Whose Lab Results Are Those, Anyway?

"As part of an ongoing effort to empower patients to be informed partners with their health care providers,"  HHS has finally issued a rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations "to allow laboratories to give a patient, or a person designated by the patient, his or her “personal representative,” access to the patient’s completed test reports on the patient’s or patient’s personal representative’s request. At the same time, the final rule eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory."

This, sadly, has been too long coming. As soon as it was apparent that the CLIA regulations combined with a perverse reading of HIPAA's Privacy Rule actually restricted the open flow of patient information to the patient themselves, the changes should have been made. Indeed, there has been no shortage of outrage over the fact that an individual using a CLIA-certified or CLIA-exempt lab (most of the largest commercial labs) had no right to their own lab result health information. I count myself among the outraged even though I have been blessed with attentive and detail oriented health care providers.

And I count it no surprise that this denial of access to health-improving, and possibly life-saving, health information was denied under the rubric of HIPAA's Privacy Rule. I tell my students, more patient disempowerment has been initiated under a statute designed to empower patients to protect their privacy from others than its authors could ever have contemplated.