HIPAA Final Rule: Modified Rule for Business Associates and Subcontractors

February 6, 2013.  Today, we cover the business associate Administrative Safeguard (b) of the Security Rule, as modified by the Final Rule:  Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications of the HIPAA Rules, which was published in the Federal Register on January 25, 2013.  The effective date of the Final Rule is March 26, 2013, and covered entities and business associates must comply by September 23, 2013. HIPAA did not directly regulate business associates of covered entities.  The HITECH Act’s 13401 statutorily changed that:  The…

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HIPAA Final Rule: More on Breach Notification Rule Changes

January 31, 2013.  Today, we briefly identify key changes or reminders regarding breach notification in the preamble of the Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules, published in the Federal Register on January 25, 2013.  The Final Rule becomes effective March 26, 2013 and requires compliance by covered entities and business associates on September 23, 2013.  Earlier this week, we have examined the changed definition of breach, the substitution of the “probability standard” for the current “harm standard” underpinning…

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BCBST Pays $1.5 Million to HHS to Settle Potential HIPAA Privacy and Security Violations

On March 13, 2012, Blue Cross Blue Shield of Tennessee (BCBST) agreed to a payment of $1.5 million to the Department of Health and Human Services (HHS) and to a corrective action plan as part of a Resolution Agreement with HHS for potential violation of Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rule violations.  According to a HHS Press Release of the same date, “the enforcement action [by HHS’ Office for Civil Rights (OCR)] is the first resulting from a breach report required by the Health Information Technology for Economic and Clinical Health (HITECH) Act Breach Notification Rule.” According to the HHS Press Release: “The investigation followed…

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OMB Clears HITECH Act Accounting of Disclosures NPRM

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR), responsible for enforcement of the HIPAA Privacy, Security, and Breach Notification Rules, will issue a Notice of Proposed Rule Making (NPRM) to modify the HIPAA Privacy Rule as necessary to implement the accounting of disclosures provisions of Section 13405(c) of the Health Information Technology for Economic and Clinical Health Act (HITECH Act) (Title XIII of the American Recovery and Reinvestment Act of 2009–Public Law 111-5).  Section 13405(c) is entitled: Accounting of Certain Protected Health Information Disclosures Required if Covered Entity Uses Electronic Health Record. The NPRM was submitted on February 9, 2011, by HHS to the Office…

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OCR Issues Draft Guidance on Security Risk Analysis

The Office for Civil Rights (OCR) of the Department of Health and Human Services  (HHS) issued on May 7, 2010, Security Rule Draft Guidance on Risk Analysis. This is the first in a “series of guidance documents [that] will assist organizations in identifying and implementing the most effective and appropriate administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic protected health information.  The materials will be updated annually, as appropriate.” This eight-page document is available online. The Draft Guidance on Risk makes the following key points: “The Security Rule does not prescribe a specific risk analysis methodology, recognizing that methods will vary dependent on the…

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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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Technical Safeguard Standards of the HIPAA Administrative Simplification Security Rule

There are five technical safeguard standards:  access control, audit controls, integrity, person or entity authentication, and transmission security. Each standard has implementation specifications, which can be required or addressable. Remember, 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. Technical…

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Physical Safeguard Standard, Device and Media Controls: Data Backup and Storage Implementation Specification-What to Do and How to Do It

In our series on the HIPAA Administrative Simplification Security Rule, Device and Medial Controls is the fourth and last Physical Safeguard Standard.  Data Backup and Storage is the fourth and last of four implementation specifications, and it is addressable.  Remember, 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…

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Physical Safeguard Standard, Device and Media Controls: Accountability Implementation Specification-What to Do and How to Do It

In our series on the HIPAA Administrative Simplification Security Rule, Device and Medial Controls is the fourth and last Physical Safeguard Standard.  Accountability is the third of four implementation specifications, and it is addressable.  Remember, 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…

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