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: Four Penalty Tiers

February 21, 2013.  Today, we examine the four penalty tiers for violations of HIPAA Rules 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. We start with two definitions, the first of which, Reasonable cause, was modified in the Final Rule, and the second of…

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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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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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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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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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HITECH and HIPAA Training: Time to Double Down

As the healthcare industry continues to digest profound HITECH changes to HIPAA Privacy and Security rules, two observations already are apparent and indisputable for covered entities and their business associates.  First, time and resources spent on a workforce that is well-trained on the Privacy and Security rules will be an investment of exponential value. Second, enforcement of those same rules will make negligent and uncorrected errors very costly. A well-trained workforce makes fewer mistakes, and identifies and fixes those that it makes. A workforce that violates the rules because it does not know them or does not care to know them makes an inviting target for HITECH’s new enforcement initiatives….

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HHS Strengthens HIPAA Enforcement

On Friday, October 30, 2009, HHS published in the Federal Register its Interim Final Rule that strengthens HIPAA enforcement under HITECH Act civil penalty revisions enacted as part of the American Recovery and Reinvestment Act on February 17, 2009.  “These HITECH Act revisions significantly increase the penalty amounts the Secretary [of HHS] may impose for violations of the HIPAA rules and encourage prompt corrective action,” according to the HHS press release.  The Interim Final Rule is effective as federal policy on November 30, 2009, and HHS requests comments by December 29, 2009. With the definition of ‘breach’ in the HITECH Act moving privacy and security violations under one requirement requiring…

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