The changing landscape of health and social care regulation

In response to the recommendations of the Francis Report, new regulations and enforcement consultations show a trend towards greater scrutiny of health and social care. We take a look at the challenges ahead for health professionals.

The Francis Report into the Mid-Staffordshire scandal recommended that fundamental standards should be imposed through legal obligations capable of being prosecuted as criminal offences and that there should be a simplification of the regulatory regime so that a single regulator had oversight. This was in response to the report’s criticisms of a negative culture that did not put patients first or apologise for mistakes, and separate criticisms that warning signs were missed by regulators due to overlapping fields of responsibility.

The new duties

The Health and Social Care Act (Regulated Activities) Regulations 2014 introduces “fundamental duties” for those carrying out activities regulated by the Care Quality Commission (CQC). These duties apply to both health and social care providers and are not limited solely to the NHS or hospital care. The regulations impose requirements that registered managers:

  • be of good character;
  • have the necessary qualifications, skills and experience; and
  • are able to furnish the CQC with information including their employment history.  

In addition, directors of health service bodies (i.e. NHS bodies) must be fit and proper persons, of good character, with appropriate qualifications, competence, skills and experience, and be capable of performing tasks intrinsic to their office. It is also a requirement that directors of health service bodies have not been responsible for or contributed to misconduct in relation to the provision of health or care services elsewhere.

The following fundamental standards must be met by those carrying out regulated activities:

  • To provide person-centred care.
  • To treat service users with dignity and respect.
  • To obtain service users’ consent to care and treatment
  • To provide safe care and treatment.
  • To safeguard service users from abuse and improper treatment.
  • To meet the nutritional and hydration needs of service users.
  • To make sure premises and equipment are clean, secure, maintained and used properly.
  • To act properly on complaints.
  • To observe good governance.
  • To have sufficient staff available.
  • To make sure the people they employ are fit and proper persons.

In addition a “duty of candour” is imposed specifically in relation to health services bodies to “act in an open and transparent way … in relation to care and treatment provided to service users”. This includes notifying the service user or their representative as soon as reasonably practicable after any unintended or unexpected incident occurs during their treatment that has or could have resulted in their death, severe or moderate harm or prolonged psychological harm (lasting over 28 consecutive days). They must also provide that person with reasonable support in relation to the incident. The notification should be given in person and be an account which is true to the best of the body’s knowledge of all the known facts. An apology must be issued, a written record must be kept of the notification and a written notification must follow including the results of any further enquiries made into the incident. 

The offences

An offence is committed if the fundamental duties are breached including:

i) Care or treatment being given without consent.

ii) A failure to provide the CQC with information connected with complaints or information relating to the assessment and monitoring of quality, safety and risk within 28 days of request.

An offence is also committed if the following are breached and that breach results in avoidable harm, exposure of service users to significant risk of harm, or theft misuse or misappropriation of money or property causing a loss to a service user:

iii) The duty to provide safe care and treatment (including doing all that is reasonably practicable to mitigate any such risks and assessing and mitigating risks of infection).

iv) The duty to safeguard service users from abuse and improper treatment (including establishing systems and processes to prevent abuse of service users and to effectively investigate allegations or evidence of abuse, not discriminating, degrading or unnecessarily or disproportionately restraining or controlling the service user to prevent a risk of harm to themselves or others).

v) The duty to meet the nutritional and hydration needs of service users (providing they consent and it is in their best interests).

It is an offence for a health service body to fail to notify a service user or their representative of a notifiable safety incident in accordance with their duty of candour, or for them to fail to comply with all the requirements of the notification process as briefly set out above. If the body can demonstrate that they took all reasonable steps and exercised all due diligence to prevent the breach, then this duty is subject to a defence.

These regulations codify good practices that will already be embedded in many bodies, but are rightly viewed as essential practices to putting patients first. Care should be taken by service providers to ensure that their systems and processes are robust enough to identify when duties arise and to ensure they are promptly addressed. A good example would be ensuring that there is an internal reporting mechanism when a notifiable safety incident may have occurred so it can be promptly investigated and, if there has been an incident, the correct steps can be taken to inform the service user and to apologise.

The majority of these provisions only come into force in April 2015, however the “fit and proper” requirement for directors of health service bodies is already in force, as is the duty of candour for health service bodies.

Regulatory change

Following the Francis Report it was recommended that regulatory reform should include a simplified framework to ensure that there was no gap in regulation between different regulatory bodies. In response, the HSE and Local Authorities (who have responsibility for the enforcement of health and safety legislation) have been consulting with the CQC to set out clearer definitions of where their respective responsibilities lie.

The Framework’s stated purpose is to “help ensure that there is effective, co-ordinated and comprehensive regulation of health and safety for patients, service users, workers and members of the public visiting these premises” It is explicitly stated to be aimed at closing “the “regulatory gap” which is said to have been “due to the restrictiveness of HSE’s health and social care investigation policy and CQC lacking the necessary powers to act to secure justice”.

Under the consultation the following responsibilities are established:

i) CQC is the lead inspection and enforcement body under the Health and Social Care Act 2008 for safety and quality of treatment and care matters involving patients and service users in receipt of health or adult social care service from a provider registered with CQC.

ii) HSE/Local Authorities are the lead inspection and enforcement bodies for health and safety matters involving patients and service users who are in receipt of health or care service from providers not registered with CQC.

iii) HSE/ Local Authorities are the lead inspection and enforcement bodies for health and safety matters involving workers, visitors and contractors.

The practical illustrations accompanying the consultation indicate that incidents such as a “service user falling from a window of a second floor premises” or “scalding of a service user in a bath/shower” would fall within the CQC’s remit. The CQC are likely to regulate in “incidents which may expose staff to some degree of harm, but the principal concern is the greater risk of harm which they create for people using the service”.

Incidents falling within the HSE/Local Authority remit include “Circumstances where the commissioner, rather than the provider, seems to have been at fault” and incidents not associated with care such as “a manual handling injury from moving ill-maintained trolleys” or construction work.

The consultation closed on 31 December 2014 and it seems highly likely that the document will be approved as the new regulatory framework.


Regulated health and social care is becoming more strictly monitored and controlled by new regulations and the closing of the “regulatory gap”. This will come as no surprise to some as it brings the health industry into line with the regulation of other industries whose activities potentially expose members of the public to risk. For health professionals and managers the challenge will be to embrace the necessary cultural changes in order to comply with the spirit of the Francis Report’s findings and embed these in the organisational values.

In the wake of Mid-Staffordshire, the efforts by regulators to ensure greater scrutiny and the new powers granted to the CQC should cause organisations to look at these issues now to ensure they are well prepared for the changing regulatory landscape.

This information is intended as a general discussion surrounding the topics covered and is for guidance purposes only. It does not constitute legal advice and should not be regarded as a substitute for taking legal advice. DWF is not responsible for any activity undertaken based on this information.

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