(1) After section 72 of the National Health Service Act 2006 insert—
NHS trusts and foundation trusts: exemption from merger legislation
Exemption from Part 3 of the Enterprise Act 2002
72A (1) For the purposes of Part 3 of the Enterprise Act 2002 (mergers), a relevant merger situation is not to be treated as having been created where two or more relevant NHS enterprises cease to be distinct enterprises.
(2) But subsection (1) does not apply to a case where two or more relevant NHS enterprises and one or more enterprises that are not relevant NHS enterprises cease to be distinct enterprises.
(3) In this section “relevant NHS enterprise” means the activities, or part of the activities, of—
(a) an NHS trust established under section 25;
(b) an NHS foundation trust.
(2) Omit section 79 of the Health and Social Care Act 2012 (competition: mergers involving NHS foundation trusts).
84 Removal of functions relating to competition etc
(1) Omit sections 72 and 73 of the Health and Social Care Act 2012 (Monitor and CMA: concurrent functions).
(2) Schedule 12 contains consequential amendments.
(1) The Health and Social Care Act 2012 is amended as follows.
(2) In section 95 (licensing: special conditions), in subsection (1)—
(a) in paragraph (a), omit “with the consent of the applicant,”;
(b) in paragraph (b), omit “with the consent of the licence holder,”.
(3) In section 100 (modification of standard conditions)—
(a) omit subsections (6) to (9);
(b) in subsection (11) omit “and section 101”.
(4) Omit section 101 (modification references to the CMA).
(5) In section 103 (standard condition as to transparency of certain criteria), in subsection (3)—
(a) in paragraph (a), for “the powers conferred on Monitor by sections 100, 101(7) and paragraph 7(2) of Schedule 10” substitute “the power conferred on NHS England by section 100”;
(b) omit paragraph (b) but not the “and” at the end.
(6) In section 141 (levy on providers: consultation), in subsection (8), omit “and section 142”.
(7) Omit section 142 (levy on providers: responses to consultation).
(8) In section 304 (regulations, orders and directions), in subsection (5), omit paragraphs (d) and (j).
(9) Omit Schedule 10 (references by Monitor to the CMA).
86 Special Health Authorities: removal of 3 year limit
(1) In the National Health Service Act 2006—
(a) omit section 28A (three year limit for special health authorities);
(b) in section 272(6), omit paragraph (zc).
(2) In the NHS Counter Fraud (Establishment, Constitution, and Staff and Other Transfer Provisions) Order 2017 (S.I. 2017/958)—
(a) in article 2, omit the definition of “the abolition date”;
(b) omit Part 4 (including Schedule 3) (abolition of the authority).
(3) In consequence of subsection (1), in the Health and Social Care Act 2012, omit section 48.
87 Tidying up etc provisions about accounts of certain NHS bodies
(1) After section 29 of the National Health Service Act 2006 insert—
Special Health Authorities: accounts and audit
29A (1) In this section a reference to a Special Health Authority is to a Special Health Authority which—
(a) performs functions only or mainly in respect of England, or
(b) neither performs functions only or mainly in respect of England, nor performs functions only or mainly in respect of Wales.
(2) A Special Health Authority must keep proper accounts and proper records in relation to the accounts.
(3) The Secretary of State may give a Special Health Authority directions as to the form in which its accounts must be kept.
(4) A Special Health Authority must prepare, in respect of each financial year, annual accounts in such form as the Secretary of State may direct.
(5) A Special Health Authority must send copies of any annual accounts prepared by it under subsection (4)—
(a) to the Secretary of State, by such date as the Secretary of State may direct, and
(b) to the Comptroller and Auditor General, as soon as is reasonably practicable following the end of the financial year in question.
(6) The Comptroller and Auditor General must examine, certify and report on the annual accounts.
(7) The Special Health Authority must lay before Parliament—
(a) a copy of the annual accounts, and
(b) the Comptroller and Auditor General’s report on them.
