HIPAA Final Rule: Business Associate Notification Timing, Policy and Procedure Updates, Retraining, and Documentation

February 1, 2013.  Today, we wrap up discussion of breach notification in the Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules.  The Final Rule is effective on March 26, 2013, and requires compliance by covered entities and business associates on September 23, 2013.  The focus is on timing of reporting a breach by a business associate to a covered entity, and, because the definition of breach was modified in the Final Rule, on the requirements to update policies and procedures,…

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HIPAA Final Rule: Breach Notification Guidance Safe Harbor

January 30, 2013.  Today, we look at the definition of unsecured protected health information and the Guidance Specifying the Technologies and Methodologies that Render Protected Health Information Unusable , Unreadable, or Indecipherable to Unauthorized Individuals [“Guidance”] as discussed in the January 25, 2013 Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act [HITECH Act]; Other Modifications to the HIPAA Rules.  The Final Rule becomes effective on March 26, 2013, and requires compliance by covered entities and business associates on September 23, 2013. Here is the definition of unsecured protected health information: “protected health information that is…

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Final Rule: Modified Definition of Breach

January 28, 2013.  Today, we want to explore the modified definition of breach in the Final HIPAA/HITECH Act Privacy, Security, Breach Notification, and Enforcement Rule published in the Federal Register on Friday, January 25, 2013. Here is the modified definition [45 CFR 164.402, Definitions, effective March 26, 2013; 78 Federal Register 5695]: Breach means the acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E [HIPAA Privacy Rule] of this part [Part 164] which compromises the security or privacy of the protected health information. (1) Breach excludes: (i) Any unintentional acquisition, access, or use of protected health information by a workforce member or…

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Final HIPAA/HITECH Act Privacy, Security, Enforcement, Breach Notification Rules Published in Federal Register January 25, 2013.

January 25, 2013.  The Final Rule is published, at last!  Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule cleared the Office of Management and Budget on January 16, was issued online on the Federal Register’s Electronic Public Inspection Desk in pre-publication format on January 17, and published in the Federal Register today.  The Final Rule is 136 pages (pp.5566-5702).  The effective date of the Final Rule is Tuesday, March 26, 2013, and the compliance date is Monday, September 23, 2013. Here is the…

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OCR of HHS FINALLY Issues HIPAA/HITECH Act Privacy, Security, Enforcement, and Breach Notification Modifications Final Rule

January 18, 2013. On January 16, 2013, the Office of Management and Budget (OMB) completed its EO 12866 regulatory review of RIN:  0945-AA03, and the long-awaited release of the Department of Health and Human Services’ Office for Civil Rights (OCR) so-called “Omnibus” Final Rule was published at 4:15 PM on January 17, 2013, in pre-publication final draft form on the Federal Register’s Electronic Public Inspection Desk.  Publication in the Federal Register is scheduled for Friday, January 25, 2013.  The title of the Final Rule is:  45 CFR Parts 160 and 164:  Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and…

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ONC Publishes Stage 2 EHR Technology Certification Criteria NPRM

On March 7, 2012, the Office of the National Coordinator for Health Information Technology (ONC) of the Department of Health and Human Services (HHS) published in the Federal Register its notice of proposed rule making (NPRM) entitled Health Information Technology:  Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record [EHR] Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology [pp. 13832-13885].  Comments to HHS may be made until 5 PM on May 7, 2012. The summary of the NPRM is included here: “Under section 3004 of the Public Health Service Act, the Secretary of Health and Human Services is proposing to revise the initial set…

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IFR for HIPAA EFT Standard to be Published in Federal Register January 10, 2012

HIPAA.com discussed in its preceding posting this Interim Final Rule (IFR) for “adoption of standards and operating rules for Electronic Funds Transfers (EFT) and operating rules for remittance advice…”, as required by the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148).  [124 STAT. 153] The Office of Management and Budget (OMB) completed its regulatory review on January 3, 2012, and the IFR is available for pre-publication review prior to January 10, 2012, when it will be published in the Federal Register.  The title of the IFR is: Administrative Simplification:  Adoption of Standards for Health Care Electronic Funds Transfers (EFTs) and Remittance Advice. The Summary in the pre-publication…

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IFR for EFT at OMB

The Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) has sent to the Office of Management and Budget (OMB) its Interim Final Rule (IFR) for “adoption of standards and operating rules for Electronic Funds Transfers (EFT) and operating rules for remittance advice….” Following the December 15 receipt and subsequent review of the IFR by OMB, the IFR is expected to be published in the Federal Register before January 1, 2012, as required by the Affordable Care Act of 2010 (Public Law 111-148). [124 STAT. 153] The legal authority for the IFR is Section 1104 (Administrative Simplification) of the Affordable Care Act.  Section 1104…

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HHS Pulls Breach Notification Final Rule

The HIPAA Administrative Simplification; Notification in the Case of Breach Final Rule (Regulation Identifier Number (RIN) 0991-AB56) has been at the Office of Management and Budget (OMB) since May 14, 2010, for Executive Order (EO) 12866 review and approval prior to publication in the Federal Register. On July 28, 2010, HHS “withdrew” this Final Rule, with the following explanation: “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…

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Final Rules for EHR Incentives and Certification Criteria at OMB for Review

The Office of Management and Budget (OMB) received in early July for Executive Order (EO) 12866 Regulatory Planning and Review two Final Rules relating to electronic health record (EHR) incentives and certification criteria required under the Health Information Technology for Economic and Clinical Health Act (HITECH Act) that was enacted on February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009. On Friday, July 2, 2010, OMB received from the Office of the Secretary at the Department of Health and Human Services (HHS) for review Health Information Technology:  Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule.  The Interim Final…

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