Corporate Compliance

Proposal would require laboratories to give patients test results

Compliance Monitor, November 2, 2011

Editor’s note: The following article is adapted from an article in the November 2011 Briefings on HIPAA.

A proposed HHS rule released in September would give patients easier access to their laboratory results.

If finalized, the “CLIA Program and HIPAA Privacy Rule: Patients Access to Test Reports,” would allow patients to request test result reports directly from laboratories. Laboratories would provide the information directly to patients or their authorized representatives.

"I think this reflects the pace at which we live our lives today," says Margret Amatayakul, MBA, RHIA, CHPS, CPHIT, CPEHR, CPHIE, FHIMSS, president of Margret A Consulting, LLC, in Schaumburg, IL. Patients want data when it is available, and the reality of the healthcare delivery system is that ordering providers are not always able to be that responsive, she says.

HHS proposed the modification to the CLIA (Clinical Laboratory Improvement Amendments of 1988) and HIPAA rules to provide patients direct access to laboratory results, says Adam Greene, Esq., MPH, partner in the Washington, DC, office of Davis Wright Tremaine, LLP.

State rules governing clinical laboratories are inconsistent, says Greene. The proposed rule would require all clinical laboratories to comply with HIPAA and respond directly to patients, he explains.

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