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Health and Care Act 2022

Type Public General Act

Publication 2022-04-28

Last updated 2025-07-07

State In force

Department Statute Law Database

Source legislation.gov.uk

articles Not indexed

Reform history JSON API

(b) create exceptions from requirements to publish or provide information imposed by virtue of subsection (1) where information is provided under a relevant scheme;

(i) require a person who holds information mentioned in subsection (1) in connection with the operation of a relevant scheme to provide the information to the Secretary of State;

(ii) permit or require the Secretary of State to publish the information.

(7) The regulations may impose requirements on a person mentioned in subsection (6)(c)(i) about the retention of information mentioned there.

(8) The provision for exceptions that may be made by the regulations includes provision authorising the Secretary of State to grant an exception from a requirement imposed by the regulations in a particular case, on grounds specified in the regulations.

(9) The regulations may provide that the disclosure of information under the regulations does not breach—

(a) an obligation of confidence owed by the person making the disclosure, or

(b) any other restriction on the disclosure of the information (however imposed), other than a restriction imposed by the data protection legislation.

(10) Provision made by the regulations may, in particular, be framed by reference to manufacturers or commercial suppliers with a specified connection to the United Kingdom or a part of it.

(11) In this section—

(a) “connected person”, in relation to a manufacturer or commercial supplier, means a person who has a connection, of a description specified in regulations made by the Secretary of State, with the manufacturer or commercial supplier;

(b) “relevant person” means—

(i) a person who provides health care in the United Kingdom or a part of it, whether or not under arrangements made by another person, or

(ii) another person who carries on activities connected with health care provided in the United Kingdom or a part of it and is of a description specified in regulations made by the Secretary of State.

(12) In this section—

“commercial supplier”, in relation to a health care product, means a person who supplies the product otherwise than in the course of providing health care;

“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;

“health care” means all forms of health care provided for individuals, whether relating to physical or mental health;

“health care product” means a medicine, medical device or other product which is supplied or prescribed in the course of the provision of health care;

“manufacturer”, in relation to a health care product, means a person who manufactures or assembles the product;

“payments or other benefits” includes any payment or other benefit— wherever it is provided, whether or not it is of a financial nature, whether it is provided under a contract or otherwise, and whether it is provided directly or through a third party.

Regulations under section 92: enforcement

93

(1) Regulations under section 92(1) may make provision for the enforcement of requirements imposed by the regulations, including provision conferring on the Secretary of State the power to impose a financial penalty on a person who, without reasonable excuse—

(a) fails to comply with such a requirement, or

(b) provides information in response to such a requirement that is false or misleading to a material extent.

(2) The amount of the financial penalty is to be specified in, or determined in accordance with, the regulations.

(3) Regulations by virtue of subsection (1) must include provision—

(a) requiring the Secretary of State, before imposing a financial penalty on a person, to give the person written notice (a “notice of intent”) of the proposed financial penalty;

(b) ensuring that the person is given an opportunity to make representations about the proposed financial penalty;

(c) requiring the Secretary of State, after the period for making representations, to decide whether to impose the financial penalty;

(d) requiring the Secretary of State, if the Secretary of State decides to impose the financial penalty, to give the person notice in writing (a “final notice”) imposing the penalty;

(e) enabling a person on whom a financial penalty is imposed to appeal to a court or tribunal in accordance with the regulations;

(f) as to the powers of the court or tribunal on such an appeal.

(4) The provision that may be made by the regulations by virtue of subsection (1) includes provision—

(a) enabling a notice of intent or final notice to be withdrawn or amended;

(b) requiring the Secretary of State to withdraw a final notice in circumstances specified in the regulations;

(c) for a financial penalty to be increased by an amount specified in or determined in accordance with the regulations in the event of late payment;

(d) as to how financial penalties are recoverable.

94

(1) Before making regulations under section 92, the Secretary of State must—

(a) obtain the consent of the Scottish Ministers in relation to any provision which—

(i) would be within the legislative competence of the Scottish Parliament, if contained in an Act of that Parliament, and

(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence;

(b) obtain the consent of the Welsh Ministers in relation to any provision which—

(i) would be within the legislative competence of Senedd Cymru, if contained in an Act of the Senedd, and

(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence;

(i) would be within the legislative competence of the Northern Ireland Assembly, if contained in an Act of that Assembly, and

(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence.

(2) Consent is not required under subsection (1)(c) in relation to any provision if—

(a) a Bill for an Act of the Northern Ireland Assembly containing the provision would require the consent of the Secretary of State under section 8 of the Northern Ireland Act 1998, and

(b) the provision does not affect, other than incidentally, a transferred matter (within the meaning of that Act).

Information standards

95

(1) The Health and Social Care Act 2012 is amended as follows.

(2) In section 250 (information standards)—

(a) for subsection (2) substitute—

(2) For the purposes of this Part “an information standard” is a standard in relation to the processing of information. (2A) An information standard must specify to whom it applies. (2B) An information standard may apply to one or more persons falling within the following paragraphs— (a) the Secretary of State; (b) NHS England; (c) a public body which exercises functions in connection with the provision of health care or of adult social care in England; (d) any person, other than a public body, who is required to be registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 in respect of the carrying on of a regulated activity (within the meaning of Part 1 of that Act).

;

(b) in subsection (3), for “services” substitute “care”;

(d) for subsection (6) substitute—

(6) The Secretary of State must— (a) have regard to any information standard published by NHS England that applies to the Secretary of State, and (b) comply with any information standard published by the Secretary of State that applies to the Secretary of State. (6A) Any other person to whom an information standard published under this section applies must comply with the information standard, except in so far as the requirement to comply is waived (see subsection (6B)). (6B) Regulations may confer on a person who publishes an information standard the power to waive a person’s requirement to comply with the information standard (in whole or in part and generally or for a specific period). (6C) The regulations may include provision— (a) limiting the circumstances in which waivers may be granted; (b) setting out the procedure to be followed in connection with waivers; (c) requiring an information standard to include specified information about waivers. (6D) For enforcement of information standards against persons other than public bodies, see section 277E.

