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NIGB

NIGB. Confidential Patient Information – Governance of secondary uses Dr Andrew Harris Chair – Ethics and Confidentiality Committee. NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE. NIGB. Information Governance:

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NIGB

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  1. NIGB Confidential Patient Information – Governance of secondary uses Dr Andrew Harris Chair – Ethics and Confidentiality Committee NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  2. NIGB Information Governance: “The structures, policies and practice used to ensure the confidentiality and security of health and social care records, especially clinical records, and to enable use of them for the benefit of the individual to whom they relate and for the public good” NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  3. NIGB The legal framework for disclosure of confidential information Confidentiality - Common law duty of confidentiality (CLDC) Fair Processing - Data Protection Act 1998 (DPA) Privacy - Human Rights Act 1998 (HRA) NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  4. NIGB • Ethics & Confidentiality Committee • Advises whether disclosures of identifiable data meet conditions of s 251 NHSA 2006 • Advise SoS - set aside legal risk of breach of CLDD • 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 FOR HEALTH AND SOCIAL CARE 4

  5. NIGB Data Protection Act Principles of processinginclude Inform patients record may be used for secondary purpose and can dissent Docs/trusts must formally authorise disclosure Must respect law eg CLDC, HRA Processors’ “equivalent” duty of confidentiality Conditions for sensitive personal data include Explicit consent “Medical purposes” NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  6. NIGB The legal categories for disclosure of confidential information Court order Statutory power Patient consent Public interest Anonymisation For secondary uses only:s251 statutory power NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  7. NIGB • Consent • Consent to treat explicit or implied • Makes disclosure legal,but no right • Temporary GP staff to anonymise or to get consent – no implied consent as CLDC • Impossible sometimes – scale, bias, health • Variety of guidance in research world • Not consenting damages trust in doctors/NHS • Ethics values autonomy – no override • Diluted: Broad, Group, Opt out, authorisation • If ID data and cannot consent, safest >>> s251 NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  8. NIGB • Public interest • Common law - to prevent crime or harm • In Scotland no s251 - some disclosures use this basis for research • In England insecure, as s251 exists and ECC advice will lower risk for patients • s 251: either improving patient care or PI - “A system which all reasonable individuals approve” • Balance benefits and risks: Exempting from CLDC needs v low risk of harm NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE 8

  9. NIGB Anonymisation NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE 9

  10. NIGB Anonymisation or Deidentification DPA only applies to personal dataIdentifiable from data held or likely to come into possession Adequate anonymisation exempts ID conceivably possible, but unlikely, with sufficient effort reasonably used (ICO interpretation DPA) Risk of ID does not affect professional conscience (CLDC) Level of security from technological treatment or handling of data appropriate to harm that might result from its release (7th data principle) NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE 10

  11. NIGB Levels of Pseudonymisation NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  12. NIGB Deidentification governance Public sceptism and re-identification risk NHS pilots and toolkit, Standards Board, Information Commissioner Parallel with mainstreaming evidence based medicine in ‘80s Apply academic computer science Health professional Caldicott responsibility NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  13. NIGB • Common law duty of confidentiality • Obviously private to a reasonable person of ordinary sensibilities if in the same position • Affects conscience of person who receives info in knowledge communicated in confidence • Detriment including damage to trust NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  14. NIGB • Human Rights Act 1988 • Duties on public bodies to uphold ECHR • A8 Respect for private, family life, home, correspondence • Interference necessary for… protection of health.. proportionate to harm • Should not stop disclosures otherwise OK(if ethical, scrutiny of unique, or v sensitive data, and inferential risk, even though de-identified) NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  15. NIGB • Legal Framework of information rights NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  16. NIGB Informational Risk Management Importance of purpose Nature of data (how sensitive) Nature of recipient (outside NHS) Appropriateness of sharing data to recipient IG of recipient organization (corporate, Caldicott) Restrictions on usage in contract Data Sharing Agreements Scope of data (minimum for purpose) Legal risk (police, potential harm, A8??) Adherence to guidelines (GMC, REC, ECC) NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  17. NIGB • No practicable alternative >> Section 251 • Specific regs: cancer and communicable disease • Class: anon, to consent, geog, linking, audit/analysis • Confidential patient info’ – ID ascertainable even with other info likely to come into possession of processor • Medical purpose necess / expedient in the interests of improving patient care or in the public interest • Only if not reasonably practicable to achieve in other way, having regard to cost and technology available • Maximum anonymity requirement NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  18. NIGB • Public Opinion • Surveys • Support research but why and integrity • REC+ECC approval 46% never 30% maybe • Need surveys which objectively assess risk • Find basis for reasonable expectation in CLDC • Can’t imply consent without evidence • Awareness and debate to change opinion • Trust in doctors: public interest to preserve NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  19. NIGB • Supporting secondary uses • ECC not regulator but governance and legal advice • ECC advises SoS - must operate within law • Interpretation – reas practicable test, equiv duty, PI • 100 applctns/yr (40/7) Fast track (15 – 20 days) • ? New regulations - honest brokers, commissioning, national audit • More anonymisation; raise IG profile, new standards • Duty to balance preservation of public trust in records custodianship with other public needs NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

  20. NIGB Ethics and Confidentiality Committee www.nigb.nhs.uk/ecc Tel: 020 7633 7052 NIGB nigb@nhs.net ECC eccapplications@nhs.net Chair ECC chairecc@adrharris.co.uk NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE 20

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