FDA Plans To Regulate Some Medical Apps

WASHINGTON -- The Food and Drug Administration is taking the first steps toward regulating the rapidly expanding field of medical applications, or apps, for smart phones and other handheld devices.

With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy. Industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to programs that let doctors view medical scans on their phones.

The FDA says it will begin regulating a handful of these programs that pose the greatest risk if they don't work appropriately.

In a draft proposal, the agency says it will regulate applications that combine with medical devices already regulated by the agency, such as heart monitors that transmit to a smartphone.

Comments

[Stewart Goss]

03:07 PM on 07/20/2011

Dying of cancer? A new treatment is out and it will save your life?

Oh, you can't use it...not FDA approved yet...even though you're dying...

[Stewart Goss]

03:04 PM on 07/20/2011

Another good intention that begins the destruction of the software and internet industry. It favors big industry, discourages innovation and increases costs. As consumers the damage will far exceed the proposed benefits. Many great inventions are discovered by accident and benefit all of humanity, in a highly regulated and protected environment they would have never come to light. So at the risk of very few being harmed, everyone is.

Go ahead. Regulate my excel spreadsheet so that it doesn't calculate a cell incorrectly and causes my heart to stop. Regulate all apps, software and the internet too...because in a free country nobody should have the right to give advise unless it is government approved.

Saw an interesting article about playgrounds today. All the safety regulations actually did more harm than good. Kids grew up to be adults who were more uncomfortable about heights and couldn't handle themselves as adriotly. Injury rates didn't change because people took greater risks thinking they were "safe". Kind of like consumers who get solar energy then use more because they perceive it to be "free".

Look at the unseen effects before you regulate, governing by gut feeling is absurd.

[Mister Grumpy]

01:33 PM on 07/19/2011

Just another thing for Republicans to complain about......... that is until they figure out a way to make a buck off of it........

[Jesse EngAmer]

04:36 PM on 07/19/2011

Interesting. To tack on to that, by overregulating this new technology we hand over monopolies to big pharma and crush innovation. Small tech startups cannot afford the increased research costs of research as approval rates have jumped from 7 months to 7.3 years. Since 1968 about 41 less new pharmaceuticals have been approved each year (Independent Institute). For the first 86 years of FDA's existence, from 1906-1992 the FDA was funded by the US Treasury Department. In 1992 however a law passed allowing pharmaceutical companies to fund their own research. Smaller companies could not compete. Furthermore this made Industry, not the public the FDA’s client. Also, overregulation can kill. In the early stages the FDA Aspirin from advertising its potential to save lives if taken during and after a heart attack until further clinical studies were performed. Dr. Carl Pepine, the co-director of cardiovascular medicine at the University of Florida College of medicine estimated that ten thousand lives could have been saved yearly. The FDA has a responsibility to protect American’s from harm, but overregulation limits the speed which new solutions can be presented to consumers. Upon reflection Dr. Repine said, “I’m disappointed that something that has such potential to save so many lives took so long. But it’s better late than never…the banning of advertising of aspirin for first heart attack prevention, may be the single most harmful regulatory policy currently pursued by any agency of the U.S. government” http://www.fdareview.org/harm.shtml

[Stewart Goss]

03:06 PM on 07/20/2011

You ever stop to think that the regulator makes a buck off of making stupid rules? Like being forced to renew your liquor license every year?

[Jesse EngAmer]

10:25 AM on 07/26/2011

Unfortunately, theres a lot of truth to that. Furthermore, if you'll recall the Vioxx incident with Dr. Graham. He was fired from the FDA for demonstrating the dangers of Vioxx a drug that proved to be extremely harmful. His boss in the FDA told him that the industry is our client, not the public.

[Jesse EngAmer]

01:29 PM on 07/19/2011

I don’t remember the first amendment being repealed do you?

Within the draft exists an affront on the constitutional protection of the Internet granted by the Supreme Court in 1997, a contradiction, a rather worrisome clause that sets a dangerous precedent and removal of funding from more pressing matters.

1) Many apps are extensions of mobile sites and Websites. Like the unenforced 1989 medical software bill, the FDA is looking to enforce the 1996 bill outlining regulation of online medical information
2) Some apps to be regulated use algorithms to compute specific patient treatment, when electronic textbooks available on mobile platforms with the same algorithms will not be regulated.
3) One clause states “when the intended use of a mobile app is for the diagnosis of disease or other conditions” the app will be regulated. Many doctors consult medical apps. Internet and social media have often led to a diagnosis a doctor could not come up with.
4) The FDA cannot afford to carry out the 2011 Food Safety and Modernization Act (FSMA). The FDA stated that “Half of all medical devices used in this country are imported” and that “it would take 9 years just to inspect every high-priority pharmaceutical facility alone” ignoring those of lower priority. The money spent regulating mobile apps could be put to much better use ensuring the safety of a much higher percentage of medical devices.

[Steven Watson]

02:33 PM on 07/19/2011

This article http://huff.to/qMBRyD doesn't make it sound as bad. I haven't read the actual FDA Draft, but it sounds like they are going to regulate apps that connect to devices that are already regulated by the FDA or turn the mobile device into a medical device. In other words things like an official X-ray scanner app or something that turns your iPad into a medical tri-corder. The thousands upon thousands of Diet apps and calorie counter apps would be unaffected.

In the long run, I don’t think they should be able to take apps off the market, but be able to give their stamp of approval to apps that they have evaluated. Would you rather have your doctor reading an X-ray on his iPad using an app from Joe Snuffy down the block or one from the developer of the X-ray machine that has been vetted by the FDA?

[Jesse EngAmer]

04:27 PM on 07/19/2011

Having the FDA regulate medical apps is and is not a good idea. The reasons why it’s smart involve when the app actually transforms the smartphone or Ipad or whatever into a medical device. If the app is intended to measure anything like vital signs or control other medical devices by maintaining medication flow or otherwise, then those apps, I’d argue, must be regulated or at least proved accurate, functional and effective.

These proposals however certainly do carry financial and political ramifications.

While the FDA cannot stop the apps from being made they certainly can stop them from being sold. The term “FDA approval” is misleading. Before the FDA approves a drug for example citizens are banned from using or producing it and failure to comply can result in SWAT like raids and a whole slew of coercive threats and actions. The FDA has its own-armed inspectors. Therefore “FDA approval” is more accurately depicted as lifting a ban on certain drugs, devices and so forth. Watch this short video from keepfoodlegal.com and you’ll see police raid stores at gunpoint for selling raw milk.
http://www.keepfoodlegal.org/category/tags/raw-milk