;

(e) in subsection (7)—

(i) at the appropriate place insert—

“health care” includes all forms of health care whether relating to physical or mental health and also includes procedures that are similar to forms of medical or surgical care but are not provided in connection with a medical condition;

;

(ii) omit the definition of “health services”.

(3) For section 251 substitute—

(251) (1) Regulations— (a) must make provision about the procedure to be followed in connection with the preparation and publication of information standards under section 250; (b) may require an information standard published under section 250 to be reviewed periodically in accordance with the regulations. (2) Before laying a draft of regulations under subsection (1) before either House of Parliament, the Secretary of State must consult such persons as the Secretary of State considers appropriate. (3) For the purposes of section 250 the Secretary of State or NHS England may adopt an information standard prepared or published by another person. (251ZA) (1) The Secretary of State may require a person to provide the Secretary of State with documents, records or other information for the purposes of monitoring the person’s compliance with information standards published under section 250. (2) A requirement under subsection (1) may specify— (a) the form and manner in which information is to be provided, and (b) when information is to be provided. (3) A requirement under subsection (1) must be in writing. (4) For enforcement of requirements under subsection (1) against persons other than public bodies, see section 277E.

(4) In section 251C (continuity of information: interpretation)—

(a) after subsection (6) insert—

(6A) “Health services” means services which must or may be provided as part of the health service in England; and for that purpose “the health service” has the same meaning as in the National Health Service Act 2006 (see section 275(1) of that Act).

;

(b) for subsection (7) substitute—

(7) “Adult social care” and “public body” have the same meaning as in section 250; and “processes and “processed” are to be read in accordance with the meaning of “processing” in that section.

(5) In section 304 (regulations etc), in subsection (5), before paragraph (k) insert—

(ja) regulations under section 250(6B) or 251(1) (regulations about waiver of information standards and the procedure for setting standards);

96

After section 251C of the Health and Social Care Act 2012 insert—

(251D) (1) A health or social care body may— (a) require another health or social care body to provide information, other than personal information, that relates only to its activities in connection with the provision of health services or adult social care in England; (b) require a private health or social care provider to provide information, other than personal information, that relates only to its activities in connection with the provision of health services, or adult social care in England, in pursuance of arrangements made with a public body. (2) A health or social care body may impose a requirement under subsection (1) only for purposes related to its functions in connection with the provision of health services or adult social care in England. (3) Regulations may create exceptions to subsection (1), which may be framed by reference to specified bodies or descriptions of bodies, descriptions of information or otherwise. (4) Subsection (1) does not require a person to process information so as to render it into a form in which it must be provided. (5) For enforcement of requirements under subsection (1)(b), see section 277E. (6) For the purposes of this section— - “adult social care” has the meaning given by section 250(7); - “health services” has the meaning given by section 251C(6A); - “health or social care body” means a public body which exercises functions in connection with the provision of health services or of adult social care in England; - “personal information” means information which is in a form that— identifies any individual, or enables the identity of any individual to be ascertained; - “private health or social care provider” means a person (other than a public body) who provides health services, or adult social care in England, pursuant to arrangements made with a health or social care body; - “public body” has the meaning given by section 250(7).

97

(1) The Health and Social Care Act 2012 is amended as follows.

(2) In section 253(1) (general duties of the Information Centre)—

(a) omit the “and” at the end of paragraph (ca);

(b) after paragraph (ca) insert—

(cb) the need to promote the effective and efficient planning, development and provision of health services and of adult social care in England,

;

, and (e) the need to balance the needs mentioned in this subsection against one another, so far as they compete.

(3) In section 261(1A) (other dissemination of information), for “the purposes of” substitute “purposes connected with”.

Collection of information from private health care providers

98

In section 259 of the Health and Social Care Act 2012 (powers to require and request provision of information), in subsection (1)—

(a) at the end of paragraph (a) omit “and”;

(b) for paragraph (b) substitute—

(aa) require any health care provider, not within paragraph (a), to provide the Centre with any information which the Centre considers it necessary or expedient to have for the purposes of complying with a direction of the Secretary of State under section 254, and (b) request any person to provide the Centre with any information which the Centre considers it necessary or expedient to have for the purposes of any function it exercises by virtue of this Chapter.

;

(d) omit subsection (4);

(e) in subsection (5), after “subsection (1)(a)” insert “or (aa)”;

(f) omit subsection (7);

(g) in subsection (9), after “subsection” insert “(1)(aa) or”;

(h) after subsection (10) insert—

(10A) For enforcement of requirements under subsection (1)(a) or (aa) against persons other than public bodies, see section 277E. (10B) In this section “health care provider” means a person who is required to be registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 in respect of the carrying on of a regulated activity (within the meaning of Part 1 of that Act) involving or connected with the provision of health care.

