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.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

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.

© Baker Donelson | Attorney Advertising

Written by:


Baker Donelson on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.