrites                        the risk of such insurance, or

(b)the agent of such a person.

6.  Forensic medicine or dental services provided under arrangements made with a local policing body as defined in section 101                     of the Police Act 1996 F36 (interpretation).E+W

7.  Primary ophthalmic services provided under Part 6 of the 2006 Act and services of a kind which, if provided in pursuance of                     that Act, would be provided as primary ophthalmic services under that Part.E+W

8.  Services which are provided at or from premises that are a registered pharmacy (within the meaning given by section 74 of                     the Medicines Act 1968 F37) and which are—E+W

(a)pharmaceutical services and local pharmaceutical services provided under Part 7 of the 2006 Act, or

(b)services of a kind which, if provided in pursuance of that Act, would be provided as pharmaceutical services or local pharmaceutical                        services under that Part or services provided in pursuance of that Act.

9.  The provision of first aid by—E+W

(a)health care professionals where it is provided in unexpected or potentially dangerous situations requiring immediate action,

(b)organisations established for that purpose, or

(c)non-health care professionals trained to deliver such treatment.

10.—(1) Defence medical and dental services being—E+W

(a)health or dental care provided by the armed services,

(b)education and training provided by the armed services to service and other personnel in connection with the provision of health                        or dental care, including the maintenance of the clinical skills of such personnel, and

(c)any service or facility falling within sub-paragraph (a) or (b) provided on behalf of the armed services under any agreement                        or arrangement made with the armed services.

(2) In sub-paragraph (1), “armed services” means the naval, military and air forces of the Crown and includes the reserve forces.                  

11.  Treatment provided in a school to the pupils of that school by a nurse who is engaged and directed by the school.E+W

 Regulations 4 to 7 and 19(3)

## SCHEDULE 3E+WInformation Required in Respect of Persons Employed or Appointed for the Purposes of a Regulated Activity

1.  Proof of identity including a recent photograph.E+W

2.  Where required for the purposes of an exempted question in accordance with section 113A(2)(b) of the Police Act 1997 F38, a copy of a criminal record certificate issued under section 113A of that Act together with, after the appointed day and                     where applicable, the information mentioned in section 30A(3) of the Safeguarding Vulnerable Groups Act 2006 (provision of                     barring information on request) F39.E+W

3.  Where required for the purposes of an exempted question asked for a prescribed purpose under section 113B(2)(b) of the Police                     Act 1997, a copy of an enhanced criminal record certificate issued under section 113B of that Act together with, where applicable,                     suitability information relating to children or vulnerable adults.E+W

4.  Satisfactory evidence of conduct in previous employment concerned with the provision of services relating to—E+W

(a)health or social care, or

(b)children or vulnerable adults.

5.  Where a person (P) has been previously employed in a position whose duties involved work with children or vulnerable adults,                     satisfactory verification, so far as reasonably practicable, of the reason why P's employment in that position ended.E+W

6.  In so far as it is reasonably practicable to obtain, satisfactory documentary evidence of any qualification relevant to the                     duties for which the person is employed or appointed to perform.E+W

7.  A full employment history, together with a satisfactory written explanation of any gaps in employment.E+W

8.  Satisfactory information about any physical or mental health conditions which are relevant to the person's capability, after                     reasonable adjustments are made, to properly perform tasks which are intrinsic to their employment or appointment for the                     purposes of the regulated activity.E+W

9.  For the purposes of this Schedule—E+W

(a)“the appointed day” means the day on which section 30A of the Safeguarding Vulnerable Groups Act 2006 comes into force;

(b)“satisfactory” means satisfactory in the opinion of the Commission;

(c)“suitability information relating to children or vulnerable adults” means the information specified in sections 113BA and 113BB respectively of the Police Act 1997.

 Regulation 5

## SCHEDULE 4E+WGood character and unfit person tests

### **PART 1**E+WUnfit person test

1.  The person is an undischarged bankrupt or a person whose estate has had sequestration awarded in respect of it and who has                     not been discharged.E+W

2.  The person is the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order or an order to like                     effect made in Scotland or Northern Ireland.E+W

3.  The person is a person to whom a moratorium period under a debt relief order applies under Part VIIA (debt relief orders)                     of the Insolvency Act 1986 F40.E+W

4.  The person has made a composition or arrangement with, or granted a trust deed for, creditors and not been discharged in respect                     of it.E+W

5.  The person is included in the children's barred list or the adults' barred list maintained under section 2 of the Safeguarding                     Vulnerable Groups Act 2006, or in any corresponding list maintained under an equivalent enactment in force in Scotland or                     Northern Ireland.E+W

6.  The person is prohibited from holding the relevant office or position, or in the case of an individual from carrying on the                     regulated activity, by or under any enactment.E+W

### **PART 2**E+WGood character

7.  Whether the person has been convicted in the United Kingdom of any offence or been convicted elsewhere of any offence which,                     if committed in any part of the United Kingdom, would constitute an offence.E+W

8.  Whether the person has been erased, removed or struck-off a register of professionals maintained by a regulator of health                     care or social work professionals.E+W

 Regulation 24

## SCHEDULE 5E+WFixed Penalty Offences

F41S.I. 2009/3112, as amended by S.I. 2010/49, 2012/921, 2012/1641 and 2013/235.

## Explanatory Note

(This note is not part of the Regulations)

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:                     

care and treatment must be appropriate and reflect service users needs and preferences (regulation 9);

service users must be treated with dignity and respect (regulation 10);

care and treatment must only be provided with consent (regulation 11)

care and treatment must be provided in a safe way (regulation 12);

service users must be protected from abuse and improper treatment (regulation 13);

service users' nutritional and hydration needs must be met (regulation 14);

all premises and equipment used must be clean, secure, suitable and used properly (regulation 15);

complaints must be appropriately investigated and appropriate action taken in response (regulation 16);

systems and processes must be established to ensure compliance with the fundamental standards (regulation 17);

sufficient numbers of suitably qualified, competent, skilled and experienced staff must be deployed (regulation 18);

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);                              

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.