Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 – Regulation 20 (Duty of Candour)

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

Skip to main content
Skip to navigation
legislation.gov.uk
https://www.nationalarchives.gov.uk
Cymraeg
Home
Explore our collections
Research tools
Help and guidance
What's new
About us
Search Legislation
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
You are here:
UK Draft Statutory Instruments
ISBN 978-0-11-111761-3
PART 3
SECTION 2
Regulation 20
Table of Contents
Content
Draft Explanatory Memorandum
Draft Impact Assessments
More Resources
Previous:
Provision
Next:
Provision
Plain View
Print Options
What Version
Draft legislation
Opening Options
Open whole Instrument
Open Instrument without Schedules
Open Schedules only
More Resources
Original: King's Printer Version
View more
Draft Legislation:
This is a draft item of legislation. This draft has since been made as a UK Statutory Instrument:
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 No. 2936
Duty of candour
This section has no associated Explanatory Memorandum
20.
—(1) A health service body must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity.
(2) As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a health service body must—
(a)
notify the relevant person that the incident has occurred in accordance with paragraph (3), and

(b)
provide reasonable support to the relevant person in relation to the incident, including when giving such notification.

(3) The notification to be given under paragraph (2)(a) must—
(a)
be given in person by one or more representatives of the health service body,

(b)
provide an account, which to the best of the health service body’s knowledge is true, of all the facts the health service body knows about the incident as at the date of the notification,

(c)
advise the relevant person what further enquiries into the incident the health service body believes are appropriate,

(d)
include an apology, and

(e)
be recorded in a written record which is kept securely by the health service body.

(4) The notification given under paragraph (2)(a) must be followed by a written notification given or sent to the relevant person containing—
(a)
the information provided under paragraph (3)(b),

(b)
details of any enquiries to be undertaken in accordance with paragraph (3)(c),

(c)
the results of any further enquiries into the incident, and

(d)
an apology.

(5) But if the relevant person cannot be contacted in person or declines to speak to the representative of the health service body—
(a)
paragraphs (2) to (4) are not to apply, and

(b)
a written record is to be kept of attempts to contact or to speak to the relevant person.

(6) The health service body must keep a copy of all correspondence with the relevant person under paragraph (4).
(7) In this regulation—
“apology” means an expression of sorrow or regret in respect of a notifiable safety incident;
“moderate harm” means—
(a)
harm that requires a moderate increase in treatment, and
(b)
significant, but not permanent, harm;
“moderate increase in treatment” means an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care);
“notifiable safety incident” means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in—
(a)
the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition, or
(b)
severe harm, moderate harm or prolonged psychological harm to the service user;
“prolonged psychological harm” means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days;
“relevant person” means the service user or, in the following circumstances, a person lawfully acting on their behalf—
(a)
on the death of the service user,
(b)
where the service user is under 16 and not competent to make a decision in relation to their care or treatment, or
(c)
where the service user is 16 or over and lacks capacity (as determined in accordance with sections 2 and 3 of the 2005 Act) in relation to the matter;
“severe harm” means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user’s illness or underlying condition.
Previous:
Provision
Next:
Provision
Back to top
Options/Help
Print Options
Print
The Whole
Instrument
PDF
The Whole
Instrument
Web page
The Whole
Instrument
Print
The Whole
Part

PDF
The Whole
Part

Web page
The Whole
Part

Print
The Whole
Cross Heading
PDF
The Whole
Cross Heading
Web page
The Whole
Cross Heading
Print
This
Section

only

PDF
This
Section

only

Web page
This
Section

only

Legislation is available in different versionsLatest Available (revised):
The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made):
The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
Draft Explanatory Memorandum
Draft Explanatory Memorandum sets out a brief statement of the purpose of a Draft Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Draft Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
the original print PDF of the as enacted version that was used for the print copy
lists of changes made by and/or affecting this legislation item
confers power and blanket amendment details
all formats of all associated documents
correction slips
links to related legislation and further information resources
Impact Assessments
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
Why the government is proposing to intervene;
The main options the government is considering, and which one is preferred;
How and to what extent new policies may impact on them; and,
The estimated costs and benefits of proposed measures.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
the original print PDF of the as made version that was used for the print copy
correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
lists of changes made by and/or affecting this legislation item
confers power and blanket amendment details
all formats of all associated documents
links to related legislation and further information resources
The data on this page is available in the
alternative data formats
listed:
HTML5
alternative version
HTML snippet
alternative version
PDF
alternative version
XML
alternative version
Akoma Ntoso
alternative version
HTML RDFa
alternative version
RDF/XML
alternative version
New site design
Help
About us
Site map
Accessibility
Contact us
Privacy notice
Cookies
All content is available under the
Open Government Licence v3.0
except where
otherwise stated
. This site additionally contains content derived from EUR-Lex, reused under the terms of the
Commission Decision 2011/833/EU
on the reuse of documents from the EU institutions. For more information see the
EUR-Lex public statement on re-use
.
©
Crown and database right