September 15, 2011

HHS Proposes Rule Giving Patients Direct Access to Lab Test Results

Yesterday, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule in the Federal Register which would allow medical patients to get their laboratory test results directly from the lab.  A copy of this proposed rule is available here.  At present, only a handful of states allow direct access to lab results.  This proposal, if it becomes effective, will give patients in most states a new right to go directly to the lab used by their doctor to obtain test results.

HHS Secretary Kathleen Sebelius has made various public statements promoting this proposed rule as empowering patients by granting greater access to personal health information.  The HHS press release about this proposal is available here.  There is no question that HHS’s proposed rule is in line with the trend of giving patients increased control over their health care choices and their health records.

The proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA) by requiring labs covered by HIPAA to securely provide test results to patients or their personal representatives.  Under this proposal, HHS has mandated that patient requests for lab tests must be authenticated.  Since there is no meaningful guidance regarding the authentication process in the proposed rule, it is unclear how laboratories will ensure that the person requesting lab results is actually the patient or a designated representative.  Similarly, labs will have to develop ways to address patient inquiries about the meaning of test results and related patient care questions that should be directed to physicians.  In fact, members of the physician community have already spoken out against giving patients direct access to test results.  Many of these comments are based on concerns that lab results are easily misunderstood and that patients may take action based on a misunderstanding and without first receiving their physician’s interpretation of the results.

There is a 60 day public comment period and we will be sure to follow further developments in connection with this proposal.

This post was contributed by Kurt Bratten.