Health and Social Care Act 2008

Regulation, code of practice and guidance E+W

20 Regulation of regulated activities E+W

[F1 (1) The Secretary of State must by regulations impose requirements that the Secretary of State considers necessary to secure that services provided in the carrying on of regulated activities cause no avoidable harm to the persons for whom the services are provided.

(2) The Secretary of State may by regulations impose any other requirements in relation to regulated activities that the Secretary of State thinks fit for the purposes of this Chapter, including in particular provision with a view to—]

(a) securing that any service provided in the carrying on of a regulated activity is of appropriate quality, and

(b) securing the health, safety and welfare of persons for whom any such service is provided.

(3) Regulations under this section may in particular—

(a) make provision as to the persons who are fit to carry on or manage a regulated activity;

(b) make provision as to the manner in which a regulated activity is carried on;

(c) make provision as to the persons who are fit to work for the purpose of the carrying on of a regulated activity;

(d) make provision as to the management and training of persons who work for the purpose of the carrying on of a regulated activity;

[F2 (da) impose requirements in connection with food or drink provided or made available to any person on hospital premises in England that are used in connection with the carrying on of a regulated activity;]

(e) make provision as to the fitness of premises;

(f) impose requirements as to the keeping of records and accounts;

(g) impose requirements as to the provision of information;

(h) impose requirements as to the financial position of a person registered as a service provider;

(i) impose requirements as to the making available to the public of information as to any charges made for the provision of any services provided in the carrying on of a regulated activity;

(j) impose requirements as to the review of the quality of any services provided in the carrying on of a regulated activity, as to the preparation of reports of such reviews, and as to the making available to the public of such reports;

(k) make provision as to the handling of complaints and disputes and the application of lessons learnt from them.

(4) Regulations made under this section by virtue of subsection (3)(b) may in particular include provision as to the control and restraint, in appropriate cases, of persons receiving health or social care or other services in connection with the carrying on of a regulated activity.

[F3 (4A) Regulations made under this section by virtue of subsection (3)(d) may in particular include provision for a specified person to set the standards which persons undergoing the training in question must attain.]

[F4 (4B) Regulations made under this section by virtue of subsection (3)(da) may in particular—

(a) specify nutritional standards, or other nutritional requirements, which are to be complied with;

(b) require that specified descriptions of food or drink are not to be provided or made available.]

(5) Regulations made under this section may make provision for the prevention and control of health care associated infections and may include such provision as the Secretary of State considers appropriate for the purpose of safeguarding individuals (whether receiving health or social care or otherwise) from the risk, or any increased risk, of being exposed to health care associated infections or of being made susceptible, or more susceptible, to them.

[F5 (5ZA) Regulations under this section must require service providers to ensure that each person working for the purpose of the regulated activities carried on by them receives training on learning disability and autism which is appropriate to the person’s role.]

[F6 (5A) Regulations under this section must make provision as to the provision of information in a case where an incident of a specified description affecting a person's safety occurs in the course of the person being provided with a service.]

[F7 (5B) In subsection (1)—

(a) “cause” means cause or contribute to, whether directly or indirectly; and

(b) harm is avoidable, in relation to a service, unless the person providing the service cannot reasonably avoid it (whether because it is an inherent part or risk of a regulated activity or for another reason).]

[F8 (5C) In subsection (3)(da) “hospital” has the meaning given by section 275 of the National Health Service Act 2006.]

[F9 (5D) In subsection (5ZA)—

• “learning disability” has the meaning given by section 1(4) of the Mental Health Act 1983;

• “service provider” means a person registered under this Chapter as a service provider in respect of a regulated activity.]

(6) In this Chapter “health care associated infection” means any infection to which an individual may be exposed or made susceptible (or more susceptible) in circumstances where—

(a) health or social care is being, or has been, provided to that or any other individual, and

(b) the risk of exposure to the infection, or of susceptibility (or increased susceptibility) to it, is directly or indirectly attributable to the provision of that care.

(7) But “health care associated infection” does not include an infection to which the individual is deliberately exposed as part of any health care.

(8) Before making regulations under this section, except regulations which amend other regulations under this section and do not, in the opinion of the Secretary of State, effect any substantial change in the provision made by those regulations, the Secretary of State must consult such persons as the Secretary of State considers appropriate.

(9) Consultation undertaken by the Secretary of State before the commencement of this section is as effective for the purposes of this section as consultation undertaken after that time.

