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: Security Standards, General Rules & Administrative Safeguard Modifications

February 5, 2013.  Today, we cover the modifications to Security Standards:  General Rules, and Administrative Safeguards in 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. Security Standards:  General Rules.  The five General Rules govern how the administrative, physical,…

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OCR Publishes HIPAA/HITECH Act Privacy and Security Compliance Audit Protocol

July 9, 2012.  Late in June, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) published its HIPAA/HITECH Act Privacy and Security Compliance Audit Protocol.  Here is OCR’s description of the program, which outlines 77 audit procedures for the HIPAA Security Rule and 88 audit procedures for the HIPAA Privacy and HITECH Act Breach Notification Rules: “The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate.  OCR established a comprehensive audit protocol that contains the requirements to be assessed through these performance audits.  The entire audit protocol is organized around modules, representing separate…

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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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Three Key Properties of HIPAA Privacy and Security of Protected Health Information

HIPAA.com has received from its readers requests for information on topics related to HIPAA Administrative Simplification Privacy and Security Rules and to updates to those rules reflected in the HITECH Act provisions of the American Recovery and Reinvestment Act of 2009, signed by President Obama on February 17, 2009.  Recently, HIPAA.com answered the question of particular interest to several readers:  what exactly is protected health information (PHI)?  In this posting, we answer the question:  what are the fundamental properties that underlie privacy and security of protected health information? Three Key Properties The three key properties that underpin privacy and security under the Health Insurance Portability and Accountability Act (HIPAA) are availability,…

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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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Nationwide Privacy and Security Framework for Electronic Exchange: Key Meaningful Use 2011 Objective Recommendation

On December 15, 2008, the Office of the National Coordinator for Health Information Technology of the U.S. Department of Health and Human Services (HHS) published its 11 page report: Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information. This report states: “[a] key factor to achieving a high-level of trust among individuals, health care providers, and other health care organizations participating in electronic health information exchange is the development of, and adherence to, a consistent and coordinated approach to privacy and security. Clear, understandable, uniform principles are a first step in developing a consistent and coordinated approach to privacy and security and a key component to…

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Integrity: What This HIPAA Security Rule Technical Safeguard Standard Means

This is the third Technical Safeguard Standard of the HIPAA Administrative Simplification Security Rule. It has one implementation specification:  mechanism to authenticate electronic protected health information. This implementation specification 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….

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Security Management Process: Risk Analysis-What to Do and How to Do It

Security Management Process is the first administrative standard of the Security Rule, and Risk Analysis is the implementation specification.  Each covered entity is required to conduct a risk analysis or assessment to determine vulnerabilities and threats and to identify and put in place risk mitigation measures for safeguarding electronic protected health information.  Electronic protected health information is the content of the HIPAA Administrative Simplification Standard Transactions and of the expected growing adoption of clinically-based electronic health record systems. What to do:  Conduct an accurate and thorough assessment of potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity. How to…

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