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New rules opening access to lab test results will empower patients to take control of their health

A final rule issued on February 3, 2014 by the U.S. Department of Health and Human Services (HHS) giving Americans increased access to their personal health information will empower patients to exercise greater control over their health, according to Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostics information services.

“Patient engagement is essential to creating a healthcare system that delivers better health outcomes at lower costs,” said Jon Cohen, M.D., senior vice president and chief medical officer, Quest Diagnostics. “HHS’s final rule means millions of Americans who previously could not access their laboratory and other health care data from clinical laboratory companies like Quest can now do so without first requiring the approval of their healthcare provider. That’s a huge win for patients who want to take responsibility for their healthcare and engage in a richer dialogue with their healthcare providers in the interest of making informed clinical decisions.”

The final rule, announced by HHS on February 3, 2014, amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to give patients (or their representatives) direct access to the patient’s laboratory test reports. At the same time, the final rule eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory that is prohibited by law from providing such access. In combination, these changes will require laboratories to provide patients access to their test reports. It does not require laboratories to interpret test results, and they may refer individuals back to their health provider for this information.

“Studies show that patients who have access to their health records tend to be more engaged in decision making than those who don’t, and may even be more likely to follow treatment protocols and other behaviors that promote favorable outcomes,” continued Dr. Cohen. “We’re hopeful that the ruling will empower people to openly communicate with their physicians regarding tests, procedures and therapies, and actively participate in their healthcare.”

Studies suggest that direct patient rights to healthcare information could improve patient participation in healthcare and possibly quality. A study in the Annals of Internal Medicine in 2009 found that patients were not informed of more than 7 percent of abnormal test results. Another study, published in Lab Medicine in 2007, found that “patients want information on their lab results” and suggests patients would be more satisfied with the healthcare system if given greater data access.

Quest Diagnostics provides patients several options for accessing their laboratory and other health data, including the company’s Gazelle mobile health app for patients.


Quest Diagnostics