(8) Nothing in subsection (2) requires any annual accounts prepared by a Special Health Authority to include matters relating to a charitable trust of which it is a trustee.
(9) Nothing in subsection (4) has effect in relation to accounts relating to a charitable trust of which the Special Health Authority is a trustee.
(2) In Schedule 4 to that Act (NHS trusts), after paragraph 11 insert—
Accounts and audit
11A (1) An NHS trust must keep proper accounts and proper records in relation to the accounts.
(2) The Secretary of State may give an NHS trust directions as to the form in which its accounts must be kept.
(3) An NHS trust must prepare, in respect of each financial year, annual accounts in such form as the Secretary of State may direct.
(4) For the audit of the annual accounts, see the Local Audit and Accountability Act 2014 (and, in particular, section 4 of that Act).
(5) The Comptroller and Auditor General may examine—
(a) the annual accounts and any records relating to them, and
(b) any report on them by the auditor or auditors.
(6) An NHS trust must send a copy of its audited annual accounts to NHS England by such date as NHS England may direct.
(7) Nothing in sub-paragraph (1) has effect in relation to accounts relating to a charitable trust of which an NHS trust is a trustee.
(8) Nothing in sub-paragraph (3) requires any accounts prepared by an NHS trust to include matters relating to a charitable trust of which it is a trustee.
(3) In consequence of subsections (1) and (2)—
(a) in section 6(3)(b) of the National Audit Act 1983, omit “Schedule 15 to the National Health Service Act 2006 or”;
(b) in the National Health Service Act 2006, omit—
(i) section 232 and the italic heading before it;
(ii) section 277(3)(n);
(iii) Schedule 15;
(c) in section 57(2A) of the Local Electoral Administration and Registration Services (Scotland) Act 2006, omit “(apart from in Schedule 15)”.
89 Repeal of spent powers to make transfer schemes etc
(1) In the Health and Social Care Act 2012, omit—
(a) sections 300 and 301;
(b) section 308(3)(i);
(c) Schedules 22 and 23.
(2) For section 302 of that Act substitute—
Transfer schemes in respect of previously transferred property
302 (1) This section applies in relation to any property, rights or liabilities transferred under a property transfer scheme made under section 300(1) (before its repeal) from a Primary Care Trust, a Strategic Health Authority or the Secretary of State to a Special Health Authority or a qualifying company.
(2) The Secretary of State may make a scheme for the transfer of any such property, rights or liabilities from the Special Health Authority or qualifying company to any of the following—
(a) a Minister of the Crown;
(b) NHS England;
(c) an integrated care board;
(d) an NHS trust;
(e) an NHS foundation trust;
(f) a qualifying company.
(3) The things that may be transferred under a scheme under this section 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;
(c) criminal liabilities, except where transfer is to a Minister of the Crown.
(4) A transfer scheme under this section may make supplementary, incidental, transitional and consequential provision and may in particular—
(a) create rights, or impose liabilities, in relation to property or rights transferred;
(b) make provision about the continuing effect of things done by 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.
(5) A transfer scheme under this section may make provision for the shared ownership or use of property.
(6) A transfer scheme under this section may provide—
(a) for the scheme to be modified by agreement after it comes into effect, and
(b) for any such modifications to have effect from the date when the original scheme comes into effect.
(7) In this section references to the transfer of property include references to the grant of a lease.
(8) In this section “qualifying company” means—
(a) a company which is formed under section 223 of the National Health Service Act 2006 and wholly or partly owned by the Secretary of State or NHS England, or
(b) a subsidiary of a company which is formed under that section and wholly owned by the Secretary of State.
(3) In Schedule 1 to the Public Records Act 1958 (bodies the records of which are public records), in Part 1 of the Table at the end of paragraph 3, omit “or section 300 of the Health and Social Care Act 2012”.
90 Abolition of Local Education and Training Boards
(1) The committees of Health Education England called Local Education and Training Boards are abolished.
(2) In consequence, the Care Act 2014 is amended as follows.
