FDA won’t regulate these apps, for now

By: Brian Dolan | Jul 19, 2011        

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Tap & Track Calorie, Weight and Exercise TrackerAccording to the FDA’s mobile medical app draft regulatory guidelines, which it made public this morning, there are a handful of different types of health and medical apps that the agency specifically said would not be regulated under the proposed guidelines. Here are the descriptions of those apps that the FDA does not plan to regulate (for now):

• Mobile apps that are electronic “copies” of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received. These types of apps do not contain any patient-specific information, but could show examples for a specific medical specialty. Examples of such medical text books include the electronic Physician’s Desk Reference and similar reference materials that are typically used as part of course instruction and are implemented as electronic books. Exemplary teaching aids and reference materials include: flash cards or quizzes that are used for training purposes or as reference material (e.g., with preloaded medical images, conditions, pictures, graphs, etc.); slideshows of common conditions; lists of medical terminology; and review materials that are to be used by medical students during training. (In contrast, mobile apps that allow the user to input patient-specific information along with reference material to automatically diagnose a disease or condition are considered mobile medical apps).

• Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness.

• Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions. Examples include: apps that determine billing codes like ICD-9 (international statistical classification of diseases); medical business accounting functions and aids that track and trend billable hours, procedures, and reminders for scheduled medical appointments or blood donation appointments; apps that automate functions such as collecting patient histories that replace paper-based entry; apps that enable insurance claims data collection and processing; and other apps that are similarly administrative in nature.

• Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication. Examples include apps that use the mobile platform as a magnifying glass (but not specifically for medical purposes), recording audio, note- taking, replaying audio with amplification, and other similar functionalities.

• Mobile apps that perform the functionality of an electronic health record system or personal health record system.

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  • Drdave

    If an App is something you can do in a book (FDA does not regulate medical text books) then it should not be FDA regulated. Books have all kinds of clinical paths and algorithms but the user implements them. I always believed this was clear. DrDave

  • http://twitter.com/Hall_MediaMaven Maureen Hall

    I think the FDA definitions generally make sense. However, I can see a grey area emerging is the health and fitness app is designed for a particular disease state, such as diabetes. Tracking blood sugar via a mobile device is convenient, but it doesn’t really have a great deal of benefit to the healthcare consumer unless it offers guidance on what actions to take to bring glucose into control.

  • http://twitter.com/rememberitnow RememberItNow!

    Dr. Dave and Ms. Hall have a point. Either way, it’s good to see that the FDA is finally outlining some rules. 

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  • Jesse_EngAmer

    What happened to the first amendment? I don’t remember it being repealed. 

    “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances”

    Many mobile apps are simply extensions of websites or mobile sites. 
    Does the FDA really have the right to regulate the Internet? For that matter, does the FDA have the right to regulate advice?

    In 1997 in the Supreme Court case Reno V ACLU a “sweeping victory for free speech rights in cyberspace” occurred wen the Supreme Court “granted the highest level of First Amendment protection to the Internet.”

    “The draft does begin by noting the history of regulating computer software going back to 1989 and which never resulted in guidance – echoing the fact that the FDA once held a public meeting on the Internet in 1996 – also with no resulting guidance.” http://www.eyeonfda.com/

    The Internet is indeed next.

    Regulating medical apps that offer medical advice is an entirely new frontier for the FDA, ignoring the fact that it is completely fiscally irresponsible, it is unconstitutional.

  • Jesse_EngAmer

    That’s a very strong point, thank you for the info. While the “medical device” aspect of it is understandable, as medical devices do fall under the FDA’s purview, and making sure a device monitoring your heart is accurately calibrated is necessary, what are your thoughts on the fact that medical apps will be regulated when the intended use of the app is diagnosis of disease or conditions?  Many doctors use apps to help with diagnosis and there been many instances when social media has saved lives by providing a diagnosis a doctor could not. The FDA should not wield the power to regulate advice and opinions.

    What are your thoughts? 

  • Drdave

    I am a strong advocate for personal responsibility in healthcare, but we have medical malpractice litigation, state regulation, practice guidelines, insurance company policies and Medicare policies mediating the practice of medicine. I do not believe that things you can get from a book fall under the FDA. Formulas in books could be wrong just as formulas in Apps could be wrong. In both instances, humans can enter wrong data, symptoms, etc so there can be error in many places. As I stated earlier, mobile computing apps with medical formulae have been around for over 15 years so I REALLY doubt that the FDA will ultimately supervise them. These are proposals only, not regulations.

