If There's a Health App For That, the FDA Wants to Regulate It

Ready for the Food and Drug Administration to start regulating your iPad? It might not be long. This week, the agency released proposed rules governing regulation of applications designed to run on a host of handheld devices. Currently, there are about 200 million such medical apps in use, with about 600 million expected to be available over the next few years. But the FDA says its new rules will only cover a narrow slice of those apps—those that, say, operate medical hardware or perform dosage calculations for doctors.

At least for now, that is. The agency is clearly looking for an excuse to extend its regulatory reach even further. In addition to the relatively small class of apps its already plans to regulate, it will reportedly “monitor the performance of apps that fall outside of its guidance and then determine whether any additional measures are necessary to protect public health.”

As with all such regulation, there are tradeoffs involved. More FDA oversight means medical apps will be slower to market and more expensive. And because these apps will be slower to develop and slower to release, fewer developers will want to commit to working on them, so patients and providers will have less access, overall, to medical technology on their mobile devices. 

But what about consumer safety? Shouldn't the FDA be looking out for patients? On that front, we can already see instances in which the FDA’s oversight of the traditional device market does more harm than good by needlessly delaying products with proven track records.

Earlier this week, the House Energy and Commerce Commission held a hearing on the FDA’s device regulation process. They heard testimony from Marti Conger, a patient advocate who in 2006 was diagnosed with a severe spinal problem. After discussing options with her doctor, she decided she wanted an artificial disc replacement that would help her retain better neck motion and avoid chronic pain associated with other potential treatments. The only problem? The device she wanted to use wasn’t yet approved by the FDA. Approval was supposed to take just a few months. It took a year.

It was a hell of a wait. “While I waited for device approval,” she told members of Congress, “my spine degenerated to the point that my neurosurgeon and I feared I was in serious danger: all of my limbs were numb, my continence was a huge issue, my balance and grip unreliable.  I was nearly a prisoner in my home for fear of paralyzing accidents.”

Finally in 2009, after much delay and additional diagnosis, Conger got her treatment—in England. The implants she wanted to use were available there, but not in the U.S. Indeed, she told Congress, thanks to the FDA, they’re still not available to many Americans: “The devices I traveled to England to receive have been available in Europe since 2005 with a strong track record, and are still years away from the marketplace in the US.”

We may not see the same sort of truly heartbreaking stories as a result of the FDA’s initial regulation of mobile medical apps, at least not right away. But the underlying effect on the market will likely be the same: Higher costs, longer waits for new treatments, and less access to medical technology that can ease an individual’s pain, help doctors provider better care, or make completing a treatment regime easier. 

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  • FDA||

    "WebMD", my ass.

  • Bill||

    If you share this story with your typical "progressive" what they might say (I have this experience a lot) is that this is just anecdotal.

    Apparently they lack the ability to see patterns.

  • Paul||

    Only humans are pattern seeking animals.

  • Old Mexican||

    As with all such regulation, there are tradeoffs involved.


    Like... your freedom.

    The agency is clearly looking for an excuse to extend its regulatory reach even further.


    Nooooo! Ya think???

  • Bill||

    Or paralysis.

  • Old Mexican||

    But what about consumer safety? Shouldn't the FDA be looking out for patients?


    YES, it should - by going away. That would be a good start.

    On that front, we can already see instances in which the FDA’s oversight of the traditional device market does more harm than good by needlessly delaying products with proven track records.


    The FDA was NOT designed nor was it intended to protect consumers from bad medicines or devices. It was created esxclusively to serve as a barrier of entry to uppity innovators and boat-rocking entrepreneurs.

    I mean, people: That's YOUR story. Protectionist schemes, tariffs, "anti-trust" laws, unionism, licensing laws... It is a real MIRACLE that a free market appeared in the US; that's a testament to people's tenacity and ingenuity and to the failure of the mercantilist mindset.

  • AlmightyJB||

    I concur. The FDA should be eliminated. Unfortunately the media will convince the people that they need more government to protect them from the evil capitalist and the FDA will get more money and more union employees that can never be fired or laid off. I'd almost enjoy watching all of the stupid people screw themselves over with their ignorance if it didn't screw me over too.

  • ||

    I love how the collectivists like to remind us that "we're all in the same boat," while they actively pursue strategies that sink the boat, even as they forcibly prevent anyone who points this out from jumping overboard to save themselves.

  • SIV||

    Is the FDA going to burn iPads and iPhones like they were Orgone accumulators?

  • Huh?||

    Excuse my use of medical terminology, but how the fuck is computer software a food or a drug? Even something like a heart monitor implant with bluetooth that could call for help, any app in the phone still would still be completely separate from the patient. So would a dosage calculator, for that matter.

  • SIV||

    Medical devices, labeling

  • Robert||

    It doesn't even have to touch the patient to be a diagnostic device.

