National Data Opt-out: FLS-DB

With data protection regulations, we all have a choice as to whether we want our confidential NHS information to be shared without our permission. Previously, the secretary of state for health and social care assigned an exemption based on need using a section 251 approval. However, the threshold for this has increased and now each audit must demonstrate how not having an exemption would affect data loss, delivery of direct care and data entry burden.

A major factor is the impact of the level of NDOO on the audit outcomes. The Confidential Advisory Group noted that the FLS-DB average case ascertainment was 43%. This means that missing an additional 6% of cases would not lead to exceptional harm to patient safety: ‘as the case ascertainment is so low, the arguments that the application of NDO will make a sufficiently great difference to patient safety to justify overriding the patients' expressed wish to opt-out of the use of their data is not made’. In comparison, the National Hip Fracture Database (NHFD) has nearly 100% case ascertainment and so was granted NDO exemption. The team at FLS-DB has already made an unsuccessful appeal.

We hope to support you further through our resources and live support sessions. Please get in touch if you have any questions or feedback by emailing flsdb@rcp.ac.uk.

Services should follow the guidance set out by NHS Digital. To comply with the national data opt-out policy, services should put procedures in place to review uses or disclosures of confidential patient information against the operational policy guidance, and check a patient’s opt-out status before entering their details onto the FLS-DB.

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