99

In Part 9 of the Health and Social Care Act 2012, after section 277 insert—

(277A) (1) The Secretary of State may require a relevant provider of adult social care services to provide the Secretary of State with information that relates to— (a) the person on whom the requirement is imposed, (b) their activities in connection with the provision of adult social care in England, or (c) any person to whom they have provided — (i) adult social care in England, or (ii) adult social care, outside England, in pursuance of arrangements made by an English local authority. (2) The Secretary of State may impose a requirement under subsection (1) only if the information is sought for purposes connected with the health care system, or adult social care system, in England. (3) A requirement under subsection (1) may specify— (a) the form and manner in which information is to be provided, and (b) when information is to be provided. (4) A requirement under subsection (1) must be in writing. (5) The provision of information under this section— (a) does not breach any obligation of confidence owed by the person providing it, but (b) is subject to any express restriction on disclosure imposed by any enactment (other than a restriction which allows disclosure if authorised by an enactment). (6) For enforcement of requirements under subsection (1), see section 277E. (7) In this section— - “adult social care”— includes all forms of personal care and other practical assistance provided for individuals who, by reason of age, illness, disability, pregnancy, childbirth, dependence on alcohol or drugs, or any other similar circumstances, are in need of such care or other assistance, but does not include anything provided by an establishment or agency for which Her Majesty’s Chief Inspector of Education, Children’s Services and Skills is the registration authority under section 5 of the Care Standards Act 2000; - “English local authority” means— a county council in England; a district council for an area in England for which there is no county council; a London borough council; the Common Council of the City of London (in its capacity as a local authority); - “relevant provider of adult social care services” means a person who is required to be registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 in respect of the carrying on of a regulated activity (within the meaning of Part 1 of that Act) involving or connected with the provision of adult social care. (277B) (1) Information provided under section 277A may not be disclosed by the Secretary of State except for purposes connected with the health care system, or adult social care system, in England. (2) Commercially sensitive information provided under section 277A may not be disclosed by the Secretary of State (even for the purposes mentioned in subsection (1)) unless the Secretary of State considers that the disclosure is appropriate, having taken into account the public interest as well as the interests of the person to whom the commercially sensitive information relates. (3) Subsections (1) and (2) do not restrict the disclosure of information where— (a) the person to whom the information relates has consented to the disclosure, (b) the information has previously been lawfully disclosed to the public, (c) the disclosure is in accordance with any court order, (d) the disclosure is necessary or expedient for the purposes of protecting the welfare of any individual, (e) the disclosure is made to any person in circumstances where it is necessary or expedient for the person to have the information for the purpose of exercising functions of that person conferred under or by virtue of any provision of this or any other Act, (f) the disclosure is in connection with the investigation of a criminal offence (whether or not in the United Kingdom), or (g) the disclosure is for the purpose of criminal proceedings (whether or not in the United Kingdom). (4) In this section “commercially sensitive information” means commercial information whose disclosure the Secretary of State thinks might significantly harm the legitimate business interests of the person to whom it relates. (277C) (1) The Secretary of State may direct the Health and Social Care Information Centre to exercise the functions of the Secretary of State under section 277A (and where a direction is given, section 277B applies accordingly). (2) The Secretary of State may direct a Special Health Authority performing functions only or mainly in respect of England to exercise the functions of the Secretary of State under section 277A (and where a direction is given, section 277B applies accordingly). (3) The Secretary of State may give directions to a body about the exercise of any functions that it is directed to exercise under subsection (1) or (2) (including directions as to the processing of information that the body obtains in exercising those functions). (277D) (1) The Secretary of State may make arrangements for any person prescribed by regulations under this subsection to exercise the functions of the Secretary of State under section 277A (and where arrangements are made, section 277B applies accordingly). (2) Arrangements under subsection (1) may— (a) provide for the Secretary of State to make payments to the person; (b) make provision as to the circumstances in which any such payments are to be repaid to the Secretary of State. (3) Section 304(9) (differential provision) applies in relation to the power to make arrangements under subsection (1) as it applies to a power of the Secretary of State to give directions under this Act.

Enforcement of duties against private providers

100

(1) The Health and Social Care Act 2012 is amended as follows.

(2) After section 277D (inserted by section 99 of this Act) insert—

(277E) (1) Regulations may make provision conferring on the Secretary of State the power to impose a financial penalty on a person, other than a public body, who without reasonable excuse— (a) fails to comply with an information standard (unless the requirement for the person to comply has been waived by virtue of regulations under section 250(6B)); (b) fails to comply with a requirement to provide information imposed under section 251ZA(1), 251D (1)(b), 259(1)(a) or (aa) or 277A(1); (c) provides information in response to such a requirement that is false or misleading to a material extent. (2) The amount of the financial penalty is to be specified in, or determined in accordance with, the regulations. (3) The regulations must include provision— (a) requiring the Secretary of State, before imposing a financial penalty on a person, to give the person written notice (a “notice of intent”) of the proposed financial penalty; (b) ensuring that the person is given an opportunity to make representations about the proposed financial penalty; (c) requiring the Secretary of State, after the period for making representations, to decide whether to impose the financial penalty; (d) requiring the Secretary of State, if the Secretary of State decides to impose the financial penalty, to give the person notice in writing (a “final notice”) imposing the penalty; (e) enabling a person on whom a financial penalty is imposed to appeal to the First-tier Tribunal in accordance with the regulations; (f) as to the powers of the Tribunal on such an appeal. (4) The provision that may be made by the regulations includes provision— (a) enabling a notice of intent or final notice to be withdrawn or amended; (b) requiring the Secretary of State to withdraw a final notice in circumstances specified in the regulations; (c) for a financial penalty to be increased by an amount specified in or determined in accordance with the regulations in the event of late payment; (d) for the recovery of financial penalties in the county court. (5) In this section “public body” has the meaning given by section 250(7). (277F) The Secretary of State may— (a) direct a Special Health Authority performing functions only or mainly in respect of England to exercise the functions of the Secretary of State under regulations made under section 277E; (b) give the Special Health Authority directions about the exercise of those functions (including directions as to the processing of information that the body obtains in exercising those functions).

(3) In section 304 (regulations etc), in subsection (5), after paragraph (ja) (inserted by section 95 of this Act) insert—

(jb) regulations under section 277E (regulations about enforcement);

Medicine information systems

101

(1) The Medicines and Medical Devices Act 2021 is amended in accordance with subsections (2) to (9).

(2) In Part 2, for the heading of Chapter 1 substitute “Regulations: general”.

