HHS Publishes Technical Corrections to January 25, 2013, HIPAA Privacy, Security, and Enforcement Rules

June 7, 2013.  Today, HHS published in the Federal Register “Technical Corrections to the HIPAA Privacy, Security, and Enforcement Rules” that were published on January 25, 2013, as 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 of the HIPAA Rules.” According to the “Summary“ in today’s Corrections Final Rule:  “These technical corrections address certain inadvertent errors and omissions in the HIPAA Privacy, Security, and Enforcement Rules that are located at 45 CFR parts 160 and 164. The effective date of the Corrections Final…

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HIPAA Final Rule: Enforcement–Factors for Determining Civil Money Penalties for HIPAA Violations

February 25, 2013.  Today, we examine factors considered in determining the amount of a civil money penalty for a HIPAA violation that are modified 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 of the HIPAA Rules, which was published in the Federal Register on January 25, 2013.  The effective date of the Final Rule is March 26, 2013, and covered entities and business associates must comply by September 23, 2013. The Department of Health and Human Services (HHS) identified “five general factors”…

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HIPAA Final Rule: Modified Rule for Business Associates and Subcontractors

February 6, 2013.  Today, we cover the business associate Administrative Safeguard (b) of the Security Rule, as modified by 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 of the HIPAA Rules, which was published in the Federal Register on January 25, 2013.  The effective date of the Final Rule is March 26, 2013, and covered entities and business associates must comply by September 23, 2013. HIPAA did not directly regulate business associates of covered entities.  The HITECH Act’s 13401 statutorily changed that:  The…

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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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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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CMS and ONC Publish Final Rules for Meaningful Use Stage 2 Security in Federal Register

September 4, 2012.  The Department of Health and Human Services (HHS) entities:  Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC), published their Final Rules for Meaningful Use Stage 2 in today’s Federal Register.  This posting focuses on the preamble relating to the following Stage 2 security objective in the CMS Final Rule entitled Medicare and Medicaid Programs; Electronic Health Record Incentive Program:  “Protect electronic health information created or maintained by the Certified EHR Technology [CEHRT] through the implementation of appropriate technical capabilities.”  Reference numbers in brackets refer to the page number(s) in the September 4, 2012,  Federal Register. Associated with this objective…

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Five HIPAA Compliance Activities Your Organization Must Undertake

HIPAA Administrative Simplification was enacted on August 21, 1996 as Subtitle F of Title II of Public Law 104-191. The so-called HITECH Act “Omnibus” regulation that modifies HIPAA privacy and security provisions will be published in the Federal Register by the end of this summer, according to the head of HHS’ National Coordinator for Health Information Technology, Farzad Mostashari, M.D. Based on the timeline in the Notice of Proposed Rule Making, compliance by all covered entities and their business associates would be required 240 days after publication, most likely sometime in May 2013, assuming the end-of-summer deadline is met.  All covered entities and their business associates will be required to comply with provisions of…

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EFT and RA Transaction Operating Rules IFC Published in Federal Register August 10

August 10, 2012.  Today, the Interim Final Rule with comment period (IFC):  Administrative Simplification:  Adoption of Operating Rules for Electronic Funds Transfers (EFT) and Remittance Advice Transactions, was published in the Federal Register.  The effective date of the IFC is the date of publication, August 10, 2012.   Comments on the IFC may be submitted to the Department of Health and Human Services (HHS) on or before October 9, 2012, with submission instructions included on page 48008 of the IFC.    The Executive Summary (without footnotes) from the IFC follows: “A.  Purpose of the Regulatory Action.  Health care spending in the United States constitutes nearly 18 percent of the US…

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OCR Publishes HIPAA/HITECH Act Privacy and Security Compliance Audit Protocol

July 9, 2012.  Late in June, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) published its HIPAA/HITECH Act Privacy and Security Compliance Audit Protocol.  Here is OCR’s description of the program, which outlines 77 audit procedures for the HIPAA Security Rule and 88 audit procedures for the HIPAA Privacy and HITECH Act Breach Notification Rules: “The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate.  OCR established a comprehensive audit protocol that contains the requirements to be assessed through these performance audits.  The entire audit protocol is organized around modules, representing separate…

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OCR’s Publicly Disclosed Large Breaches Now Top 20 Million Impacted Individuals

May 16, 2012.  The Department of Health and Human Services’ (HHS) HIPAA/HITECH Act privacy and security enforcement arm, Office for Civil Rights (OCR), is responsible under the HITECH Act to publicly disclose privacy and security breaches that affect 500 or more individuals on its Breach Notification Web site.  With the now reported Utah Department of Health hacking/IT incident breach occurring in the period March 10-April 2, 2012 and affecting a reported 780,000 individuals, the total number in 435 breaches reported since September 22, 2009, now totals 20,079,189 impacted individuals.  Of the total number of breaches where location of breached information is known (e.g., electronic or hard copy source), 72% of…

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