M. Leeann Habte

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The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration (FDA) and the Brookings Center for Health Policy, the Planning Board emerged out of an FDA action plan in 2012 seeking to strengthen the medical device post-market surveillance system by…
The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy, security, and breach notification rules. OCR also released a template that Covered Entities and Business Associates may use to keep track of their business associate relationships. The release of the updated audit protocol and Business Associate tracking template is part of the implementation…
How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR), the Food and Drug Administration (FDA), and the HHS Office of the National Coordinator for Health Information Technology (ONC) joined together to provide a user-friendly web-based interactive tool to guide developers who are entering the heavily regulated mobile health…
The Office of Civil Rights (OCR) within the U.S. Department of Health and Human Services (DHHS) recently announced that it has initiated Phase 2 of its audit program to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy, security, and breach notification rules (the HIPAA Audit Program). OCR has been under scrutiny in recent years for its lack of oversight and enforcement activity. In September 2015, the…
As we enter the sixth year of the Medicare and Medicaid Electronic Health Records Incentive Programs (commonly referred to as the “Meaningful Use Programs”), the Centers for Medicare & Medicaid Services (CMS) continues to make adjustments to the Meaningful Use Programs to better accommodate providers and suppliers. Two recent updates are described below.…
Almost thirty years after the last substantive change to the federal regulations governing the confidentiality of alcohol and drug abuse patient records, the Substance Abuse and Mental Health Services Administration (SAMHSA) today published a proposed rule (Proposed Rule) to modernize the regulations at 42 CFR Part 2 (the Part 2 Rule). Public comment period on the Proposed Rule is open until April 11, 2016.…
The American Health Lawyers Association last week published an analysis of one of the first cases involving a cyber liability insurance policy. The e-alert is republished below. Please note that any further reproduction of this work requires the advance written permission of the American Health Lawyers Association. On May 11, the U.S. District Court for the District of Utah handed down what may be the first decision in a cyber liability policy coverage dispute. The case…
The American Health Lawyers Association last week published an analysis of the changes to the Medicare penalties and bonus payments for Eligible Professionals under the electronic health records meaningful use program under the Doc-Fix bill.  The changes restructure the penalties and bonus payments under the quality framework established by the Merit-based Incentive Payment System.  The e-alert is republished below.  Please note that any further reproduction of this work requires the advance written permission of the…
The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic Health Information (“Guide”). The Guide is a tool intended to assist providers as they work to comply with federal programs’ requirements administered through HHS and its various offices (such as ONC). Last published in 2011, the new 2015 version of the…
The Centers for Medicare & Medicaid Services (“CMS”) released the Stage 3 proposed rule to the Medicare and Medicaid Electronic Health Records Incentive Programs (“Proposed Rule”) on March 20, 2015. To provide context, eligible professionals (“EPs”) and hospitals must attest to demonstrating meaningful use of certified electronic health record (“EHR”) technology to qualify for incentive payments through the Medicare and Medicaid EHR Incentive Programs. Failure to demonstrate meaningful use generally results in negative payment adjustments under the…