1. CONFIDENTIALITY & PRIVACY IN HEALTHCARE CONFIDENTIALITY & PRIVACY IN HEALTHCARE Ethics & Law Paquita de Zulueta. Apothecaries 2015

2. AIMS Deeper understanding of the ethical and legal principles underpinning confidentiality and privacy. Deeper understanding of the ethical and legal principles underpinning confidentiality and privacy. Exploration of the threats and challenges to privacy, and the safeguards to promote & protect it. Exploration of the threats and challenges to privacy, and the safeguards to promote & protect it.

3. A TRAGIC EXAMPLE A TRAGIC EXAMPLE Jacinta Saldanha

4. EVERYDAY EXAMPLES

5. EXAMPLES FROM GP

6. ABUSE OF CONFIDENTIALITY “GAGGING ORDERS” “GAGGING ORDERS”

7. An Ancient Ethical Principle HIPPOCRATES 5 th Century BC ‘ All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal’. ‘ All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal’.

8. ETHICAL FOUNDATIONS RESPECT for AUTONOMY RESPECT for AUTONOMY PROMISE KEEPING PROMISE KEEPING CONSEQUENCES CONSEQUENCES VIRTUE ETHICS VIRTUE ETHICS

9. Dual Function Fundamental right to privacy – intrinsic value - independent ethical principle. Fundamental right to privacy – intrinsic value - independent ethical principle. Instrumental value of confidentiality Instrumental value of confidentiality - serves the greater good of providing effective healthcare. - serves the greater good of providing effective healthcare.

10. Is confidentiality a decrepit concept? Siegler 1982 – “in nonbureaucratic, noninstitutional medical encounters…meticulous care should be taken to guarantee that patients’ medical & personal medical personal information will be kept confidential.” Siegler 1982 – “in nonbureaucratic, noninstitutional medical encounters…meticulous care should be taken to guarantee that patients’ medical & personal medical personal information will be kept confidential.” Kennedy 1994. Impact of 1990 reforms leading to an ‘assault’ on confidentiality. ‘NHS purposes’ too broad a concept. Kennedy 1994. Impact of 1990 reforms leading to an ‘assault’ on confidentiality. ‘NHS purposes’ too broad a concept.

11. “The Modern NHS” Montgomery 1999. …”we are reaching that stage where the concept of confidentiality has become sufficiently misleading that it should be abandoned in favour of the idea of limited usage of information.” Montgomery 1999. …”we are reaching that stage where the concept of confidentiality has become sufficiently misleading that it should be abandoned in favour of the idea of limited usage of information.” “We need to think hard about how to explain to patients how confidentiality will work in the brave new world”. “We need to think hard about how to explain to patients how confidentiality will work in the brave new world”.

12. Is Confidentiality a‘decrepit concept’? Multiple gatekeepers. Multiple gatekeepers. The ‘NHS Family’. The ‘NHS Family’. Integrated Care Records System. Integrated Care Records System. Media and IT. Social media. Media and IT. Social media. New statutes. NHS reforms. New statutes. NHS reforms. Outsourcing of work, multiple agencies. Outsourcing of work, multiple agencies. ‘The Audit Society- rituals of verification’ ‘The Audit Society- rituals of verification’ Anti Terrorism agenda Anti Terrorism agenda ‘Big data’ - Care.data ‘Big data’ - Care.data 100,000 Genome project 100,000 Genome project

13. GMC – New Guidance 2009 Key Changes Section 251 NHS Act 2006 allows for disclosure of patient identifiable information. Section 251 NHS Act 2006 allows for disclosure of patient identifiable information. Recognition that victims of neglect or abuse may have impaired capacity. Recognition that victims of neglect or abuse may have impaired capacity. Genetic information – permissible disclosure in public interest or to prevent others from serious harm. Genetic information – permissible disclosure in public interest or to prevent others from serious harm. Supplementary guidance. Supplementary guidance.