(3) After that Chapter insert—

(7A) (1) The appropriate authority may by regulations make provision about the establishment and operation by the Health and Social Care Information Centre (“the Information Centre”) of one or more information systems for purposes relating to— (a) the safety of human medicines, including the safety of clinical decisions relating to human medicines; (b) the quality and efficacy of human medicines. (2) The regulations may (among other things) make provision— (a) about the information in relation to human medicines which may or must be entered or retained in an information system established under subsection (1); (b) requiring information to be provided to the Information Centre for the purposes of its functions under the regulations; (c) about the use or disclosure of information contained in an information system established under subsection (1); (d) requiring the Information Centre to have regard to specified matters in exercising its functions under the regulations. (3) The provision mentioned in subsection (2)(a) and (b) may relate to— (a) information for specified purposes, (b) information that the Information Centre considers it necessary or expedient to have for the purposes of its functions under the regulations, (c) information (including information relating to individuals) which is of a specified description, or (d) information (including information relating to individuals) which is of a description set out in a direction in writing given by the appropriate authority. (4) The provision mentioned in subsection (2)(b) may include provision— (a) requiring, or enabling the Information Centre to require, specified persons or descriptions of persons to whom subsection (5) applies to provide information to the Information Centre; (b) about the manner in which, and the time at which, those persons must provide information, or for those matters to be determined by the Information Centre; (c) about any procedural steps the Information Centre must follow in requiring a person to provide information to it; (d) requiring specified persons or descriptions of persons to whom subsection (5) applies to record or retain information which they are, or may be, required to provide to the Information Centre under the regulations; (e) in relation to the enforcement of any requirement imposed by or under the regulations. (5) This subsection applies to any person who provides services, or exercises any powers or duties, relating to— (a) human medicines, (b) health, or (c) education. (6) The provision mentioned in subsection (2)(c) may include provision about— (a) the analysis by the Information Centre of information that is contained in an information system (whether alone or in combination with other information) for the purposes mentioned in subsection (1) or for other purposes; (b) the publication by the Information Centre of information that is contained in an information system or has been analysed in combination with such information; (c) the disclosure (other than by way of publication) of information mentioned in paragraph (b) to specified persons or descriptions of persons, or for specified purposes; (d) the use or further disclosure by any person of information disclosed to them under the regulations. (7) Regulations conferring on the appropriate authority a power to give a direction by virtue of subsection (3)(d) must — (a) provide that the power includes power to vary or revoke the directions by a subsequent direction, and (b) in the case of a power exercisable in relation to Wales or Scotland, require the Secretary of State— (i) where a proposed direction relates to Wales, to consult the Welsh Ministers before giving it, and (ii) where a proposed direction relates to Scotland, to consult the Scottish Ministers before giving it. (8) Where regulations under subsection (1) include provision by virtue of subsection (4)(a) which requires, or enables the Information Centre to require, the provision of individual health information held for the purposes of the health service established under section 1 of the National Health Service (Scotland) Act 1978, the regulations must provide for the information to be collected by the Scottish Ministers, or a person designated by them, on behalf of the Information Centre, subject to specified exceptions. (9) Regulations by virtue of subsection (8) may— (a) confer powers or duties (including discretions) on the Scottish Ministers, a designated person or the Information Centre; (b) provide for powers or duties conferred on the Scottish Ministers to be treated for the purposes of section 2 of the National Health Service (Scotland) Act 1978 as functions relating to the health service (within the meaning of that Act). (10) Where regulations under subsection (1) include provision by virtue of subsection (4)(a) which requires, or enables the Information Centre to require, the provision of individual health information held for the purposes of the health service in Wales, the regulations must provide for the information to be collected by the Welsh Ministers, or a person designated by them, on behalf of the Information Centre, subject to specified exceptions. (11) Regulations by virtue of subsection (10) may confer powers or duties (including discretions) on the Welsh Ministers, a designated person or the Information Centre. (12) Regulations under subsection (1) may provide that the disclosure of information by virtue of this section does not breach— (a) an obligation of confidence owed by the person making the disclosure, or (b) any other restriction on the disclosure of the information (however imposed), other than a restriction imposed by the data protection legislation. (13) In this section— - “data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018; - “health service”, in relation to Wales, has the meaning given by section 206(1) of the National Health Service (Wales) Act 2006; - “human medicine” has the same meaning as in Part 2 (see section 9); - “individual health information” means information (however recorded) which relates to— the physical or mental health or condition of an individual, the diagnosis of an individual’s condition, or an individual’s care or treatment, or is (to any extent) derived directly or indirectly from information relating to any of those matters; - “specified” means specified in regulations under subsection (1). (7B) (1) A person to whom information is disclosed under regulations under section 7A (1) commits an offence if the person uses or discloses that information in contravention of the regulations. (2) A person guilty of an offence under this section is liable— (a) on summary conviction in England and Wales, to imprisonment for a term not exceeding 51 weeks, to a fine or to both; (b) on summary conviction in Scotland or Northern Ireland, to imprisonment for a term not exceeding 6 months, to a fine not exceeding level 5 on the standard scale or to both. (3) In relation to an offence committed before the coming into force of section 281(5) of the Criminal Justice Act 2003, the reference in subsection (2)(a) to 51 weeks is to be read as a reference to 6 months.

(4) In section 19 (medical devices: information systems)—

(a) in subsection (6)—

(i) in paragraph (b) for “contained in an information system” substitute “that is contained in an information system or has been analysed in combination with such information”;

(ii) in paragraph (c) for “contained in an information system” substitute “mentioned in paragraph (b)”;

(b) after subsection (7) insert—

(7A) Regulations under this section may provide that the disclosure of information by virtue of this section does not breach— (a) an obligation of confidence owed by the person making the disclosure, or (b) any other restriction on the disclosure of the information (however imposed), other than a restriction imposed by the data protection legislation.

(5) In section 43 (power to make consequential etc provision)—

(a) in subsection (1), for “This section” substitute “Subsection (2)”;

(b) after subsection (2) insert—

(3) Provision made by regulations under section 7A or 19 by virtue of subsection (2)(a) may include provision— (a) changing the territorial extent of provisions of Chapter 2 of Part 9 of the Health and Social Care Act 2012 (constitution and functions etc of the Health and Social Care Information Centre), or (b) otherwise amending that Chapter.

(6) In section 44 (scope of powers of Northern Ireland departments) after “2(1)” insert “, 7A(1)”.

