HIPAA Final Rule: More on Business Associate Uses & Disclosures in the Business Associate Contract

March 11, 2013.  Today, we continue going through the HIPAA Privacy Rule, section by section, as 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. Our focus last week was on 45 CFR 164.502: Uses and disclosures of protected health information:  General Rules, and,…

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HIPAA Final Rule: Enforcement by State Attorneys General

February 26, 2013.  Today, we examine the HIPAA Rules enforcement role established by the HITECH Act for State attorneys general as 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. As of February 18, 2009, Section 13410(e) of the HITECH Act granted State attorneys…

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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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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 Touts its 10 Step Plan for Meeting Meaningful Use Privacy and Security Attestation Requirements

In a recent Tweet, the Office of the National Coordinator for Health Information Technology (ONC) stated:  “Move into the 21st Century and check out the Privacy & Security 10-Step Plan before you implement an Electronic Health Record.”  ONC makes the following recommendation to an Eligible Professional (EP) covered entity participating in the Medicare and Medicaid Financial Incentive Program for Adoption and Meaningful Use of Certified Electronic Health Record (EHR) Technology:  “An EP must meaningfully use certified EHR technology for an EHR reporting period, and then attest to CMS [the Centers for Medicare & Medicaid Services] that he or she has met meaningful use for that period.  Start your 10-step process at…

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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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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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ONC Issues Meaningful Use Guide for Privacy & Security Attestation Compliance

May 9, 2012.  The Office of the National Coordinator for Health Information Technology (ONC) has issued a Guide to Privacy and Security of Health Information (Version 1.1 022312).  This Guide is targeted to medical practitioners who participate in the Medicare and Medicaid Program for Adoption and Meaningful Use of Certified Electronic Health Record Technology. Chapters are: 1. What Is Privacy & Security and Why Does It Matter? 2. Privacy & Security and Meaningful Use. 3.  Privacy & Security Step Plan for Meaningful Use. 4.  Integrating Privacy and Security into Your Practice. 5.  Privacy and Security Resources. The Guide highlights two of the Stage 1 Meaningful Use Objectives and Corresponding Measures…

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