What does this mean? In a nutshell, patients in all 50 states are now guaranteed the right to access the results of tests conducted by freestanding labs. (The right to test results from labs within hospitals, other health care facilities and physician offices has already been in place under HIPAA, and a handful of states have already guaranteed direct patient access to freestanding lab test results.) The compliance date for the rule is eight months out, in early October, in order to give labs time to put necessary processes into place.
What exact changes were made to the regs? This was a surgical strike. The Clinical Laboratory Improvement Amendments (CLIA) regulations were revised to permit labs to provide results to patients, and the HIPAA regulations were revised to eliminate lab test results from the (very short) list of records not covered by HIPAA's patient access rule. Thus, if a patient asks, CLIA permits and HIPAA requires that a lab provide the results.