Health Information Management

Understand the proposed regulation requires HIPAA-covered labs to release test results directly to patients

HIM-HIPAA Insider, November 15, 2011

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Patients may have easier access to laboratory results under an HHS proposed rule, "CLIA Program and HIPAA Privacy Rule: Patients' Access to Test Reports," released in September.

If finalized, the rule would allow patients to request test result reports directly from labs, which would then 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 immediately available, and the reality of the healthcare delivery system is that the ordering provider is not always able to be that responsive, she says.
 
HHS proposed the modification to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the HIPAA rules to provide patients with direct access to laboratory results, says Adam Greene, JD, MPH, partner in the Washington, DC, office of Davis Wright Tremaine, LLP.
 
CMS, OCR, and the Centers for Disease Control and Prevention came together to draft the proposed rule and HHS expects to publish the final rule later this year.
 
Labs affected by the change will need to set up a policy and procedure to handle direct patient requests, says Kate Borten, CISSP, CISM, president of The Marblehead Group in Marblehead, MA.
 
Editor’s note: For additional information, access the article in its entirety in the November issue of Briefings on HIPAA.



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