Medical research using governments' health claims databases: with or without patients' consent?

J Public Health (Oxf). 2018 Dec 1;40(4):871-877. doi: 10.1093/pubmed/fdy034.

Abstract

Taking advantage of its single-payer, universal insurance system, Taiwan has leveraged its exhaustive database of health claims data for research purposes. Researchers can apply to receive access to pseudonymized (coded) medical data about insured patients, notably their diagnoses, health status and treatments. In view of the strict safeguards implemented, the Taiwanese government considers that this research use does not require patients' consent (either in the form of an opt-in or in the form of an opt-out). A group of non-governmental organizations has challenged this view in the Taiwanese Courts, but to no avail. The present article reviews the arguments both against and in favor of patients' consent for re-use of their data in research. It concludes that offering patients an opt-out would be appropriate as it would best balance the important interests at issue.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research / ethics
  • Biomedical Research / legislation & jurisprudence
  • Biomedical Research / methods*
  • Biomedical Research / statistics & numerical data
  • Databases as Topic
  • Humans
  • Informed Consent / ethics
  • Informed Consent / legislation & jurisprudence
  • Informed Consent / statistics & numerical data*
  • Insurance Claim Review / ethics*
  • Insurance Claim Review / legislation & jurisprudence
  • Taiwan
  • Universal Health Insurance