On September 12, 2011, HHS Secretary Kathleen Sebelius announced a proposed rule entitled, CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports. According to HHS, the proposed rule would expand the rights of patients to access their health information through the use of health information technology (HIT) by removing a CLIA regulatory provision that is seen as imposing a barrier to the electronic exchange of health information. Specifically, the new rules would allow patients to gain access to test results reports directly from labs. The proposed rule would amend HHS’s Clinical Laboratory Improvement Act of 1988 (CLIA) regulations to provide that, upon request of a patient, the laboratory may provide direct patient access to completed test results that the laboratory, using its authentication processes, can identify as belonging to the patient. The proposed rule would also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to require CLIA-certified laboratories and CLIA-exempt laboratories to provide such information, upon request, directly to individuals or their personal representatives by removing the exceptions for such labs from the provision that provides individuals with the right of access to their protected health information.

The proposed rule, which is scheduled for publication in the September 14, 2011 Federal Register, may be found at the following web address:  http://www.gpo.gov/fdsys/pkg/FR-2011-09-14/pdf/2011-23525.pdf.   Comments must be submitted by November 13, 2011.