The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: A Litany of Fundamental Flaws?
| Author | Ruth Stirton |
| Date | 01 March 2017 |
| DOI | http://doi.org/10.1111/1468-2230.12255 |
| Published date | 01 March 2017 |
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LEGISLATION
(Regulated Activities) Regulations 2014:
A Litany of Fundamental Flaws?
Ruth Stirton∗
This article argues that the Health and Social Care Act 2008 (Regulated Activities) Regulations
2014 are fatally flawed notwithstanding the apparent rigour of the process which produced
them. These Regulations were the product of considerable deliberation following a sensitively
executed public inquiry yet, it is argued, they rely too heavily on the rhetoric of criminal
law while failing to take into account the competing norms for compliance and the impact
of NHS budget constraints. Further, they push the CQC towards a heavy-handed deterrence
approach to enforcement, which will increase hostility between regulateesand the inspectorate,
and ultimately reduce the scope for developing the transparency about failures which is sorely
needed in the NHS. This article challenges the contemporary wisdom that it is primarily
knee-jerk regulatory responses that suffer from fatal flaws of this nature.
This article argues that the Health and Social Care Act 2008 (Regulated Ac-
tivities) Regulations 20141are fatally flawed. This criticism is often levelled at
knee-jerk responses to policy crises created without the benefit of time and
thought. Yet, these Regulations were the product of a sensitively executed
public inquiry. I argue that the 2014 Regulations will fail because they rely too
heavily on the rhetoric of criminal law while failing to take into account the
competing norms for compliance and the impact of NHS budget constraints.
They push the CQC towards a deterrence approach to enforcement, increasing
hostility between regulatees and inspectors, and ultimately reducing the scope
for developing the transparency about failures which is sorely needed in the
NHS. This article challenges the contemporary wisdom that it is primarily
knee-jerk regulatory responses that suffer from fatal flaws of this nature.
THE 2014 REGULATIONS
The 2014 Regulations enact the ‘fundamental standards of minimum safety
and quality’2recommended by the Francis inquiry into the Stafford Hospital
fiasco in the 2010s. This framework of standards is to be met by health and
∗Lecturer in Healthcare Law, University of Sussex. All URLs accessed18 January 2016. Thank you
to TT Arvind, Martin Lodge, Lindsay Stirton, Joanna Shapland, Tarik Kochi, JoBr idgeman, Kenny
Veitch and The Mason Institute, where I worked as a visiting scholar while this paper was in
preparation.
1 2014/2936 (the 2014 Regulations).
2 Robert Francis QC, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry
Executive Summary 2013 at http://www.midstaffspublicinquiry.com/sites/default/files/report/
Executive%20summary.pdf, table of recommendations.
C2017 The Author.The Moder n Law Review C2017 The Modern Law Review Limited. (2017) 80(2) MLR 299–324
Published by John Wiley& Sons Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA
social care providers in England and Wales. Their aim is to protect the dignity
of service users while ensuring a high level of safety across health and social
care services. The 2014 Regulations encompass twelve minimum standards
covering fourteen ‘regulated activities’. These activities make up the business
of healthcare provision, including personal care; accommodation for persons
requiring nursing or personal care; accommodation for persons requiring treat-
ment for substance abuse; treatment of disease, disorder or injury; assessment
or medical treatment for persons detained under the Mental Health Act 1983;
surgical procedures; diagnostic or screening procedures; management or supply
of blood and blood derived products; transport services, triage and medical
advice provided remotely; maternity and midwifery services; termination of
pregnancies; nursing care; and family planning services.3They apply across
all regulated activities, and providers must meet standards in relation to those
activities that they engage in.
Many of the new standards are similar to those in place previously. The
2014 Regulations replace the Health and Social Care Act 2008 (Regulated
Activities) Regulations 2010,4all of which can be mapped directly onto the
2014 Regulations. Some of the 2010 Regulations map onto a single regulation
in the 2014 Regulations, such as the care and welfare of service users5which has
become person-centred care,6or respecting and involving service users7which
has become dignity and respect.8Some regulations have been merged to form
a single new regulation in the 2014 Regulations, such as the new regulation
on premises and equipment9which is made up from the 2010 Regulations on
cleanliness and infection control,10 safety and suitability of premises11 and safety
and suitability of equipment.12 One of the 2010 Regulations, cleanliness and
infection control13 has been split and now forms part of the new regulations
on premises and equipment14, and safe care and treatment15.Seefigure1fora
map of how the 2010 Regulations map onto the 2014 Regulations.
There are two important changes in the 2014 Regulations. First is the
new duty of candour introduced in regulation 20. This requires health service
bodies to ‘act in an open and transparent way’ about errors.16 This entails
providing a full account and apology to the relevant individuals whenever a
notifiable incident has occurred.17 The second important difference in the 2014
Regulations is the change in tone. The language has more imperativeforce than
that in the 2010 Regulations. For example, regulation 11 (2010) provides that
3 2014 Regulations, Schedule 1.
4 2010/781 (the 2010 Regulations).
5 2010 Regulations, reg 9.
6 2014 Regulations, reg 9.
7 2010 Regulations, reg 17.
8 2014 Regulations, reg 10.
9ibid, reg 15.
10 2010 Regulations, reg 12.
11 ibid, reg 15.
12 ibid, reg 16.
13 ibid, reg 12.
14 2014 Regulations, reg 15.
15 ibid, reg 12.
16 ibid, reg 20.
17 ibid, reg 20(3).
300 C2017 The Author. The Modern Law Review C2017 The Modern Law Review Limited.
(2017) 80(2) MLR 299–324
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