QUESTION:    I understand that our patients can now directly obtain their lab results from the lab, and don’t have to get that information from their physician or his or her office. I’m very concerned with my patients receiving those test reports without the benefit of my description and interpretation of them. I don’t know how patients are going to have the knowledge to understand what they’ll be reading, and that could be harmful to them. What is this all about?

ANSWER:    Until this year, the Clinical Laboratory Improvement Amendments (“CLIA”) did not allow a patient to directly access his or her completed test reports. At the same time, while HIPAA championed an individual’s direct access to medical record information, the Privacy Rule said not for lab reports, to be in step with CLIA.

A new federal rule changes all of that. By the new rule, both the CLIA and HIPAA regulations have been revised to allow a patient, or his or her personal representative, to have the right of direct access to the lab results.

As to why this was done, the Department of Health and Human Services (“HHS”) states that it “believes that this right is crucial to provide individuals with vital information to empower them to better manage their health and take action to prevent and control disease. In addition, removing barriers in this area supports the commitments and goals of the Secretary of the Department of Health and Human Services…and the Administrator of CMS regarding personalized medicine, an individual’s active involvement in his or her own health care, and the widespread adoption of EHRs [electronic health records] by 2014.”

As to the concern that patients will not be able to understand the lab results without their physicians’ involvement, HHS states: “This rule does not diminish the role of the health care provider in interpreting the laboratory test reports for his/her patient in the context of the patient’s medical condition. We expect that individuals will continue to obtain their test reports and the interpretation of those test reports from their health care provider.”

HHS also believes: “that the rule will further encourage ordering and treating providers to more proactively discuss with patients the range of possible test results and what the results may mean for the particular patient before or at the time the test is ordered.”

The new rule does not require the testing lab to provide any interpretation information or material to the patient involved.

The world of medical records is changing, and that’s not just because of the switch to EHRs or providers desire to meet the meaningful use rules in order to receive the incentive payments that come with that. Collectively, recent industry practices, rules or rules in the making make patient access more direct (patient portals, this new rule), enhancing patients’ rights. Others treat or propose to treat EHR as less private than they are now (proposed revisions to the federal drug and alcohol medical records laws, practices necessary for health information exchanges to best perform).

These changes are not all pulling in the same direction, and there are likely more changes to come. Look for a coming article in our Action Kit of Hospital Law publications to read more in-depth about all of these changes and what you should know to best manage them.