Subscribe to RSS
![](/products/assets/desktop/img/oa-logo.png)
DOI: 10.15265/IY-2016-035
Building a Privacy, Ethics, and Data Access Framework for Real World Computerised Medical Record System Data: A Delphi Study
Contribution of the Primary Health Care Informatics Working GroupCorrespondence to:
Publication History
10 November 2016
Publication Date:
06 March 2018 (online)
Summary
Background: Privacy, ethics, and data access issues pose significant challenges to the timely delivery of health research. Whilst the fundamental drivers to ensure that data access is ethical and satisfies privacy requirements are similar, they are often dealt with in varying ways by different approval processes. Objective: To achieve a consensus across an international panel of health care and informatics professionals on an integrated set of privacy and ethics principles that could accelerate health data access in data-driven health research projects.
Method: A three-round consensus development process was used. In round one, we developed a baseline framework for privacy, ethics, and data access based on a review of existing literature in the health, informatics, and policy domains. This was further developed using a two-round Delphi consensus building process involving 20 experts who were members of the International Medical Informatics Association (IMIA) and European Federation of Medical Informatics (EFMI) Primary Health Care Informatics Working Groups. To achieve consensus we required an extended Delphi process.
Results: The first round involved feedback on and development of the baseline framework. This consisted of four components: (1) ethical principles, (2) ethical guidance questions, (3) privacy and data access principles, and (4) privacy and data access guidance questions. Round two developed consensus in key areas of the revised framework, allowing the building of a newly, more detailed and descriptive framework. In the final round panel experts expressed their opinions, either as agreements or disagreements, on the ethics and privacy statements of the framework finding some of the previous round disagreements to be surprising in view of established ethical principles.
Conclusion: This study develops a framework for an integrated approach to ethics and privacy. Privacy breech risk should not be considered in isolation but instead balanced by potential ethical benefit.
#
#
-
References
- 1 De Lusignan S, Crawford L, Munro N. Creating and using real-world evidence to answer questions about clinical effectiveness.. J Innov Health Inform 2015; 22 (Suppl. 03) 368-73.
- 2 Ohrt C, Roberts KW, Sturrock HJ, Wegbreit J, Lee BY, Gosling RD. Information systems to support surveillance for malaria elimination.. Am J Trop Med Hyg 2015; Jul 93 (Suppl. 01) 145-52.
- 3 Degeling C, Johnson J, Kerridge I, Wilson A, Ward M, Stewart C. et al. Implementing a One Health approach to emerging infectious disease: reflections on the socio-political, ethical and legal dimensions.. BMC Public Health 2015; Dec 29 15 (Suppl. 01) 1307.
- 4 Kaye J. The tension between data sharing and the protection of privacy in genomics research.. Annu Rev Genomics Hum Genet 2012; 13: 415-31.
- 5 European Union.. EU Directive 95/46/EC – The Data Protection Directive.. Available from http://www.dataprotection.ie/docs/EU-Directive-95-46-EC--Chapter-2/93.htm. Accessed on 8 Feb 2016
- 6 Australian Privacy Principles.. Available from https://www.oaic.gov.au/privacy-law/privacy-act/australian-privacy-principles. Accessed on 8 Feb 2016
- 7 World Medical Association.. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.. JAMA 2013; 310 (Suppl. 20) 2191-4.
- 8 McCarthy RL. Ethics and patient privacy.. J Am Pharm Assoc 2008; 48 (Suppl. 06) e144-52 quiz e153-4.
- 9 Wright D, Friedewald M. Integrating privacy and ethical impact assessments.. Science and Public Policy 2013; 40 (Suppl. 06) 755-66.
- 10 Beauchamp TL, Childress JF. Principles of Biomedical Ethics, fourth edition.. New York: Basic Books; 1994
- 11 Thompson AK, Faith K, Gibson JL, Upshur RE. Pandemic influenza preparedness: an ethical framework to guide decision-making.. BMC Med Ethics 2006; 7: E12.
