French Scandal

Bart’s Corner: French Breast Implant Safety Scandal

There is an ongoing safety issue (read: scandal) in France regarding the use of non-medical grade silicone in breast prosthesis implants.This is a scandal that has been playing out now for about four years. There is much information available in both English and French. There is a good summary on Wikipedia. Here’s the background: The…

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Safeguarding Patient Data – Part One: More Data, More Opportunities for a Breach

Data. Indeed, it may be one of year’s biggest buzzwords, but data’s impact and possibilities for the healthcare industry continue to have many insiders, myself inclused, very excited. Its potential for increased efficiencies and effectiveness in providing a more comprehensive care is vast. But many questions still remain: how do we get our hands on…

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Exchange Plans’ Hidden Challenge: Co-Insurance

According to a recent report from the Department of Health and Human Services, over 8 million Americans enrolled to receive health insurance through the Affordable Care Act’s health insurance exchanges. The expansion of lives covered also comes with expanded benefits: preventive care, lab services, prescription benefits, and emergency services are among the Ten Essential Benefits…

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To Outsource or Not To Outsource? That May No Longer Be a Question

The healthcare landscape is changing dramatically… and many changes are yet to come. As such, outsourcing has increased in an effort to drive down cost and comply with the ever-changing regulatory environment.   Here are 4 outsourcing trends in the pharmaceutical and healthcare industries: Crisis Management Recall Support: During any given recall, the need to…

Adverse Event Data

Earlier this year FDA announced that it is planning to make access to much of its structured data, including the adverse event data in its safety database FAERS, available more easily to the public. Dr. Taha Kass-Hout, the Chief Health Informatics Officer of FDA wrote on the website that FDA is developing an initiative…


Off-Label Use & Safety

There has been a lot of discussion regarding the off-label use of drugs.  This has been a focus of interest for FDA, EMA, MHRA and other health agencies around the world and certainly has been an issue and concern at companies over the years.  This is a complex issue with implications for public health, patient…