FDA and medical smartphone apps
From the article:
…federal regulators lurched into action a year ago, offering their thinking on how to police this vast new frontier. Just as they were putting the finishing touches on a plan, lawmakers intervened. The Senate moved to put the plan on hold after tech firms convinced lawmakers that more government oversight would stifle innovation and cost jobs.
“There are two completely different mindsets,” said Merrill Matthews, a resident scholar at the Institute for Policy Innovation. “The app people think: Where is there a need and how do I fill it? And the FDA thinks: Where is there a problem and how can I control it?”
There’s a fine balance between a regulation free, wild wild west scenario and the stupidity which is our patent, trademark, and copyright system. It’s true that the mobile tech space moves way too fast for an agency like the FDA. However, I guarantee, the first person that gets hurt from a medical app is going to sue everyone under the sun and blame the government for not protecting the average Joe/Jane.
#ScienceEveryday
http://www.chicagotribune.com/business/ct-biz-0626-health-apps-20120626,0,4426493.story
June 26, 2012
Makes total sense that there’d be this kind of regulation, considering what’s at stake.
June 26, 2012
Scott Sneddon It’s one of those damned if you do and damned if you don’t. Clearly there should be some oversight. The problem is, can the FDA work fast enough. The conservatives and libertarians will cry that the big bad government is stifling innovation. The poor sod who gets hurt from one of these apps will cry that the greedy company was reckless. It’s a tough problem to tackle.
June 26, 2012
The FDA can’t keep up the jobs they have- let alone this new area. If they were better funded, and had some attractive job tracks- they could attract folks who understand the tech enough to draw that line. But the Gov’t can’t commit to fully funding the FDA these days…
June 26, 2012
Chad Haney agreed, it’s a thorny business. Making medical apps is probably not for the iPhone SDK garage hacker.
June 26, 2012
mary Zeman it’s kind of a circular problem. People on the left say we can do more to protect and help our citizens if the government had more funds to hire the right people. The people on the right say government is too big we need to strip away oversight, etc. Here’s my opinion on industry vs. academic institutions http://goo.gl/5u6Ov
June 26, 2012
I can’t imagine a phone app being a substitute for the real thing? They are like those blood pressure devices you can use at home..good for a quick check up, but not the most reliable. Are those things FDA approved, does anyone know?
June 26, 2012
Rajini Rao and mary Zeman straight out of grad school I applied for a job at CDRH. The guy I interviewed with said that it would take a while to hire me into the job he really wanted me for. He said the best he could do, was hire me as a post-doc/fellow doing research on latex condoms. I passed on that.
June 26, 2012
Rajini Rao I think the home blood pressure devices have to have 501k (medical device clearance) from the FDA.
June 26, 2012
LOL! You passed on free “coverage”?
June 26, 2012
I would have been testing them in a lab, fully clothed Rajini Rao Where is Feisal Kamil ?
June 26, 2012
Upon reflection, that makes sense..as would the glucose monitoring devices. Staggering to think of phone apps getting the same medical clearance, though.
June 26, 2012
Clothes need not be an impediment, Chad Haney .
June 26, 2012
ach du Lieber