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NATIONAL INFORMATION GOVERNANCE BOARD

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Presentation on theme: "NATIONAL INFORMATION GOVERNANCE BOARD"— Presentation transcript:

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NIGB Information Governance and Confidentiality Clinical Audit and Improvement Conference 8 - 9 February 2011 Karen Thomson Information Governance Manager NATIONAL INFORMATION GOVERNANCE BOARD

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Starting points NIGB Patients and the public have an interest in good quality health and care service provision Clinical audit is a key tool in ensuring the effective provision of good quality healthcare Informed consent and personal autonomy should underpin the provision of health and social care; NATIONAL INFORMATION GOVERNANCE BOARD Drawn from NIGB principles

3 What are we going to cover? NIGB
Information governance Legal framework Spectrum – local to national clinical audit Secure approaches for lawful and ethical processing Consent De-identification Issues Role of NIGB, ECC & 251 NATIONAL INFORMATION GOVERNANCE BOARD

4 Information governance NIGB
Information governance is the term used to describe the principles, processes, legal and ethical responsibilities for managing and handling information. It sets the requirements and standards that organisations need to achieve to ensure that information is handled legally, securely, efficiently and effectively. Information Governance Standards Framework ISB 1512 NATIONAL INFORMATION GOVERNANCE BOARD

5 Legal requirements NIGB
Legal requirements for processing confidential personal data Common law duty of Confidentiality (CLDC) Data Protection Act Human Rights Act 1998 NATIONAL INFORMATION GOVERNANCE BOARD General requirements Health warning, little in the way of directly relevant case law. Extrapolating from what case law there is so much open to interpretation. But – also have professional standards, policy and ethical dimension to consider. CLDC – obviously private in nature – necessary quality of confidence, imparted with expectation, not in public domain, damage but distress caused by breach of trust sufficent.

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Human Rights Act NIGB 8(1) Everyone has the right to respect for his private and family life, his home and his correspondence. 8(2) There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others. NATIONAL INFORMATION GOVERNANCE BOARD Human Rights Act underpins common law duty of confidentiality Schedule 1 – Articles from ECHR Article 8(2) sets out the derogations and lists a number of purposes. In accordance with the law – means that there should be protections set out in statute for such interferences [Copland v UK 62617/00 [2007] ECHR 253 (3 April 2007) URL: ]

7 Data Protection Act - 8 principles NIGB
Fairly and lawfully, schedule 2 & schedule 3; Obtained for specific purposes and only used for compatible purposes; Adequate, relevant & not excessive; Accurate; Only kept for as long as necessary for the agreed purpose; In accordance with the rights of the subject; Organisational and technical measures to protect data; Only transferred outside European Economic Area (EEA) with equivalent protections. NATIONAL INFORMATION GOVERNANCE BOARD DPA minimum framework / foundation for lawful processing but recognises may be other legal requirements that will need to be met in addition in specific circumstances and contexts. Must also meet at least one of the requirements in both Schedule 2 and at least one in Schedule 3 for confidential /sensitive personal data.

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Key points of law NIGB Need to inform patients of the purposes and disclosures before information is used Disclosure of identifiable data breaches confidentiality unless there is a legal basis Legal bases for disclosure: Statute – no specific statutory basis, but S251 patient consent public interest – test balance of public interests - should not be relied on for routine data flows de-identification NATIONAL INFORMATION GOVERNANCE BOARD No statutory support for clinical audit Public interest test has a high threshold and should not be relied on – HRA “ in accordance with the law” – common law not generally adequate safeguards should be set out in statute.

9 Approaches for processing NIGB
Consent De-identification of data prior to use S251 Which route is appropriate? Depends on the circumstances NATIONAL INFORMATION GOVERNANCE BOARD Not one answer, horses for courses what is appropriate in the particular set of circumstances PIAG guidance can be found on DH website

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Consent NIGB Consent (defined in Directive 95/46/EC) ‘The data subject’s consent’ shall mean any freely given specific and informed indication of his wishes by which the data subject signifies his agreement to personal data relating to him being processed. (Article 2(h)) NATIONAL INFORMATION GOVERNANCE BOARD

11 De-identification NIGB
Personal data “data which relate to a living individual who can be identified from those data, or from those data and other information which is in the possession of, or is likely to come into the possession of the data controller…” i.e. combination of identifying data items or other information available which makes data identifiable and therefore personal. To cease being personal data all means of identification should be removed prior to disclosure to the point of minimal risk from inference. NATIONAL INFORMATION GOVERNANCE BOARD ICO technical guidance on personal data. Reduce risk of identification to minimal level Information in the possession of likely to come into – disclosures to third parties need to be careful about what other information they may have access to.

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NIGB & ECC NIGB Role of NIGB - To promote higher standards for information governance across health and social care The NIGB’s Ethics and Confidentiality Committee advises Secretary of State on Section 251 and whether activities meet the conditions of S251 Confidential and for “medical purpose” Only for 2° use: “Not solely or principally for determining care or treatment to individuals” Must comply with DPA Must be no practicable alternative NATIONAL INFORMATION GOVERNANCE BOARD Replaced the Care Record Development Board (CRDB) and the Patient Information Advisory Group (PIAG). Advises NIGB on ethical issues and NHS & SC organisations on ethical dimension of IG issues. MoU with NRES in development

13 Application of S251 to audit NIGB
NCASP audits Need to demonstrate that identifiable data is necessary, AND That consent is not practicable because of scale or retrospective data PIAG guidance 2004 currently under review by NIGB – working with NCAAG and HQIP NATIONAL INFORMATION GOVERNANCE BOARD

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Issues NIGB Culture – implied consent can be perceived as “consent not needed” , lack of information given to patients about how their information is used. Consent - how to get the specificity balance right? Recording to facilitate implementation. De-identification – how ensure effective de- identification when disclose to 3rd parties How safeguard utility whilst also protecting patient confidentiality & the relationship of trust NATIONAL INFORMATION GOVERNANCE BOARD Consent – need to consider both purposes and disclosure Consent for what and consent for who

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Key messages NIGB Clinical audit is a secondary use Patients must be informed lawful basis for use & disclosure De-identified data – identifiability is context specific Consent – specific, informed, capacity, freely given & indicated S251 In accordance with rights of subject – opt out NATIONAL INFORMATION GOVERNANCE BOARD

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Final word… NIGB Health Bill may bring changes for some? NIGB working on advice / guidance on clinical audit, with stakeholders NATIONAL INFORMATION GOVERNANCE BOARD

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NIGB for ECC: Tel: NATIONAL INFORMATION GOVERNANCE BOARD


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