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Fed Now Regulating Health Care Apps (and That's Not a Bad Thing)


You know a new technology has really arrived when the government starts regulating it. That’s why it’s big news that the FDA is going to start regulating some smartphone and tablet health apps. More:

Agency officials said their goal is to oversee apps that function like medical devices, performing ultrasounds, for example, and that could potentially pose risks to patients. Tens of thousands of health apps have sprung up in recent years, including apps that count steps or calories for fitness and weight loss, but agency officials said they would not regulate those types of apps.

Some apps have already gotten the agency’s stamp of approval. One turns a phone paired with a special case into a portable electrocardiogram machine. Others make a phone double as an ultrasound device or a tool for measuring a person’s glucose levels.

Med tech is a crucial area where too much overregulation could crush a burgeoning industry, but (so far) it looks like the FDA is working with a pretty light and judicious touch. And as one doctor notes, lack of clairty about how the government would treat new health care apps has held innovation back slightly; a little regulatory clarity could help spur the industry to new levels of output. Nothing could be more timely.

[Hospital technology image courtesy of Shutterstock]

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  • rheddles

    Regulation of health care apps is a bad thing.

    People will believe that since the apps have been reviewed, tested and certified (or so they will believe) by the FDA they must be beneficial and efficacious. Nothing could be further from the truth.

    When an app has been demonstrated to do harm (a tort) there is a legal remedy. And word will get around quickly that the app is harmful.

    But having the government “regulate” things lulls people into thinking they don’t have to be skeptical about claims producers make. Nothing could be further from the truth. People need to take responsibility for what they do and not offload that responsibility on the government.

    • bpuharic

      It’s funny to read about the right’s simplistic faith in non-existent market remedies when they’ve explicitly forced such remedies out of the market place

      The right has led efforts for ‘tort’ reform, in spite of the fact medical malpractice has minimal effects on healthcare costs.

      And they ignore the fact that negligence in medical affairs often shows up as dead bodies. Quite a bit different than a bad TV or a car that won’t start.

      AND they believe the cost of information is free. That’s not true in thermodynamics and it’s not true in economics.

      But the right has all kinds of myths and fables about the way the world works.

      • Corlyss

        “faith in non-existent market remedies”

        It’s hard to have a market when the omnivorous state insists on meddling in everything in order to save the poor, the stupid, the lame, the halt, and what remains of a middle class that the state’s own confiscatory policies have rendered fearful, mute, and neutered.

        • bpuharic

          Yeah imagine the state protecting the poor! I can understand right wing hatred of the very idea, when, after TARP, low capital gains taxes, etc. we KNOW the role of the state is to protect the rich!

          Your post is nothing but worthless cliches.

    • f1b0nacc1

      While I share yoru skepticism of governmental interference on a broad basis, this looks like the sort of light touch that I could at least tolerate as long as it continues to remain light. No marketplace can operate without some rules, and allowing the lawyers (and more importantly the vampires in tort litigation) to set those rules will do more to cripple that marketplace than will some (and I stress SOME) regulatory intervention.
      I suspect that neither of us particularly trust government regulators (with good reason), but I don’t share your trust of lawyers and their ilk even more. Sadly, there is going to have to be some rules-making here, and we don’t get to exclude ignorant ‘crats and rapacious lawyers from the mix. While the lesser of two evils is still evil, it is also LESSER, so in this case, I will go with that…

      • bpuharic

        Exactly. Adam Smith recognized that there is no such thing as a ‘free’ market absent govt regulations since players will try to manipulate the market for their own purposes.

        Especially in areas such as healthcare which are VERY price inelastic.

  • Corlyss

    “That’s why it’s big news that the FDA is going to start regulating some smartphone and tablet health apps.

    OF COURSE THAT IS A BAD THING! Sometimes I wonder why I bother with ViaMeadia at all, the lack of serious analysis borders on the shocking in many of the stories. The uncritical rah-rah-ing for statist intrusions into the private sector, as if nothing about the last 40 years of encroachments had made any impression at all, is really troubling in a group that’s supposed to be so sophisticated. It’s almost as though this is a site only minimally less ivory-towerish than the leftist mouthpieces that dominate the rest of academia.

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