HHS has issued a final rule to amend the Clinical Laboratory Improvement Amendments of 1988 to now allow laboratories to give a patient, or a patient's personal representative, access to his or her complete laboratory test results when requested.
Patients will still be able to receive test results from their physicians, but the final rule offers them the option to receive them directly from the laboratory while assuring their privacy is still protected.
The final rule also eliminates the exception under HIPAA's Privacy Rule that grants a patient access to his or her health information when it is held by a CLIA-certified or CLIA-exempt laboratory.
Three HHS agencies jointly issued the final rule: CMS, the Centers for Disease Control and Prevention and the Office for Civil Rights.
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