Ober|Kaler Healthcare Information Privacy, Security and Technology Bulletin: Changes to HIPAA Privacy Rule and CLIA Regs Will Require Laboratories to Release Test Results to Patients


If the most recent proposed changes to the HIPAA Privacy Rule and CLIA regulations are finalized as proposed, laboratories across America will be obligated to provide test results to individual patients upon request. The changes to CLIA and the HIPAA Privacy Rule are coordinated and, taken together, would result in a marked change from the current web of state-specific laboratory laws (which often prohibits providing patients their own test results) and will require many laboratories to develop HIPAA compliant policies and procedures for accepting, processing, and responding to patient requests for protected health information. For laboratories, a patient request for health information maintained by the laboratory would include a copy of the requesting patient’s laboratory reports.

The proposed rule (“NPRM”) [PDF] was published on September 14, 2011 in the Federal Register. Comments may be filed in the typical fashion, and, to be considered, must be filed by 5 p.m. on November 14, 2011. The NPRM specifically requests comments on several areas, including, especially, the burdens created by this new requirement for laboratories.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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