Final Rule: Modified Definition of Breach

January 28, 2013.  Today, we want to explore the modified definition of breach in the Final HIPAA/HITECH Act Privacy, Security, Breach Notification, and Enforcement Rule published in the Federal Register on Friday, January 25, 2013. Here is the modified definition [45 CFR 164.402, Definitions, effective March 26, 2013; 78 Federal Register 5695]: Breach means the acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E [HIPAA Privacy Rule] of this part [Part 164] which compromises the security or privacy of the protected health information. (1) Breach excludes: (i) Any unintentional acquisition, access, or use of protected health information by a workforce member or…

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HITECH Act Privacy and Security Final Rules Needed Now

Since September 23, 2009, the enforcement arm of the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), has been required to publicly disclose breaches involving 500 or more individuals discovered and reported by covered entities and their business associates. As of October 25, 2011, OCR has reported 345 such breaches involving a total of 11,959,488 individuals.  Not reflected yet in the OCR disclosed breaches are two involving 6.5 million individuals:  a Nemours breach of 1.6 million individuals and a TRICARE breach involving 4.9 million individuals.  Together, these two recently reported breaches represent 54.4% of the total number of individuals affected by the publicly disclosed breaches…

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OCR Stepping Up HIPAA Security Enforcement

Health Data Management (HDM) reported today, May 12, that the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) is going to strengthen HIPAA Security Rule enforcement, based on statements made on Tuesday, May 11 by the OCR Deputy Director for Privacy, Susan McAndrew, at the Safeguarding Health Information conference in Washington, DC, co-sponsored by OCR and the National Institute of Standards and Technology (NIST).  “To boost enforcement of the security rule, OCR has added investigators in 10 regional offices, McAndrew notes,” as reported by Joe Goedert in the HDM article, “OCR Boosting Security Enforcement,” which is available online. This report comes several days after…

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HHS Issues Interim Final Rule for HITECH ‘Breach Notification’

U.S. Department of Health and Human Services Secretary, Kathleen Sebelius, has issued the Interim Final Rule for Breach Notification for Unsecured Protected Health Information.  The Interim Final Rule was signed by Secretary Sebelius on August 6, 2009, filed at the Federal Register on Wednesday, August 19, 2009, and will be published on Monday, August 24, 2009, in the Federal Register.  The effective date of the Interim Final Rule will be 30 days after publication, and will cover both covered entities and business associates of covered entities.  Here is the Summary of the Interim Final Rule: “The Department of Health and Human Services (HHS) is issuing this interim final rule with…

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Transmission Security: What This HIPAA Security Rule Technical Safeguard Standard Means

This is the fifth and last Technical Safeguard Standard of the HIPAA Administrative Simplification Security Rule.  It has two implementation specifications:  integrity controls; and encryption.  Each is addressable.  Addressable does not mean “optional.”  Rather, an addressable implementation specification means that a covered entity must use reasonable and appropriate measures to meet the standard.  As we have noted in earlier postings on HIPAA.com, business associates of covered entities will be required to comply with the Security Rule safeguard standards, beginning February 17, 2010.  This requirement is one of the HITECH Act provisions of the American Recovery and Reinvestment Act (ARRA), signed by President Obama on February 17, 2009. For compliance with…

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Access Control: What This HIPAA Security Rule Technical Safeguard Standard Means

This is the first Technical Safeguard Standard of the HIPAA Administrative Simplification Security Rule. It has four implementation specifications:  unique user identification; emergency access procedure; automatic logoff; and encryption and decryption. The first two are required; the last two are addressable. Addressable does not mean “optional.” Rather, an addressable implementation specification means that a covered entity must use reasonable and appropriate measures to meet the standard. As we have noted in earlier postings on HIPAA.com, business associates of covered entities will be required to comply with the Security Rule safeguard standards, beginning February 17, 2010. This requirement is one of the HITECH Act provisions of the American Recovery and Reinvestment…

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