(7) In section 45 (consultation)—

(a) after subsection (1) insert—

(1A) In relation to proposed regulations under section 7A(1), the Secretary of State must— (a) where the regulations relate to Wales, specifically consult the Welsh Ministers, and (b) where the regulations relate to Scotland, specifically consult the Scottish Ministers.

;

(b) in subsection (6), for paragraph (a) (but not the “and” at the end) substitute—

(a) in relation to regulations made under section 2(1) or 7A(1), the appropriate authority within the meaning given by section 2(6), (aa) in relation to regulations made under section 10(1), the appropriate authority within the meaning given by section 10(6),

(8) In section 46 (reporting requirements)—

(a) in subsections (1), (3)(b) and (4)(a), after “2(1),” insert “7A(1),”;

(b) in subsection (5), in paragraphs (a) and (b) of the definition of “relevant authority”, after “2(1)” insert “, 7A(1)”.

(9) In section 47 (procedure for regulations), in subsection (2), after “2(1)” insert “, 7A(1)”.

(10) In section 253 of the Health and Social Care Act 2012 (general duties of Information Centre), after subsection (2) insert—

(2A) Subsections (1) and (2) do not apply in relation to the functions of the Information Centre by virtue of the Medicines and Medical Devices Act 2021.

PART 3 — Secretary of State's powers to transfer or delegate functions

Relevant bodies and Special Health Authorities

102

In this Part—

“relevant body” means— Health Education England, the Health and Social Care Information Centre, the Health Research Authority, the Human Fertilisation and Embryology Authority, the Human Tissue Authority, or NHS England;

“Special Health Authority” means a Special Health Authority established under section 28 of the National Health Service Act 2006.

Power to transfer functions between bodies

103

(1) The Secretary of State may by regulations transfer a function of a relevant body to another relevant body.

(2) Regulations under this section may be made only if the Secretary of State considers that they serve the purpose of improving the exercise of public functions, having regard to—

(a) efficiency,

(b) effectiveness,

(d) securing appropriate accountability to Ministers.

(3) Regulations under this section may not transfer a function of NHS England if the Secretary of State considers that to do so would make NHS England redundant.

(4) The provision which may be made by regulations under this section by virtue of section 183(1)(a) includes provision—

(a) modifying functions of either relevant body (see further section 105(1));

(b) modifying the constitutional or funding arrangements of either relevant body (see further section 105(2) and (3));

(c) abolishing the relevant body from which functions are transferred, where the Secretary of State considers that it is redundant as a result of the transfer of functions.

(5) Where—

(a) regulations under this section contain provision for a body to exercise a function that is exercisable in relation to Scotland, Wales or Northern Ireland,

(b) immediately before that provision takes effect, the function is exercisable by another body whose constitutional arrangements contain provision (however expressed) for the body to include a member whose experience, functions or appointment are connected with that part of the United Kingdom, and

(c) the Secretary of State considers that the constitutional arrangements of the body referred to in paragraph (a) do not contain corresponding provision as to membership,

the Secretary of State must make provision by virtue of section 183(1)(a) modifying the constitutional arrangements of the body referred to in paragraph (a) so that they contain corresponding provision as to membership.

(6) In this section, “Minister” means a Minister of the Crown (as defined by section 8 of the Ministers of the Crown Act 1975).

Power to provide for exercise of functions of Secretary of State

104

(1) The Secretary of State may by regulations provide for a relevant body to exercise specified functions of the Secretary of State on behalf of the Secretary of State.

(2) The functions that may be specified are —

(a) any functions of the Secretary of State which relate to the health service in England;

(b) any other functions that the Secretary of State may provide for a Special Health Authority to exercise.

(3) The provision which may be made by regulations under this section by virtue of section 183(1)(a) includes provision—

(a) modifying functions of the relevant body (see further section 105(1));

(b) modifying the constitutional or funding arrangements of the relevant body (see further section 105(2) and (3)).

(4) Where—

(a) regulations under this section contain provision for a relevant body to exercise a function of the Secretary of State that is exercisable in relation to Scotland, Wales or Northern Ireland,

(b) immediately before that provision takes effect, the Secretary of State’s function is exercisable by a body whose constitutional arrangements contain provision (however expressed) for the body to include a member whose experience, functions or appointment are connected with that part of the United Kingdom, and

(c) the Secretary of State considers that the relevant body’s constitutional arrangements do not contain corresponding provision as to membership,

the Secretary of State must make provision by virtue of section 183(1)(a) modifying the relevant body’s constitutional arrangements so that they contain corresponding provision as to membership.

(5) Regulations under this section may make provision for determining whether and in what circumstances the Secretary of State or a relevant body is liable for the exercise of the specified functions by the relevant body.

(6) The specification of a function in regulations under this section does not preclude the Secretary of State from exercising the function.

(7) In this section “the health service” has the same meaning as in the National Health Service Act 2006 (see section 275(1) of that Act).

Scope of powers

105

(1) In sections 103 and 104, references to modifying the functions of a body include—

(a) conferring a function on the body;

(b) abolishing a function of the body;

(d) changing the conditions under which the body exercises a function.

(2) In sections 103 and 104, references to the constitutional arrangements of a body include matters relating to—

(a) the name of the body;

(b) the chair of the body (including qualifications and procedures for appointment and functions);

(d) staff of the body exercising functions on its behalf (including qualifications and procedures for appointment and functions);

(e) the body’s powers to employ staff;

(f) governing procedures and arrangements (including the role and membership of committees and sub-committees);

(g) reports and accounts.

(3) In sections 103 and 104, references to modifying the funding arrangements of a body include—

(a) modifying the extent to which it is funded by a Minister;

(b) conferring power on the body to charge fees for the exercise of a function (and to determine their amount).

(4) Regulations under section 103 or 104 may repeal and re-enact (but may not create)—

(a) a power to make subordinate legislation,

(b) a power of forcible entry, search or seizure,

(d) a criminal offence.

(5) The provision which may be made by regulations under section 103 or 104 may be made by repealing, revoking or amending provision made by or under an Act, whenever passed or made.