Textual Amendments

F1 S. 20(1) and the opening words of (2) substituted (1.10.2015) by Health and Social Care (Safety and Quality) Act 2015 (c. 28), ss. 1(2), 6(4); S.I. 2015/1438, reg. 3(a)

F2 S. 20(3)(da) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 173(a), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F3 S. 20(4A) inserted (1.10.2014) by Care Act 2014 (c. 23), ss. 95, 127(1); S.I. 2014/2473, art. 3(f)

F4 S. 20(4B) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 173(b), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F5 S. 20(5ZA) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(2), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F6 S. 20(5A) inserted (7.7.2014 for specified purposes, 15.7.2014 in so far as not already in force) by Care Act 2014 (c. 23), ss. 81, 127(1); S.I. 2014/1714, arts. 2(a), 3(1)

F7 S. 20(5B) inserted (1.10.2015) by Health and Social Care (Safety and Quality) Act 2015 (c. 28), ss. 1(3), 6(4); S.I. 2015/1438, reg. 3(a)

F8 S. 20(5C) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 173(c), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F9 S. 20(5D) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(3), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

Modifications etc. (not altering text)

C1 Pt. 1 excluded (6.4.2010) by The Health and Social Care Act 2008 (Commencement No.16, Transitory and Transitional Provisions) Order 2010 (S.I. 2010/807), arts. 1(1)(a), 17(4)(c) (5)(b)

C2 Pt. 1 excluded (6.4.2010) by The Health and Social Care Act 2008 (Commencement No.16, Transitory and Transitional Provisions) Order 2010 (S.I. 2010/807), arts. 1(1)(a), 14(4)(c)

Commencement Information

I1 S. 20 partly in force; S. 20 in force for specified purposes at Royal Assent, see s. 170

I2 S. 20 in force at 12.1.2009 for specified purposes by S.I. 2008/3168, art. 2

I3 S. 20 in force at 6.4.2010 in so far as not already in force by S.I. 2010/807, art. 2(1), Sch. 1 para. 5 (with Pt. 3)

[F10 20A Functions relating to processing of information by registered persons E+W

(1) The Commission has the following functions in relation to the processing of relevant information—

(a) to monitor the practice followed by registered persons in relation to such processing, and

(b) to keep [F11 NHS England] F12 ... informed about the practice being followed by registered persons in relation to such processing.

(2) The Commission must, in exercising those functions, seek to improve the practice followed by registered persons in relation to the processing of relevant information.

(3) In this section “relevant information” means—

(a) patient information,

(b) any other information obtained or generated in the course of the provision of the health service continued under section 1 of the National Health Service Act 2006,

(c) any other information obtained or generated in the course of the exercise by an English local authority of its adult social services functions, and

(d) any other information obtained or generated in the course of the carrying on by an English local authority of adult placement schemes in connection with which arrangements are made for the provision of personal care.

(4) In subsection (3) “patient information” means—

(a) information (however recorded) which relates to the physical or mental health or condition of an individual (“P”), to the diagnosis of P's condition or to P's care or treatment, and

(b) information (however recorded) which is to any extent derived, directly or indirectly, from that information,

whether or not the identity of the individual in question is ascertainable from the information.

(5) In this section—

• “adult placement scheme” and “personal care” each have such meaning as they have from time to time in regulations under section 20;

• “processing”, in relation to information, has the same meaning as in [F13 Parts 5 to 7 of the Data Protection Act 2018 (see section 3(4) and (14) of that Act);]

• “registered person” means a person registered under this Chapter as a manager or service provider in respect of a regulated activity.]

Textual Amendments

F10 S. 20A inserted (1.4.2013) by Health and Social Care Act 2012 (c. 7), ss. 280(3), 306(4); S.I. 2013/160, art. 2(2) (with arts. 7-9)

F11 Words in s. 20A substituted (1.7.2022) by Health and Care Act 2022 (c. 31), s. 186(6), Sch. 1 para. 1(1)(2); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F12 Words in s. 20A(1)(b) omitted (1.7.2022) by virtue of Health and Care Act 2022 (c. 31), s. 186(6), Sch. 5 para. 35; S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F13 Words in s. 20A(5) substituted (25.5.2018) by Data Protection Act 2018 (c. 12), s. 212(1), Sch. 19 para. 153 (with ss. 117, 209, 210); S.I. 2018/625, reg. 2(1)(g)

21 Code of practice relating to health care associated infections E+W

(1) The Secretary of State may issue a code of practice about compliance with any requirements of regulations under section 20 which relate to the prevention or control of health care associated infections.

