FDA Moving Toward Major Infrastructure Overhaul And It’s Getting Complicated – Partnerships With Other Government En
Posted Apr 05 2010 11:42am
I am not picking on the FDA by any means, but there’s just a lot of work to be done after years of “infrastructure neglect”. When you read the link below they had to give out a grant to an insurance agency to help create and test their new safety program connected to the Sentinel Initiative.
There are some old things on the books that need changed with software rulings and laws too, such as what we saw last year with MRI machine operators needing to file a 90 notice before updating their Windows operating system, something we do every Tuesday now, standard operating procedure for PCs.
When I read about the FDA regulating health IT, they are not ready for it; however with working with other government entities it can and will improve their processes and knowledge as some of the other departments have some of what they need, information and technologies. This is why it is dangerous to have leaders who disregard or don’t acknowledge how technology is affecting how we live our lives today and how healthcare is top at intertwining here.
They have a lot of consumer products that are running wild with advertising that they can help cure diseases and stretching perhaps some of what should be claimed on packaging. This is also monitored on the medical device and prescription drug side too and it’s on ongoing battle.
The meaning of “medical devices” is also evolving with technology as we read about today. Software is just as important if not more important in how devices function as someday there will be a data recording chip in almost everything we used or implant.
Unless the data reporting device situation is coordinated with better implementation methodologies, you may end up someday having to wait at Verizon or AT &T for an “FDA approved” cell phone too. Right now the market is to sell, sell, sell and hey if you can be cornered into insanity with a dozen devices, they’ll do it, so again use common sense and get involved. Demand that your information be routed through a PHR first so you are in control.
What makes their job even more difficult is the lack of “meaningful use” consideration for devices that report data, so many just seem to be forgetting this big emerging part of technology as it results in accumulating and distributing patient medical record data, non participants don’t get this as they don’t participate, thus have little or no exposure.
With little or no exposure or the curiosity to learn, we end up with “magpies” who just repeat, repeat and repeat. The term medical devices has evolved whether we choose to recognize this fact or not, so the FDA can use all the help from CMS, the FCC, NIH and more. It’s a big job around that place today with a lot of information to aggregate and get it done quickly.
Our leaders are throwing money at a lot of this which is a good thing, but do they know what they are throwing money at? If they participated they would know. Here’s a project approved by the FDA that involves devices that report data, good reading here.
How much of this technology is disruptive too and gets in the way of living our lives like a human, good study at UCLA working on finding out.
We need to know about this as insurers are rapidly focusing on biometric monitoring as well as of course we don’t always trust their motives and for good reasons in many instances. Shareholders come before participatory sensing in their book along with profits.
Not only is the FDA having to assure safety, but they need to ensure processes, drugs and devices are now “legally” implemented as well or they could find themselves in court for omitting such details too. This requires huge infrastructure updates as fast as they can get it done. The former Commish of the FDA was not known for his tech leadership and thus for many years things just kind of sat there with little or no growth with the times. He’s in a think tank now so maybe combined with some new methodologies we might have a meeting of the minds a bit, after all he was around the FDA for a long time.
Did we ever seen Andrew von Eschenbach sporting anything like a BlackBerry (grin). I think you get the picture here. BD
As a small federal agency with a big mission, the Food and Drug Administration has operated for years with underfunded and overtaxed information technology systems.
In 2007, FDA’s Science Board concluded that the agency’s IT systems were obsolete, unstable and inadequate to fulfill its mandate to oversee food, drugs and medical devices. That news came as no surprise to those familiar with the agency. “The IT systems at the FDA have been antiquated for some time,” said Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, a watchdog group.