(6) The provision which may be made by regulations under section 103 or 104 by virtue of section 183(1)(a) includes provision repealing, revoking or amending provision made by or under any of the following, whenever passed or made—

(a) an Act;

(b) an Act of the Scottish Parliament;

(d) Northern Ireland legislation.

(7) In this section, “Minister” means a Minister of the Crown (as defined by section 8 of the Ministers of the Crown Act 1975).

Transfer schemes in connection with regulations

106

(1) The Secretary of State may, in connection with regulations under section 103 or 104, make one or more schemes for the transfer of property, rights and liabilities (“transfer schemes”).

(2) A transfer scheme in connection with regulations under section 103 may provide for the transfer of property, rights or liabilities to any appropriate person from the relevant body from which functions are transferred by the regulations.

(3) A transfer scheme in connection with regulations under section 104 may provide for the transfer of property, rights or liabilities to any appropriate person from—

(a) the Secretary of State,

(b) a Special Health Authority, or

(4) The things that may be transferred under a transfer scheme include—

(a) property, rights and liabilities that could not otherwise be transferred;

(b) property acquired, and rights and liabilities arising, after the making of the scheme;

(5) A transfer scheme may—

(a) create rights, or impose liabilities, in relation to property or rights transferred;

(b) make provision about the continuing effect of things done by, on behalf of or in relation to the transferor in respect of anything transferred;

(c) make provision about the continuation of things (including legal proceedings) in the process of being done by, on behalf of or in relation to the transferor in respect of anything transferred;

(d) make provision for references to the transferor in an instrument or other document in respect of anything transferred to be treated as references to the transferee;

(e) make provision for the shared ownership or use of property;

(f) make provision which is the same as or similar to the TUPE regulations;

(g) make other consequential, supplementary, incidental or transitional provision.

(6) A transfer scheme may provide—

(a) for modifications by agreement;

(b) for modifications to have effect from the date when the original scheme came into effect.

(7) In subsection (5)(f), “the TUPE regulations” means the Transfer of Undertakings (Protection of Employment) Regulations 2006 (S.I. 2006/246).

(8) For the purposes of this section—

(a) references to rights and liabilities include rights and liabilities relating to a contract of employment;

(b) references to the transfer of property include the grant of a lease.

(9) For the purposes of subsection (8)(a)—

(a) an individual who holds employment in the civil service of the State is to be treated as employed by virtue of a contract of employment, and

(b) the terms of the individual’s employment in the civil service of the State are to be treated as constituting the terms of the contract of employment.

(10) In this section “appropriate person” means—

(a) any relevant body,

(b) the Secretary of State,

(d) a Special Health Authority, or

(e) an NHS trust established under section 25 of the National Health Service Act 2006.

Transfer schemes: taxation

107

(1) The Treasury may by regulations make provision varying the way in which a relevant tax has effect in relation to—

(a) anything transferred under a scheme under section 106, or

(b) anything done for the purposes of, or in relation to, a transfer under such a scheme.

(2) The provision which may be made under subsection (1)(a) includes in particular provision for—

(a) a tax provision not to apply, or to apply with modifications, in relation to anything transferred;

(b) anything transferred to be treated in a specified way for the purposes of a tax provision;

(c) the Secretary of State to be required or permitted to determine, or specify the method for determining, anything which needs to be determined for the purposes of any tax provision so far as relating to anything transferred.

(3) The provision which may be made under subsection (1)(b) includes in particular provision for—

(a) a tax provision not to apply, or to apply with modifications, in relation to anything done for the purposes of or in relation to the transfer;

(b) anything done for the purposes of, or in relation to, the transfer to have or not have a specified consequence or be treated in a specified way;

(c) the Secretary of State to be required or permitted to determine, or specify the method for determining, anything which needs to be determined for the purposes of any tax provision so far as relating to anything done for the purposes of, or in relation to, the transfer.

(4) Regulations under this section are subject to annulment in pursuance of a resolution of the House of Commons.

(5) In this section references to the transfer of property include the grant of a lease.

(6) In this section—

“relevant tax” means income tax, corporation tax, capital gains tax, value added tax, stamp duty or stamp duty reserve tax;

“tax provision” means a provision of an enactment about a relevant tax.

108

(1) Before making regulations under section 103 or 104, the Secretary of State must—

(a) obtain the consent of the Scottish Ministers in relation to any provision—

(i) which would be within the legislative competence of the Scottish Parliament, if contained in an Act of that Parliament, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or

(ii) which modifies the functions of the Scottish Ministers;

(b) obtain the consent of the Welsh Ministers in relation to any provision—

(i) which would be within the legislative competence of Senedd Cymru, if contained in an Act of the Senedd, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or

(ii) which modifies the functions of the Welsh Ministers;

(i) which would be within the legislative competence of the Northern Ireland Assembly, if contained in an Act of that Assembly, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or

(ii) which modifies the functions of a Northern Ireland department.

(2) Consent is not required under subsection (1)(c)(i) in relation to any provision if—

(a) a Bill for an Act of the Northern Ireland Assembly containing the provision would require the consent of the Secretary of State under section 8 of the Northern Ireland Act 1998, and

(b) the provision does not affect, other than incidentally, a transferred matter (within the meaning of that Act).

(3) Before making regulations under section 103 or 104, the Secretary of State must consult the following about a draft of the regulations—

(a) any body to which the regulations relate, and

(b) such other persons as the Secretary of State considers appropriate.

(4) If, as a result of consultation under this section, it appears to the Secretary of State appropriate to change the draft regulations, the Secretary of State must carry out such further consultation with respect to the changes as the Secretary of State considers appropriate.

(5) It is immaterial for the purposes of this section whether consent is obtained or consultation is carried out before or after the commencement of this section.

PART 4 — The Health Services Safety Investigations Body

Introductory

Establishment of the HSSIB

109

(1) A body corporate called the Health Services Safety Investigations Body is established.

