

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

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ams6110
_promotes innovation, protects patient safety, and avoids regulatory
duplication_

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

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betterth
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...](http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm#Part_A))
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The FDA isn't some archaic, out-of-date and ineffective regulatory agency.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.

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ef4
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.

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Zenst
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.

