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Confidential patient information and the regulations

Last updated on 17 Oct 2022

What is confidential patient information and why is it used?

Confidential patient information is a legal term defined in Section 251 of the NHS Act 2006. It applies to both living and deceased patients and meets the definition if all of the following apply:

  • the information is identifiable or likely to be identifiable - this is determined on a case-by-case basis but can include identifiers such as:
    • NHS number, name, address and date of birth, or
    • where the activity requires information on rare illnesses that could potentially identify a patient or
    • where the patient could be identified from other data likely to be held by the person or organisation receiving the data
  • the information was provided under circumstances where the individual is owed an obligation of confidence
  • conveys information about the physical or mental health or condition of an individual, a diagnosis of their condition, or information on their care or treatment

Under the common law duty of confidentiality, if information is given in circumstances where it is expected that a duty of confidence applies, that information cannot normally be disclosed without patient consent.

However, there are certain circumstances when confidential patient information can be used for the benefit of research and other important activities without patient consent. An alternative legal basis is required which is commonly Section 251 support. You can find examples of activities relying on Section 251 support in our registers of approved applications.

What is Section 251?

This is a shorthand term and refers to section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002.

Section 251 was established as it was recognised that there were essential activities of the NHS, and important medical research, that required the use of confidential patient information where it was not possible to use anonymised information and obtaining consent was not practical.

Section 251 allows the common law duty of confidentiality to be lifted temporarily to enable disclosure of confidential patient information for medical purposes. Whilst it is commonly referred to as ‘Section 251’ support, support is actually given under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002. Therefore, they are same thing.

What does Section 251 support mean?

CAG reviews research and non-research applications and advises under the framework of the Health Service (Control of Patient Information) Regulations 2002. They will consider whether there is sufficient public interest to temporarily lift the common law duty of confidentiality and enable access to the requested confidential patient information. Using the CAG advice as a basis for their consideration, the following bodies act as the decision maker on whether Section 251 support can be provided:

Data dissemination

The Health and Social Care Act 2012 (as amended), states that NHS Digital must pay careful attention to CAG advice on data dissemination.

In turn, CAG considers advice requests from NHS Digital in relation to its dissemination framework, more information on which can be found on the NHS Digital website.

All of the advice we give to NHS Digital is available in our minutes.

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