Industry News

HHS Publishes CLIA Program and HIPAA Privacy Final Rule

The Department of Health and Human Services (HHS) recently published a final rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations.  The final rule also eliminates the exception to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule,  which allows state laws to prohibit a CLIA-certified or CLIA-exempt laboratory from providing an individual access to his or her protected health information.  Accordingly, the final rule will permit a patient or a person designated by the patient to have direct access to the patient’s completed laboratory test reports.  The state laws that limit individuals’ access to completed test reports are now preempted by the final rule. The final rule also requires laboratories to provide patients with their completed test reports within 30 days of a request, but does not require the laboratory to explain the results to the patients. 

The final rule takes effect on April 7, 2014. HIPAA-covered laboratories will have 180 days from the effective date of the final rule to comply with the regulations.

The final rule is available at:

CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports; Final Rule, 79 Fed Reg. 25, 7290 (Feb. 6, 2014).