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FDA Approves Voice Guided Epinephrine Injector: Auvi-Q

Posted on August 15, 2012 I Written By

I recently went on vacation and stayed with a friend who has a son that is highly allergic to any and all dairy products.  My first thought was how terrible it would be to live without ice cream, cheese, or even a bowl of cereal, but then I realized just how tough it must be.  Dairy is in everything, and is a huge part of what most kids eat.  I can only imagine how hard it must be for them to make sure their son is safe.

Like most people who suffer from severe allergic reactions, they always carry a couple of epinephrine injectors just in case they miss something and he has a severe reaction.  Not being someone who has to deal with that, I don’t have a lot of experience with them, but I can’t imagine that they have actually changed much over the years.  I mean how much can you do to a needle that injects you with epinephrine?

The answer is something very simple, that may very well save some lives.  A company by the name of Sanofi recently received FDA approval for a voice-guided epinephrine injector called Auvi-Q.  This new device provides step by step audio instructions of how to properly use the injector.  It also provides visual cues including an alert light to signal that the injection is complete.  A video demonstration of its use can be found below.

It is entirely reasonable to think that a person having a severe allergic reaction could freak out and not remember how to give themselves an injection, so this device provides a solution to a very real problem.  On top of that, it could also be very useful in the event that the patient needs help from someone else to give the injection that may not be familiar with how to do so.  In either case the instructions are also written on the packaging to help ensure proper use.

In this day and age of new gadgets and apps that don’t really serve a worthwhile purpose, it is always refreshing to see an improvement on a well-known product that could very well save lives.



Worried About HIPAA? Don’t Forget GINA

Posted on I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

As if we don’t have enough acronyms to worry about, there’s one we may not yet have discussed here which is also worth considering. In addition to HIPAA, the Genetic Information  Nondiscrimination Act (GINA) may become a factor in how we handle EMR data security.

In theory, GINA is primarily aimed at the workplace, as its purpose is to bar an employer from requesting or obtaining an individual’s genetic information at any stage of employment. But since GINA construes this to mean not only the results of genetic tests, but anything related to family medical history,even providers who don’t do occupational medicine may have some serious data security issues to consider.

GINA became law in 2008 and regulations have already been promulgated which restrict access to occupational health information. Agencies are beginning to develop their positions on GINA violations, too.

For example, the EEOC recently concluded that if personal health information and occupational health information are stored in the same electronic medical record, it’s probably a violation of both HIPAA and the Americans with Disabilities Act (which also restricts health data access).  The EEOC’s opinion came in the form of an informal discussion letter, and isn’t binding, but you can see where this is ehaded.

Perhaps more frighteningly, individuals can bring private lawsuits for violation of GINA, unlike with HIPAA. So as bad as being slapped with a citation for HIPAA violations can be, a GINA violation may have even wider implications.

Sorry to be a Dolly Downer, folks, but it’s better to know about this than find out about it later. While you may not need to make big changes in your security plans due to GINA, you should probably give it some thought.