Legislation – Health and Social Care Act 2012

Health and Social Care Act 2012, CHAPTER 1 is up to date with all changes known to be in force on or before 04 April 2026. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.

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CHAPTER 1Information standards

F1Powers to publish standards

250Powers to publish information standards

(1)

The Secretary of State or F2NHS England may prepare and publish an information standard.

F3(2)

For the purposes of this Part “an information standard” is a standard in relation to the processing of information F4and includes, among other things, a standard relating to information technology or IT services used, or intended to be used, in connection with the processing of information (see section 250A).

(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 F5in, or in relation to, England of health care or of adult social care F6…;

(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).

F7(e)

a relevant IT provider.

(3)

The Secretary of State may exercise the power under subsection (1) only in relation to information concerning, or connected with, the provision F8in, or in relation to, England of health F9care or of adult social care F10….

(4)

F11NHS England may exercise the power under subsection (1) only in relation to information concerning, or connected with, the provision of NHS services.

F12(5)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F13(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.

(d)

any person (other than a public body) who provides health services, or adult social care in England, pursuant to arrangements made with a public body exercising functions in connection with the provision of such services or care.

(7)

In this F14Chapter—

“adult social care”—
1. (a)
  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
2. (b)
  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;
F15“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;
F16“information technology” includes—
1. (a)
  computers,
2. (b)
  other devices whose uses include the processing of information by electronic means (“IT devices”),
3. (c)
  parts, accessories and other equipment made or adapted for use in connection with computers or IT devices,
4. (d)
  software and code made or adapted for use in connection with computers or IT devices, and
5. (e)
  networks and other infrastructure (whether physical or virtual) used in connection with other information technology;
“IT service” means an information technology service, including any service (whether physical or virtual) which consists of, or is provided in connection with, the development, making available, operation or maintenance of information technology;
F17…
F18“NHS services” means services the provision of which is arranged by NHS England or an integrated care board (including services the provision of which is arranged by it in the exercise of functions of another person by virtue of any provision of the National Health Service Act 2006);
F19“processing” has the same meaning as in Parts 5 to 7 of the Data Protection Act 2018 (see section 3(4) F20… of that Act);
“public body” means a body or other person whose functions—
1. (a)
  are of a public nature, or
2. (b)
  include functions of that nature,
but in the latter case, the body or person is a public body to the extent only of those functions.
F21“relevant IT provider” means a person involved in marketing, supplying, providing or otherwise making available—
1. (a)
  information technology,
2. (b)
  an IT service, or
3. (c)
  a service which consists of processing information using information technology,
whether for payment or free of charge, but only so far as the technology or service is used, or intended to be used, in connection with the provision in, or in relation to, England of health care or of adult social care.

F22250AStandards relating to information technology

(1)

An information standard relating to information technology or IT services may, among other things, make provision about—

(a)

the design, quality, capabilities or other characteristics of such technology or services;

(b)

contracts or other arrangements under which such technology or services are marketed, supplied, provided or otherwise made available.

(2)

An information standard may include technical provision about information technology or IT services, including provision about—

(a)

functionality;

(b)

connectivity;

(c)

interoperability;

(d)

portability;

(e)

storage of, and access to, information;

(f)

security of information.

(3)

An information standard may make provision by reference to open standards or proprietary standards.

F24251F23… Procedure etc

(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.

F25(3)

The power under section 250(1) may be exercised by—

(a)

adopting an information standard prepared or published by another person, including as it has effect from time to time, or

(b)

making provision by reference to an international agreement or another document, including as it has effect from time to time.

F26Compliance with standards

F24251ZAF27Monitoring compliance

(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.

F28251ZBNotice requesting compliance by relevant IT providers

(1)

If the Secretary of State has reasonable grounds to suspect that a relevant IT provider is not complying with an information standard which applies to the provider, the Secretary of State may give the provider a written notice which—

(a)

identifies the standard in question,

(b)

sets out the Secretary of State’s grounds for suspecting that the provider is not complying with the standard,

(c)

asks the provider to comply with the standard within a period specified in the notice,

(d)

asks the provider, within a period specified in the notice, to provide evidence to the Secretary of State’s satisfaction that the provider is complying with the standard, and

(e)

if the Secretary of State considers it appropriate, sets out the steps that the Secretary of State considers the provider must take, within a period specified in the notice, in order to comply with the standard.

(2)

A period specified for the purposes of subsection (1)(c), (d) or (e) must be a period of at least 28 days beginning with the day on which the notice is given.

(3)

The Secretary of State may, by giving the relevant IT provider a further written notice, vary or revoke a notice given under subsection (1).

251ZCPublic censure of relevant IT providers

(1)

(2)

The statement may include the text of a notice given to the provider under section 251ZB.

(3)

Before publishing a statement under this section, the Secretary of State must give the relevant IT provider—

(a)

a copy of the terms of the proposed statement, and

(b)

an opportunity to make representations about the decision to publish a statement and the terms of the statement.

(4)

If, after considering any representations, the Secretary of State decides to publish the statement, the Secretary of State must inform the relevant IT provider before publishing it.

(5)

This section does not authorise the processing of information if the processing would contravene the data protection legislation (but in determining whether it would do so, take into account the power conferred by this section).

(6)

In this section, “the data protection legislation” has the same meaning as in the Data Protection Act 2018 (see section 3 of that Act).

251ZDExercise of functions of Secretary of State by other persons

(1)

The Secretary of State may—

(a)

direct a public body to exercise some or all of the functions listed in subsection (3), and

(b)

give the public body directions about the exercise of those functions, including directions about the processing of information that the body obtains in exercising those functions.

(2)

The Secretary of State may make arrangements for a person prescribed by regulations under this subsection to exercise some or all of the functions listed in subsection (3).

(3)

Those functions are—

(a)

the Secretary of State’s functions under section 251ZA, so far as they relate to relevant IT providers, and

(b)

the Secretary of State’s functions under section 251ZB.

(4)

Arrangements under subsection (2) may—

(a)

provide for the Secretary of State to make payments to the person, and

(b)

make provision as to the circumstances in which such payments are to be repaid to the Secretary of State.

(5)

Section 304(9) applies in relation to the power to make arrangements under subsection (2) as it applies to a power of the Secretary of State to give directions under this Act.

Accreditation

251ZEAccreditation of information technology etc

(1)

Regulations may make provision for the establishment and operation of a scheme for the accreditation of information technology and IT services so far as used, or intended to be used, in connection with the provision in, or in relation to, England of health care or of adult social care.

(2)

The regulations may provide for the scheme to be established and operated by a person specified in the regulations (“the operator”).

(3)

The regulations may, among other things, confer power on the operator—

(a)

to establish the procedure for accreditation under the scheme,

(b)

to set the criteria for accreditation under the scheme (“the accreditation criteria”),

(c)

to keep an accreditation under the scheme under review, and

(d)

to charge a reasonable fee in respect of an application for accreditation.

(4)

The regulations may, among other things, make provision requiring the operator—

(a)

to set some or all of the accreditation criteria by reference to information standards,

(b)

to publish details of the scheme, including the accreditation criteria,

(c)

to provide for the review of a decision to refuse an application for accreditation, and

(d)

to provide advice to applicants for accreditation with a view to ensuring that the accreditation criteria are met.

Changes to legislation: