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Who regulates health and social care

HSE is the national independent regulator for health and safety in the workplace. This includes private or publicly owned health and social care settings in Great Britain. We work in partnership with our co-regulators in local authorities to inspect, investigate and where necessary take enforcement action. Further guidance on whether work activities are regulated by HSE or the local authority can be found on our web page, Is HSE the correct enforcing authority?

There are many other bodies responsible for regulating different aspects of these sectors, many of whom have more specific powers and legislation than HSE and may therefore be in a better position to respond to patient or service user incidents or complaints. For more detailed guidance, please refer to our A-Z guide to the Health and Safety (Enforcing Authority) Regulations 1998.

Our role in patient and service user incident investigation

HSE leads on employee health and safety.  HSE may also consider investigation of patient or service user deaths or serious injuries, where there is an indication that a breach of health and safety law was a probable cause or a significant contributory factor. However, other regulators e.g. Care Quality Commission (CQC), General Medical Council (GMC) and Nursing and Midwifery Council (NMC), often have much more specific legislation, and may therefore be better placed to secure justice, or necessary improvement in standards.  The roles of these bodies are described below, where we also link to relevant agreements with them.

HSE sets out its overall public safety policy and priorities for enforcement on our website. In general we will only investigate where:

The ‘established standards’ that HSE will consider, in deciding whether investigation is appropriate, include:

‘Established standards’ will not, in general, include those which cover:

Systemic failures in management systems may include:

In general, we will not investigate where:

The policy in practice – some worked examples

The examples provided on our website illustrate how this policy works in practice in certain situations.

These will be added to over time, to help translate the overall policy and guidance into consistent decision making.

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Other regulators

Health and social care are devolved matters and there are different regulators in England, Scotland and Wales. The powers, roles, remits and ways of working of each of these regulators are all different. A brief summary of their roles and responsibilities follows. Further information can be found on their websites:

Regulators in England

CQC register and therefore license care services under the Health and Social Care Act 2009 and associated regulations. They take into account the ‘Essential Standards of Quality and Safety ’ and monitor providers to make sure they continue to comply with the requirements. CQC focuses on outcomes for people who use services and assess these using information from a wide range of sources. This includes reports of incidents, as well as information from both people who use services and that which CQC seeks directly. CQC have a wide range of enforcement powers that they can use, if they find care services are not meeting essential standards.

HSE and CQC have a Liaison Agreement which sets out a framework to ensure that both organisations share appropriate information in a timely manner and where necessary, co-ordinate their activities in relation to incidents resulting in avoidable deaths or major injuries to patients or service users. At present this agreement only covers healthcare settings regulated by CQC.

The Health and Social Care Bill 2012 introduced changes to the role of Monitor to include the responsibility to license providers of NHS services in England and exercise functions in the following areas:

Regulators in Scotland

Guidance for HSE and HIS inspectors - has been produced on working arrangements between the two organisations.

HSE has a Working Arrangements Protocol with Scottish Local Authorities and the Care Inspectorate. The aim of the agreement is to describe and promote effective working arrangements between the respective organisations.

Regulators in Wales

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UK-wide regulators

Medicines and Healthcare Products Regulatory Agency (MHRA) - The MHRA is a government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. It is an executive agency of the Department of Health. The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.

As the UK Competent Authority, the MHRA is responsible for the regulation of devices throughout the UK and for issuing Medical Devices Alerts (MDAs). In Scotland, Health Facilities Scotland (HFS), which is part of NHS Scotland, works closely with the MHRA, and will notify MHRA of each adverse incident report in Scotland and the results of any investigation. For example, HFS may identify a need for a MDA and will liaise with MHRA on the need for and drafting of the alert.

HFS, receives adverse incident reports from NHS Boards and Local Authorities. It is responsible for coordinating investigations so that, as far as possible, root causes can be established and remedial action taken to prevent or reduce any identified risks.

HSE has an agreement with the MHRA which formalises current working arrangements on matters concerning medical devices, such as: co-operating on non-fatal accident investigations; investigating fatal accidents; sharing information and awareness-raising.   

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Professional bodies

In addition to these regulators, there are also professional regulatory bodies who aim to ensure that proper standards are maintained by health and social care professionals and act when they are not. In order to practice in the UK, professionals are required to register with the appropriate body.

These bodies fulfil similar functions for different professions across the UK. Their main duties are to:

A summary of the professions covered by each body follows. For further information on their role, please check their websites:

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Healthcare Professional bodies

The work of these professional bodies is regulated by the Professional Standards Authority for Health and Social Care (previously known as the Council for Healthcare Regulatory Excellence). This authority aims to protect the health and well-being of patients and the public by scrutinising and overseeing the work of regulatory bodies that set standards for training and conduct of health and care professionals.

Social Care Professional bodies

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Further Information

Updated 2013-05-02