  • ||

    It's really, really disturbing how, under Obama, multiple regulatory agencies have gone into super regulate mode, as if they've specifically been instructed to expand their reach as much as they can while they can. It's probably just the scumbag bureaucrats who run the places seeing an opportunity, but man, it's nasty. We can't be rid of Obama and his administration soon enough.

    Of course, I shudder to think of what replaces him. We'll be very lucky if it is less encouraging to regulatory agencies.

  • SIV||

    Team Red executive branches don't put the Public Health Nazis into overdrive. Same for the Enviro bureacracies. You hear a lot of bitching about that from Team Blue when they are out of power

  • Paul||

    Shyeah, you also hear from Team Blue about how Team Red is cutting government to the bone! Starving the beast! All the while government grows geometrically under Team Red.

    It's about opportunity, not reality.

  • Old Mexican||

    Re: Episiarch,

    It's really, really disturbing how, under Obama, multiple regulatory agencies have gone into super regulate mode[...]


    Epi, the saddest part is that even if Obama and the Dems lose the WH and both houses, these agencies will not be reduced or shut down nor their regulatory schemes be rolled back in their entirety. That seldom happens! The Republi-rats LOVE the extra power allowed by the existence of these bureaucracies just as their Dem-a-gogue counterparts.

    The ratchet effect...

  • Robert||

    It feels like they want to regulate for the hell of it. It's like what they'd really like to do would be to have every business take their inventory out and set it on fire.

  • ||

    ...Conger got her treatment—in England. The implants she wanted to use were available there, but not in the U.S.

    I say lock her smuggler ass in Federal PMITA Prison. Think what could happen if that unapproved device got loose, how many children would be maimed or killed. How do we know she wasn't just acting as a mule, then selling that unapproved hardware on the black market?

    This is a serious threat to the physical and moral safety of the nation, and should be dealt with accordingly.

  • The Man||

    I don't think you mean 200 million applications in use. I think you mean there are several apps that might be in use on 200 million devices. It's impossible in the current technological environment to develop 200 million apps—there aren't 200 million developers.

  • pmains||

    More likely, he means there are 200 million instances (installations) of apps on X number of devices where X

  • pmains||

    ack. Where X << 200 million.

  • ||

    Old Mexican's too fucking fast, so he beat me to it, but it has to be said constantly:

    Abolish the fucking FDA, period. Why won't the FUCKING FEDERALES ABOLISH THE FUCKING FDA?

  • ||

    The FDA is responsible for more premature deaths in this country than every war we ever fought. There is not a single life saving drug or device brought to market since its creation that was not delayed for years while patients died. Tons of useful drugs have been shelved because small companies cannot afford the approval process or have been made to through useless additional trials. Yes--I am still pissed off that the company I invested in with a drug to cure Wilson's disease was denied because they could not prove the drug would not cause birth defects. The FDA apparently did not care that women with the disease are generally infertile, so birth defects are not likely to be an issue. They did not give a damn about the suffering, and just wanted to make sure their bureaucratic keisters did not get caught in a knot in case a miracle happened and an afflicted woman did give birth.

  • Robert||

    What tests were done to try to provide evidence? Was something wrong with standard teratogenicity tests?

  • ||

    The problem was with the population used in the double blind testing. I don't remember all of the details.

  • ||

    Interesting post. A specific example of this would be Asprin. As you said, overregulation can kill. In it’s early stages the FDA banned Asprin 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 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

  • jtuf||

    The FDA is proof that even a purely secular system can prevent innovation much to people's detriment.

  • ||

    This is only the most recent move in a game that the FDA has been playing for a while. I first learned about this in the early 2000s, when working for a manufacturer of medical equipment. At the time the FDA was "concerned" over the volume of sound delivered over mp3-player headphones, and the possible use of iPods and the like for "sonic therapy." They were wanting to subject the manufacturers of players and targeted software or recordings to the rigorous (draconian!) standards of oversight and record-keeping that medical device manufacturers must obey.

    Even back then, I knew -- and I may even have written in Reason's blogspace -- that this day would come. And worse is coming if we don't do anything to prevent it. Years ago, chafing under all the federal and state regulation of the place where I worked at the time, I declared that it was really no different than having a government job. (Except for the lack of a union, I suppose.) I began to long for true, mostly unregulated private-sector employment, as I had once enjoyed during the "Wild West" days of Silicon Valley. Today, it is beginning to look as if "we are all government employees, now." That, of course, is fascism.

  • ||

    More fiscally irresponsible regulation from the FDA. Big surprise.

    Medical apps are 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… it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority.” The FDA is lacking in resources and manpower. The FDA’s budget was slashed recently by 258 million. This new set of regulations is only one instance of new regulations that are taking away resources from more important areas. This lack of resources has made the 2011 Food Safety and Modernization Act reactionary instead of preventative as 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. 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.

    Initially, for the first 86 years of FDA's existence, from 1906-1992the U.S. treasury department funded the FDA. In 1992 a law passed allowing pharmaceutical companies to provide funding for their own research that smaller companies could not put forth.

    Once again the FDA kills growth and initiative in favor of Big Pharma.

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