HHS and CMS Team Up to Propose New Rule to Give Patients Direct Access to their Clinical Pathology Laboratory Test Results

Draft language of new rule would change existing requirements on access to medical laboratory test results as defined in CLIA and HIPAA laws

Big changes lie ahead in how clinical laboratories and pathology groups must give patients access to their medical laboratory test results. Last week, federal agencies published a draft rule that specifies how patients or their authorized representatives are to be given direct access to their medical laboratory test results.

This draft rule was made public on September 12 by the Department of Health and Human Services (HHS), along with the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the HHS Office for Civil Rights. Two days later, on September 14, the proposed rule was published in the Federal Register. There will be a 60-day period from the date of this publication for public comment on the proposed rule. (more…)