National Data Opt-Out Programme

Introduction

The National Data Opt-Out (NDO) is a service to allow individuals to choose in specified circumstances if data from their NHS health record is shared for healthcare research and planning. This can include to plan and improve health and care services; and research and development in to cures for serious illnesses. It was introduced in 2018 to implement the opt-out process proposed by the National Data Guardian’s Review of Data Security, Consent and Opt-Outs. 

A patient is able to set an opt-out via a number of channels that include online, digitally assisted and non-digital channels. Any patient with an NHS number is able to set a National Data opt-out. The opt-out is stored in a central repository against their NHS number on the NHS Spine and is not set or visible to the GP practice. The National Data opt-out will also continue after the patients’ death. The opt-out applies regardless of how the data is stored – electronically or paper based.

To find out more about the benefits of data sharing, how your data is protected and more about your choice visit the your NHS data matters website.

Further National Data Opt-Out information is also available from NHS Digital. 

How to opt out or update your choice

Patients who decide they do not want their confidential patient information used for planning and research purposes can make an informed choice and set (or change) their national data opt-out themselves. The practice cannot set or view this on your behalf. 

If you choose to opt-out you can follow the process by visiting the your NHS data matters website or call 0300 303 5678.

How the national data opt-out is applied

Health and care organisations are required to apply national data opt-outs in line with the NHS National Data Opt-Out Policy.

NHS Digital has developed a technical service which enables health and adult social care organisations to check if their patients have a national data opt-out in order to enable them to comply with the opt out.

This service can be used in two ways:

• Organisations can submit a list of NHS numbers that they need to disclose and the service looks these up against the central repository of national data optouts. It returns a “cleaned list” of those that do not have a national data opt-out i.e. it removes the NHS numbers for those with a national data opt-out. This is most suitable for one-off and infrequent disclosures of data.
• Organisations can submit the NHS numbers for all patients with whom they have a legitimate relationship and then store temporarily the list of patients who do not have an opt-out at the current time and whose data they may be able to disclose. There are a number of policy rules around the storage and use of this “temporary cache” of data which are set out below. This is most suitable for large scale and frequent disclosures of data.

What data is affected?

Broadly it is data that meets all of the following three conditions:

• a) identifiable or likely identifiable (for example from other data likely to be in the possession of the data recipient);

AND

• b) given in circumstances where the individual is owed an obligation of confidence;

AND

• c) conveys some information about the physical or mental health or condition of an individual, a diagnosis of their condition; and/or their care or treatment.

The opt-out does not apply to data that has been anonymised in line with ICO guidance. It is also worth noting that the opt-out only applies to patient data. It covers any and all data that is disclosed for purposes beyond direct patient care.

Invoice validation

Broadly, the opt-out does not apply to data used for invoice validation. Specifically, it does not apply to invoice validation for non-contracted activity. For contracted activity, anonymised data should be used. The opt-out does not apply where a patient has given their explicit consent for the use of their data for payment and invoice validation.

Data opt-outs do not apply to data disclosed to NHS BSA for the payment of prescription charges, specifically where the data is disclosed under Regulation 18A of National Data Opt-out Operational Policy Guidance Document.

The opt-out does apply to data disclosed for payment purposes which rely on section 251 support unless it relates to non-contracted activity or specific conditions have been approved by the Confidentiality Advisory Group (CAG).

Risk stratification

The national data opt-out does not apply to data disclosures for risk stratification for case finding but does apply where support under Section 251 is relied upon to support the disclosure.

For the purpose of the National Data Opt-Out, risk stratification has been split into two functions, Risk Stratification for case finding and Risk Stratification for planning. Therefore the policy lines that are relevant to risk stratification are as follows:

• National data opt-outs do not apply to risk stratification for case finding, where carried out by a provider involved in an individual’s care, as this should be treated as individual care.
• National data opt-outs do not apply where the data for risk stratification is anonymised in line with the ICO Code of Practice on Anonymisation.
• National data opt-outs do apply to data disclosures for risk stratification which rely on Section 251 support unless the standard condition requiring patient opt- outs to be respected is waived.

What data is not affected?

Consent

The national data opt out does not apply where explicit consent has been obtained from the patient for the specific purpose. This can include if a patient has previously opted- out but wishes for that data to be processed for a specific purpose. The consent would override the national data opt-out and data could be processed for that specific purpose only. Other information that is applicable under the opt-out and is not covered by the explicit consent would still be subject to the opt-out if applied.

Communicable disease and risks to public health

The national data opt-out does not apply to the disclosure of confidential patient information required for the monitoring and control of communicable disease and other risks to public health. This includes any data disclosed where Regulation 3 of The Health Service Regulations 2002 provides the lawful basis for the common law duty of confidentiality to be lifted. 

Public interest

The national data opt-out does not apply to the disclosure of confidential patient information where there is an overriding public interest in the disclosure, i.e. the public interest in disclosing the data overrides the public interest in maintaining confidentiality.

Direct care

The national data opt-out does not apply to direct care as defined in Section 251.