14. Section 251 NHS Act 2006 Secretary of State has Secretary of State has interim power to ensure that personal identifiable information, needed to support a range of important work such as clinical audit, record validation and research, can be used without consent of patients. interim power to ensure that personal identifiable information, needed to support a range of important work such as clinical audit, record validation and research, can be used without consent of patients.

15. CONSENT TO DISCLOSURE IMPLIED (INFERRED) CONSENT IMPLIED (INFERRED) CONSENT Sharing information within Health Care Team. Sharing information within Health Care Team. “PRESUMED CONSENT” – “OPTING OUT” “PRESUMED CONSENT” – “OPTING OUT” EXPRESS (EXPLICIT) CONSENT EXPRESS (EXPLICIT) CONSENT Disclosure of personal information for Disclosure of personal information for Audit, research, epidemiology, administration. Reports for third parties e.g. insurance. Audit, research, epidemiology, administration. Reports for third parties e.g. insurance. Access to Medical Records Act 1988. Access to Medical Records Act 1988. NON-CONSENSUAL DISCLOSURE NON-CONSENSUAL DISCLOSURE

16. NON-CONSENSUAL DISCLOSURE KEY GMC ‘EXCEPTIONS ’ Disclosures required by law, to law courts or to statutory regulatory bodies. Disclosures required by law, to law courts or to statutory regulatory bodies. Required by third parties e.g. insurance companies, occupational health. Required by third parties e.g. insurance companies, occupational health. Protection of third parties from serious harm or in the best interests of patient lacking capacity. Protection of third parties from serious harm or in the best interests of patient lacking capacity. Disclosure in the ‘public interest’. Disclosure in the ‘public interest’. NB: Always inform patients where practicable. NB: Always inform patients where practicable.

17. PUBLIC INTEREST “…To protect individuals or society from risks of serious harm such as communicable diseases or serious crime; or to enable medical research, education or other secondary uses of information that will benefit society over time.” [para36 GMC 2009].

18. COMMON LAW ‘Old model’ Balancing: Balancing: Public interest in doctors keeping confidences Vs Vs Public interest in protecting society or individuals from harm

19. EGDELL – Key principles 1. There must be a real and persistent risk of danger. 2. Disclosure must be to a person with a legitimate interest in receiving the information. 3. Even when public interest requires disclosure, this must be confined to what is strictly necessary. W v Egdell. 1990 (CA)

20. THE HUMAN RIGHTS ACT 1998 Article 8: Private & family life. Article 8: Private & family life. Article 10: Freedom of expression. Article 10: Freedom of expression. Legislation permitting breaches must: Pursue a legitimate aim Pursue a legitimate aim Be considered necessary in a democratic society Be considered necessary in a democratic society Be proportionate to the need. Be proportionate to the need.

21. HUMAN RIGHTS Key ‘Privacy’ Cases Douglas v Hello! (2001). Douglas v Hello! (2001). Venables v News Group Newspapers Ltd (2001) Venables v News Group Newspapers Ltd (2001) Wainwright v Home Office (2003,HL) Wainwright v Home Office (2003,HL) Campbell v MGN Ltd (2003, HL) Campbell v MGN Ltd (2003, HL)

22. Why is Campbell so important? Balancing Article 8 vs Article 10 SHIFT from public interest to individual rights and privacy.

23. PRIVACY & THE LAW Emphasis on values underpinning respect for private life – privacy, personal autonomy & dignity. Emphasis on values underpinning respect for private life – privacy, personal autonomy & dignity. Broader notion than confidentiality. Broader notion than confidentiality. The need for a confidential relationship is not so important. The need for a confidential relationship is not so important.

