Big Data Clinical Research: Validity, Ethics, and Regulation

E Andrew Balas, Marlo M Cavnar Vernon, Farah Magrabi, Lynne Thomas Gordon, Joanne Sexton

Research output: Chapter in Book/Report/Conference proceedingConference contribution

6 Scopus citations

Abstract

Electronic Health Records (EHR) promise improvement for patient care and also offer great value for biomedical research including clinical, public health, and health services research. Unfortunately, the full potential of EHR big data research has remained largely unrealized. The purpose of this study was to identify rate limiting factors, and develop recommendations to better balance unrestricted extramural EHR access with legitimate safeguarding of EHR data in retrospective research. By exploring primary, secondary, and tertiary sources, this review identifies external constraints and provides a comparative analysis of social influencers in retrospective EHR-based research. Results indicate that EHRs have the advantage of reflecting the reality of patient care but also show a frequency of between 4.3-86% of incomplete and inaccurate data in various fields. The rapid spread of alternative analytics for health data challenges traditional interpretations of confidentiality protections. A confusing multiplicity of controls creates barriers to big data EHR research. More research on the use of EHR big data is likely to improve accuracy and validity. Information governance and research approval processes should be simplified. Comprehensive regulatory policies that do not exclusively cover health care entities, are needed. Finally, new computing safeguards are needed to address public concerns, like research access only to aggregate data and not to individually identifiable information.

Original languageEnglish (US)
Title of host publicationMEDINFO 2015
Subtitle of host publicationeHealth-Enabled Health - Proceedings of the 15th World Congress on Health and Biomedical Informatics
EditorsAndrew Georgiou, Indra Neil Sarkar, Paulo Mazzoncini de Azevedo Marques
PublisherIOS Press
Pages448-452
Number of pages5
ISBN (Electronic)9781614995630
DOIs
StatePublished - Jan 1 2015
Event15th World Congress on Health and Biomedical Informatics, MEDINFO 2015 - Sao Paulo, Brazil
Duration: Aug 19 2015Aug 23 2015

Publication series

NameStudies in Health Technology and Informatics
Volume216
ISSN (Print)0926-9630
ISSN (Electronic)1879-8365

Other

Other15th World Congress on Health and Biomedical Informatics, MEDINFO 2015
CountryBrazil
CitySao Paulo
Period8/19/158/23/15

Keywords

  • Clinical Research
  • Electronic Health Records
  • Health Services Research
  • Public Health

ASJC Scopus subject areas

  • Biomedical Engineering
  • Health Informatics
  • Health Information Management

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  • Cite this

    Balas, E. A., Vernon, M. M. C., Magrabi, F., Gordon, L. T., & Sexton, J. (2015). Big Data Clinical Research: Validity, Ethics, and Regulation. In A. Georgiou, I. N. Sarkar, & P. M. de Azevedo Marques (Eds.), MEDINFO 2015: eHealth-Enabled Health - Proceedings of the 15th World Congress on Health and Biomedical Informatics (pp. 448-452). (Studies in Health Technology and Informatics; Vol. 216). IOS Press. https://doi.org/10.3233/978-1-61499-564-7-448