(2) The code may—

(a) operate by reference to provisions of other documents specified in it (whether published by the Secretary of State or otherwise);

(b) provide for any reference in it to such a document to take effect as a reference to that document as revised from time to time;

(c) make different provision for different cases or circumstances.

(3) The Secretary of State must keep the code under review and may from time to time—

(a) revise the whole or any part of the code, and

(b) issue a revised code.

Commencement Information

I4 S. 21 in force at 12.1.2009 for specified purposes by S.I. 2008/3168, art. 2

[F14 21A Learning disability and autism training: code of practice E+W

(1) The Secretary of State must issue a code of practice about compliance with requirements imposed by virtue of section 20(5ZA) (requirements relating to training on learning disability and autism).

(2) The code must make provision about—

(a) the content of training;

(b) training appropriate to different roles;

(c) circumstances in which it is appropriate for training to be delivered in person;

(d) the involvement of people with learning disability, autistic people, or their carers, in the provision of training;

(e) accreditation of training;

(f) procurement of training;

(g) monitoring and evaluation of the impact of training;

(3) The code may make different provision for different cases or circumstances.

(4) The Secretary of State must, at least once every five years—

(a) review the code, and

(b) lay before Parliament a report setting out the findings of the review.]

Textual Amendments

F14 S. 21A inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(4), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

22 [F15 Codes of practice: consultation and Parliamentary scrutiny] E+W

(1) Where the Secretary of State proposes to issue a code of practice under section 21 [F16 or 21A], the Secretary of State must—

(a) prepare a draft of the code, and

(b) consult such persons as the Secretary of State considers appropriate about the draft.

(2) Where the Secretary of State proposes to issue under section 21 [F17 or 21A] a revised code which in the opinion of the Secretary of State would result in a substantial change in the code, the Secretary of State must—

(a) prepare a draft of the revised code, and

(b) consult such persons as the Secretary of State considers appropriate about the change.

(3) Where, following consultation under subsection (1) or (2) [F18 in relation to a draft of a code or revised code under section 21], the Secretary of State issues the code or revised code (whether in the form of the draft or with such modifications as the Secretary of State thinks fit), it comes into force at the time when it is issued by the Secretary of State.

(4) Where—

(a) any document by reference to whose provisions the code operates as mentioned in section 21(2)(a) and (b) is a document published by the Secretary of State in connection with the Secretary of State's functions relating to health or social care,

(b) the Secretary of State proposes to revise the document, and

(c) in the opinion of the Secretary of State, the revision would result in a substantial change in the code,

the Secretary of State must, before revising the document, consult such persons as the Secretary of State considers appropriate about the change.

(5) Where—

(a) any document by reference to whose provisions the code operates as mentioned in section 21(2)(a) and (b) is not one to which subsection (4)(a) of this section applies,

(b) the document is revised, and

(c) in the opinion of the Secretary of State, the revision results in a substantial change in the code,

the Secretary of State must consult such persons as the Secretary of State considers appropriate about whether the code should be revised in connection with the change.

[F19 (5A) Where, following consultation under subsection (1) or (2) in relation to a draft of a code or revised code under section 21A, the Secretary of State decides to proceed with the draft (in its original form or with modifications), the Secretary of State must lay a copy of the draft before Parliament.

(5B) The Secretary of State may not issue the code or revised code if, within the 40-day period, either House of Parliament resolves not to approve it.

(5C) In this section “40-day period” means—

(a) the period of 40 days beginning with the day on which the draft is laid before Parliament, or

(b) if the draft is not laid before each House on the same day, the period of 40 days beginning with the later of the days on which it is laid before Parliament.

(5D) For the purposes of subsection (5C), no account is to be taken of any whole days that fall within a period during which—

(a) Parliament is dissolved or prorogued, or

(b) either House of Parliament is adjourned for more than four days.]

(6) Consultation undertaken by the Secretary of State before the commencement of this section is as effective for the purposes of this section as consultation undertaken after that time.

Textual Amendments

F15 S. 22 heading substituted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(5)(a), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F16 Words in s. 22(1) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(5)(b), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F17 Words in s. 22(2) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(5)(c), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F18 Words in s. 22(3) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(5)(d), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F19 S. 22(5A)-(5D) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(5)(e), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

Modifications etc. (not altering text)

C3 S. 22(3) modified (12.1.2009) by Health and Social Care Act 2008 (Commencement No.6, Transitory and Transitional Provisions) Order 2008 (S.I. 2008/3168), art. 4

Commencement Information

I5 S. 22 in force at 12.1.2009 for specified purposes by S.I. 2008/3168, art. 2

23 Guidance as to compliance with requirements E+W

[F20 (1) The Commission must issue guidance about compliance with the requirements of regulations under section 20, other than requirements which relate to—

(a) the prevention or control of health care associated infections, or

(b) training on learning disability or autism.]

