Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Clinical Laboratory Improvement Amendments


Comment: One comment expressed concern that the proposed definition of health care operations did not include activities related to the quality control clinical studies performed by laboratories to demonstrate the quality of patient test results. Because the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") requires these studies that the comment asserted require the use of protected health information, the comment suggested including this specific activity in the definition of "health care operations."

Response: We do not intend for the privacy regulation to impede the ability of laboratories to comply with the requirements of CLIA. Quality control activities come within the definition of "health care operations" in § 164.501 because they come within the meaning of the term "quality assurance activities." To the extent they would not come within health care operations, but are required by CLIA, the privacy regulation permits clinical laboratories that are regulated by CLIA to comply with mandatory uses and disclosures of protected health information pursuant to § 164.512(a).

Comment: One comment stated that the proposed regulation's right of access for inspection and copying provisions were contrary to CLIA in that CLIA permits laboratories to disclose lab test results only to "authorized persons." This comment suggested that the final rule include language adopting this restriction to ensure that patients not obtain laboratory test results before the appropriate health care provider has reviewed and explained those results to the patients.

A similar comment stated that the lack of preemption of state laws could create problems for clinical laboratories under CLIA. Specifically, this comment noted that CLIA permits clinical laboratories to perform tests only upon the written or electronic request of, and to provide the results to, an "authorized person." State laws define who is an "authorized person." The comment expressed concern as to whether the regulation would preempt state laws that only permit physicians to receive test results.

Response: We agree that CLIA controls in these cases. Therefore, we have amended the right of access, § 164.524(a), so that a covered entity that is subject to CLIA does not have to provide access to the individual to the extent such access would be prohibited by law. Because of this change, we believe the preemption concern is moot.