Research using electronic health records: Balancing confidentiality and public good
Katharine A. Wallis 1 , Kyle S. Eggleton 1 , Susan M. Dovey 2 3 , Sharon Leitch 2 , Wayne K. Cunningham 3 , Martyn I. Williamson 21 University of Auckland, Department of General Practice and Primary Health Care, Auckland, New Zealand
2 University of Otago, Dunedin School of Medicine, Dunedin, New Zealand
3 Royal College of Surgeons in Ireland - Medical University of Bahrain, Bahrain
Correspondence to: Katharine A. Wallis, Department of General Practice & Primary Health Care, University of Auckland, 261 Morrin Road, Auckland 1072, New Zealand. Email: k.wallis@auckland.ac.nz
Journal of Primary Health Care 10(4) 288-291 https://doi.org/10.1071/HC18040
Published: 19 December 2018
Journal Compilation © Royal New Zealand College of General Practitioners 2018.
This is an open access article licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Abstract
General practitioners are increasingly approached to participate in research and share de-identified patient information. Research using electronic health records has considerable potential for improving the quality and safety of patient care. Obtaining individual patient consent for the use of the information is usually not feasible. In this article we explore the ethical issues in using personal health information in research without patient consent including the threat to confidentially and the doctor-patient relationship, and we discuss how the risks can be minimised and managed drawing on our experience as general practitioners and researchers.
References
[1] McDonald L, Lambrelli D, Wasiak R, et al. Real-world data in the United Kingdom: opportunities and challenges. BMC Med. 2016; 14 97| Real-world data in the United Kingdom: opportunities and challenges.Crossref | GoogleScholarGoogle Scholar |
[2] Kostkova P, Brewer H, de Lusignan S, et al. Who owns the data? Open data for healthcare. Front Public Health. 2016; 4 7
[3] Wellcome Trust. Towards consensus for best practice: use of patient records from general practice for research. London, 2009. [cited 2018 March 4]. Available from: https://wellcome.ac.uk/sites/default/files/wtx055661_0.pdf.
[4] New JP, Leather D, Bakerly ND, et al. Putting patients in control of data from electronic health records. BMJ. 2018; 360 j5554
| Putting patients in control of data from electronic health records.Crossref | GoogleScholarGoogle Scholar |
[5] Carter P, Laurie GT, Dixon-Woods M. The social licence for research: why care.data ran into trouble. J Med Ethics 2015 41 404–9.
| The social licence for research: why care.data ran into trouble.Crossref | GoogleScholarGoogle Scholar |
[6] Wellcome Trust. Summary report of qualitative research into public attitudes to personal data and linking personal data. 2013. [cited 2017 October 3]. Available from: http://www.wellcome.ac.uk/stellent/groups/corporatesite/@msh_grants/documents/web_document/wtp053205.pdf.
[7] Mello MM, Lieou V, Goodman SN. Clinical trial participants’ views of the risks and benefits of data sharing. N Engl J Med. 2018; 378 2202–11.
| Clinical trial participants’ views of the risks and benefits of data sharing.Crossref | GoogleScholarGoogle Scholar |
[8] Wellcome Trust. Understanding patient data. 2017. [cited 2018 March 4]. Available from: https://understandingpatientdata.org.uk/.
[9] Privacy Act 1988, Stat. 119 (Australia). 1988. [cited 2017 October 17]. Available from: https://www.legislation.gov.au/Series/C2004A03712.
[10] Privacy Act 1993, Stat. 28 (NZ). 1993. [cited 2012 October 15]. Available from: http://www.legislation.govt.nz/act/public/1993/0028/latest/DLM296639.html?search=ts_act_privacy_resel8p=18sr=1.
[11] Health Information Privacy Code 1994, Stat. (NZ). 1994. [cited 2012 October 15]. Available from: http://www.privacy.org.nz/health-information-privacy-code/.
[12] Health Insurance Portability and Accountability Act (HIPAA) 1996, Stat. 1936 (US). 1996. [cited 2017 October 19]. Available from: https://www.hhs.gov/hipaa/for-professionals/privacy/index.html.
[13] Wallis K. Cervical screening legislation is unethical and has the potential to be counter-productive. N Z Med J. 2007; 120 U2840
[14] NHS Digital. General Data Protection Regulation (GDPR) guidance. UK. 2018. [cited 2018 May 23]. Available from: https://digital.nhs.uk/information-governance-alliance/General-Data-Protection-Regulation-guidance.
[15] National Data Guardian. Dame Fiona Caldicott. Review of data security, consent and opt-outs. UK: Govt. of UK. 2016. [cited 2018 April 30]. Available from: https://www.gov.uk/government/publications/review-of-data-security-consent-and-opt-outs.
[16] Dovey SM, Leitch S, Wallis KA, et al. Epidemiology of patient harms in New Zealand: Protocol of a General Practice records review study. JMIR Res Protoc. 2017; 6 e10
| Epidemiology of patient harms in New Zealand: Protocol of a General Practice records review study.Crossref | GoogleScholarGoogle Scholar |
[17] Runciman W, Hibbert P, Thomson R, et al. Towards an international classification for patient safety: key concepts and terms. Int J Qual Health Care. 2009; 21 18–26.
| Towards an international classification for patient safety: key concepts and terms.Crossref | GoogleScholarGoogle Scholar |
[18] Health Practitioners Competence Assurance Act 2003, Stat. 48 (NZ). 2003. [cited 2012 October 15]. Available from: http://www.legislation.govt.nz/act/public/2003/0048/latest/DLM203312.html?search=ts_act_health+practitioners_resel8p=18sr=1.
[19] Leitch S, Dovey S, Wallis KA, et al. Characteristics of a stratified random sample of New Zealand general practices. J Prim Health Care. 2018; 10 114–24.
| Characteristics of a stratified random sample of New Zealand general practices.Crossref | GoogleScholarGoogle Scholar |
[20] Hill EM, Turner EL, Martin RM, et al. “Let’s get the best quality research we can”: public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study. BMC Med Res Methodol. 2013; 13 72
| “Let’s get the best quality research we can”: public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study.Crossref | GoogleScholarGoogle Scholar |
