FDA's Sentinel Initiative Will Need to Embrace Mobility Sooner or Later–Better Sooner Than Later–Data Beyond the Des
Posted Sep 15 2010 6:12pm
This is one “huge” project and the targets and technologies change frequently, maybe hourly if we really had all the data to look at. Technology is out there throwing us a new left curve every day and when it available and simple, consumers want it now. No longer are we in the days to where the IT folks could spent a few weeks and build the system or systems someone wants, it’s one big ass job today, as many are finding out – why – there’s a huge mother load of code that needs to be written.
As more software applications come on to the market, there’s more code to make them work with other applications on the desktop and on mobile devices. The FDA is probably working as fast as they can but as each day progresses, guess what, we have more potential information and data to add. When it came to safety last year, the FDA had to give a contract to an insurance agency to pilot, as they were not ready for it yet and the insurance company had the IT infrastructure.
When we get right down to what the Sentinel project is, it is business intelligence.
As a consumer product becomes available, it’s not always that easy and fast to connect it to the healthcare infrastructure as one may think, and yes it pretty much can be done, but it takes time. You want to make sure those coders are getting it right, and let’s think about medical devices that use software, as those have been heavy in the news today with imaging and other types of devices, don’t rush the code heads on those issues. Even big companies don’t get everything 100% and deal with growing and changing technologies as we are reminded every week with our Tuesday updates.
In the news today the FBI said they were going to take a lot of their Sentinel IT issues back in house and rely less on contractors, so perhaps this is maybe what the FDA might be looking at too, but the infrastructure needs to be built first! There’s no magic want to wave. The FDA stands to become the “most connected” government agency out there due to all the various areas they touch and are responsible for.
Certainly I’m a bit of a broken record but this is where it’s at with mobile data and showing and finding value. This is part of the reason I made the comments about being connected as this same technology could authenticate MDS for e-prescribing too, so one technology goes a long, long way and with using the cloud it could be built faster too. It’s time to seriously start thinking about mobile technology since they are going to be participating in approving such devices more and more. First hand experience says all. BD
A national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, medical devices--and ultimately all FDA-regulated products once they reach the market--is now on the horizon. Launched in May 2008 by FDA, the Sentinel Initiative aims to develop and implement a proactive system that will complement existing systems that the Agency has in place to track reports of adverse events linked to the use of its regulated products.