- 12 Tangwa GB. Ethical principles in health research and review process.. Acta Tropica 2009; 112 (Suppl. 01) S2-7.
- 13 Malin B, Loukides G, Benitez K, Clayton EW. Identifiability in biobanks: models, measures and mitigation strategies.. Human Gen 2011; 130 (Suppl. 03) 383-92.
- 14 Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.. Hastings Cent Rep 2013: S16-27.
- 15 Di Iorio CT, Carinci F, Brillante M, Azzopardi J, Beck P, Bratina N. et al. Cross-border flow of health information: is ‘privacy by design’ enough? Privacy performance assessment in EUBIROD.. Eur J Public Health 2013; 23 (Suppl. 02) 247-53.
- 16 Babu GR, Tn S, Bhan A, Lakshmi JK, Kishore M. An appraisal of the tuberculosis programme in India using an ethics framework.. Indian J Med Ethics 2014; 11 (Suppl. 01) 11-5.
- 17 Willison DJ, Ondrusek N, Dawson A, Emerson C, Ferris LE, Saginur R. et al. What makes public health studies ethical? Dissolving the boundary between research and practice.. BMC Med Ethics 2014; 15: 61.
- 18 OECD, Health Data Governance: Privacy, Monitoring and Research, OECD Health Policy Studies, Paris: OECD Publishing, 2015. Available from http://dx.doi.org/10.1787/9789264244566-en. Accessed on 8 Feb 2016
- 19 Liyanage H, de Lusignan S, Liaw ST, Kuziemsky CE, Mold F, Krause P. et al. Big Data Usage Patterns in the Health Care Domain: A Use Case Driven Approach Applied to the Assessment of Vaccination Benefits and Risks. Contribution of the IMIA Primary Healthcare Working Group.. Yearb Med Inform 2014; Aug 15 9: 27-35.
- 20 Liyanage H, de Lusignan S, Liaw ST, Kuziemsky CE, Mold F, Krause P, Fleming D, Jones S. Big Data Usage Patterns in the Health Care Domain: A Use Case Driven Approach Applied to the Assessment of Vaccination Benefits and Risks. Contribution of the IMIA Primary Healthcare Working Group.. Yearb Med Inform. 2014; Aug 15 9: 27-35.
- 21 Ahmann E. Guns in the home: nurses’ roles.. Pediatr Nurs 2001; 27 (Suppl. 06) 587-90 605.
- 22 Swanson JW, Bonnie RJ, Appelbaum PS. Getting serious about reducing suicide: More “how” and less “why”.. JAMA 2015; 314 (Suppl. 21) 2229-30.
- 23 OECD.. Strengthening Health Information Infrastructure for Health Care Quality Governance: Good Practices, New Opportunities and Data Privacy Protection Challenges (2013) OECD Health Policy Studies.. Available from http://www.oecd.org/publications/strengthening-health-information-infrastructure-for-health-care-quality-governance-9789264193505-en.htm Accessed on 8 Feb 2016
Correspondence to:
-
References
- 1 De Lusignan S, Crawford L, Munro N. Creating and using real-world evidence to answer questions about clinical effectiveness.. J Innov Health Inform 2015; 22 (Suppl. 03) 368-73.
- 2 Ohrt C, Roberts KW, Sturrock HJ, Wegbreit J, Lee BY, Gosling RD. Information systems to support surveillance for malaria elimination.. Am J Trop Med Hyg 2015; Jul 93 (Suppl. 01) 145-52.
- 3 Degeling C, Johnson J, Kerridge I, Wilson A, Ward M, Stewart C. et al. Implementing a One Health approach to emerging infectious disease: reflections on the socio-political, ethical and legal dimensions.. BMC Public Health 2015; Dec 29 15 (Suppl. 01) 1307.
- 4 Kaye J. The tension between data sharing and the protection of privacy in genomics research.. Annu Rev Genomics Hum Genet 2012; 13: 415-31.
