Business Associate Agreements – a First Look at Indemnification

A party’s responsibilities under HIPAA generally come from two sources – the law itself and the business associate agreement entered into between the covered entity (the health care provider or health plan) and the business associate (its vendor). While all parts of a business associate agreement are important, there are certain terms that are most likely to affect the parties’ liability and obligations. One of these key terms is , and it is often the section of the business associate agreement that lawyers most often fight over. Folks often wonder why lawyers tend to focus so much on this section, and the short answer is that when things go wrong–such…

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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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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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HIPAA Final Rule: Business Associate Notification Timing, Policy and Procedure Updates, Retraining, and Documentation

February 1, 2013.  Today, we wrap up discussion of breach notification 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 to the HIPAA Rules.  The Final Rule is effective on March 26, 2013, and requires compliance by covered entities and business associates on September 23, 2013.  The focus is on timing of reporting a breach by a business associate to a covered entity, and, because the definition of breach was modified in the Final Rule, on the requirements to update policies and procedures,…

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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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ONC Issues Meaningful Use Guide for Privacy & Security Attestation Compliance

May 9, 2012.  The Office of the National Coordinator for Health Information Technology (ONC) has issued a Guide to Privacy and Security of Health Information (Version 1.1 022312).  This Guide is targeted to medical practitioners who participate in the Medicare and Medicaid Program for Adoption and Meaningful Use of Certified Electronic Health Record Technology. Chapters are: 1. What Is Privacy & Security and Why Does It Matter? 2. Privacy & Security and Meaningful Use. 3.  Privacy & Security Step Plan for Meaningful Use. 4.  Integrating Privacy and Security into Your Practice. 5.  Privacy and Security Resources. The Guide highlights two of the Stage 1 Meaningful Use Objectives and Corresponding Measures…

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OCR Penalizes Physician Practice for HIPAA Privacy and Security Rule Violations

April 18, 2012.  Late last week, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) executed a Resolution Agreement and included Corrective Action Plan (Appendix A) as a settlement for violations of HIPAA Privacy and Security Rules by a physician practice, Phoenix Cardiac Surgery, P.C., of Phoenix and Prescott, AZ. In its April 17, 2012, News Release, HHS stated: “The incident giving rise to OCR’s investigation was a report that the physician practice was posting clinical and surgical appointments for its patients on an Internet-based calendar that was publicly accessible. On further investigation, OCR found that Phoenix Cardiac Surgery had implemented few policies and…

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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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Physical Safeguard Standard, Workstation Use-What to Do and How to Do It

In our series on the HIPAA Administrative Simplification Security Rule, Workstation Use is the second Physical Safeguard Standard.  There is no defined implementation specification for this standard.  Implementation of policies and procedures pertaining to this standard are required.  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. What is Required A covered entity must implement policies and procedures that specify the proper functions to be…

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