NIGB

1. NIGB NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution Break out Sessions Information Strategy & Governance NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE #NIGB #HSCIG Leeds – Birmingham - London

2. Consent for Consent An Information Governance Framework to Enable Research and Improve Patient Care Dr Murat Soncul Head of Information Governance NIGB Collaborative Workshops27-29 June 2012

3. Objectives • Introduction • Transition and empowerment • Concept and objectives • Stakeholder involvement • Key aspects • Challenges and lessons learnt • Next steps • Conclusions

4. 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 Henry Maudsley BRH in 1896 – Now the Imperial War Museum

5. 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 Centrefor Mental Health with the Institute of Psychiatry, KCL. Member of Kings Health Partners Academic Health Sciences Centre.

6. 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

7. Transition

8. Empowerment Secure Network Data Interchange with GP systems PROMs My Care Plan My Monitor Resources Diary Trust Electronic Patient Record ePJS Personal Health Record HealthVault Connection Centre Pseudonymisation Research Information System CRIS

9. Design and Governance Trust Board Strategic Steering Groups Programme Board Design Authority Caldicott CommitteeCRIS Oversight Committee ICT Security Committee Stakeholder reference groups Implementation groups Monitoring Committees

10. C4C – Concept and Objectives No 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.

11. 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.

12. 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.

13. 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

14. Next steps Review of initial results / feedback Monitoring of implementation Caldicott review Well-informed patients Appropriately trained staff

15. 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

16. Thank you! Dr Murat Soncul Head of Information Governance Murat.Soncul@slam.nhs.uk NIGB Collaborative Workshops27-29 June 2012

17. NIGB NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution Break out Sessions Information Strategy & Governance NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE #NIGB #HSCIG Leeds – Birmingham - London

18. Consent and the Information Revolution Dr Tony Calland Chairman of BMA Medical Ethics Committee and NIGB member

19. 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

20. 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 ?

21. 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?

22. 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…..

23. 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

24. Better use of quality information (2) • 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 !

25. Better use of quality information (3) • 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 .

26. 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.

27. NIGB NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution Break out Sessions Information Strategy & Governance NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE Leeds – Birmingham - London #NIGB #HSCIG

28. Cross-sector information sharing “STRIKING THE BALANCE” Practical Guidance On the application of Caldicott Guardian Principles to Domestic Violence and MARACs (Multi Agency Risk Assessment Conferences) Christopher Fincken Chairman UK Council of Caldicott Guardians

29. “STRIKING THE BALANCE” "Any fool can make things complicated, but it requires a genius to make things simple." E.F. Schumacher

30. “STRIKING THE BALANCE” “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

31. “STRIKING THE BALANCE” Who knows about us?

32. “STRIKING THE BALANCE” 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 care But Vets!

33. “STRIKING THE BALANCE” 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.

34. “STRIKING THE BALANCE” 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)

35. “STRIKING THE BALANCE” The Fourth Category – When: • No one knows • Its not clear • No one can agree Ask the Caldicott Guardian!

36. “STRIKING THE BALANCE” HIPPOCRATES OF KOS 460 BC – ca. 370 BC Doctor and Philosopher Hippocratic oath - Duty of Confidentiality History Changes but trust does not. Modern Society demands Confidentiality is no longer absolute.

37. “STRIKING THE BALANCE” Mental Capacity – 4 tests. • Understanding • Making judgements • Retaining • Communicating Capacity affected by pain, fear, love!

38. “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.

39. “STRIKING THE BALANCE” • 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.

40. “STRIKING THE BALANCE” Disclosures should be: • Relevant • Proportionate • Risk Based • Health Disclosures should come last

41. “STRIKING THE BALANCE” 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.

42. “STRIKING THE BALANCE” 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.

43. “STRIKING THE BALANCE” Assessing (Not measuring) Risk of harm CAADA 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

44. Complying with Caldicott Principles “STRIKING THE BALANCE” The 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 don’t, 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”.

45. “STRIKING THE BALANCE” Practical 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 & 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

46. “STRIKING THE BALANCE” Other Sources of Guidance Confidentiality: NHS Code of Practice Supplementary Guidance: Public Interest Disclosures http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_122031.pdf Information sharing: Guidance for practitioners and managers https://www.education.gov.uk/publications/standard/publicationDetail/Page1/DCSF-00807-2008 Co-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 : ukccgsecretariat@nhs.net Christopher Fincken can be contacted by mobile 07891 641090 or email : caldicottguardian@hotmail.co.uk

47. NIGB NIGB IG Collaborative Workshops The Reality of Delivering the Information Revolution Break out Sessions Information Strategy & Governance NATIONAL INFORMATION GOVERNANCE BOARD FOR HEALTH AND SOCIAL CARE #NIGB #HSCIG Leeds – Birmingham - London