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mHealth Trials Are Happening, Without the Clinic

Scott Mace, for HealthLeaders Media, December 4, 2012

But more to the point, I'm sure mHealth will provide, and probably already has, examples of disease diagnosis and treatment that do not involve doctors. There are laws against practicing medicine without a license, of course. Lack of enforcement of these laws is due to the fact that no one apparently is being harmed by these apps.

The question has to be, will the mHealth apps of the future be accused of enabling medical practice without a license. Will someone suffer serious bodily harm or die because of an app?

I wish I could say with confidence that that day will never come. However, apps are getting smarter every month. I wish I could say the same about people, but despite the knowledge-spreading effect of social networks, there are too many examples of bogus science being spread that way to expect social networks alone to help the average patient to keep up with what's medically proven and what is quackery.

In other words, it's probably not a question of if healthcare apps will be regulated, but when, and which ones, and how much.

Drugs and medical devices go through rigorous discovery, testing, and clinical trial phases before doctors can begin prescribing them. The healthcare IT system must police itself or the same kind of requirements will be imposed, at some point, on some or all of the technology rushing to market. I do not hold out faith that the free market alone will be sufficient to do all the necessary policing.

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1 comments on "mHealth Trials Are Happening, Without the Clinic"


Wayne Caswell (12/5/2012 at 8:48 AM)
Will the consumer medical device and app be more accurate or helpful than the average general practitioner, or the mediocre one, or the top-notch one? Will low prices extend availability to more people and justify trade offs? Who gets to decide: consumers, medical practitioners, health institutions, insurers, employers, or regulators, and what will influence their decision? What might be the role of advertising? This is a relatively new and fast growing area with lots of unanswered questions. So, what may trigger government regulators to seek answers?