NIGB

Slide 1

NIGBNATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARENIGB IG Collaborative Workshops

The Reality of Delivering the Information RevolutionLeeds Birmingham - LondonBreak out SessionsInformation Strategy & Governance#NIGB #HSCIG

Consent for Consent

An Information Governance Framework to Enable Research and Improve Patient Care

Dr Murat SonculHead of Information Governance

NIGB Collaborative Workshops 27-29 June 2012

Objectives IntroductionTransition and empowermentConcept and objectives Stakeholder involvementKey aspects Challenges and lessons learnt Next stepsConclusions

Introduction- HistoryBethlem Royal Hospital founded in 1247. Oldest psychiatric institution in the world.

Maudsley Hospital founded in 1930 with 30K donation from Dr Henry Maudsley.

South London and Maudsley NHS Foundation Trust was formed in 1999.

William Hogarth - 1735

BRH in 1896 Now the Imperial War Museum

Henry Maudsley

Introduction- TodayProvider of mental health and substance misuse services from 4 hospitals and 100 community sites.

Largest provider of specialist mental health services in Europe.Jointly operates the NIHR Biomedical Research Centre for Mental Health with the Institute of Psychiatry, KCL.

Member of Kings Health Partners Academic Health Sciences Centre.

TransitionImplemented a single electronic health records system across all clinical services in 2006.

ePJSTailored to the needs of services200,000 health recordsElectronic records directly linked to legacy recordsReporting tools for better data quality, improved outcomes and regulatory compliance

CRISInformatics to make best use of clinical informationEnabling research Effective anonymisation/pseudonymisation

Transition

EmpowermentTrust Electronic Patient RecordePJSData Interchange with GP systemsResearch Information SystemCRISPROMsMy Care PlanResourcesDiaryPseudonymisationSecure NetworkHealthVaultConnection CentrePersonalHealth Record

My Monitor

Design and GovernanceTrust BoardStrategic Steering Groups

Programme Board Design Authority

Caldicott Committee CRIS Oversight Committee

ICT Security Committee

Stakeholder reference groupsImplementation groups

Monitoring Committees

C4C Concept and ObjectivesNo decisions about me without me!

To develop the pseudonymised research database (CRIS) that extracts data from electronic health records (ePJS) for non-contact research to facilitate contact research.

To design a process to seek explicit patient consent to be contacted to discuss potential participation in research study/clinical trial.

To maintain the principle of initial communication within the clinical care team.

To enable de-anonymisation in a safe haven for patients who have consented.

Key aspectsConsent for Consent is an integral part of the electronic health records system (ePJS).

Initial contact for C4C is made by the clinician who has a therapeutic relationship with the patient.

Patients specific wishes are recorded.

C4C decision revisited by the clinician during the course of care, especially when there are substantial changes to diagnosis and at discharge.

Key aspects C4C data is linked to the pseudonymised research database for translation in the safe haven.

Authorised researchers with ethics approved projects utilise the pseudonymised research database (CRIS) to identify patients that match their research criteria.

Approved researchers in SLaM only gain access to contact details of patients who have given consent.

Patients wishes are monitored.

Projects that each patient is associated with are recorded.

Key learning points and challengesInformation governance and ethics led

Regulatory approval

Clinical service ownership

Patient awareness

Guidance and training for clinical and research staff

Capacity to consent

Proxy arrangements

Monitoring to limit involvement and avoid overload

Next steps

Review of initial results / feedback

Monitoring of implementation

Caldicott review

Well-informed patients

Appropriately trained staff

Conclusions Development of an EPR that meets the requirements of the organisation Effective anonymisation / pseudonymisation that enables researchConsent and security models for complianceActive stakeholder involvement (patients, carers, clinicians, researchers and service leads)Senior management ownership Information governance is an enabler when appropriately and timely involved

Thank you!

Dr Murat SonculHead of Information Governance

[email protected]

NIGB Collaborative Workshops 27-29 June 2012NIGBNATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARENIGB IG Collaborative Workshops

The Reality of Delivering the Information RevolutionLeeds Birmingham - LondonBreak out SessionsInformation Strategy & Governance#NIGB #HSCIGConsent and the Information RevolutionIbrahim HasanAct Now Trainingwww.actnow.org.ukWHICH IS THE ODD ONE OUT?www.actnow.org.uk

www.actnow.org.ukData ProtectionBreach of ConfidenceHuman RightsFreedom of InformationThe Lawwww.actnow.org.ukWhat is Consent?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

www.actnow.org.ukImportance of ConsentClause 26 Standard Commissioning Contract

The Data Protection Act 1998

ICO Data Sharing Code

www.actnow.org.ukImportance of ConsentClause 26 Standard Commissioning Contract



www.actnow.org.ukFirst DP PrinciplePersonal data shall be processed fairly and lawfully