(2) In this Part that body is referred to as “the HSSIB”.

(3) Schedule 13 contains further provision about the HSSIB.

Investigations

Investigation of incidents with safety implications

110

(1) The HSSIB has the function of investigating incidents that—

(a) occur in England during the provision of health care services, and

(b) have or may have implications for the safety of patients.

(2) The purpose of the investigations is to—

(a) identify risks to the safety of patients, and

(b) address those risks by facilitating the improvement of systems and practices in the provision of NHS services or other health care services in England.

(3) In particular, where an investigation relates to an incident that did not occur during the provision of NHS services, the HSSIB must consider whether, in relation to any risks identified, the systems and practices in the provision of NHS services could be improved.

(4) The purpose of the investigations does not include assessing or determining—

(a) blame,

(b) civil or criminal liability, or

(5) In this Part, an incident within subsection (1) is called a “qualifying incident”.

Deciding which incidents to investigate

111

(1) The HSSIB’s function under section 110 includes determining which qualifying incidents it will investigate, subject to subsection (2).

(2) The Secretary of State may direct the HSSIB to carry out an investigation of—

(a) a particular qualifying incident that has occurred, or

(b) qualifying incidents that have occurred and are of a particular description.

(3) A direction under subsection (2) may specify the date by which the HSSIB must publish its final report (see section 113).

(4) A direction under subsection (2)—

(a) must be in writing;

(b) may be varied or revoked by subsequent directions;

(5) Once the HSSIB has begun an investigation into a qualifying incident, it must, in such manner as it thinks appropriate, publish a statement which—

(a) reports that it has begun the investigation,

(b) contains a brief description of the incident, and

(6) The HSSIB may give advance notice of a statement under subsection (5) to any person the HSSIB considers may be affected by the investigation.

(7) Where the HSSIB discontinues an investigation, it must, in such manner as it thinks appropriate, publish a statement which—

(a) reports that it has discontinued the investigation, and

(b) gives its reasons for doing so.

(8) Where the HSSIB determines not to investigate a qualifying incident, it may give notice of its determination to any person the HSSIB considers to have an interest in the determination.

(9) Notice under subsection (8) may include—

(a) a brief description of the incident, and

(b) the HSSIB’s reasons for not investigating it.

Criteria, principles and processes

112

(1) The HSSIB must determine and publish—

(a) the criteria it will use in determining which incidents it investigates,

(b) the principles which are to govern investigations,

(d) the processes for ensuring that, so far as reasonable and practicable, patients and their families are involved in investigations.

(2) The processes determined under subsection (1)(c) must include—

(a) the procedures and methods to be used in investigations (including in the interviewing of persons), and

(b) the time periods within which the HSSIB aims to complete investigations.

(3) Different processes under subsection (1)(c) or (d) may be determined for different descriptions of investigation.

(4) Anything published under subsection (1)(d) must be—

(a) easily accessible to patients and their families, and

(b) capable of being easily understood by them.

(5) The HSSIB must review the criteria, principles and processes—

(a) within the period of three years beginning with their publication under subsection (1), and

(b) subsequently within each period of five years beginning with the completion of the previous review.

(6) If the HSSIB revises the criteria, principles and processes it must publish them as revised.

(7) In determining or revising the criteria, principles and processes the HSSIB must consult—

(a) the Secretary of State, and

(b) any other persons the HSSIB considers appropriate.

Reports

Final reports

113

(1) When the HSSIB completes an investigation, it must publish a report on the outcome of the investigation (the “final report”).

(2) The final report must—

(a) contain a statement of findings of fact made as a result of the investigation and an analysis of those findings,

(b) make such recommendations as to the action to be taken by any person as the HSSIB considers appropriate, and

(c) set out the HSSIB’s conclusions on the matters it considered in accordance with section 110(3) (but only if that provision is applicable to the investigation).

(3) The final report must focus on ascertaining risks to the safety of patients and any recommendations as to the action to be taken by any person must focus on addressing those risks (rather than on the activities of individuals involved in the incident).

(4) In particular, the final report may not include an assessment or determination of—

(a) blame,

(b) civil or criminal liability, or

(5) Information which is protected material (see section 122(2)) may be disclosed in a final report if the HSSIB determines that the benefits to the safety of patients served by the disclosure outweigh—

(a) any adverse impact on current or future investigations by deterring persons from providing information to the HSSIB, and

(b) any adverse impact on securing the improvement of the safety of health care services provided to patients in England.

(6) The final report may not, without their consent, include the name of any individual—

(a) who has provided information to the HSSIB for the purposes of the investigation, or

(b) who was involved in the incident being investigated.

(7) Where an investigation is carried out pursuant to a direction under section 111, the HSSIB must send a copy of the final report to the Secretary of State.

Interim reports

114

(1) While the HSSIB is carrying out an investigation, it may publish a report on any matter relating to the investigation (an “interim report”).

(2) An interim report may—

(a) contain a statement of findings of fact made as a result of the investigation to date and an analysis of those findings,

(b) make such recommendations as to the action to be taken by any person as the HSSIB considers appropriate, and

(3) Subsections (3) to (7) of section 113 apply in relation to an interim report as they apply in relation to a final report.

Draft reports

115

(1) Before it publishes a final or interim report, the HSSIB—

(a) must send a draft of the report to any person who the HSSIB reasonably believes could be adversely affected by the report, and

(b) may send a draft of the report to any other person who the HSSIB believes should be sent a draft.

(2) If a person who the HSSIB reasonably believes could have been adversely affected by the report has died, the draft report must be sent to the person (if any) who appears to the HSSIB to best represent the interests of the person who has died.

(3) The HSSIB must notify every person to whom a draft report is sent that the person has an opportunity to comment on the draft report before the deadline specified by the HSSIB.

(4) If a person’s comments on a draft report are not taken into account in the final or interim report as published, the HSSIB must explain to the person why that is.

Response to reports

116

(1) This section applies where a final or interim report includes recommendations as to the action to be taken by any person.

