HHS final CLIA rule allows reports to patients

In a major change from past policy, the Department of Health and Human Services (HHS) published a final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act (HIPAA) regulations to permit CLIA-certified laboratories to provide copies of completed test reports to patients (or their representatives) upon request.

The policy change was made possible by including a provision in the CLIA regulations authorizing the release of test results directly to patients and by removing the HIPAA exceptions to an individual’s right of access to information maintained by CLIA-exempt laboratories. In the past, HHS has left it up to state law to determine whether laboratories can release test results directly to patients, rather than through their treating providers. Most states prohibit the release of test results directly to patients.

The preamble to the final rule states that opponents to the move said releasing test results to individuals "without the benefit of provider interpretation and without contextual knowledge that may be necessary to properly read and understand results" could lead to misinformation and unnecessary concern. Many consumer advocates, however, said that increasing access to test results will result in better-informed patients.

Some commenters had suggested restricting access to "sensitive" tests result, such as HIV, cancer, and pregnancy tests. HHS rejected that notion and said patients have a "broad right of access" to health information under the HIPAA Privacy Rule. HHS also said that categorizing testing into "sensitive" and "non-sensitive" categories would be subjective and not necessarily help patients in any way.