Robert Belfort, Project HealthDesign Regulatory and Assurance Advisory Group, Manatt, Phelps & Phillips, LLP
The federal government recently took an important step to advance its goal of enabling individuals to play a more active role in their health care. On September 12, 2011, the U.S. Department of Health and Human Services (HHS) released a proposed regulation that would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to allow individuals to gain access to lab test results directly from laboratories. Although individuals could always get their lab test results from their doctor’s office, the potential for health information technology tools to facilitate broader exchange of information and the growing interest of individuals in being more active participants in their care appears to have driven HHS to propose the change.
Why Can’t Individuals Access Their Lab Test Results Directly From Labs Right Now?
Most clinical laboratories are regulated under the CLIA regulations, which provide that labs may only release test results to specified recipients, including “individuals authorized under state law to order or receive tests” and to “the individual responsible for using the test results and the laboratory that initially requested the test.” CLIA does not define “individuals responsible for using the test results.” So to whom labs can disclose test results usually depends on what state law says about who is authorized to order or receive tests. Only a few states place patients in that category. Further, HIPAA exempts the provision of clinical lab results by labs from provisions generally requiring health care providers to give patients access to their medical information.
How Would the Proposed Rule Fix the Problem?
The fix to this problem is surprisingly simple — at least as legal and regulatory changes go. HHS is proposing to add a new section to the CLIA regulations to specify that, upon an individual’s request, the laboratory may provide the individual with access to his or her completed lab test results that, using the laboratory’s authentication processes, can be identified as belonging to that individual. At the same time, HHS would remove the exceptions in the HIPAA Privacy Rule that exempt lab test results from the information that laboratories must provide to individuals upon request. If adopted, the proposed changes to the HIPAA Privacy Rule would preempt any contradictory state laws that prohibit a HIPAA-covered laboratory from directly providing access to an individual.
Rationale for Providing Individuals with Direct Access to Lab Test Results
Lab test results are critical to an individual’s efforts to take control over his or her health care. Today, however, lab test results rarely make it to individuals. A 2009 study published in the Archives of Internal Medicine indicated that health care providers failed to notify patients (or document notification) of abnormal test results more than 7 percent of the time. The National Coordinator for Health IT recently put the figure closer to 20 percent.
Consumer groups like the National Partnership for Women and Families are lining up in support of the proposal. Indeed, the proposal seems consistent with Project HealthDesign’s mission of increasing individuals’ engagement in their health care. But we want to hear from the current Project HealthDesign teams and other researchers:
Is HHS’s proposed regulation to enable individuals to directly access their lab test results from labs a positive development? Do you see any potential downfalls that could result from this new policy?