Final Rule on Breach Notification for Unsecured Protected Health Information Delayed for Additional Review

The following statement was recently posted on the U.S. Department of Health & Human Services’ Office of Civil Rights website:  

“The Interim Final Rule for Breach Notification for Unsecured Protected Health Information, issued pursuant to the Health Information Technology for Economic and Clinical Health (HITECH) Act, was published in the Federal Register on August 24, 2009, and became effective on September 23, 2009.  During the 60-day public comment period on the Interim Final Rule, HHS received approximately 120 comments.

“HHS reviewed the public comment on the interim rule and developed a final rule, which was submitted to the Office of Management and Budget (OMB) for Executive Order 12866 regulatory review on May 14, 2010.  At this time, however, HHS is withdrawing the breach notification final rule from OMB review to allow for further consideration, given the Department’s experience to date in administering the regulations.  This is a complex issue and the Administration is committed to ensuring that individuals’ health information is secured to the extent possible to avoid unauthorized uses and disclosures, and that individuals are appropriately notified when incidents do occur.  We intend to publish a final rule in the Federal Register in the coming months.”

See Breach Notification Final Rule Update

CMS Holds Training Teleconference on EHR Final Rules

On Thursday, July 22, 2010, the Centers for Medicare and Medicaid Services (CMS) held a publicly available teleconference to give an overview of the 800+ page Final Rule on Meaningful Use (MU) under the HITECH Act, as well as an overview of the Final and Proposed Rules on Temporary & Permanent Certification Program and the Final Rule on the Standards and Certification Criteria for electronic health records (EHRs).  CMS is making an “encore recording” of the 90-minute teleconference available until 11:00 pm, Saturday, July 24, 2010.  Call toll-free, 1-800-642-1689 and enter the conference ID 87841621 to hear the encore recording.  CMS will post an audio recording link to the teleconference on its EHR Incentive Programs website sometime in August 2010.  The slides accompanying the audio are available on that same website, here (scroll to Downloads and click on the links for the July 22, 2010 Training materials). 

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HHS Releases Final Rule on “Meaningful Use” of Electronic Health Records

Update: On December 29, 2010, HHS published in the Federal Register a “Correcting Amendment” to its Final Rule on Meaningful Use, which can be viewed here.

HHS Secretary Kathleen Sebelius wasted no time in putting the brand new CMS Director to work on July 13, 2010, in announcing the release of two rules under the Health Information Technology for Clinical and Economic Health Act (HITECH), including the Final Rule on Meaningful Use and the Final Rule on Initial Set of EHR Standards and Certification Criteria. Donald M. Berwick, MD, MPP, FRCP, was sworn in as Director of the Centers for Medicare and Medicaid Services on Monday afternoon, July 12, 2010, and by the next morning was primed to discuss the important role of health information technology (HIT) in America. In addition to Dr. Berwick’s participation at the press briefing, other participants included David Blumenthal, MD, the Chief Coordinator for the HHS Office of National Coordinator of HIT (ONC), Regina Benjamin, MD, U.S. Surgeon General, and Regina Holiday, an individual who shared a personal experience involving access to health information and how such access impacts the care of patients. 

Quick Reference: The CMS Fact Sheet on both Final Rules is available here. 

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HHS and ONC Announce Briefing on Meaningful Use Rule

UPDATE: Watch the LIVE webcast here.

According to HealthcareIT News, federal officials have announced that, on Tuesday morning, July 13, 2010, at 10:00 am EST, the Centers for Medicare and Medicaid (CMS) and the Office of National Coordinator (ONC) will release the final rule on making a “meaningful use” of electronic health records under the HITECH Act.

HHS Office of Civil Rights updates HIPAA Breach Website

As indicated in a July 8, 2010 press briefing, the Office of Civil Rights (OCR) of the United States Department of Health & Human Services (HHS) has updated its HIPAA breach notification webpage.  This is the webpage where OCR is posting breaches of unsecured Protected Health Information (PHI) affecting 500 or more individuals.  The format includes brief summaries of the incidents reported to the HHS Secretary that OCR has investigated and closed.  The format also allows users to search and sort the posted breaches by entity, state, date, number of individuals affected, type of breach, and location of breached information.  There are currently 107 breach notifications posted, all occurring since September 9, 2009.  The breaches reported thus far indicate that theft ranks #1 as the type of activity leading to a breach. A quick run-down of the stats reflect the following:

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