Health and Care Bill (HL Bill 71)

Part 2 continued    

(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)5education.

(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
10combination 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)15the disclosure (other than by way of publication) of information
mentioned in paragraph (b) to specified persons or descriptions
of persons, or for specified purposes;
the use or further disclosure by any person of information
disclosed to them under the regulations.

(7)20Regulations 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
25Scotland, 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)30Where 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
35provide 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 confer powers or duties
(including discretions) on the Scottish Ministers, a designated person
40or the Information Centre.

(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
45for 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
5information 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
10data 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
  15section 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—

  (a)

  20the physical or mental health or condition of an
  individual,

  (b)

  the diagnosis of an individual’s condition, or

  (c)

  an individual’s care or treatment,

  or is (to any extent) derived directly or indirectly from
  25information relating to any of those matters;

• “specified” means specified in regulations under subsection (1).

7B Offence of disclosing information

(1)A person to whom information is disclosed under regulations under
section 7A(1) commits an offence if the person uses or discloses that
30information 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)35on 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
40subsection (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
45been 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
5the 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)10in 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
15of 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)”
20insert “, 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—

(1A)(a)25where 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)
30substitute—

“(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
3510(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)40In 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
45Information Centre by virtue of the Medicines and Medical Devices Act
2021.”

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

88 Relevant bodies

In this Part, “relevant body” means—

(a)5Health Education England,

(b)the Health and Social Care Information Centre,

(c)the Health Research Authority,

(d)the Human Fertilisation and Embryology Authority,

(e)the Human Tissue Authority, or

(f)10NHS England.

89 Power to transfer functions between bodies

(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
15considers that they serve the purpose of improving the exercise of public
functions, having regard to—

(a)efficiency,

(b)effectiveness,

(c)economy, and

(d)20securing 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
25of section 150(1)(a) includes provision—

(a)modifying functions of either relevant body (see further section 91(1));

(b)modifying the constitutional or funding arrangements of either
relevant body (see further section 91(2) and (3));

(c)abolishing the relevant body from which functions are transferred,
30where 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
35Ireland,

(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
40with 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 150(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
58 of the Ministers of the Crown Act 1975).

90 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)10The 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)15The provision which may be made by regulations under this section by virtue
of section 150(1)(a) includes provision—

(a)modifying functions of the relevant body (see further section 91(1));

(b)modifying the constitutional or funding arrangements of the relevant
body (see further section 91(2) and (3)).

(4)20Where—

(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
25function 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
30arrangements do not contain corresponding provision as to
membership,

the Secretary of State must make provision by virtue of section 150(1)(a)
modifying the relevant body’s constitutional arrangements so that they
contain corresponding provision as to membership.

(5)35Regulations 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)40In this section “the health service” has the same meaning as in the National
Health Service Act 2006 (see section 275(1) of that Act).

91 Scope of powers

(1)In sections 89 and 90, 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)5In sections 89 and 90, 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)10members 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)15governing procedures and arrangements (including the role and
membership of committees and sub-committees);

(g)reports and accounts.

(3)In sections 89 and 90, references to modifying the funding arrangements of a
body include—

(a)20modifying 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 89 or 90 may repeal and re-enact (but may not
create)—

(a)25a 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 89 or 90 may
30be 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 89 or 90 by
virtue of section 150(1)(a) includes provision repealing, revoking or amending
provision made by or under any of the following, whenever passed or made—

(a)35an 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
408 of the Ministers of the Crown Act 1975).

92 Transfer schemes in connection with regulations

(1)The Secretary of State may, in connection with regulations under section 89 or
90, 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 89 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)5A transfer scheme in connection with regulations under section 90 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)10any 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
15the scheme;

(c)criminal liabilities.

(5)A transfer scheme may—

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

(b)20make 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)25make 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)30make 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
35came 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
40to a contract of employment;
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)45the 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)the Scottish Ministers,

(d)5a Northern Ireland department,

(e)the Welsh Ministers,

(f)an integrated care board,

(g)a Special Health Authority, or

(h)an NHS trust.

93 10Transfer schemes: taxation

(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 92, or

(b)anything done for the purposes of, or in relation to, a transfer under
15such 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)20anything 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
25anything 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)30anything 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
35anything 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—

• 40“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.

94 Consultation on draft regulations

(1)Before making regulations under section 89 or 90 the Secretary of State must
consult the following about a draft of the regulations—

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

(b)5the Scottish Ministers, if the draft regulations, so far as applying in or
as regards Scotland, make provision—

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

(ii)for any matter in relation to which functions are exercisable by
10the Scottish Ministers,

(c)the Welsh Ministers, if the draft regulations, so far as applying in or as
regards Wales, make provision—

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

(ii)15for any matter in relation to which functions are exercisable by
the Welsh Ministers,

(d)such Northern Ireland department or departments as the Secretary of
State considers appropriate, if the draft regulations, so far as applying
in or as regards Northern Ireland, make provision—

(i)20which would be within the legislative competence of the
Northern Ireland Assembly if contained in an Act of that
Assembly, or

(ii)for any matter in relation to which a Northern Ireland
department exercises functions, and

(e)25such other persons as the Secretary of State considers appropriate.

(2)Consultation is not required under subsection (1)(d)(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
30section 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)If, as a result of consultation under subsection (1), it appears to the Secretary of
State appropriate to change the draft regulations, the Secretary of State must
35carry out such further consultation with respect to the changes as the Secretary
of State considers appropriate.

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

Part 4 40The Health Services Safety Investigations Body

Introductory

95 Establishment of the HSSIB

(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

96 Investigation of incidents with safety implications

(1)5The 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)10address 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
15relation 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)20whether 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”.

97 Deciding which incidents to investigate

(1)The HSSIB’s function under section 96 includes determining which qualifying
25incidents 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)30A direction under subsection (2) may specify the date by which the HSSIB must
publish its final report (see section 99).

(4)A direction under subsection (2)—

(a)must be in writing;

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

(c)35may 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)40contains a brief description of the incident, and