(3) In section 100 (objectives, priorities and outcomes), in subsection (4)—
(a) after paragraph (a), insert “and”;
(b) omit paragraph (c) and the “and” before it.
(4) Omit sections 103 to 107 and the italic heading before them (local functions).
(5) In section 108 (tariffs), in subsection (9), omit “an LETB or”.
(6) In section 119 (interpretation and supplementary provision), in the table in subsection (1), omit the entries relating to the following—
appointment criteria
;
commissioner of health services
;
LETB
.
(7) In Schedule 5 (Health Education England)—
(a) in paragraph 9, in sub-paragraph (3), omit “(including a committee which HEE is required to appoint under section 103(1) (LETBs))”;
(b) in paragraph 13—
(i) in sub-paragraph (2), omit “(but see sub-paragraph (5))”;
(ii) omit sub-paragraph (5);
(c) in paragraph 26, in sub-paragraph (2)—
(i) omit paragraph (a);
(ii) in paragraph (b), omit “other”;
(d) in paragraph 27, in sub-paragraph (2)—
(i) omit paragraph (a) and the “and” at the end;
(ii) in paragraph (b), omit “other”.
(8) Omit Schedule 6 (local education and training boards).
91 Hospital patients with care and support needs: repeals etc
(1) In the Care Act 2014—
(a) for section 74 substitute—
Discharge of hospital patients with care and support needs
74 (1) Where a relevant trust is responsible for an adult hospital patient and considers that the patient is likely to require care and support following discharge from hospital, the relevant trust must, as soon as is feasible after it begins making any plans relating to the discharge, take any steps that it considers appropriate to involve—
(a) the patient, and
(b) any carer of the patient.
(2) In performing the duty under subsection (1), a relevant trust must have regard to any guidance issued by NHS England.
(3) For the purposes of this section, a relevant trust is responsible for a hospital patient if the relevant trust manages the hospital.
(4) In this section—
“adult” means a person aged 18 or over;
“carer” means an individual who provides or intends to provide care for an adult, otherwise than by virtue of a contract or as voluntary work;
“relevant trust” means—
an NHS trust established under section 25 of the National Health Service Act 2006, or
an NHS foundation trust.
;
(b) omit Schedule 3 (assessment notices etc in relation to the discharge of hospital patients with care and support needs).
(2) The Community Care (Delayed Discharges etc) Act 2003 is repealed.
(3) In consequence of subsection (1)—
(a) in section 14 of the Coronavirus Act 2020, omit subsection (8);
(b) the Care and Support (Discharge of Hospital Patients) Regulations 2014 (S.I. 2014/2823) are revoked.
(4) In consequence of subsection (2)—
(a) in Schedule 1 to the Local Authority Social Services Act 1970, omit the entry relating to the Community Care (Delayed Discharges etc) Act 2003;
(b) in the Children Act 1989—
(i) in section 17ZA(6)(b), omit sub-paragraph (iii);
(ii) in section 17ZD(8)(b), omit sub-paragraph (iii);
(c) in Schedule 2 to the Social Services and Well-being (Wales) Act 2014 (anaw 4), in Table 1—
(i) in the English language text, omit the entry relating to the Community Care (Delayed Discharges etc) Act 2003;
(ii) in the Welsh language text, omit the entry relating to Deddf Gofal Cymunedol (Rhyddhau Gohiriedig etc) 2003.
92 Information about payments etc to persons in the health care sector
(1) The Secretary of State may by regulations require manufacturers or commercial suppliers of health care products, or connected persons, to—
(a) publish information about payments or other benefits provided by them to relevant persons, or
(b) provide such information to the Secretary of State.
(2) The regulations may make further provision about when and how the information is to be published or provided.
(3) The information may, in particular, include information about—
(a) a payment or other benefit,
(b) the person who provided it, or
(c) the person who received it.
(4) The regulations may make provision permitting or requiring the further sharing, publication or use of the information.
(5) The regulations may impose requirements on manufacturers or commercial suppliers of health care products, or connected persons, about the retention of information relating to payments or other benefits provided by them to relevant persons.
