is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, July 1st, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Manufacturers of medical devices and drugs had enough exemptions in the HIPAA privacy regulation that they could obtain most needed information in spite of the stringent controls on privacy rights. Occasionally such manufacturers needed to work under a Business Associate Agreement (BAA). However, the new statutory changes, including the privacy provisions of the HITECH Act, greatly increase the risk to manufacturers who work under BAAs. They are now directly liable under the HIPAA security regulations.
In this audio conference, FDA compliance attorney Bob Klepinski discusses the implications of this latest round of changes, how drug and device companies are expected to conduct themselves within this new HIPAA world, and the perils of failing to do so.
Showing posts with label HITECH. Show all posts
Showing posts with label HITECH. Show all posts
Monday, May 31, 2010
Thursday, May 13, 2010
Complying with Breach Notification Provisions of the HITECH Act
is being presented by Kate Borten, President, of The Marblehead Group and airs on Thursday, June 17th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The HITECH Act’s requirement for breach notification is the first national law – and the most sweeping – to call for the notification of individuals whose Protected Health Information (PHI) has been breached. The law and subsequent HHS rule are enforceable now, and organizations that incur a breach and fail to fulfill all of the standards are subject to both state and federal penalties.
This audio conference summarizes the breach notification requirements under the HITECH Act, highlighting areas that are particularly challenging for organizations, such as defining incidents and determining harm. It explains how breach notification steps fit into the mandated incident response plan and the need for proactive planning. Additionally, the speaker draws upon several real-life case studies to highlight important lessons learned.
The HITECH Act’s requirement for breach notification is the first national law – and the most sweeping – to call for the notification of individuals whose Protected Health Information (PHI) has been breached. The law and subsequent HHS rule are enforceable now, and organizations that incur a breach and fail to fulfill all of the standards are subject to both state and federal penalties.
This audio conference summarizes the breach notification requirements under the HITECH Act, highlighting areas that are particularly challenging for organizations, such as defining incidents and determining harm. It explains how breach notification steps fit into the mandated incident response plan and the need for proactive planning. Additionally, the speaker draws upon several real-life case studies to highlight important lessons learned.
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