FDA Launches Huge Online Database of Adverse Events

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA collected between 2004 and 2013 available to the public in a more user friendly and easily …

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Proposed Change to HIPAA Privacy Rule Could Provide Law Enforcement with New Tool in Battle Against Gun Violence

The Department has proposed modifying the HIPAA Privacy Rule to expressly permit certain HIPAA covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a Federal “mental health prohibitor” that disqualifies them from …

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HIPAA Policies and Training Matter

A recent first-of-kind breach notification settlement underscores the importance of having written policies and procedures in place to address HIPAA data privacy requirements. On December 27, 2013, a settlement was reached between the Department of Health and Human Services (DHHS) and the Massachusetts-based …

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OCR Releases Protocol for HITECH-Mandated Audits

OCR Releases Protocol for HITECH-Mandated Audits The Health Information Technology for Economic and Clinical Health Act (HITECH), enacted as part of the American Recovery and Reinvestment Act of 2009, requires HHS to periodically audit covered entities and business associates for compliance with applicable …

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OCR Takes Aim at Heart Doctors

On April 17, 2012, the Office of Civil Rights (OCR) announced a $100,000 settlement with Phoenix Cardiac Surgery, P.C. over violations of the HIPAA privacy and security rules. OCR began its investigation based on a report that the physician practice was posting clinical and surgical appointment information on a …

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Medical Residents Subject to FICA Taxes

On January 11, 2011, the U.S. Supreme Court, in a unanimous opinion, upheld a Treasury regulation that subjects medical residents to FICA employment taxes if they work 40 or more hours per week. This decision brings closure to many years of dispute and litigation over the issue. In reaching this decision, the …

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