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24 Sep 2013, 9:43 am by Geoff Cockrell
Greenway Medical Technologies, Inc. has announced it will be acquired by Vista Equity Partners for approximately $644 million. [read post]
16 Sep 2013, 3:21 pm by Cynthia Marcotte Stamer
September 23 Business Associate Agreement Update Deadline September 23, 2013 also is the final deadline established in the Final Omnibus HIPAA Rule for Covered Entities and their business associations to update the business associate agreements required by HIPAA to reflect application of the breach notification, business associate, and many of HIPAA’s requirements to directly cover business associates and other aspects of the Health Information Technology for Economic and… [read post]
28 Aug 2013, 8:51 am
Affinity filed a breach report with the HHS Office for Civil Rights (OCR) on April 15, 2010, as required by the Health Information Technology for Economic and Clinical Health, or HITECH Act. [read post]
9 Aug 2013, 8:18 am by Spencer Aronfeld
In addition to DePuy, now owned by Johnson and Johnson and considered to be the world’s largest orthopedic device maker, both Zimmer, Inc. and Biomet, Inc. were also founded and continued to be based in Warsaw. [read post]
15 Jul 2013, 1:18 pm
” According to Bloomberg, a gynecologist who worked as a Bard consultant on the vaginal implants testified in a deposition that he suggested clinical trials of the devices, but that Bard rejected the idea because the vaginal-mesh technology was developing so quickly that a multiyear clinical trial would cost several million dollars and that results would be outdated in the three or four years it would take to get the study published. [read post]
12 Jul 2013, 8:49 am by Cynthia Marcotte Stamer
HIPAA Privacy, Security & Breach Notification Rules Require PHI Safeguards & Other Protections The Breach Notification Rule added to HIPAA under the Health Information Technology for Economic and Clinical Health, or HITECH Act requires HIPAA-covered entities to notify OCR, affected individuals and the media promptly of a breach of “unsecured protected health information” (UPHI) impacting more than 500 individuals. [read post]
14 Jun 2013, 12:53 pm by Cynthia Marcotte Stamer
Health plans, health care providers, health care clearinghouses (covered entities) and their business associates should confirm their existing policies, practices and training for communicating with the media and others comply with the Privacy Rule requirements of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in light of a Resolution Agreement with Shasta Regional Medical Center (SRMC) announced by the U.S. [read post]
12 Jun 2013, 12:22 pm by FHH Law
Medtronic, Inc., which develops medical devices, wants expanded eligibility for Medical Testing Experimental Radio Licenses to include all sponsors and sponsor-investigators as defined by the FDA, and requests a clarification that cost reimbursement for clinical trials is not a violation of the equipment marketing rules. [read post]
6 Jun 2013, 3:43 pm by Cynthia Marcotte Stamer
The Department of Health & Human Services Office of Civil Rights (OCR) on June 6, 2013 released an advance copy of to Technical Corrections  (Technical Corrections) to the Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notifications Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule (Omnibus Rule) previously published… [read post]