(2) The HSSIB must, in such manner as it thinks appropriate, send the report to that person or make it available to them.

(3) The report must specify the deadline for that person to provide a written response.

(4) Before that deadline, the person must respond to the HSSIB in writing setting out the actions they propose to take in pursuance of the recommendations.

(5) The HSSIB may publish the response.

(6) Subsection (4) does not require a person to do anything that they could be required to do by an Act of Senedd Cymru made without the consent of a Minister of the Crown.

Admissibility of reports

117

(1) A final report, an interim report and the draft of a final or interim report sent to a person under section 115 are not admissible in any proceedings within subsection (2).

(2) Those proceedings are—

(a) proceedings to determine civil or criminal liability in respect of any matter;

(b) proceedings before any employment tribunal;

(d) proceedings to determine an appeal against a decision made in proceedings falling within paragraphs (a) to (c).

(3) But the High Court may order that a final or interim report is admissible in proceedings within subsection (2) on an application by a person who is a party to the proceedings or otherwise entitled to appear in them.

(4) The HSSIB may make representations to the High Court about any application under subsection (3).

(5) The High Court may make an order under subsection (3) only if it determines that the interests of justice served by admitting the report outweigh—

(a) any adverse impact on current or future investigations by deterring persons from providing information for the purposes of investigations, and

(b) any adverse impact on securing the improvement of the safety of health care services provided to patients in England.

Investigatory powers etc

Powers of entry, inspection and seizure

118

(1) If an investigator considers it necessary for the purposes of an investigation, the investigator may—

(a) enter and inspect premises in England, other than premises used wholly or mainly as a private dwelling;

(b) inspect and take copies of any document at, or capable of being viewed using equipment at, the premises;

(d) seize and remove from the premises any document, equipment or other item (unless that would risk the safety of any patient).

(2) In subsection (1)(b) the reference to inspecting and taking copies of any document includes requiring any document which is kept in electronic form to be produced in a form in which it is legible and can be taken away.

(3) Where any document, equipment or other item is seized by an investigator, or any copy of a document is taken, it may be retained by the HSSIB for so long as is necessary for the purposes of the investigation.

(4) An investigator exercising any power conferred by this section must, if asked, produce evidence of the investigator’s authority from the HSSIB to act on its behalf.

(5) The powers conferred by subsection (1) may be exercised in relation to premises in which there is a Crown interest, but only if the HSSIB gives reasonable notice to the occupier of the premises of its intention to enter and inspect the premises.

(6) But if the Secretary of State certifies that it appears to the Secretary of State appropriate in the interests of national security that the powers conferred by subsection (1)—

(a) should not be exercisable in relation to any premises in which there is a Crown interest and which are specified in the certificate, or

(b) should not be exercisable in relation to any such premises which are so specified except in circumstances specified in the certificate,

those powers are not exercisable in relation to those premises or (as the case may be) are not exercisable except in the circumstances specified.

(7) In this section “Crown interest” means—

(a) an interest belonging to a government department or held in trust for Her Majesty for the purposes of a government department;

(b) an interest belonging to Her Majesty in right of the Crown;

(d) an interest belonging to the Duchy of Cornwall.

Powers to require information etc

119

(1) An investigator may by notice require any person—

(a) to attend at a specified time and place and to provide information by answering questions;

(b) to provide specified information, or information of a specified description, by a specified date;

(c) to provide specified documents, equipment or items, or documents, equipment or items of a specified description, by a specified date.

(2) An investigator may give a person a notice only if the investigator reasonably believes that—

(a) in the case of a requirement under subsection (1)(a), the person is able to provide information which is necessary for the purposes of an investigation;

(b) in the case of a requirement under subsection (1)(b)—

(i) it is necessary to obtain the information for the purposes of an investigation, and

(ii) the person is able to provide it;

(i) it is necessary to obtain the document, equipment or other item for the purposes of the HSSIB’s investigation function, and

(ii) the person is able to provide it.

(3) But a person is not required by virtue of subsection (1) to provide any information, document, equipment or other item where—

(a) its provision would risk the safety of any patient,

(b) its provision might incriminate the person, or

(c) in the case of information or a document, the person would be entitled to refuse to provide it in any proceedings in any court on the grounds that it is the subject of legal professional privilege.

(4) A notice must—

(a) specify the grounds for the investigator believing the matters in subsection (2),

(b) give an explanation of the consequences of failing to comply with the notice (see section 121), and

(5) If a notice requires a person to provide anything which is kept in electronic form, the notice may require it to be provided in a form in which it is legible.

(6) An investigator may withdraw a notice under subsection (1) by giving notice of withdrawal to the person to whom the notice was given.

(7) Where any document, equipment or other item is provided to an investigator pursuant to a notice, it may be retained by the HSSIB for so long as is necessary for the purposes of the HSSIB’s investigation function, unless its retention would risk the safety of any patient.

(8) Where a person attends to answer questions pursuant to a notice under subsection (1)(a), the HSSIB—

(a) must reimburse the person the reasonable costs incurred in attending;

(b) may record, by any means, the answers given.

(9) In this section “specified” means specified in the notice.

Voluntary provision of information etc

120

A person may disclose any information, document, equipment or other item to the HSSIB if the person reasonably believes that the disclosure is necessary for the purpose of enabling the HSSIB to carry out its investigation function.

Offences relating to investigations

121

(1) A person commits an offence if the person—

(a) intentionally obstructs an investigator in the performance of functions conferred by section 118, or

(b) fails without reasonable excuse to comply with a notice given under section 119.

(2) A person commits an offence if the person provides information to the HSSIB for the purposes of the HSSIB’s investigation function which the person knows or suspects is false or misleading in a material respect.

(3) It is a defence for a person charged with an offence under subsection (2) to show that—

(a) the person reasonably believed that the information would assist the HSSIB in carrying out its investigation function, and

(b) at the time of providing the information the person informed the HSSIB that the person knew or suspected that it was false or misleading.

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