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: Enforcement: Willful Neglect

February 20, 2013.  Today, we begin examination of HITECH Act modifications of HIPAA Enforcement, focusing on the meaning and consequences of willful neglect 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. Willful neglect is defined as “conscious, intentional failure or reckless indifference to the…

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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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Reported Breaches of 500 or More Individuals up to 93 and Affecting Over 2.5 Million Individuals; Enforcement and Penalties

As of Friday, June 4, 2010, 93 breaches affecting 500 or more individuals have been reported on the Office for Civil Rights (OCR) Web site. The total number affected has gone beyond 2-1/2 million individuals today, and stands at 2,565,352 individuals. Of the 87 breaches involving breach of hard copy or electronic protected health information, 26% involve hard copy or paper records and 74% records on electronic media or devices. Overall, 71% of the 93 breaches involve theft or loss of records, many of which might have been avoided by appropriate securing of hard copy records and electronic media and devices. Below we remind readers of the Department of Health…

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Today, February 17, Business Associates Must be in Compliance with HIPAA Security Rule

Today, Wednesday, February 17, 2010, Business Associates of Covered Entities must be able to demonstrate that they are in compliance with administrative, physical, and technical safeguards of the HIPAA Security Rule, as required by the HITECH Act, enacted one year ago today as part of the American Recovery and Reinvestment Act of 2009.  In addition, Business Associate Agreements must be rewritten or amended to specifically require a Business Associate’s compliance with the Security Rule as part of its “satisfactory assurances.”  Financial penalties for noncompliance discovered during a compliance audit or complaint investigation could be severe, especially for willful neglect. Here are the appropriate authorities: Section 13401 of Part 1 (Improved…

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Final HIPAA Enforcement Rule

DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Parts 160 and 164 | RIN 0991–AB29 HIPAA Administrative Simplification: Enforcement AGENCY: Office of the Secretary, HHS. ACTION: Final rule. Download (Requires Acrobat Reader)