Increasingly we are seeing models or frameworks that are changing the healthcare equation to put the patient at the center. ACOs and the Patient-Centered Medical Home are recent examples of this important trend. One of the Stage 1 meaningful use objectives examines the timing in which patients have electronic access to their results. Meeting this objective requires the patient to have access to his or her results within four business days of the results’ availability to the ordering provider. Many certified EHRs provide this functionality through a patient portal.
I recently had the opportunity to discuss patient access to laboratory data with our Medical Advisory Board. The consensus was that patients should indeed have unfettered access to these results; they are, after all, their results.
Interestingly, patient access to lab results made its way into the Federal Register on September 14 in the form of a proposed rule entitled “CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports.” Today a patient can make a request in writing to any heathcare entity and that entity is compelled by the HIPAA Privacy Rule to convey the test results to the patient.
Unbeknownst to me, laboratories have been exempt from this rule. Instead, they are only required to release the results to an “authorized person,” the person responsible for using the test results in the treatment context, and the referring lab. In most states, the “authorized person” is the ordering provider.
The context within which this proposed rule was created reflects the ongoing sea change I referenced above. Among other duties, the ONC Health IT Policy committee has been tasked with identifying barriers to the adoption and utilization of health IT. The existing Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations are thought by many of the stakeholders in this effort to be such a barrier.
If this proposed rule makes its way into the final rule category, minor changes in both the CLIA and the 1996 HIPAA Privacy Rule will be made. As a result, your patients will be afforded the opportunity to request access to their results and to the source of those results (i.e., the lab performing them).
The public comment period for the proposed rule closes on November 14. I know some nephrologists will have concerns about patients seeing their results before the physician has had time to review them. But this is clearly the direction the winds of change are blowing.
I am interested in your thoughts related to patient access to data. Comment below to join the conversation.
Leave a Reply