- 5 European Union.. EU Directive 95/46/EC – The Data Protection Directive.. Available from http://www.dataprotection.ie/docs/EU-Directive-95-46-EC--Chapter-2/93.htm. Accessed on 8 Feb 2016
- 6 Australian Privacy Principles.. Available from https://www.oaic.gov.au/privacy-law/privacy-act/australian-privacy-principles. Accessed on 8 Feb 2016
- 7 World Medical Association.. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.. JAMA 2013; 310 (Suppl. 20) 2191-4.
- 8 McCarthy RL. Ethics and patient privacy.. J Am Pharm Assoc 2008; 48 (Suppl. 06) e144-52 quiz e153-4.
- 9 Wright D, Friedewald M. Integrating privacy and ethical impact assessments.. Science and Public Policy 2013; 40 (Suppl. 06) 755-66.
- 10 Beauchamp TL, Childress JF. Principles of Biomedical Ethics, fourth edition.. New York: Basic Books; 1994
- 11 Thompson AK, Faith K, Gibson JL, Upshur RE. Pandemic influenza preparedness: an ethical framework to guide decision-making.. BMC Med Ethics 2006; 7: E12.
- 12 Tangwa GB. Ethical principles in health research and review process.. Acta Tropica 2009; 112 (Suppl. 01) S2-7.
- 13 Malin B, Loukides G, Benitez K, Clayton EW. Identifiability in biobanks: models, measures and mitigation strategies.. Human Gen 2011; 130 (Suppl. 03) 383-92.
- 14 Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.. Hastings Cent Rep 2013: S16-27.
- 15 Di Iorio CT, Carinci F, Brillante M, Azzopardi J, Beck P, Bratina N. et al. Cross-border flow of health information: is ‘privacy by design’ enough? Privacy performance assessment in EUBIROD.. Eur J Public Health 2013; 23 (Suppl. 02) 247-53.
- 16 Babu GR, Tn S, Bhan A, Lakshmi JK, Kishore M. An appraisal of the tuberculosis programme in India using an ethics framework.. Indian J Med Ethics 2014; 11 (Suppl. 01) 11-5.
- 17 Willison DJ, Ondrusek N, Dawson A, Emerson C, Ferris LE, Saginur R. et al. What makes public health studies ethical? Dissolving the boundary between research and practice.. BMC Med Ethics 2014; 15: 61.
- 18 OECD, Health Data Governance: Privacy, Monitoring and Research, OECD Health Policy Studies, Paris: OECD Publishing, 2015. Available from http://dx.doi.org/10.1787/9789264244566-en. Accessed on 8 Feb 2016
- 19 Liyanage H, de Lusignan S, Liaw ST, Kuziemsky CE, Mold F, Krause P. et al. Big Data Usage Patterns in the Health Care Domain: A Use Case Driven Approach Applied to the Assessment of Vaccination Benefits and Risks. Contribution of the IMIA Primary Healthcare Working Group.. Yearb Med Inform 2014; Aug 15 9: 27-35.
- 20 Liyanage H, de Lusignan S, Liaw ST, Kuziemsky CE, Mold F, Krause P, Fleming D, Jones S. Big Data Usage Patterns in the Health Care Domain: A Use Case Driven Approach Applied to the Assessment of Vaccination Benefits and Risks. Contribution of the IMIA Primary Healthcare Working Group.. Yearb Med Inform. 2014; Aug 15 9: 27-35.
- 21 Ahmann E. Guns in the home: nurses’ roles.. Pediatr Nurs 2001; 27 (Suppl. 06) 587-90 605.
- 22 Swanson JW, Bonnie RJ, Appelbaum PS. Getting serious about reducing suicide: More “how” and less “why”.. JAMA 2015; 314 (Suppl. 21) 2229-30.
- 23 OECD.. Strengthening Health Information Infrastructure for Health Care Quality Governance: Good Practices, New Opportunities and Data Privacy Protection Challenges (2013) OECD Health Policy Studies.. Available from http://www.oecd.org/publications/strengthening-health-information-infrastructure-for-health-care-quality-governance-9789264193505-en.htm Accessed on 8 Feb 2016