HIPAA Final Rule: Modification of Business Associate Definition, Part (4)–Personal Health Record Vendor

February 12, 2013.  Today, we examine the role of the personal health record vendor in paragraph (3)—the third paragraph of four—of the business associate definition, 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. Here is the second of three parts of this…

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HIPAA Final Rule: Modification of Business Associate Definition, Part (3)

February 11, 2013.  Today, we start to examine (3)—the third paragraph of four—of the business associate definition, 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. Here is the first of three parts of this paragraph, (i), which is the subject of today’s…

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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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HIPAA Final Rule: More on Breach Notification Rule Changes

January 31, 2013.  Today, we briefly identify key changes or reminders regarding breach notification in the preamble of 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, published in the Federal Register on January 25, 2013.  The Final Rule becomes effective March 26, 2013 and requires compliance by covered entities and business associates on September 23, 2013.  Earlier this week, we have examined the changed definition of breach, the substitution of the “probability standard” for the current “harm standard” underpinning…

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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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OCR Announces November 2011 Start of Privacy and Security Compliance Audits

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is responsible for privacy and security enforcement under Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) Act provisions. OCR has announced that it is initiating compliance audits beginning this month, as authorized by the HITECH Act.  This action precedes the imminent release of the Final HIPAA/HITECH Act Privacy, Security, Breach Notification, and Enforcement Rules, expected before the end of 2011, and will strengthen enforcement and accountability for compliance with existing and forthcoming Rule modifications.   To avoid the consequences of potential penalties for non-compliance, covered entities and business…

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HITECH Act Privacy and Security Final Rules Needed Now

Since September 23, 2009, the enforcement arm of the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), has been required to publicly disclose breaches involving 500 or more individuals discovered and reported by covered entities and their business associates. As of October 25, 2011, OCR has reported 345 such breaches involving a total of 11,959,488 individuals.  Not reflected yet in the OCR disclosed breaches are two involving 6.5 million individuals:  a Nemours breach of 1.6 million individuals and a TRICARE breach involving 4.9 million individuals.  Together, these two recently reported breaches represent 54.4% of the total number of individuals affected by the publicly disclosed breaches…

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Nearly 8.3 Million Individuals Impacted by 249 Privacy and Security Breaches Reported by HHS; More Training on Safeguarding PHI Required

Under the Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the American Recovery and Reinvestment Act of 2009, covered entities are required to report to the Secretary of the U.S. Department of Health and Human Services (HHS) any privacy or security breach affecting 500 or more individuals within 60 days of discovery of the breach by the covered entity or its business associate.  The HHS Office for Civil Rights (OCR), which is responsible for privacy and security enforcement under the Health Insurance Portability and Accountability Act (HIPAA) and HITECH Act provisions that strengthened privacy and security enforcement, is required to post those breaches…

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200 Breaches Impacting Almost 5.9 Million Individuals, with Theft and Loss of Laptops and PEDs Major Cause

December 2, 2010.M Under the Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the American Recovery and Reinvestment Act of 2009, covered entities are required to report to the Secretary of the Department of Health and Human Services (HHS) any breach affecting 500 or more individuals within 60 days of discovery of the breach by the covered entity or its business associate.  The HHS Office for Civil Rights (OCR), which is responsible for HIPAA privacy and security enforcement,  is required to post these HIPAA privacy or security breaches on its Web site (please note that this URL is a change from the initial…

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