Congress passes bill allowing FDA to regulate smartphone apps

http://news.yahoo.com/congress-passes-bill-allowing-fda-regulate-smartphone-apps-002106746.html

by VMG • 14 years ago

21 4 14 years ago

news.yahoo.com

ams6110• 14 years ago

promotes innovation, protects patient safety, and avoids regulatory duplication

Yes, the government has an excellent track record at achieving those objectives.

betterth• 14 years ago

This isn't fair. The FDA does a pretty decent job at it's regulation. I'd say we have the best (or near the best) regulated food supply and drug supply of any nation. It's impressive when you consider that the country is also the third largest by population and fourth by land mass.

I develop for one of the countries largest medical software companies ("EHR companies" now, I guess), so I have a little bit of an idea of what medical software does and what the industry wants to do with apps. (And dealing with regulation). Some Telehealth solutions go far beyond just displaying EHR data and help actively manage a patient's health by taking/accepting certain vitals, drug reminders, etc. And apps are going to be doing this / already doing this.

The FDA absolutely is the regulator for medical devices. Here is the relevant federal code (http://www.fda.gov/RegulatoryInformation/Legislation/Federal...) that covers medical devices. And I do absolutely agree that a smartphone app, when used to manage patient healthcare, patient ehrs, drug schedules, etc is a 'medical device' that should be regulated by the FDA.

The FDA isn't some archaic, out-of-date and ineffective regulatory agency. They do a good job and aren't shy about recalls, huge fines and enforcing compliance.

ef4• 14 years ago

Can anybody claim with a straight face that there's even a problem here? Where's the evidence of harm?

It seems so transparent that this is just a bureaucracy trying to enhance it's own power / relevance / budgetary future.

Zenst• 14 years ago

Now they have to regulate them, will they then become liable for any that slip thru that should in all fairness of been regulated.

Who will regulate the refulator and who regulates them and were does joe public come into the equation. Who gains, who loses, stay tuend to next weeks episode of Soap.

Congress passes bill allowing FDA to regulate smartphone apps

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