HHS Pulls Breach Notification Final Rule

The HIPAA Administrative Simplification; Notification in the Case of Breach Final Rule (Regulation Identifier Number (RIN) 0991-AB56) has been at the Office of Management and Budget (OMB) since May 14, 2010, for Executive Order (EO) 12866 review and approval prior to publication in the Federal Register. On July 28, 2010, HHS “withdrew” this Final Rule, with the following explanation: “The Interim Final Rule for Breach Notification for Unsecured Protected Health Information, issued pursuant to the Health Information Technology for Economic and Clinical Health (HITECH) Act, was published in the Federal Register on August 24, 2009, and became effective on September 23, 2009. During the 60-day public comment period on the…

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EHR Incentive and Certification Criteria Final Rules Published in Federal Register

The EHR Incentive and Certification final rules were published in the Federal Register this morning, July 28, 2010.  HIPAA.com provides the title, summary, effective date, and URL for each below. Department of Health and Human Services, Centers for Medicare & Medicaid Services, “42 CFR Parts 412, 413, 422, and 495;  Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final Rule, Federal Register, 75(144), Wednesday, July 28, 2010, pp. 44313-44588. Summary:  This final rule implements the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA)(Public Law 111-5) that provide incentive payments to eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) participating in Medicare and Medicaid programs…

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OMB Completes Review of Final Rules for EHR Incentive Program and for Initial Certification Criteria

On Friday, July 9, 2010, the Office of Management and Budget (OMB) completed review of the two Final Rules:  Health Information Technology:  Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record (RIN:  0991-AB58) and Electronic Health Record (EHR) Incentive Program (RIN: 0938-AP78).  RIN means Regulatory Identification Number, used to track a regulatory action through its development.  These rules are on a fast track, follow on the heels of the June 24 Final Rule:  Establishment of the Temporary Certification Program for Health Information Technology (75 Federal Register 36157-36209), and are expected to be available for prepublication inspection at the Federal Register imminently.  For additional information and updates,…

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

The Office for Civil Rights (OCR) regularly updates 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 second of three postings that analyzes the data from these 107 breaches. This posting (II) covers paper breaches. The first posting (I) covered electronic breaches, and the final posting (III) looks at the prevalence of business associate…

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HIPAA Privacy, Security, Enforcement Rule Modifications NPRM at Federal Register

This morning, July 8, 2010, HHS’ Modifications to the HIPAA Privacy, Security, and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act Notice of Proposed Rulemaking (NPRM) was posted at the Federal Register for public access prior to publication.  It will be published on Wednesday, July 14, 2010.  The 234 page NPRM can be accessed in portable document format (pdf) online at:  http://www.ofr.gov/OFRUpload/OFRData/2010-16718_PI.pdf.  There will be a 60-day comment period relating to the content of the NPRM.  HIPAA.com will provide a synopsis of the NPRM in a series of postings following publication in the Federal Register.

Final Rules for EHR Incentives and Certification Criteria at OMB for Review

The Office of Management and Budget (OMB) received in early July for Executive Order (EO) 12866 Regulatory Planning and Review two Final Rules relating to electronic health record (EHR) incentives and certification criteria required under the Health Information Technology for Economic and Clinical Health Act (HITECH Act) that was enacted on February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009. On Friday, July 2, 2010, OMB received from the Office of the Secretary at the Department of Health and Human Services (HHS) for review Health Information Technology:  Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule.  The Interim Final…

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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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