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Medicine Software Government

FDA Will Regulate Some Apps As Medical Devices 130

chicksdaddy writes "In an important move, the U.S. Food & Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices. The agency said on Monday that, while it doesn't see the need to vet 'the majority of mobile apps,' because they pose 'minimal risk to consumers,' it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed 'using the same regulatory standards and risk-based approach that the agency applies to other medical device.' The line between a mere 'app' and a 'medical device' is fuzzy. The FDA said it will look to the 'intended use of a mobile app' when determining whether it meets the definition of a medical 'device.' The Agency may study the labeling or advertising claims used to market it, or statements by the device maker and its representatives. In general, 'when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or it is intended to affect the structure of any function of the body of man, the mobile app is a device.'"
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FDA Will Regulate Some Apps As Medical Devices

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  • by rolfwind ( 528248 ) on Tuesday September 24, 2013 @04:13PM (#44940713)

    Stating the app is only for entertainment/educational purposes only.

    • by Zumbs ( 1241138 )
      App developers can do that, but it would effectively cut their app off from being used by doctors and nurses. Why? Because if an error happens and the doctor/nurse used such an app, the doctor/nurse would be liable. And it would most likely also significantly reduce the price they could ask for the app.
  • Or just be another black hole that taxpayer dollars funnel into?
    [Think medical device fraud via Medicare/Medicaid that is STILL rampant]

    • by alen ( 225700 )

      part of the ruling says that companies have to disclose where they get their data from. if they are lifting data from copyrighted works they will have to admit it and get sued

    • Will this really protect the consumer?

      it could...

      ex: iphone app for diabetics...you test your blood on a dongle conncted to the phone and the data gets sent via internet to your doctor's office or to a parent

      if you don't check or your blood sugar goes below a set limit the system sends txt message reminders to you/your parents/your doctor

      this data is covered by HIPPA [wikipedia.org]

      HIPPA has privacy rights built in, but I've also read it has some back doors for doctors to share info w/ big pharma

      it's not perfect but it's *

  • by PseudoCoder ( 1642383 ) on Tuesday September 24, 2013 @04:24PM (#44940887)

    Would they then be subject to the O-care medical device tax? Let's not forget what it was all about to begin with.



    • Doesn't it depend on whether the apps are considered to be something that is purchased at retail by the general consumer? Things like mechanical and powered wheelchairs, portable oxygen concentrators, glucose monitors and personal heart rate monitors are not taxed. NMR and x-ray machines are taxed.
    • More than likely, yes! They would be subjected to the tax among other filing fees and what not. Effectively it should shut the app down. However, what if these apps were open sourced? Would the feds shut them down and go after anyone torrenting the source code?

  • Witnessed this myself at the birth ward when my wife gave birth last month. Took a photo of a health monitor BSOD while giggling in the hallway, but haven't posted it anywhere. Isn't there a website where you can post BSOD's in funny places?
    • The Daily WTF. [thedailywtf.com]

      Their Error'd [thedailywtf.com] series is chock full'o this kind of failage.

      The only risk is that someone's already submitted a screenie of any given inappopriate BSOD, but the only way to know is to try. Or read it through first.

    • This may sound silly, but it is also very important to report the issue to the device manufacturer, if you can. The FDA sets very strict rules on how companies have to handle feedback they receive from you, so your feedback will be taken very seriously. IANAL etc.
  • I think Apple's terms of service says it all and that all medical apps need tossed out since they would break the tos of the device. Or am I missing something. http://www.apple.com/legal/sla/docs/iOS7.pdf [apple.com]

    • by mjr167 ( 2477430 )
      Don't ALL OS TOS say that? I'm pretty sure windows says that and they do use it in nuke plants...
      • FWIW, most of the electronic components IN a phone are also sold with a disclaimer like that. Typical example here:

        http://www.analog.com/en/content/analog_devices_terms_and_conditions/fca.html [analog.com]

        Use in Life Support and Other Critical Applications

        Products sold by Analog Devices are not designed, intended or approved for use in life support, implantable medical devices, transportation, nuclear, safety or other equipment where malfunction of the Product can reasonably be expected to result in personal injury, death, severe property damage or severe environmental harm. Buyer uses or sells Products for use in such critical applications at Buyer's own risk and agrees to defend, indemnify and hold harmless Analog Devices from any and all damages, claims, suits or expenses resulting from such use.

