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Direct-to-Patient Laboratory Test Reporting:  Balancing Access With Effective Clinical Communication

Michael J. Young, MPhil1,2; Ethan Scheinberg, BTL3; Harold Bursztajn, MD4,5
[+] 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.
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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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