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, “to allow for further consideration, given the Department’s experience to date in administering the regulations.

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 involvement.

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.

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.

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 and Human Services (HHS) enforcement efforts for violations of the HIPAA Privacy and Security rules, and the increased penalty structure for violations of those rules and the HITECH Act Breach Notification Rule.

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.

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.

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.

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