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CLIA update makes way for direct disclosure of patient lab results

Laboratories are now allowed to give patients access to their full test reports as a result of an update to the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The rule also grants the same permission to personal representatives designated by a patient. Disclosure of patient lab results falls under the HIPAA Privacy Rule, which regulates the transmission of protected health information to patients or their approved personal representatives.

The rule was proposed in September 2011 to allow patients access to their lab results without the consent of their provider. The proposal was met with resistance by the American Hospital Association and HIMSS, who predicted that the rule change would increase operational and compliance costs for providers.

“Information like lab results can empower patients to track their health progress, make decisions with their health care professionals, and adhere to important treatment plans,” said HHS Secretary Kathleen Sebelius in a release announcing the final rule.

This rule gives patients more freedom to view their records, though it’s unclear if they will take advantage of the opportunity. A recent Xerox survey concluded that 83% of Americans have concerns about the security of digital health records and only 32% want their records converted to EHRs. Though the update to CLIA isn’t specific to digital records — the Xerox survey reflects that patients, due to security worries, are reluctant to allow their data to be shared in new ways.

The transmission of secure information, even within a hospital, is also a concern for providers. This issue is further complicated by the rise in usage of mobile device among physicians. Some providers have responded by installing an in-house, Short Message Service (SMS) to ensure the safe distribution of patient information, including lab data. Before going the SMS route, Frisbie Memorial Hospital in Rochester, N.H., analyzed where their internal communications issues were occurring. They found the sharing of patient lab results in their emergency department was one of their trouble spots.

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