NIGB NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution

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NIGB IG Collaborative Workshops

The Reality of Delivering the Information Revolution

Leeds – Birmingham - London

Break 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

– Introduction– Transition and empowerment– Concept and objectives – Stakeholder involvement– Key aspects – Challenges and lessons learnt – Next steps– Conclusions

Introduction- History

Bethlem 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 MuseumHenry Maudsley

Introduction- Today

Provider 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.

Transition

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

ePJS– Tailored to the needs of services– 200,000 health records– Electronic records directly linked to legacy records– Reporting tools for better data quality, improved outcomes and

regulatory compliance

CRIS– Informatics to make best use of clinical information– Enabling research – Effective anonymisation/pseudonymisation

Transition

Empowerment

Trust Electronic Patient RecordePJS

Data Interchange with GP systems

Research Information SystemCRIS

PROMs My Care Plan Resources Diary

Pseudonymisation

Secure Network

HealthVaultConnection Centre

PersonalHealth Record

My Monitor

Design and GovernanceTrust Board

Strategic Steering Groups

Programme Board Design Authority

Caldicott Committee CRIS Oversight Committee

ICT Security Committee

Stakeholder reference groups

Implementation 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 aspects

Consent 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 challenges• Information 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 research

– Consent and security models for compliance– Active 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 2012

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Consent and the Information Revolution

Dr Tony Calland

Chairman of BMA Medical Ethics Committee and NIGB member

Consent

Full explicit consent Implied consent through “fair processing” Linked consent through NHS Constitution Consent should be informed. Consent may be subject limited, time limited Dissent must be allowed

The Information Revolution

Right information, right person, right time Connecting and joining up systems Better use of quality information Culture of openness and transparency Who stands up for “privacy” Will public trust be eroded ?

Right information, right person, right time

What is right information? – Patient expectations– Is this the entire medical record? – Who decides – patient or clinician?– Currently implied consent – different consent

model needed for wider sharing? Who is the right person?

– Individual clinician or wider healthcare team including administrators?

Connecting and joining up systems

Clear benefits of greater sharing – seamless care

Electronic shared records – Consent model? Joining up beyond healthcare – e.g. social

care and beyond…..

Better use of quality information (1)

Commissioning – key feature of H&SC Act– Blur between primary and secondary uses– Sharing across whole CCGs?– Unclear what data are needed. – Lack of clarity as to the legal basis for data use


Risk Stratification– Predicting which patients are at high risk of

hospital admission– Primary or secondary use – should patient

consent be obtained for processing? – Consent essential if healthcare beyond the

primary care team is being used– Patients should NEVER be surprised !


Research– Support data for research purposes but must not

undermine confidentiality– Use anonymised data or seek consent or s251– Evidence shows that patients want to be asked re

use of identifiable data for research– Patients must have the right to dissent from their

records being used for research and their decision recorded .

Culture of openness and transparency

Support transparency agenda Risks to confidentiality even if identifiers are

removed and when databases are linked Support new de-identification standard – processes

to ensure effectively anonymised. Future data mining technology and linkage

techniques need to be understood and risks and benefits assessed to protect patient trust.

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Cross-sector information sharing

“STRIKING THE BALANCE”

Practical GuidanceOn the application of

Caldicott Guardian Principles to Domestic Violence and MARACs

(Multi Agency Risk Assessment Conferences)

Christopher FinckenChairman UK Council of Caldicott Guardians


"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)


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:

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

2. When required by Law (Mandatory)

3. When there is a legal gateway (Permissible)


The Fourth Category – When:• No one knows• Its not clear• No one can agree

Ask the Caldicott Guardian!



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.1. Understanding2. Making judgements3. Retaining4. Communicating

Capacity affected by pain, fear, love!


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: • Relevant• Proportionate • Risk Based• Health 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 life• Has (……) 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:

1. 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.

2. Identifiable information only when absolutely necessary – It is clearly necessary to use identifiable information to support MARAC processes.

3. Only the minimum required should be used – Disclosures must be proportionate and based on risk and relevance.

4. Need to know access – MARAC “needs to know” even if some agencies don’t, confidentiality maintained by representatives personally signing specific confidentiality agreement.

5. 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.

6. 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 BALANCE” Practical Guidance

On the application ofCaldicott Guardian Principles

to Domestic Violence and MARACs (Multi Agency Risk Assessment Conferences)

Author

Christopher FinckenChairman UK Council of Caldicott Guardian

Published by DH & UKCCG

http://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.pdf Information 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 harm

http://www.caada.org.uk/ General Medical Council Guidance http://www.gmc.uk.org/guidance/ethical guidance/confidentiality.asp What 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]


http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_122031.pdf

https://www.education.gov.uk/publications/standard/publicationDetail/Page1/DCSF-00807-2008

http://www.caada.org.uk/

http://www.gmc.uk.org/guidance/ethical

mailto:[email protected]

mailto:[email protected]

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Documents

NIGB NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution