What is a Regulated Activity (CQC)?

A regulated activity is a specific type of care or treatment, as defined by law, that legally requires registration with the Care Quality Commission in England. These activities impact a person’s health, safety, or well-being and include procedures like surgery, personal care, and diagnostics. Providing them without registration is a criminal offence.

If you’re setting up or running a health or social care service in England, it’s important to understand how the space is regulated, what the regulations are, and who they are enforced by. 

You might have already heard the phrase ‘regulated activity’. Any provider who engages in listed regulated activities must register with the Care Quality Commission (CQC), the independent regulator of health and adult social care in England. The CQC’s job is to ensure that services are safe, effective, caring, responsive, and well-led. But knowing exactly how this applies to you and the steps you need to take for full compliance can be a lot to add to your plate, especially when you’re juggling clinical responsibilities or launching a new service.

That’s where DKJ Support Services can help. We specialise in supporting healthcare providers with CQC compliance, registration, and bid management. Whether you’re opening a private clinic, expanding your existing services, or looking to lighten the load of regulatory paperwork, we use our real-world experience to guide you through the process with clarity and confidence. We can also help prepare your team with mock CQC inspections, giving you a practical way to assess readiness before the real thing.

In this article, we break down the essentials: what regulated activities are, who the CQC regulates, and who regulates the CQC itself.

What is a regulated activity?

A regulated activity is a type of care or treatment that you legally need permission to provide in England. If you plan to carry out these services, you must register with the CQC. 

These are activities that can affect a person’s health, safety, or well-being, so it’s important an external body like the CQC has oversight, ensuring that the service is delivered in a safe, effective way.

The CQC’s job is to make sure these activities are carried out safely and to the right standards as outlined in legislation. If you’re not registered and you offer these services, you are breaking the law.

What counts as a regulated activity?

Regulated activities are set out in law under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Here are some of the most common ones:

• Treatment of disease, disorder or injury
• Surgical procedures
• Diagnostic and screening procedures
• Personal care
• Nursing care
• Maternity and midwifery services
• Termination of pregnancies
• Management of blood and blood-derived products
• Transport services, triage and medical advice provided remotely
• Family planning services

This list is not exhaustive. The CQC website offers full details if you’re unsure whether your service is included.

Why are these activities regulated?

Regulation is there to keep people safe. It ensures that the service you’re offering meets certain standards of quality and safety. If you’re a provider, regulation gives you a clear structure to work within, and if you’re a patient or service user, it helps you know that the care you receive is being monitored by an independent body.

Who does the CQC regulate?

Types of Providers

The CQC regulates anyone who provides regulated activities. This includes individuals, partnerships, and organisations. If you fall into any of the following categories and provide any of the services listed in the previous section, you need to register:

• GP practices
• Private doctors and clinics
• NHS hospitals and trusts
• Private hospitals
• Care homes and nursing homes
• Home care providers (domiciliary care)
• Dentists (NHS or private)
• Ambulance services
• Online health services (e.g. digital prescriptions, remote consultations)
• Mental health services
• Cosmetic and aesthetic clinics offering surgical procedures
• Community health services

Individuals Who Must Register

If you run a service as a self-employed practitioner or sole trader and offer regulated activities, you will need to register. In some cases, you may also need a Registered Manager. This is someone who has day-to-day responsibility for the care and services delivered.

In many cases, especially if you’re delivering the care yourself, you will be both the provider and the Registered Manager. However, if someone else is responsible for the day-to-day running of the service – for example, a clinical director or senior nurse – that person may need to be registered as the Registered Manager. This individual is legally accountable for ensuring care is safe, effective, and meets all CQC regulations.

Larger organisations must appoint a Nominated Individual. This is the person who will represent the organisation to the CQC and take responsibility for meeting the regulations.

How do you become a Registered Manager?

To become a Registered Manager, you need to apply to the CQC as part of the registration process for a regulated activity. A Registered Manager is the person who is responsible for the day-to-day running of the service, making sure that care is safe, well-led, and meets the required standards.

The registration process will look at the following criteria, assessing your:

• Relevant experience. You should have practical experience in managing or delivering care. For clinical services, this often includes a background in nursing, healthcare management, or another relevant field.
  
• Qualifications. While formal qualifications aren’t always required, having a health or social care management qualification (such as a Level 5 Diploma in Leadership for Health and Social Care) strengthens your application.
  
• Disclosure and Barring Service (DBS) check. You must pass a criminal record check to ensure you’re suitable for the role.
  
• Application form. You’ll complete a Registered Manager application as part of the CQC provider registration process. This includes details about your background, training, and understanding of the regulations.
  
• Interview performance. The CQC may carry out a ‘fit person’ interview to assess your knowledge, leadership skills, and understanding of your responsibilities.
  

Once approved, your name will be included on the registration, and you’ll be legally accountable for ensuring the service meets CQC standards.

How do you become a Nominated Individual?

A Nominated Individual is someone appointed by an organisation to act as the official contact between the provider and the CQC. This person must have the authority and oversight to ensure that the provider is meeting its legal obligations.

To become a Nominated Individual, you must:

• Hold a senior role. You’ll usually be a company director, partner, chief executive, or someone with overall responsibility for care services.
  
