If an individual requests access from a clinical laboratory to a test report on the individual, is the laboratory required to interpret the test results for the individual?

This guidance remains in effect only to the extent that it is consistent with the court’s order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded.

No. There is no requirement in the HIPAA Privacy Rule that clinical laboratories interpret test results for patients. An individual has a right under the HIPAA Privacy Rule merely to inspect or receive a copy (or direct the copy to a designated third party), upon request, of the completed test reports (as well as other information in the designated record set) maintained by a laboratory that is a covered entity. Laboratories may continue to refer patients with questions about the test results back to their ordering or treating providers. However, while not required, a laboratory providing a test report to an individual that has requested access to the report may also provide educational or explanatory materials regarding the test results to individuals if it chooses to do so. Similarly, a laboratory that wishes to include a disclaimer, caveat, or other statement explaining the limitations of the laboratory data for diagnosis or treatment or other purposes may do so.

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