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Consumer Access to Clinical Lab Results Means Both Opportunity and Risk

MAR 11

As a part of the Federal Government’s efforts to encourage patients to get more involved with their own care, on February 3, the Department of Health and Human Services (HHS) announced a new federal law that allows patients to access their clinical lab results without having to make the request through their clinician. The ruling was first proposed in 2011 and acts as an amendment to the well-known Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Amendments (CLIA).

The HHS pronouncement comes with both pros and cons.

Individuals having greater ability to play a more active role in their health care and have more informed conversations with their health care providers should result in better health outcomes. Further, studies have shown that between 7% – 26% of abnormal test results are not communicated to patients in a timely manner, resulting in a substantial number of patients not being informed of clinically significant test results. The HHS ruling should reduce the volume of untimely communication of abnormal test results. Additionally, the rule will further encourage providers to more proactively educate patients on the range of possible test results and what the results may mean prior to the patient ordering the test results from the lab.


What Are The Issues?

Generally, granting patients greater opportunity to take ownership of their healthcare is a step forward, however as the rule allows patients access to their records without their doctor’s insights, misinterpretation is likely. The HHS ruling only calls for normal test result ranges to be published, but does not call for direct interpretation from a provider or lab. The ramifications of misinterpretation are significant, ranging from patients overreacting unnecessarily, to possibly neglecting results that are serious and require action. However, the rule requires that results be granted to patients thirty days post-request, so providers should have sufficient time to receive test results in advance of their patient and manage communication as necessary.


What Are The Opportunities?

Economically, the ruling creates a unique market opportunity for innovators in the health information request market. The HHS estimates that there are nearly 23,000 labs that do not have procedures or infrastructure in place to grant patients direct access to their lab results and could cost labs between two million and ten million dollars to be able to provide the required services. Labs without these procedures in place must develop or outsource a secure way for their patients to access their health information.

Potentially more costly than implementing these procedures, is implementing an unsecure method of transmitting lab results to patients. The reported range of costs associated with each incident of improper disclosure of protected health information is $8,000 to $300,000 [Source]. Companies operating in the Healthcare IT market already have capabilities to grant patients direct access to patient data via their patient portals.  As part of Meaningful Use Stage 2, healthcare providers are already required to have at least 50% of their patients’ health information available to view online, download, and transmit within 36 hours of discharge and must ensure that at least 5% of patients actually access their health information remotely to receive meaningful use incentive payments. Companies operating in this space have a great opportunity to create adjacent revenue streams by deploying their services to labs that cannot possibly develop secure portals for their patients to receive test results prior to April 3.

Prior to this ruling, seven states had already allowed direct access for patients to their clinical lab results, while thirteen explicitly prohibited it.  Seven others allowed it with doctor permission, and twenty-three had no regulation either way.  While the ruling is aimed to enable consumer transparency and control, we’re predicting most labs will be ill-equipped to handle the new inbound consumer requests for some time, and we will watch this evolving story closely as April 3 effective date for this ruling rapidly approaches.

Let us know what you think.

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Michael Noel