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

Information Governance: 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

The legal framework for disclosure of confidential information 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

Ethics & Confidentiality Committee 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 4

NIGB Data Protection Act Principles of processing include 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

The legal categories for disclosure of confidential information 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

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

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 8

NIGB Anonymisation Superficial Partial Remove name and address Also remove number identifiers Might not identify immediately but easy with other data Cannot identify from data alone Clinical, Teaching Local audit – not 2ry Plans needing postcode, Monitor attendance Train staff, Confidentiality in contracts, Local procedures, Caldicott advice NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE 9 9

Anonymisation or Deidentification NIGB Anonymisation or Deidentification DPA only applies to personal data Identifiable 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 10

Levels of Pseudonymisation NIGB Levels of Pseudonymisation Reversible (Disclosive) Irreversible (linked anon) /Unlinked Remove postcode Key code and encrypt e.g. sex, disease, hosp, ethnic, dates diag /episode, birth year Cannot identify with reasonable effort and resource ID impossible from published sources; DPA exempt National audit Research, Surveillance DH, Care quality Commission, publications IG of recipient org Risk assess links Use of RECs and ECC Small group data Inference controls NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

Deidentification governance 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

Common law duty of confidentiality 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

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

NIGB Legal Framework of information rights CDC Confidentiality DPA Data Protection HRA Privacy Patient data + Superficial and partial anon Reversible key coded - May not Irreversible/ fully anonymised NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE

Informational Risk Management 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

No practicable alternative >> Section 251 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

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

Supporting secondary uses 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 ]

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 20