(6) The regulations may—
(a) authorise the Secretary of State to designate as a “relevant scheme” any scheme under which information about payments or other benefits to relevant persons is collected or published by a person other than the Secretary of State, if the Secretary of State considers that the provision of information under the scheme would render compliance with some or all of the requirements imposed by the regulations unnecessary;
(b) create exceptions from requirements to publish or provide information imposed by virtue of subsection (1) where information is provided under a relevant scheme;
(c) if such exceptions are created—
(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.
(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.
(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;
(c) obtain the consent of the Department of Health in Northern Ireland in relation to any provision which—
(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).
(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”;
(c) omit subsection (5);
(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—
Information standards: procedure etc
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.
Information standards: compliance
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);
.
97 General duties of the Health and Social Care Information Centre etc
(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,
;
(c) at the end of paragraph (d) insert
, 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”.
99 Collection of information about adult social care
In Part 9 of the Health and Social Care Act 2012, after section 277 insert—
CHAPTER 3 Information about adult social care
Provision of adult social care information to Secretary of State
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.
Restrictions on onward disclosure of information
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.
Directions to certain bodies to exercise functions under this Chapter
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).
Arrangements with third parties
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.
100 Enforcement of duties against private providers
(1) The Health and Social Care Act 2012 is amended as follows.
(2) After section 277D (inserted by section 99 of this Act) insert—
CHAPTER 4 Enforcement
Enforcement of provisions under this Part
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).
Directions to Special Health Authority to exercise functions under section 277E
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);
.
(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—
CHAPTER 1A Regulations: information systems
Information systems
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).
Offence of disclosing information
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.
102 Relevant bodies and Special Health Authorities
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.
(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,
(c) economy, and
(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).
104 Power to provide for exercise of functions of Secretary of State
(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).
(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;
(c) changing the purpose or objective for which the body exercises a function;
(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);
(c) members of the body (including the number of members, 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,
(c) a power to compel the giving of evidence, or
(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;
(c) a Measure or Act of Senedd Cymru;
(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).
106 Transfer schemes in connection with regulations
(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
(c) any relevant body ceasing to exercise functions of the Secretary of State as a result of the regulations.
(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;
(c) criminal liabilities.
(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,
(c) an integrated care board,
(d) a Special Health Authority, or
(e) an NHS trust established under section 25 of the National Health Service Act 2006.
(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.
(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;
(c) obtain the consent of a Northern Ireland department in relation to any provision—
(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.
(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.
110 Investigation of incidents with safety implications
(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
(c) whether action needs to be taken in respect of an individual by a regulatory body.
(5) In this Part, an incident within subsection (1) is called a “qualifying incident”.
(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;
(c) may provide for a person to exercise a discretion in dealing with any matter.
(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
(c) sets out, in general terms, the issues that the HSSIB expects to consider in the investigation.
(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.
(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,
(c) the processes to be followed in carrying out investigations, and
(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.
(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
(c) whether action needs to be taken in respect of an individual by a regulatory body.
(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.
(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
(c) set out the HSSIB’s conclusions to date on the matters it has considered in accordance with section 110(3).
(3) Subsections (3) to (7) of section 113 apply in relation to an interim report as they apply in relation to a final report.
(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.
(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.
(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;
(c) proceedings before a regulatory body (including proceedings for the purposes of investigating an allegation);
(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.
(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;
(c) inspect any equipment or other item 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;
(c) an interest belonging to Her Majesty in right of the Duchy of Lancaster;
(d) an interest belonging to the Duchy of Cornwall.
(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;
(c) in the case of a requirement under subsection (1)(c)—
(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
(c) attach evidence of the investigator’s authority from the HSSIB to exercise the powers conferred by this section.
(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.
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.
(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.
(4) If a person charged with an offence under subsection (2) relies on the defence under subsection (3), and evidence is adduced which is sufficient to raise an issue with respect to that defence, the court must assume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.
