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July 9, 2014

Direct-to-Patient Laboratory Test ReportingBalancing Access With Effective Clinical Communication

Author Affiliations
  • 1Harvard Medical School, Boston, Massachusetts
  • 2Petrie–Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, Massachusetts
  • 3Harvard Law School, Cambridge, Massachusetts
  • 4Harvard Medical School Program in Psychiatry and the Law of the Beth Israel Deaconess Medical Center and the Massachusetts Mental Health Center, Boston
  • 5American Unit of the UNESCO Bioethics Chair, Cambridge, Massachusetts
JAMA. 2014;312(2):127-128. doi:10.1001/jama.2014.5823

In February 2014, the Department of Health and Human Services (HHS) issued a landmark ruling allowing patients direct access to completed medical laboratory reports.1 The ruling took effect April 7, 2014, and gives laboratories 180 days from that date to comply. Although this recent change to the Clinical Laboratory Improvement Amendments (CLIA) empowers patients by removing access barriers to personal health information, it raises a variety of clinical and ethical questions involving practitioners, patients, and society. To capture the benefits of the change and to minimize potential challenges, clinicians will need to proactively counsel patients to ensure that patients do not engage in detrimental self-interpretation of test results, especially because of the abundance of information and misinformation made available through the Internet and other sources.2

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