  • Jesse_EngAmer

    Once, again, excellent point. I agree that there are boundaries the FDA need respect. Thank you for the response. 

  • swattz101

    I’m not sure how this goes against our First Amendment rights. Looking at your comments, you seem to have a better grip on this than I do, but on the surface, having the FDA regulate commercial medical apps looks like a good idea. As far as I can tell, they are not stopping us from using social apps that might help to get an alternative diagnosis.
    I agree with some of the points that you have made that the FDA cannot regulate opinions. As far as I can tell, they will not be regulating the internet. In the long run, they will not be able to stop apps from being made, just be able to put the FDA stamp of approval on some.

  • Drdave

    I think the FDA reached too far in several areas but like any good negotiator, they put in things that are “easy” to give up in coming to a final set of regulations/guidelines.  The FDA cannot protect us from ourselves but there are lawyers who believe that is their duty.  Medical Devices are under the FDA domain but medical text books are not so anything that is simply a medical e-book is probably our of their supervision. 

  • Jesse_EngAmer

    Let me begin by saying thank you for your response. I’ll address your points one at a time.

    To begin, 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. 

    Why it is not a good idea is partly financial and partly political and partly historical. 

    The financial aspect is two-fold. 1) Medical apps that transform phones and tablet pcs into medical devices are but a small proportion of our medical devices. 50% of our medical devices and 80% of our pharmaceuticals are imported according to the FDA themselves in their report Pathway to Global Product Safety and Quality.  They also said themselves that “The safety of America’s food and medical products remains under serious threat.” Lastly they stated “it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority,” because as it stands, the FDA has neither the resources nor the manpower to perform such duties. In fact the FDA’s budget was slashed recently by 258 million. This new set of regulations pertaining to medical apps is only one instance of new regulations that are taking away resources from more important areas others include dietary supplements, energy drinks, salt, calories etc.  This lack of resources has driven the 2011 Food Safety and Modernization Act to be purely reactionary instead of preventative because to accomplish these goals the FDA will need to establish a myriad of partnerships, coalitions and improved intelligence-gathering techniques.  Even then, resources will still be deployed on  “data-driven risk analytics.” Hardly all-inclusive, hardly preventative.  

    2) By overregulating this new field of technology and handing over monopolies to big pharma, we crush innovation. Many companies, especially small tech startups cannot afford the increased research. For example since 1968 about 41 less new pharmaceuticals have been approved each year according to the Independent Institute and even more aren’t even researched due to the costs associated. Back in the day the U.S. treasury department funded the FDA. For the first 86 years of FDA’s existence, from 1906-1992 that’s how it was. Starting in 1992 however a law passed allowing pharmaceutical companies to provide funding for their own research that smaller companies could not put forth.  Furthermore, as shown in the past, overregulation can kill. A key example of this is aspirin. In the early stages the FDA banned its makers from advertising its potential to save lives if taken during and after a heart attack until further clinical studies were performed. Upon completion of additional clinical testing, 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. While the FDA has a responsibility to protect American’s from harm, its attempt over-regulate limits the speed which new solutions can be presented to consumers. Thus, FDA’s inefficient bureaucracy hindered a life saving solution from reaching tens of thousands of patients. 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
    The next aspect is political. It is an infringement upon constitutionally protected commercial speech under the purview of the First Amendment. Commercial speech gained constitutional protection in 1980 following Supreme Court case Central Hudson Gas & Electric v Public Service Commission.

    Lastly, is the technological aspect. To quote Eyeonthefda.com “The draft does begin by noting the history of regulating computer software going back to 1989 and which never resulted in guidance – echoing the fact that the FDA once held a public meeting on the Internet in 1996 – also with no resulting guidance.  One hopes for progress on both fronts.” 

    To address your last point, 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

    I hope I addressed everything,

    Jesse

  • CassieKiehl

    I agree with DrDave that the excluded list is a no-brainer, especially for coding programs like SpeedECoder. I do see, though, how dangerous inaccurate applications could be. I hope the FDA follows a good middle path.

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