Schedule 2

Schedule 3

www.actnow.org.uk25Schedule 2 ConditionsConsentContractual purposesLegal obligationProtect vital interestsPublic functions justice, public duty etcLegitimate interestswww.actnow.org.uk26Schedule 3 Conditions Explicit consent Employment rights/obligations Vital interests Legitimate club use In public domain Public functions Legal proceedings/advice Medical purposes Equality Monitoring

www.actnow.org.uk27Importance of ConsentClause 26 Standard Commissioning Contract



www.actnow.org.ukWhat is Data Sharing?the disclosure of data from one or more organisations to a third party organisation or organisations, or the sharing of data between different parts of an organisation.

www.actnow.org.ukWhat is Consent?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

www.actnow.org.ukExplicit Consentconfidential or particularly sensitive information is going to be shared without a clear legal basis

the individual would be likely to object should the data be shared without his or her consent

the sharing is likely to have a significant impact on an individual/group

www.actnow.org.ukFair Processing CodeWho you areWhy you are going to share personal dataWho you are going to share it with actual named organisations or types of orgaisnationswww.actnow.org.ukCode Section 6Privacy Notices

Single or multiple?

When and who www.actnow.org.ukPAPER FORMS

I give my consent for...www.actnow.org.uk34DATA PROTECTION NOTICEWe may, from time to time, pass on your name and address to companies whose products we think will interest you. Please tick the box if you do not wish us to do so.www.actnow.org.uk35

www.actnow.org.ukTelephoneHello!

Youre through to Rupert.

Please note that calls may be recorded for

www.actnow.org.uk3738SummaryConsent:

Must be informedShould normally be explicit but can be implied (written is preferable but can be verbal)Must be willing and not inferred from a non responseMust be sought again if things change significantlyCan be withdrawn Practitioners must:

Use clear accessible languageExplain there are times when confidentiality can not be maintainedBe aware of relevant legislation Follow local policies and protocolswww.actnow.org.ukClause 60 Standard Commissioning Contractwww.actnow.org.uk7th DP PrincipleAppropriate technical and organisational measures shall be taken against unauthorised or unlawful processing of personal data and against accidental loss or destruction of, or damage to, personal data.www.actnow.org.ukwww.ActNow.org.uk

www.actnow.org.ukContracts With Data ProcessorsProcessor to act only on Controllers instructions

Mirror Controllers obligations

SecurityEmployeeswww.actnow.org.uk42More ImportantSchedule 1 Part 2 prequsites to compliance:Must be a contract in writing with processor which must state

1. Data processor only to act on instructions2. DP must be required to comply with 7 the principle:Security & reliability of staff

Biggest ICO Fine

www.actnow.org.ukThe Future of Consent?NHS Re Organisation

New EU Data Protection Regulationwww.actnow.org.uk

www.actnow.org.uk

www.actnow.org.ukGetting in Touch

[email protected]

01924 451054

@ActNowTraining

www.actnow.org.ukNIGBNATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARENIGB IG Collaborative Workshops

The Reality of Delivering the Information RevolutionLeeds Birmingham - LondonBreak out SessionsInformation Strategy & Governance#NIGB #HSCIGCross-sector information sharingSTRIKING THE BALANCEPractical GuidanceOn the application ofCaldicott Guardian Principles to Domestic Violence and MARACs (Multi Agency Risk Assessment Conferences)Christopher FinckenChairman UK Council of Caldicott Guardians

STRIKING THE BALANCE

"Any fool can make things complicated, but it requires a genius to make things simple."E.F. Schumacher

It cannot be ethically justified if we hold information that we know could prevent serious harm to others and yet knowingly decide not to share it.

Christopher Fincken - Striking the Balance



Who knows about us?Domestic Abuse Abuse & Violence Large Scale National Problem

Can be behind closed doors but agencies and individuals may also be aware.

Not just health and social careBut Vets!


MARACs (Multi Agency Risk Assessment Conferences)STRIKING THE BALANCE

Local, multi agency victim-focused meeting where information is shared on the highest risk cases of domestic abuse between different agencies including: police, criminal justice, health, child protection, housing, IDVAs (Independent Domestic Violence Advisers) as well as other specialists from the statutory and voluntary sectors. A safety plan for each victim is then created. An individuals Information can be shared only:

With Valid Consent (For Consent to be valid they must have mental capacity)

When required by Law (Mandatory)

When there is a legal gateway (Permissible)


The Fourth Category When:No one knowsIts not clearNo one can agree

Ask the Caldicott Guardian!STRIKING THE BALANCE


HIPPOCRATES OF KOS 460 BC ca. 370 BCDoctor and Philosopher Hippocratic oath - Duty of Confidentiality History Changes but trust does not.Modern Society demands Confidentiality is no longer absolute.Mental Capacity 4 tests.UnderstandingMaking judgementsRetainingCommunicating

Capacity affected by pain, fear, love!STRIKING THE BALANCE

CONSENT & CAPACITY

All information shared about both victims and perpetrators must be in the context of the normal requirements of information sharing without consent, in this case on the basis of prevention and detection of crime or serious harm.