(5) A person who commits an offence under this section is liable on summary conviction to a fine.
(6) Subsections (1)(a) and (5) apply to persons in the public service of the Crown as they apply to other persons.
(1) The HSSIB, or an individual connected with the HSSIB, must not disclose protected material to any person.
(2) In this Part “protected material” means any information, document, equipment or other item which—
(a) is held by the HSSIB, or an individual connected with the HSSIB, for the purposes of the HSSIB’s investigation function,
(b) relates to a qualifying incident (whether or not investigated by the HSSIB), and
(c) has not already been lawfully made available to the public.
(3) In this Part “individual connected with the HSSIB” means—
(a) a member of the HSSIB,
(b) a member of a committee or sub-committee of the HSSIB,
(c) an investigator, or
(d) an individual (other than an investigator) who works for the HSSIB.
(4) For the purposes of subsection (3)(d) an individual “works for” the HSSIB if the individual works—
(a) under a contract of employment with the HSSIB,
(b) under a contract of apprenticeship with the HSSIB,
(c) under a contract under which the individual undertakes to do or perform personally any work or services for the HSSIB, or
(d) as an agency worker within the meaning of the Agency Workers Regulations 2010 (S.I. 2010/93) in circumstances where the HSSIB is the hirer within the meaning of those Regulations.
(5) An individual who was, but has ceased to be, connected with the HSSIB must not disclose to any person, other than the HSSIB or an individual connected with the HSSIB, any information, document, equipment or other item held by that individual—
(a) which the individual obtained because they were connected with the HSSIB,
(b) which, at the time they ceased to be connected with the HSSIB, was protected material, and
(c) which has not already been lawfully made available to the public.
(1) Section 122(1) does not apply to a disclosure which is required or authorised by—
(a) Schedule 14,
(b) any other provision of this Part, or
(c) regulations made by the Secretary of State.
(2) Regulations under subsection (1)(c) may, for example, require or authorise disclosures of protected material by reference to—
(a) the kind of material that it is (for example, a particular kind of equipment),
(b) the matters to which it relates,
(c) the person from whom it was obtained,
(d) the purpose for which it was produced or is held, or
(e) the purpose for which it is disclosed.
(3) But regulations under subsection (1)(c) may not require or authorise disclosures of protected material by reference to the qualifying incident to which the material relates.
(4) Regulations under subsection (1)(c) may provide for a person to exercise a discretion in dealing with any matter.
(5) Subject to subsection (6), regulations under subsection (1)(c) may provide that disclosures which are required or authorised by the regulations do not breach—
(a) obligations of confidence owed by the person making the disclosure, or
(b) any other restrictions on disclosure.
(6) Nothing in regulations under subsection (1)(c) operates to require or authorise disclosures which would contravene the data protection legislation (but, for the purposes of this subsection, in determining whether any disclosure required or authorised by the regulations would do so, take the requirement or authorisation into account).
(1) A person commits an offence if the person—
(a) breaches the prohibition in section 122(1) by knowingly or recklessly disclosing protected material to another person, and
(b) knows or suspects that the disclosure is prohibited.
(2) An individual who was, but has ceased to be, connected with the HSSIB commits an offence if the individual—
(a) breaches the prohibition in section 122(5) by knowingly or recklessly disclosing any information, document, equipment or other thing to another person, and
(b) knows or suspects that the disclosure is prohibited.
(3) Subsection (4) applies where protected material is disclosed to a person not connected with the HSSIB—
(a) in a draft report sent to the person under section 115(1),
(b) under paragraph 2, 3 or 4 of Schedule 14 (disclosures for purposes of an investigation, offence or safety risk), or
(c) under regulations under section 123(1)(c).
(4) The person not connected with the HSSIB to whom protected material is disclosed as specified in subsection (3) commits an offence if the person—
(a) knowingly or recklessly discloses the protected material to another person without reasonable excuse, and
(b) knows or suspects that it is protected material.
(5) A person who commits an offence under this section is liable on summary conviction to a fine.