Opt-outs and section 251
Two distinct beyond-care opt-outs
Type 1 opt-out
A Type 1 opt-out is recorded at the GP practice/system and prevents identifiable GP record data leaving the GP IT system for purposes beyond direct care. It remains part of the current opt-out landscape while reform options are being developed. It is distinct from a national data opt-out and must be tested before a primary-care extraction. SRC-007 SRC-033
National data opt-out
The national data opt-out applies to many uses or disclosures of confidential patient information beyond individual care in England. It generally does not apply to ordinary individual care, properly anonymous information, uses based on explicit patient consent, mandatory legal requirements, or a qualifying overriding-public-interest case. Applicability and any exemption must be checked against current operational policy. SRC-009
The opt-out is a choice mechanism, not an Article 6 lawful basis and not confidentiality authority. The DCB3058 standard makes operational compliance a scoped information-standard requirement. SRC-021
Type 1 and national data opt-outs operate at different points and can both matter. Record each result separately; do not assume one check substitutes for the other.
Section 251/COPI route
NHS Act 2006 section 251 enables regulations to set aside confidentiality obligations for defined medical purposes where anonymised information is not practicable and the statutory criteria are met. The Control of Patient Information Regulations 2002 implement routes including support subject to approval and conditions. SRC-008 SRC-030
A proposal must record:
- the precise approved purpose and regulation;
- why consent or anonymous information is not practicable;
- the approval body, reference, duration and conditions;
- data items, recipients and security controls;
- national data opt-out application;
- review, expiry and deletion.
Do not carry section 251 support into a new purpose, recipient, dataset or period without validation.