(2) The guidance may, if the Commission thinks fit, also relate to compliance for the purposes of this Chapter with the requirements of any other enactments.

(3) The guidance may—

(a) operate by reference to provisions of other documents specified in it (whether published by the Commission or otherwise);

(b) provide for any reference in it to such a document to take effect as a reference to that document as revised from time to time;

(c) make different provision for different cases or circumstances.

(4) The Commission may from time to time revise guidance issued by it under this section and issue the revised guidance.

Textual Amendments

F20 S. 23(1) substituted (18.11.2022) by The Health and Care Act 2022 (Further Consequential Amendments) Regulations 2022 (S.I. 2022/1200), regs. 1(1), 2

Commencement Information

I6 S. 23 in force at 11.12.2009 by S.I. 2009/3023, art. 2(b) (with arts. 3-17) (as amended (8.2.2010) by S.I. 2010/47, art. 2)

24 Consultation in relation to guidance under s. 23 E+W

(1) Where the Commission proposes to issue guidance under section 23, it must—

(a) prepare a draft of the guidance, and

(b) consult such persons as the Commission considers appropriate about the draft.

(2) Where the Commission proposes to issue under section 23 revised guidance which in its opinion would result in a substantial change in the guidance, the Commission must—

(a) prepare a draft of the revised guidance, and

(b) consult such persons as the Commission considers appropriate about the change.

(3) Where, following consultation under subsection (1) or (2), the Commission issues the guidance or revised guidance (whether in the form of the draft or with such modifications as the Commission thinks fit), it comes into force at the time when it is issued by the Commission.

(4) Where—

(a) any document by reference to whose provisions the guidance operates as mentioned in section 23(3)(a) and (b) is a document published by the Commission,

(b) the Commission proposes to revise the document, and

(c) in the opinion of the Commission, the revision would result in a substantial change in the guidance,

the Commission must, before revising the document, consult such persons as the Commission considers appropriate about the change.

(5) Where—

(a) any document by reference to whose provisions the guidance operates as mentioned in section 23(3)(a) and (b) is not one to which subsection (4)(a) of this section applies,

(b) the document is revised, and

(c) in the opinion of the Commission, the revision results in a substantial change in the guidance,

the Commission must consult such persons as the Commission considers appropriate about whether the guidance should be revised in connection with the change.

(6) Consultation undertaken by the Commission before the commencement of this section is as effective for the purposes of this section as consultation undertaken after that time.

Commencement Information

I7 S. 24 in force at 11.12.2009 by S.I. 2009/3023, art. 2(b) (with arts. 3-17) (as amended (8.2.2010) by S.I. 2010/47, art. 2)

25 Effect of code under s. 21 [F21 or 21A] and guidance under s. 23 E+W

(1) [F22 Codes of practice under sections 21 and 21A] and guidance under section 23 are to be taken into account—

(a) in the making of any decision by the Commission under this Chapter;

(b) in any proceedings for the making of an order under section 30;

(c) in any proceedings on an appeal against such a decision or order;

(d) in any proceedings for an offence under section 33 or under regulations under section 20.

(2) [F23 Codes of practice under sections 21 and 21A and] guidance under section 23 [F24 are] also admissible in evidence in other criminal or civil proceedings.

(3) A failure to observe any provision of a code of practice under section 21 [F25 or 21A] or guidance under section 23 does not of itself make a person liable to any criminal or civil proceedings.

Textual Amendments

F21 Words in s. 25 heading inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(6)(a), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F22 Words in s. 25(1) substituted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(6)(b), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F23 Words in s. 25(2) substituted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(6)(c)(i), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F24 Word in s. 25(2) substituted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(6)(c)(ii), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

F25 Words in s. 25(3) inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 181(6)(d), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)

Commencement Information

I8 S. 25 in force at 12.1.2009 for specified purposes by S.I. 2008/3168, art. 2

I9 S. 25 in force at 11.12.2009 in so far as not already in force by S.I. 2009/3023, art. 2(c) (with arts. 3-17) (as amended (8.2.2010) by S.I. 2010/47, art. 2)