Pathologists give thumbs up to new rule granting patients direct access to lab results

The new federal rule that pre-empts many state laboratory laws and permits direct communication of test results between labs and patients has received the blessing of the College of American Pathologists, an 18,000-physician medical specialty society.

“We are pleased that the HHS has expanded patient rights and access to laboratory records, while recognizing the vital role pathologists and laboratories have in patient healthcare,” said CAP President Dr. Gene Herbek in a news release. “As this rule is implemented, the CAP will work with laboratories on compliance with regulations and with HHS on its guidance to providers and patients.”

The 101-page rule released Monday modifies both the Clinical Laboratory Improvement Amendments statute, which regulates 239,000 healthcare testing labs, and the Health Insurance Portability and Accountability Act, the main federal healthcare data privacy and security law.

Through a combination of state laws, CLIA and HIPAA, labs in 39 states and U.S. territories have been barred from the direct communication of test results to patients. The prohibitions have been deemed by the government, lab companies and others as a barrier to the goal of achieving interoperability of healthcare information.

Absent these bans, patients' personal health records or mobile devices could be configured to automatically receive test results, although the new rule affords labs 30 days to respond to a patient's request for test results. Labs have 180 days from the date of publication (expected Thursday) in the Federal Register to comply.

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