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.

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 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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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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Clock Running Down on Business Associate Compliance with HIPAA Security Rule Required by HITECH Act

Less than one month to go:  Business Associates must comply with the HIPAA Security Rule no later than Wednesday, February 17, 2010.  Here are relevant provisions from the American Recovery and Reinvestment Act, Public Law 111-5, which included HITECH Act Subtitle D:  Privacy. 42 USC 17931 (PART 1–IMPROVED PRIVACY PROVISIONS AND SECURITY PROVISIONS, Section 13401:  Application of Security Provisions and Penalties to Business Associates of Covered Entities; Annual Guidance on Security Provisions). (a)  APPLICATION OF SECURITY PROVISIONS.–Sections 164.308 (Administrative Safeguards), 164.310 (Physical Safeguards), 164.312 (Technical Safeguards), and 164.316 (Policies and Procedures and Documentation Requirements) of title 45, Code of Federal Regulations, shall apply to a business associate of a covered…

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Exploring HIPAA and HITECH Act Definitions: Part 16

From now through early December, HIPAA.com is providing a run through of HIPAA transaction & code set, privacy, and security definitions, along with relevant HITECH Act definitions pertaining to breach notification, securing of protected health information, and electronic health record (EHR) standards development and adoption. These definitions are key to understanding the referenced HIPAA and HITECH Act enabling regulations that are effective now and that will require compliance by covered entities and business associates now or in the months ahead, as indicated in HIPAA.com’s timeline. Each posting will contain three definitions, with a date reference to the Federal Register, Code of Federal Regulations (CFR), or statute, as appropriate. Exploring HIPAA…

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Exploring HIPAA and HITECH Act Definitions: Part 15

From now through December, HIPAA.com is providing a run through of HIPAA transaction & code set, privacy, and security definitions, along with relevant HITECH Act definitions pertaining to breach notification, securing of protected health information, and electronic health record (EHR) standards development and adoption. These definitions are key to understanding the referenced HIPAA and HITECH Act enabling regulations that are effective now and that will require compliance by covered entities and business associates now or in the months ahead, as indicated in HIPAA.com’s timeline. Each posting will contain three definitions, with a date reference to the Federal Register, Code of Federal Regulations (CFR), or statute, as appropriate. Exploring HIPAA and…

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Exploring HIPAA and HITECH Act Definitions: Part 14

From now through December, HIPAA.com is providing a run through of HIPAA transaction & code set, privacy, and security definitions, along with relevant HITECH Act definitions pertaining to breach notification, securing of protected health information, and electronic health record (EHR) standards development and adoption. These definitions are key to understanding the referenced HIPAA and HITECH Act enabling regulations that are effective now and that will require compliance by covered entities and business associates now or in the months ahead, as indicated in HIPAA.com’s timeline. Each posting will contain three definitions, with a date reference to the Federal Register, Code of Federal Regulations (CFR), or statute, as appropriate. Exploring HIPAA and…

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Exploring HIPAA and HITECH Act Definitions: Part 13

From now through December, HIPAA.com is providing a run through of HIPAA transaction & code set, privacy, and security definitions, along with relevant HITECH Act definitions pertaining to breach notification, securing of protected health information, and electronic health record (EHR) standards development and adoption. These definitions are key to understanding the referenced HIPAA and HITECH Act enabling regulations that are effective now and that will require compliance by covered entities and business associates now or in the months ahead, as indicated in HIPAA.com’s timeline. Each posting will contain three definitions, with a date reference to the Federal Register, Code of Federal Regulations (CFR), or statute, as appropriate. Exploring HIPAA and…

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Exploring HIPAA and HITECH Act Definitions: Part 12

From now through December, HIPAA.com is providing a run through of HIPAA transaction & code set, privacy, and security definitions, along with relevant HITECH Act definitions pertaining to breach notification, securing of protected health information, and electronic health record (EHR) standards development and adoption. These definitions are key to understanding the referenced HIPAA and HITECH Act enabling regulations that are effective now and that will require compliance by covered entities and business associates now or in the months ahead, as indicated in HIPAA.com’s timeline. Each posting will contain three definitions, with a date reference to the Federal Register, Code of Federal Regulations (CFR), or statute, as appropriate. Exploring HIPAA and…

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