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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OMB Completes Review of HIPAA/HITECH Act Privacy, Security, Enforcement Rule Modifications NPRM

On July 1, 2010, the Office of Management and Budget (OMB) completed review of the Notice of Proposed Rulemaking (NPRM) entitled: Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act](RIN:  0991-AB57).  The NPRM was received at OMB for review on April 12, 2010.  It likely will be published in the Federal Register imminently. Legal authority for the NPRM is in Sections 13400 to 13410 of Subtitle D (Privacy) of the HITECH Act, which was enacted as part of the American Recovery and Reinvestment Act of 2009 (Public Law 111-5), enacted on February 17, 2009. Those sections cover:…

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OCR Reports 107 Breaches Affecting Over 4 Million Individuals (I)

As of the July 4th holiday weekend, the Office for Civil Rights (OCR) has updated again its Web site listing of breaches affecting 500 or more individuals.  As of July 2, 2010, there were 107 breaches listed that were reported to have occurred between September 22, 2009 and June 11, 2010. Individuals affected by these publicly listed breaches totaled 4,086,980.  Six of the 107 breaches, or 5.6% of the total, affected 3,353,627 individuals, or 82% of the total.  This is the first of three postings that analyzes the data from these 107 breaches.  This posting (I) covers electronic breaches, the next posting (II) covers hard copy (paper) breaches, and the…

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OCR Identifies 36 Entities with Breaches Affecting 500 or More Individuals

On Monday, February 22, 2010, the federal government, through the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS), began enforcing the Breach Notification Rule for breaches occurring on or after that date.  The Breach Notification for Unsecured Protected Health Information; Interim Final Rule, was published in the Federal Register on Monday, August 24, 2009 [74 FR 42739-42770] and was effective September 23, 2009.  Since September 22, 2009, 36 breaches of privacy or security of protected health information (PHI) affecting 500 or more individuals have been reported to OCR.  The total number of individuals affected was 1,073,657, with two of the breaches involving 359,000 (FL)…

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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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HHS Secretary Sebelius Delegates Oversight and Enforcement of HIPAA Security Rule to OCR

U.S. Health and Human Services (HHS) Secretary Kathleen Sebelius has delegated oversight and enforcement of the HIPAA Administrative Simplification Security Rule Standards for Protection of Electronic Protected Health Information to HHS’s Office of Civil Rights (OCR), effective July 27, 2009.  Since October 7, 2003, the Security Rule had been the responsibility of HHS’s Center for Medicare & Medicaid Services (CMS). OCR also has responsibility for the HIPAA Administrative Simplification Privacy Rule.  This delegation brings responsibility for administrative, technical, and physical standards for safeguarding of protected health information in each rule under one authority, and likely will facilitate enforcement of the HITECH Act breach, notification, and business associate security rule compliance…

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Nationwide Privacy and Security Framework for Electronic Exchange: Key Meaningful Use 2011 Objective Recommendation

On December 15, 2008, the Office of the National Coordinator for Health Information Technology of the U.S. Department of Health and Human Services (HHS) published its 11 page report: Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information. This report states: “[a] key factor to achieving a high-level of trust among individuals, health care providers, and other health care organizations participating in electronic health information exchange is the development of, and adherence to, a consistent and coordinated approach to privacy and security. Clear, understandable, uniform principles are a first step in developing a consistent and coordinated approach to privacy and security and a key component to…

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HITECH Privacy Provisions Include HIPAA Privacy Definitions and New or Broadened Concepts

This posting is one of several that outline the HITECH privacy provisions of the American Recovery and Reinvestment Act that President Obama signed into law on Tuesday, February 17, 2009, in Denver, CO. Here, we reproduce the definitions that appear in Subtitle D—Privacy, Section 13400. Definitions, that appear in the Conference Report on page H1345 of Congressional Record—House, February 12, 2009. These definitions are critical in understanding the content of the new HITECH privacy provisions and how they relate to existing HIPAA Administrative Simplification Privacy Rule standards. HIPAA Privacy Definitions: BreachBusiness AssociateCovered EntityDisclosureElectronic Health RecordHealth Care Operations Health Care ProviderHealth PlanNational CoordinatorPaymentPersonal Health RecordProtected Health Information SecretarySecurityStateTreatmentUseVendor Of Personal Health…

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