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Should Medical Apps Be Regulated?
maximus1 writes "There's a tidal wave of medical-related apps coming to smartphones and tablets that will be used by doctors and patients alike. But how should the medical establishment deal with them? Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations. Obstetrician Kurian Thott, developer of an app called iRounds that helps communication between doctors, thinks they should be released quickly and the market should decide which take off. What do you think?"
So why regulate apps? You can more or less claim your snake oil does anything you want, so long as you hide a disclaimer some place that your claims have not been confirmed by the FDA. If we're going to regulate medical self help and remedies then it should be all inclusive, not limited to apps.
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Speaking as someone who works as a mobility specialist in the medical products industry, the FDA already issues guidance in this area. It won't be long before the guidance turns into regulation.
So why regulate apps?
Because regulation artificially narrows the supply, making the profits more lucrative for the incumbents. You did notice the guy pushing for regulation was a doctor already doing apps. Once he's in, regulation is good for him.
Oh, I misunderstood your question. You were looking for a good reason to regulate apps. Sorry, I can't help you there.
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Yes, they absolutely should; for the consumer, to prevent abominations like this. I would say that anything more interactive than a reference document or log book. For more real medical software (i.e. patient monitors or diagnostic tools), just because it's on a smartphone and not a dedicated box doesn't mean it suddenly stops being a medical tool.
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If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation. This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.
"Medical Apps" is a broad range of things. Apps that make medical decisions for you certainly should be. Are they making a diagnosis? Telling you treatment? Yes.
On the other hand, Apps that help you track things (Say your glucose levels) or tracks your prescriptions - don't need that added cost / regulation.
I'd be curious to see - are the big companies pushing for this? FDA approval isn't cheap OR fast. Small innovators are able to disrupt this market which has been held strongly by the giant medical firms - who can't be quick and innovate.
We have a fine line to walk between stifling innovation and regulation.
We are on our way to regulating everything, anyways.
I can't even be astonished by new cries for regulation. It is a very sorry world we are creating. We push aside religion for being too invasive and controlling and then ask the government to be even more invasive and controlling than the religion could ever hope to be.
Uh, the other guy who DIDN'T think that regulations were needed was - also a doctor.
Personally, I don't think you should regulate these. Who's going to do it? How many friggin 'lawyer' screens are you going to create (hint: more than we already have)?
Do you then regulate every 'medical' website? Most of these apps either could be duplicated by a web site or already have been.
Where, exactly, do you stop?
What happens when doctors or even medical professional societies disagree (think stroke treatment with clot busting drugs - the American Academy of Emergency Physicians and the American Neurologic Society (or whatever prof society the neurologists hang out on) disagree pretty vehemently. That's fine, it's expected but how do you 'regulate' that?
Faster! Faster! Faster would be better!
If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation.
This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.
The DSM-IV, which is simply a list of diagnostic criteria for psychiatric disorders, is available in e-book format as an "app". Is that app a medical device? What about a paper copy of the DSM-IV that I carry around in my pocket? Is that a medical device, too?
Because regulation artificially narrows the supply
And artificially strips out dangerous or faulty procedures, chemicals etc. before they experience the joys of the free market on the public who have to enjoy the burdens of what's happening. Because your medical information is *private* and letting anyone have at your private medical information without any regulation means that information could be used against you.
Because letting people take random chemicals to see if some of them cure whatever disease they have definitely isn't a good idea, but it's cheap, so we could do that.
It does however depend a lot on what apps actually do. I'm not sure you need to highly regulate the applications used by medical professionals to handle payroll or scheduling or room booking. There are custom software packages for a lot of those because all hospitals face similar problems and so on, so it makes sense then to not have to completely re-engineer your payroll system just because your hospital is not the hospital one block over. But if you're talking about tracking a patient's blood sugar and providing advice based on that tracking you're into a whole collection of privacy rules (how secure is this data? Who am I sending the data to?) and providing medical advice from something that isn't a medical professional.
Which tends to show they're talking past each other a bit. The one doctor is making an app to deal with strokes, that's almost certainly into the category of medical advice (at least potential medical advice) and tracking a lot of deeply private medical information. The other guy is helping doctors communicate information between rounds, so there are privacy implications, but he's not necessarily intending that information to ever actually see a patient.