The Health and Social Care (Regulated Activities) Regulations 2014

Guidance note

The new Regulations became law in November 2014 and have far reaching obligations. We look at the fundamental standards imposed by the Regulations and what they mean for the NHS and independent providers of health care services. 

After a lengthy consultation process, the Health and Social Care (Regulated Activities) Regulations 2014 became law on 27 November 2014.


Although the main focus for many commentators has been the provisions which impose a statutory duty of candour and what that means for the NHS against the backdrop of the Mid Staffs scandal, there are other important duties (described as “fundamental standards”) imposed by the Regulations and which have a much broader application. They apply to all providers of health and social care, whether in the public or independent sector and whether those services are NHS-funded or not. As such, the reach of the Regulations goes significantly beyond the NHS and the Duty of Candour. It is important to bear in mind that the fundamental standards, including the Duty of Candour, will apply to all CQC-registered providers by April 2015.

The fundamental duties imposed by the Regulations, beyond candour, are vital in the provision of health and social care and carry the potential of criminal liability for their breach. Many of these duties amount to the codification of obligations which many well-run organisations will have no difficulty in discharging, although some carry with them a real prospect of prosecution.


Fit and proper

The Regulations require those who carry out regulated activities (essentially where CQC registration is required) to achieve certain minimum professional standards. In the case of individuals (including registered managers) and those acting in partnership, they must be of good character and able to perform the tasks that are relevant to the service they are providing. There are similar obligations on corporate bodies in relation to the nominated individual they must employ to supervise the service itself. In addition, each director of a health service organisation which provides health services must be a “fit and proper” person. The following requirements must be satisfied:

  • They must of good character.
  • They must have appropriate experience, skills, qualifications and competence.
  • They must be capable of performing the tasks which are intrinsic to their office.
  • They must not have been responsible for or contributed to any misconduct in relation to the provision of health or care services elsewhere.

These duties come into force on 1 April 2015 apart from the “fit and proper” requirement for directors of health service bodies, which came into force on 27 October 2014.

Fundamental service standards

The Regulations also impose fundamental standards in the provision of health and care services which must be met. Many service users will be surprised to see that it was felt necessary to impose obligations in relation to such obvious needs.

The list includes the following duties:

  • To provide person-centred care.
  • To treat service users with dignity and respect.
  • To provide safe care and treatment.
  • To safeguard service users from abuse and improper treatment.
  • 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.

Candour, openness and transparency

An additional “fundamental standard” which applies only to health service bodies is the statutory Duty of Candour. Under paragraph 20 of the Regulations:

“A health service body must act in an open and transparent way in relation to care and treatment provided to service users…”

The Duty of Candour is imposed on all NHS providers where any unintended or unexpected harm is caused to a service user above a certain threshold. The specific duty is triggered by the death of the service user, as accelerated by the incident (as opposed to their underlying condition) or where severe or moderate harm, moderate prolonged pain or psychological harm is caused as a result of the incident. The concept of ‘moderate harm’ includes increases in treatment, such as a return to surgery, and severe harm includes the removal of the wrong limb or organ. Psychological harm must be present for 28 consecutive days.

Once the provider is aware of the incident  and the harm threshold is triggered the provider must:

  • notify the service user (or their carer) of it;
  • provide all information directly relevant to it; and
  • provide reasonable support in respect of the incident.

In addition to imposing obligations of truthfulness in respect of dealings with a service user after such an incident, and the requirements to make the notification in writing and to record it, the notification must be accompanied by an apology. The Regulations define "apology" as "an expression of sorrow or regret…"

Failure to explain that there has been a notifiable safety incident can lead to prosecution. Other non-compliance issues can be dealt with by way of a warning notice from the CQC.

It is anticipated that the Duty of Candour will be extended to all providers from April 2015.


Although the statutory Duty of Candour as imposed by the Regulations is currently limited to health service bodies, organisations which provide publicly-funded health or care services cannot avoid the obligation to behave with candour when things go wrong. A Duty of Candour is imposed on providers through the standard commissioning contract, and the legislation which applies to all providers registered with the CQC requires certain incidents to be notified to the CQC.

Given the “business as usual” nature of the fundamental standards beyond candour, it is perhaps surprising that they will not come into force until 1 April 2015. We will be keeping a close eye on developments and will report as and when they happen.

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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