It should be clear to all those staff involved:What information they CAN SHARE and under what circumstances.What information they CANNOT SHARE and under what circumstances.What they should do if they are NOT SURE or are challenged, who they can ask for advice and how and to whom the matter should be escalated.


Disclosures should be: RelevantProportionate Risk BasedHealth Disclosures should come last


It cannot be ethically justified if we hold information that we know could prevent serious harm to others and yet knowingly decide not to share it.


Where to strike the balance between maintaining the individuals confidentiality and privacy and wider considerations such as protection from harm, acting in what is believed to be in the individuals best interest or setting aside the interest of the individual in the interests of third parties or society at large.


Assessing (Not measuring) Risk of harmCAADA Check list 24 Questions including:Has the current incident resulted in injury? Are you very frightened? Are you feeling depressed or having suicidal thoughts?Are you pregnant or have you recently had a baby? Is the abuse happening more often?Is the abuse getting worse?Has (..) ever used weapons or objects to hurt you?Has () ever attempted to strangle/choke/suffocate/drown you?Does (..) do or say things of a sexual nature that make you feel bad or that physically hurt you or someone else? (If someone else, specify who.)Has (.) ever mistreated an animal or the family pet?Has (..) had problems in the past year with drugs (prescription or other), alcohol or mental health leading to problems in leading a normal lifeHas () ever threatened or attempted suicide?

N.B. + Respect Professional Judgement


Complying with Caldicott PrinciplesThe MARAC process to be correctly implemented must comply with ALL Caldicott Principles:

Formally justify the purpose It cannot be ethically justified if we hold information that we know could prevent serious harm to others and yet knowingly decide not to share it.Identifiable information only when absolutely necessary It is clearly necessary to use identifiable information to support MARAC processes.Only the minimum required should be used Disclosures must be proportionate and based on risk and relevance.Need to know access MARAC needs to know even if some agencies dont, confidentiality maintained by representatives personally signing specific confidentiality agreement.All must understand their responsibilities A statement should, and generally is, read out at start of each MARAC reminding participants of their ethical and legal responsibilities. Health representatives should understand and draw on this and other guidance referenced below. Caldicott Guardians as gatekeepers to the individuals information should ensure that their organisation is effectively engaged with the MARAC process.Comply with and understand the law- Caldicott Guardians should understand and authorise MARAC information sharing appropriately and where authority is delegated they should retain oversight to ensure all disclosures are Caldicott Compliant.


STRIKING THE BALANCEPractical GuidanceOn the application ofCaldicott Guardian Principles to Domestic Violence and MARACs (Multi Agency Risk Assessment Conferences)AuthorChristopher FinckenChairman UK Council of Caldicott GuardianPublished by DH & UKCCGhttp://www.dh.gov.uk/health/2012/04/striking-the-balance-guidance-on-information-sharing/

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_133589

Other Sources of Guidance

Confidentiality: NHS Code of PracticeSupplementary Guidance: Public Interest Disclosureshttp://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_122031.pdfInformation sharing: Guidance for practitioners and managershttps://www.education.gov.uk/publications/standard/publicationDetail/Page1/DCSF-00807-2008Co-ordinated Action Against Domestic Abuse (CAADA) is a national charity supporting a strong multi-agency response to domestic abuse. CAADA provides practical tools, training, guidance, quality assurance, policy and data insight to support professionals and organisations working with domestic abuse victims. The aim is to protect the highest risk victims and their children those at risk of murder or serious harmhttp://www.caada.org.uk/General Medical Council Guidance http://www.gmc.uk.org/guidance/ethical guidance/confidentiality.aspWhat about our materials? FAQs, Info sharing without consent form, representatives toolkit. Also, should we design a more tailored research form which would help inform good decision making for health professionals?-----------------------------------------------------------------------------------------------------------------------------------------------------The UK Council of Caldicott Guardians can be contacted via the Secretariat email : [email protected] Fincken can be contacted by mobile 07891 641090 or email : [email protected]


NIGBNATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARENIGB IG Collaborative Workshops

The Reality of Delivering the Information RevolutionLeeds Birmingham - LondonBreak out SessionsInformation Strategy & Governance#NIGB #HSCIG

NIGB

Documents

Transcript of NIGB