24. MULTIPLE STATUTES REQUIRING DISCLOSURE Police & Criminal Evidence Act 1984 (PACE) superseded by Serious Organised Crime and Police Act 2005 (SOCPA) Police & Criminal Evidence Act 1984 (PACE) superseded by Serious Organised Crime and Police Act 2005 (SOCPA) Road Traffic Act 1988 Road Traffic Act 1988 Public Health Act 1984 Public Health Act 1984 Children’s Act 1989 Children’s Act 1989 Audit Commission Act 1998 Audit Commission Act 1998 Terrorism Act 2000. Terrorism Act 2000. NHS Act 2006. NHS Act 2006. Health and Social Care Act 2003/8/12 Health and Social Care Act 2003/8/12

25. THREATS

26. Patient Data – How Safe?

27. PROTECTION OF PRIVACY: ‘TRADITIONAL’ VS ‘DATA PROTECTION’ ‘Data protection/information governance model’ based on the Data Protection Act. Records ‘fit for purpose’: accurate, relevant and adequate. Collective responsibility system vs privileged relationship. More proactive and robust? BMA discussion paper 2005.

28. WHAT ARE THE SAFEGUARDS? Professional codes and traditions Professional codes and traditions Common law and statutes Common law and statutes NHS code of practice. NHS code of practice. Caldicott Report 1997: 6 key principles and Caldicott guardians. Caldicott Report 1997: 6 key principles and Caldicott guardians. Electronic patients’ records: ‘sealed envelope’/locked, passwords etc. Electronic patients’ records: ‘sealed envelope’/locked, passwords etc.

29. SAFEGUARDS - STATUTES Data Protection Act 1998 Data Protection Act 1998 Access to Health Records Act 1990 Access to Health Records Act 1990 Human Rights Act 1998 Human Rights Act 1998 Computer Misuse Act 1990 Computer Misuse Act 1990 NHS Act 2006 – Ethics & Confidentiality Committee (ECC). NHS Act 2006 – Ethics & Confidentiality Committee (ECC).

30. CARE.DATA An initiative to extract data from NHS primary care medical records unless patients have opted out. Linked to hospital data and ‘pseudo- anonymised’ but postal code and NHS number included. An initiative to extract data from NHS primary care medical records unless patients have opted out. Linked to hospital data and ‘pseudo- anonymised’ but postal code and NHS number included. The BMA, under pressure from GPs, have requested that this can only operate with patients ‘opting in’. The BMA, under pressure from GPs, have requested that this can only operate with patients ‘opting in’.

31. ‘Social License’ Failure Defects in warrants of trust – lack of consultation. Scope for linking sensitive data to individuals. Defects in warrants of trust – lack of consultation. Scope for linking sensitive data to individuals. Rupture of traditional role, expectations and duties of GPs. Rupture of traditional role, expectations and duties of GPs. Uncertainty of care.data as a public good. Use by commercial companies and big pharma for ‘health purposes’. Uncertainty of care.data as a public good. Use by commercial companies and big pharma for ‘health purposes’. Carter P, Laurie GT, Dixon-Woods M. JME 2015;0:1-6. The social license for research: why care.data ran into trouble. doi 10.1136/medethics2014-102374

32. CASE DISCUSSION

33. CONCLUSION I Confidentiality remains a fundamental, albeit not absolute, professional duty and is key to trust. It can inadvertently be breached, or another more compelling ethical duty may take precedence. Confidentiality remains a fundamental, albeit not absolute, professional duty and is key to trust. It can inadvertently be breached, or another more compelling ethical duty may take precedence.

34. CONCLUSION II With the increased complexity in healthcare, the greater emphasis on accountability, ‘personalised’ & marketised medicine, and the (wild) enthusiasm for ‘big data’, we witness the dominant ethical/legal framework shifting back to a utilitarian cost-benefit calculus with both the traditional concept of confidentiality and the more modern rights-based concept of privacy under threat. With the increased complexity in healthcare, the greater emphasis on accountability, ‘personalised’ & marketised medicine, and the (wild) enthusiasm for ‘big data’, we witness the dominant ethical/legal framework shifting back to a utilitarian cost-benefit calculus with both the traditional concept of confidentiality and the more modern rights-based concept of privacy under threat.

35. Any Questions? p.dezulueta@imperial.ac.uk @HVHForum