7. Policy considerations for specific organisations or purposes

The following policy statements apply to data processing in support of payments and invoice validation:

• Unless there is no alternative, data flows for payments and invoice validation should not use identifiable data. In such cases anonymised data can almost certainly be used and national data opt-outs would not apply - provided data is anonymised in line with the ICO Code of Practice on Anonymisation.
• National data opt-outs do not apply where a patient has given their explicit consent for the use of their data for payment and invoice validation. All organisations within health and adult social care should be as transparent as possible as to how confidential patient information is being disclosed for payment purposes in order to better manage patient expectations.

• In accordance with the recommendations made in the NDG review, national data opt-outs do not apply to data disclosed for the purpose of non-contracted invoice validation (non-contracted activity refers to services delivered by a health or care provider, where there is no agreed contract with the patient’s responsible commissioner e.g. a patient receiving treatment in area that is outside of the CCG area where they are registered).
• National 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 the National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018
• National data opt-outs only apply to data disclosure for payment purposes which rely on S.251 support unless the standard condition requiring patient opt-outs to be respected is waived.

NHS England have a S.251 approval (CAG 7-07(a-c)/2013) in place covering data flows for invoice validation to Controlled Environments for Finance within CCGs and Commissioning Support Units. For more information and advice on applying national data opt-outs in relation to this S.251 approval see NHS England’s website.

The national data opt-out does not apply to data disclosures for risk stratification for case finding but does apply where support under S.251 of the NHS Act 2006 is relied upon to support the disclosure.

The NDG review considered risk stratification for case finding and risk stratification for planning as two separate functions. The Review goes on to state that: “risk stratification for case finding, where carried out by a provider involved in an individual’s care or by a data processor acting under contract with such a provider, should be treated as direct care for the purpose of the opt out (and therefore should not be subject to the opt out of personal confidential data being used for purposes beyond direct care)”.

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, (or by a data processor acting under contract with such a provider) 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 only apply to data disclosures for risk stratification which rely on S.251 support unless the CAG approval letter states that the national data opt-out should not apply (the assumption being that if section 251 approval is required, this could not be considered as an individual, or direct, care purpose.

National data opt-outs apply where confidential patient information about an individual’s health and adult social care provided in England is disclosed outside of England in line with the wider policy and is shared using section 251 support.

This includes information disclosed to the home nations, that is Wales, Scotland, Northern Ireland, the Isle of Man or Channel Islands but also other countries, for example where data is disclosed with S.251 support for research purposes.

Where researchers need to identify people to participate in research studies, the national data opt-out may apply to this process depending on the mechanism used to identify potential research subjects.

In certain scenarios, researchers may need to access confidential patient information to identify people with particular conditions or characteristics to invite them to take part in clinical trials and other interventional studies. This process is often referred to as seeking “consent for consent”. There are a number of established mechanisms for identifying potential research subjects which are set-out in the 2013 IG Review and the application of the national data opt-out to each of these is summarised below:

The national data opt-out does not apply to confidential patient information flowing to Public Health England (PHE) under the following approvals:

• National Cancer Register (PIAG 03(a)/2001);
• National Congenital Anomaly and Rare Diseases Register (CAG 10-02(d)/2015).

These national disease registers continue to operate separate opt-out mechanisms. For further information, see the National Cancer Registration and Analysis Service and National Congenital Anomaly and Rare Disease Registration Service websites. Data should continue to flow to PHE in full under these approvals as these specific opt-outs are registered directly with PHE and are applied by PHE on landing.

In addition to the specific national disease register opt-outs PHE also applies national data opt-outs to its onward releases of data from the national disease registers to other organisations in line with the national data opt-out policy.

The national data opt-out does not apply to data flowing into the Office for National Statistics (ONS) solely for the production of official statistics.

The NDG review recognised the importance of maintaining the integrity of official statistics and for this reason it did not make “data flows into the ONS for the production of official statistics part of the proposed opt-out”.

The ONS has a range of legal gateways that it can use to access data for statistical purposes under the Statistics and Registration Service Act 2007, as amended by the Digital Economy Act 2017. The national data opt-out does not apply to data accessed by ONS for the production of official statistics, specifically:

• national data opt-outs do not apply to confidential patient information flowing into ONS under section 45A – section 45C of the Statistics and Registration Service Act 2007 (as inserted by the Digital Economy Act 2017) for the production of official statistics.
• national data opt-outs do not apply to patient registration information disclosed to ONS under section 43 of the Statistics and Registration Service Act 2007 because this is not confidential patient information.