• Be formally appointed by the provider. The provider will name you as the Nominated Individual in their registration application or when updating their registration.
  
• Complete a section in the registration form. You must provide personal and professional details, explain your role, and show how you oversee the quality and safety of the services.
  
• Pass a DBS check. Like Registered Managers, Nominated Individuals must undergo a criminal background check. They are accountable to the CQC and may be contacted directly during inspections or investigations.

Is registration optional?

You can’t legally operate a service that carries out regulated activities without CQC registration. If you do, you could face:

• Fines up to £4,000
• Criminal prosecution
• Enforcement action, including closure of the service

Registration is your legal licence to provide care.

Who regulates the CQC?

You might be wondering, “If the CQC checks on us, who checks on them?”

The CQC is an independent regulator, but that doesn’t mean it’s above scrutiny. It is accountable to:

• UK Parliament
• Department of Health and Social Care (DHSC)
• Health and Social Care Select Committee
• National Audit Office (NAO)

These organisations make sure the CQC does its job properly, spends public money wisely, and continues to protect people receiving care.

What do these public bodies do?

Parliament’s role may be self-explanatory as the ultimate authority for laws and regulations in the UK, including the framework that the CQC must follow, but it does not typically involve itself in day-to-day inspections. Instead, it ensures that the rules governing health and social care are up-to-date, effective, and fair, with the ability to ask questions or launching parliamentary inquiries if there are concerns.

Oversight usually falls upon the other bodies listed:

• Department of Health and Social Care (DHSC) – The DHSC oversees health and adult social care policy in England, setting the overall strategic direction for the CQC and monitoring its performance from a government level. The CQC is required to report regularly to the DHSC on its work, including how it inspects services, enforces regulations, and uses its funding. Although the CQC is independent, this body ensures that it stays aligned with national health priorities and operates within its remit.
  
• Health and Social Care Select Committee: Made up of Members of Parliament, this committee is responsible for holding both the CQC and DHSC to account. They do this by reviewing how well the CQC is performing, especially in response to public concerns, scandals, or changes in policy. The committee can summon CQC leaders to give evidence, question decisions, and recommend improvements. It acts as a direct line between the public and Parliament, making sure issues raised by patients, families, or care staff are properly examined.
  
• National Audit Office (NAO): As the public spending watchdog, NAO audits how public money is used by organisations like the CQC. Its job is to check whether the CQC is delivering value for money – in other words, whether it is spending taxpayers’ money wisely, efficiently, and effectively. If the NAO finds that funds are being mismanaged or that processes are not working well, it publishes reports and makes recommendations to Parliament.
  
• Parliamentary and Health Service Ombudsman (PHSO): The PHSO steps in when someone feels they have been treated unfairly or suffered injustice because of how the CQC handled a complaint or process. For example, if someone complains to the CQC and believes the response was inadequate, they can escalate it to the Ombudsman. The Ombudsman is independent and investigates whether the CQC followed proper procedures. This adds another level of accountability and offers the public a way to challenge poor service.

So, although the CQC is independent in its inspections and decisions, it is still under tight scrutiny to make sure it works fairly and effectively.

Frequently Asked Questions (FAQs)

Do I need to register with the CQC?

If you carry out a regulated activity in England, then yes, you need to register. It doesn’t matter whether you work privately or for the NHS.

What happens if I don’t register?

Running a service without registration is illegal. The CQC can fine you, close your service, or prosecute you in court.

Can I register as an individual?

Yes. If you’re a sole trader or practitioner delivering regulated activities, you must register. You may also need to appoint a Registered Manager.

How long does CQC registration take?

It can take several weeks, depending on how complex your service is. You’ll need to provide documents, undergo background checks, and demonstrate how you’ll meet regulations.

Is registration different for private and NHS services?

No. The rules are the same. If you carry out a regulated activity, whether privately or through the NHS, you must register.

Can I appeal a CQC decision?

Yes. You can challenge inspection findings through the factual accuracy process or appeal certain enforcement actions to the First-tier Tribunal.

How often does the CQC inspect services?

It depends on the level of risk or previous inspection ratings. If concerns are raised, they may inspect sooner. Inspections can be announced or unannounced.

What are the CQC’s fundamental standards?

These are the basic standards of care that must never be broken. They include:

• Safe care and treatment
• Dignity and respect
• Consent to care
• Safeguarding from abuse
• Clean and suitable premises
• Staff training and oversight

Navigating CQC Compliance with DKJ Support Services

Deciphering CQC regulation can feel overwhelming, especially if you’re trying to focus on delivering excellent care. That’s where we come in.

At DKJ Support Services, we use our real-world experience in primary care and private clinical practice to help you get registered, stay compliant, and reduce the weight of CQC compliance and other vital admin tasks like bid management. We’re not your typical consultants but rather experts from experience: we’ve lived it, worked it, and understand what’s on your plate.

Whether you’re setting up a clinic, expanding your services, or just want to get things right the first time – we’re here to help.

Let us take care of the paperwork, so you can take care of your patients.

Sources:

• Care Quality Commission (Registration) Regulations 2009
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
• CQC – Regulated activities
• CQC – Registration
• CQC – Regulations for service providers and managers
• Health and Social Care Committee
• National Audit Office, historical audit reports (c. 2015)
• Parliamentary and Health Service Ombudsman