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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ONC Touts its 10 Step Plan for Meeting Meaningful Use Privacy and Security Attestation Requirements

In a recent Tweet, the Office of the National Coordinator for Health Information Technology (ONC) stated:  “Move into the 21st Century and check out the Privacy & Security 10-Step Plan before you implement an Electronic Health Record.”  ONC makes the following recommendation to an Eligible Professional (EP) covered entity participating in the Medicare and Medicaid Financial Incentive Program for Adoption and Meaningful Use of Certified Electronic Health Record (EHR) Technology:  “An EP must meaningfully use certified EHR technology for an EHR reporting period, and then attest to CMS [the Centers for Medicare & Medicaid Services] that he or she has met meaningful use for that period.  Start your 10-step process at…

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CMS and ONC Publish Final Rules for Meaningful Use Stage 2 Security in Federal Register

September 4, 2012.  The Department of Health and Human Services (HHS) entities:  Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC), published their Final Rules for Meaningful Use Stage 2 in today’s Federal Register.  This posting focuses on the preamble relating to the following Stage 2 security objective in the CMS Final Rule entitled Medicare and Medicaid Programs; Electronic Health Record Incentive Program:  “Protect electronic health information created or maintained by the Certified EHR Technology [CEHRT] through the implementation of appropriate technical capabilities.”  Reference numbers in brackets refer to the page number(s) in the September 4, 2012,  Federal Register. Associated with this objective…

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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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ONC Publishes Stage 2 EHR Technology Certification Criteria NPRM

On March 7, 2012, the Office of the National Coordinator for Health Information Technology (ONC) of the Department of Health and Human Services (HHS) published in the Federal Register its notice of proposed rule making (NPRM) entitled Health Information Technology:  Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record [EHR] Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology [pp. 13832-13885].  Comments to HHS may be made until 5 PM on May 7, 2012. The summary of the NPRM is included here: “Under section 3004 of the Public Health Service Act, the Secretary of Health and Human Services is proposing to revise the initial set…

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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 Encryption: What to Do and How to Do It

In our series on the HIPAA Administrative Simplification Security Rule, this is the second of two implementation specifications for the Technical Safeguard Standard, Transmission Security.  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 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. What to…

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Transmission Security Integrity Controls: 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 Technical Safeguard Standard, Transmission Security.  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 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. What to Do Implement…

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