FDASIA meeting: The good and bad

By Diana Manos
08:35 AM
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WASHINGTON — I just spent three long days covering the open public forum on the FDASIA report. Federal officials, at the end, said they got from the meeting exactly what they were hoping to get: feedback. 

Indeed, participants said they want to take back to their offices the reams and reams of discussion that were recorded and figure out how to weave it into the final FDASIA report they will create after final comments come in on July 7.
 
So you want a few of my take-aways? (Well. All right. Since you asked!
 
In no particular order:
  • The mobile health and health IT markets are going to mutate beyond our wildest dreams — and soon. Trying to make and keep fresh policy around this is kind of like trying to keep lettuce from wilting in the sun. But what choice do we have? We have to try.
  • Lots of people think voluntary safety instances should be gathered and reported, much like the said it’s done in the aviation industry. A couple of problems with that. Trying to figure out near-miss safety instances when it comes to health IT is tricky, because there is the human factor involved every time. Who or what was really responsible for the error? The people, or the IT? But learning about near misses and fixing the problems early — even in the development stage — is a whole lot better than finding out about something after people have been hurt.
  • EHR and app developers might want to reveal mistakes in their systems that have caused harm, or have nearly caused harm, but it will probably be a cold day in heck before their lawyers will agree to that.
 
For a bit of comic relief:
Knock knock. 
Who’s there? 
Interoperability. 
Interoperability who?
(Exactly)
 
It’s still what everyone wishes could be focused on and conquered.
 
Did you happen to catch the meeting? What were some of your take-aways?
 
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