The application of the national data opt-out to any disclosures of confidential patient information to the ONS for any other purposes (for example, research) and which are not for the production of official statistics will be considered in line with this policy, taking into account the legal basis for satisfying the common law duty of confidentiality for the data flow (i.e. the opt out will apply where data is used with Section 251 support.)

The national data opt-out does not apply to disclosures of confidential patient information for the purpose of allowing participation in National Screening Programmes endorsed by the UK National Screening Committee.

The NDG review took a specific position on population screening programmes: “Some uses of information for public health purposes can be seen as direct care, that is where they relate to the care of an individual. This includes the oversight and provision of population screening programmes”.

For the avoidance of doubt national data opt-outs do not apply to confidential patient information flowing under the following approvals:

• NHS Breast, Bowel and Cervical Cancer Screening Programmes (15/CAG/0207)
• NHS Abdominal Aortic Aneurysm Screening Programme (ECC 3-04(o)/2011)

These screening programmes continue to operate separate opt-out mechanisms for patients who do not wish to be invited for screening.

Public Health England (PHE) is responsible for the national coordination and quality assurance of the population screening programmes.

PHE applies national data opt-outs to its onward releases of data from the national screening programmes to other organisations in line with the national data opt-out policy.

The national data opt-out does not apply to confidential patient information about people with learning disabilities and/or autism who are in hospital for their mental health or due to challenging behaviour which is disclosed under the following approval:

• Assuring Transformation: Enhanced Quality Assurance Process Data flow (CAG 8-02 (a-c)/2014).

These flows continue to operate a separate opt-out mechanism and details of how to opt-out of the Assuring Transformation data collection can be found on the NHS England webpages. This exemption is time limited until the end of the “Building the Right Support Programme”.

The national data opt-out does not apply to the National Cancer Patient Experience Survey (CPES), Under 16 Cancer Patient Experience Survey (U16 CPES), National Diabetes Experience Survey (NDES), or CQC NHS Patient Survey Programmes. These will continue to run unaffected, subject to S251 and other relevant approvals, under their current arrangements.

These national surveys will continue to operate separate opt-out mechanisms and details of how to opt out of these surveys are provided by the organisations undertaking the surveys, typically locally, for example posters in A&E for opting out of the A&E survey.

The policy for the application of national data opt-outs to data flows into and out of NHS Digital (formerly known as the Health and Social Care Information Centre (HSCIC)) is as follows. It should be noted that these recognise NHS Digital’s role as the national safe haven and the specific powers it has under the Health and Social Care Act 2012:

7.10.1: Data flows into NHS Digital

National data opt-outs do not apply to flows of data into NHS Digital where these are required under s259 of the Health and Social Care Act 2012 following a Direction from Secretary of State or NHS England or a mandatory request.

This was supported by the NDG Review:

“The Review proposes that personal confidential data should be passed to the HSCIC, as the statutory safe haven of the health and social care system, to de-identify or anonymise and share it with those that need to use it. If HSCIC were able to disseminate high quality anonymised data based on a complete dataset, it would reduce the need for these organisations to access personal confidential data. For that reason the Review recommends that, in due course, the opt-out should not apply to any flows of information into the HSCIC”.

NB: Where S. 251 support is relied on for flows of data into NHS Digital they will be subject to the national data opt-out.

7.10.2: Disclosures by NHS Digital

National data opt-outs do apply to disclosures of confidential patient information by NHS Digital in line with this policy.

7.10.3: Return of data to submitting organisation

National data opt-outs do not apply to data disclosed by NHS Digital in accordance with section 261(4) of the 2012 Act where NHS Digital is disclosing confidential patient information to the organisation from whom NHS Digital originally collected the confidential patient information.

Specifically, this covers data returned to the submitting organisation providing no additional confidential information is supplied. For example, the return of Secondary Uses Service (SUS) data to providers. Additional information which is not confidential and which the submitting organisation would be permitted to receive includes items derived or calculated from the submitted information such as age or CCG of residence.

7.10.4: Open data and publications

National data opt-outs do not apply to open data or statistics published by NHS Digital where this is subject to disclosure controls and is fit for publication.

Such data is deemed to be anonymous and individuals cannot be identified.