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Under Proposed Rule, Patients Will Receive Clinical Test Results Directly

Ever have a medical test done and then had to wait around – sometimes anxiously, depending on the test – to get the lab test results from your doctor? That’s about to change. Yesterday, the Department of Health and Human Services (HHS) proposed regulations that would give patients the ability to access their clinical lab test results directly from the lab, instead of having to wait to receive the results from their health care provider. This change further empowers patients to manage their own health care and organize electronic copies of their own data – a major benefit of the health care system’s transition to digital records.

Under old rules – issued in 1988 – called the Clinical Laboratory Improvement Amendments (CLIA), laboratories were restricted from disclosing test results to patients directly. Instead, labs could only send the test results to health care providers, people authorized to receive test results under state law, or other labs. Only a handful of states permit labs to send patients test results directly, and some of these states require the provider’s permission before patients can have the results. The HIPAA Privacy Rule reflected this restriction, exempting CLIA-regulated labs (which are the great majority of clinical labs) from patients’ existing right to access their health information.

Requiring labs to send test results to health care providers instead of patients does not always work out in the patient’s favor. A 2009 study published in the Archive of Internal Medicine indicated that 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 at 20 percent. This failure rate could lead to more medical errors and missed opportunities for early treatment.

Yesterday’s proposed regulations will change how test results get to patients. The proposed regulations would modify CLIA to permit labs to send results directly to patients, and the proposed regulations would also modify the HIPAA Privacy Rule to give patients the right to access or receive their lab results. Contrary state laws would be preempted. As with patients’ existing right of access, patients would have the ability to request their lab results in a particular form or format; for example, patients could request a paper copy of their test results, or to have the results sent electronically to the patients’ personal health record. (For more information on patients’ right to access their medical data, see CDT’s page on Getting Your Medical Records.)

Although patients would no longer have to go to health care providers to receive their test results, this does not mean providers are cut out of the conversation. Labs will almost certainly send providers the results as well as patients, so providers can still reach out to patients to explain or provide context to the test results.

The proposed regulations are a logical move for a health care system transitioning to digital records. Patients will be able to enjoy greater openness and transparency of their records – not to mention that patients will receive their test results more consistently. Providing patients with a copy of their records can cut down on duplicate tests and may reduce the burden on providers to promptly route data to patients themselves. Patients play a critical role in their own health care, and it is encouraging to see HHS issue regulations that embrace that fact.