        I'm pretty sure that any smartphone app-based system isn't exactly going to be a critical care/life support type of device, though.

    • I wonder if this is just waiving liability or does it mean they would refuse to approve the app ?
      Medical software can have 3 types of use:
      -records display (display of data)
      -diagnostic (take your temperature)
      -therapeutic (shock your heart or cut tissue)
      You see many companies jumping up and down, claiming to want in the medical space, but they usually are talking about records display only.

      Well, great, I guess now I'll never get my iMissileLauncher....

  • Can't have cheap apps cutting into the business of big campaign donors.
    • This new guidance *relaxes* the regulations, meaning that the barrier to entry for releasing a medical app has been lowered. Before Monday, if you wanted to sell a medical app on a mobile platform, you needed FDA approval. As of Monday, large swaths of medical apps are no longer required to comply with Federal Drug and Cosmetic Act.

      • I thought reading the article was a violation of Slashdot rules...
        • I kinda sorta work in this industry, so I already knew about this guidance. In fact, I kinda sorta knew it was going to happen before it was official. So I didn't really have to read the article. :)

  • What if I open source my DIY ultrasound code? Or my STL files of the 3D printed parts? Should I be expecting a gag order?
    • What if I open source my DIY ultrasound code? Or my STL files of the 3D printed parts? Should I be expecting a gag order?

      Source code != App. STL != part. They say they will control apps. Not your problem.

  • is the first step to eliminating it.

    • ... and I suppose the FDA potentially could have been challenged and/or lobbied to have better testing & controls around things like this by the insurance industry (who pay for the treatments). Increased regulation typically comes re-actively from our government as a result of people screwing up, or getting screwed.
  • I can certainly understand wanting to qualify a mobile app that controls an insulin pump or something like that (Appendix C), but Appendix B indicates the FDA intends to regulate applications that "are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness" such as meal logs, calorie counters, exercise activity, brain games, etc. Sounds like you can kiss a whole bunch of useful apps goodb
  • by melstav ( 174456 ) on Tuesday September 24, 2013 @11:34PM (#44944383)

    DISCLAIMER: I am, (among other hats) a software developer for a medical device manufacturer in the United States.

    Seriously, people. The FDA's stance has *ALWAYS* been that if something has a medical purpose or is an accessory to a medical device, then it *IS* a medical device, even with software. See: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices [fda.gov], dated 2005.

    For the purposes of this document, we refer to devices that contain one or more software components, parts, or accessories, or are composed solely of software as “software devices,” including:

    • firmware and other means for software-based control of medical devices
    • stand-alone software applications
    • software intended for installation in general-purpose computers
    • dedicated hardware/software medical devices.
    • accessories to medical devices when those accessories contain or are composed of software.

    This guidance applies to software devices regardless of the means by which the software is delivered to the end user, whether factory-installed, installed by a third-party vendor, or field-installed or -upgraded.

    So, yes, apps with a medical purpose are medical devices, just like any other piece of software.

    Which means they *ARE* subject to the "Obamacare Tax" -- Which is *NOT* a "sales tax" to be paid by the consumer. It's an "income tax" to be paid by the manufacturer / developer.

    This also means that if your app is categorized as a medical device, you (the developer) have to register with the FDA as a device manufacturer, which costs a couple thousand dollars a year, and means that every few years, the FDA sends someone out to review your quality control system, which includes your testing methodologies, what complaints you've received and how you've handled them, how you document your development process, etc.

    AND what your software does determines what kind of medical device the FDA calls it. And the kind of medical device determines whether you are required to get the FDA's permission before you distribute it. (even if you distribute it for free) And yes, applying for that permission costs money, whether it's approved or not.

    And, by the way: Each country makes its own rules about what makes a medical device and what you're required to do to be able to legally distribute it in that country. And in most countries that includes software.

  • It seems that literally nobody can be bothered to actually understand what happened ("nanny state" "snuffing" "innovation" with "unnecessary regulations"). The FDA's guidance, released this past Monday, is RELAXING regulations - it is EXEMPTING whole categories of applications from regulation.

    FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"

    FDA has ALREADY been regulating medical apps. For a long time. The proble

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