Towards a confidential system of researching for the common good

1. Towards a confidential system of researchingfor the common good Professor Joe Barry Dept. of Public Health & Primary Care, TCD Health Intelligence, Population Health, HSE Promoting Health Research & Protecting Patient Rights Portarlington, November 29, 2006

2. Outline of Presentation • Define Epidemiology and Public Health • Examples • Our ethical and legal framework • Challenges • A way forward

3. Epidemiology & Public Health

4. Do poor people die at an earlier age than rich people?

5. Irish Data on Health Inequalities Source: “Inequalities in Mortality 1989-1998”, IPHI 2001

6. Has alcohol caused more, or fewer deaths in Ireland recently?

8. Do we have a big underage drinking problem?

9. Percentages of boys and girls who have been ‘really drunk’

10. Is our suicide rate really increasing?

12. Ethical and Legal Framework • Medical Council • Data Protection Acts • Research Ethics Committees • Various guidelines • Our job descriptions

13. Medical Council • Confidentiality - 4 exceptions • Data protection compliant • Consent if patients involved • Anonymity • Research Ethics Committees

14. Data Protection Acts • Fair access and processing • Special, explicit and lawful purpose(s) • Use and disclosure appropriate • Safe and secure • Accurate and up-to-date • Relevant and not excessive • Retain only as long as necessary • Available to individual

15. Q.Can I as a doctor, consultant or hospital doctor use patient data for research or statistical purposes? A. Ideally you should make patients aware in advance if you intend to use their data for your own research purposes. However, the Act provides that such uses of personal data are permitted, even where the patient was not informed in advance, provided that no damage or distress is likely to be caused to the individual. Source: Data Protection Commissioner, UCC Summer School, September 2004

16. Legal boundaries to privacy and confidentiality Paragraphs 3 and 4 provide for other exceptions: “(….) where processing of the data is required for the purposes of preventative medicine, medical diagnosis, the provision of care or treatment, or the management of healthcare services, and where those data are processed by a health professional subject under national law or rules established by national competent bodies to the obligation of professional secrecy or by another person also subject to an equivalent obligation of secrecy.” Source: European Guidance for Healthcare Professionals on Confidentiality and Privacy in Healthcare, EuroSOCAP, 2006. www.eurosocap.org

17. “Information from hospital records is to be analysed anonymously (unlinked) to identify risk factors predicting poor outcomes from surgery. As the hospital staff cannot be redeployed to extract and anonymise the information, a trained nurse or clerical officer from the research team is assigned to copy and anonymise the information. Here too, although the justification for the study would still need to be considered by an Ethics Committee, the infringement of confidentiality is minimal and there are unlikely to be significant ethical or legal objections to this aspect of the study.” Source: Medical Research Council Ethics Series, Personal Information in Medical Research, 2003

18. National patient/client identifier and data protection “A number of factors have been identified as hindering research in the health services. One of these is the absence of a national patient/client identifier that would allow much better assessment of health outcomes and the quality of care patients and clients receive in the health services. This issue is being addressed in the context of the proposal of the Minister for Social, Community and Family Affairs that every citizen is assigned an RSI number from birth. The Minister proposes that the same system be used in relation to the health services, with due regard to the need to protect the confidentiality of the professional/client relationship.”

19. Will the closure of small A/E units put lives at risk?

21. The percentage of cases of RTA within 60 minutes of a public acute hospital

22. The percentage of cases of AMI within 60 minutes of a public acute hospital

23. How many heroin takers are there in Dublin?

24. Prevalence estimates and corresponding rates per thousand population by age and sex, Dublin 1996 and 2001 Source: Prevalence of Opiate use in Ireland 2000-2001. A 3-source Capture Recapture Study. NACD

26. Actions - Quality and Fairness … Action 111 - An independent Health Information and Quality Authority will be established Action 115 - The National Health Information Strategy will be published and implemented Action 116 - There will be a sustained programme of investment in the development of national health information systems as set out in the National Health Information Strategy

27. Actions - Quality and Fairness … Action 117 - Information and communications technology will be fully exploited in service delivery Action 118 - Information-sharing systems and the use of electronic patient records will be introduced on a phased basis Action 121 - Health information legislation will be introduced

28. Actions - Health Information … Action 13 - Health information will be geo-coded by small area Action 17 - A legislative framework to support the National Health Information Strategy will be developed Action 18 - A framework for information governance will be developed Action 19 - A national health information standards framework will be developed

29. Actions - Health Information … Action 24 - A system to evaluate and monitor the implementation of the National Health Information Strategy will be established Action 27 - The Health Information and Quality Authority will review and update the National Health Information Strategy every year and submit it to the Minister of Health and Children for approval

30. Challenges • Costs • Culture • Consent - routine datasets • Getting the balance right • Individual v common good • Differing values • Who decides?

31. A Way Forward • Extension of today • Revisit DoHC documents • Health Information Bill • Training • Governance Structures