National data opt-outs: How does this apply to CRANE?
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The national data opt-out service allows patients to opt-out of their confidential patient information being used for purposes other than their immediate clinical care. All NHS organisations are required to be compliant with the national data opt-out policy.
Guidance on the deadline for compliance and how to comply is provided on the NHS website: https://digital.nhs.uk/services/national-data-opt-out/operational-policy-guidance-document/compliance-with-the-national-data-opt-out
For national clinical audits such as the CRANE, where families consent to the audit function of CRANE, and registry information is collected with Section 251 approval:
1. Cleft services are advised to continue to verify the consent status of patients, to be able to collect both registry and audit (outcomes) information – as detailed in our information leaflets.
- In addition, the withdrawal of patients’ consent can be implemented at any time by changing the patient’s consent status to ‘No’.
2. An important consideration for cleft services is to remember that CRANE also has a registry function.
- Therefore there is a minimum dataset that CRANE is allowed to collect, on all children born with a cleft, under our Section 251 approval. For a reminder of these data items please consult the CRANE Data Dictionary found in the Resources section of this website.
- Nevertheless, if the parent chooses to opt-out of their child’s confidential patient information being used for purposes other than their immediate clinical care, none of the child’s data should be recorded in CRANE – this includes both registry and audit data.
Please see the flow diagram below for a visual representation of the information above.
You can also download our user guide about the National Data Opt-out.
If you would like further information on how cleft services can ensure they are compliant with the national data opt-out, specifically with regard to the CRANE, please do contact us with your questions.
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