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Breach Notification Regulation History

01/25/13 - Omnibus HIPAA Rulemaking (78 FR 5566)

08/24/09 - HITECH Breach Notification Interim Final Rule

04/17/09 -HITECH Act Breach Notification Guidance and Request for Public Comment Breach Notification Guidance and RFI (74 FR 19006)

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.

Until such time as a new final rule is issued, the Interim Final Rule that became effective on September 23, 2009, remains in effect.

View the Combined Regulation Text (as of March 2013).This is an unofficial version that presents all the HIPAA regulatory standards in one document. The official version of all federal regulations is published in the Code of Federal Regulations (CFR). View the official versions at 45 C.F.R. Part 160Part 162, and Part 164.

 

Reports to Congress on Breach Notifications

Content created by Office for Civil Rights (OCR)
Content last reviewed on July 26, 2013
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