Can I Be Sued for a HIPAA Violation?

I am asked that question almost weekly. While the answer has traditionally been “no,” the legal landscape is shifting and the risk of being sued continues to increase. Let’s first start with some background. As some of you may know, HIPAA does not include a “private right of action.” This means that an individual may not file a claim against a covered entity or a business associate in order to enforce HIPAA or seek damages in response to a HIPAA violation. For example, a patient is not able to sue a dentist if the dentist fails to distribute a Notice of Privacy Practices or enter into a business associate agreement….

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HIPAA Final Rule: More on Business Associate Uses & Disclosures in the Business Associate Contract

March 11, 2013.  Today, we continue going through the HIPAA Privacy Rule, section by section, as modified in 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. Our focus last week was on 45 CFR 164.502: Uses and disclosures of protected health information:  General Rules, and,…

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HIPAA Final Rule: Enforcement by State Attorneys General

February 26, 2013.  Today, we examine the HIPAA Rules enforcement role established by the HITECH Act for State attorneys general as modified in 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. As of February 18, 2009, Section 13410(e) of the HITECH Act granted State attorneys…

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HIPAA Final Rule: Enforcement: Four Penalty Tiers

February 21, 2013.  Today, we examine the four penalty tiers for violations of HIPAA Rules in 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. We start with two definitions, the first of which, Reasonable cause, was modified in the Final Rule, and the second of…

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HIPAA Final Rule: Enforcement: Willful Neglect

February 20, 2013.  Today, we begin examination of HITECH Act modifications of HIPAA Enforcement, focusing on the meaning and consequences of willful neglect in 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. Willful neglect is defined as “conscious, intentional failure or reckless indifference to the…

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Final HIPAA Rule: Security Statutory Authority and Direct Regulation of Business Associates

February 4, 2013.  Today, we cover the security safeguards of the HIPAA 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. The statutory authority for applicability of the HIPAA Security Rule is in Section 13401 of the HITECH Act (123 STAT….

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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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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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Information Access Management: Isolating Healthcare Clearinghouse Functions-What to Do and How to Do It

In our series on the HIPAA Administrative Simplification Security Rule, this is the first implementation specification for the Administrative Safeguard Standard (Information Access Management). This implementation specification is required. What to Do If a healthcare clearinghouse is part of a larger organization, the clearinghouse must implement policies and procedures that protect the electronic protected health information of the clearinghouse from unauthorized access by the larger organization. Remember, a clearinghouse is defined as a covered entity, but also can serve in the role of a business associate to other covered entities, namely a health plan or healthcare provider. How to Do It This implementation specification is required, but is not likely…

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