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FDA Starts to Tackle Regulation of Health and Medical Apps

The views expressed are those of the author and are not necessarily those of Scientific American.


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doctors medical health apps fda regulationOn-the-go doctors can already see your latest MRI or CT scan via a smart phone or tablet. But would you want them to be able to download an app that essentially turns an iPad into an EKG to determine if you are having a heart attack?

Earlier this year, the U.S. Food and Drug Administration (FDA) gave its first official governmental blessing to a medical app, one that allows physicians to view images on mobile devices in order to make diagnoses from a distance. Since then, the agency has added several other so-called mobile medical (MobMed) apps to its sanctioned list. But with hundreds of thousands of programs out there, the cash-strapped office has said it has no plans to regulate all health or medical apps. Instead, it is proposing, in draft guidelines released July 21, to assess only a small fraction of programs, in particular those that enable a communication device to work as a medical one (e.g. an EKG or ECG machine) or let doctors make diagnoses (e.g. the already approved imaging app).

Like food and cosmetics, however, most apps in the health and medical field will be released to customers without any government testing or approval.

"It is the manufacturer of the app’s responsibility to ensure safety & effectiveness," Bakul Patel, an FDA policy advisor, said during a July 20 live chat via Twitter about the proposed guidelines. With the inevitable onslaught of updates, keeping track of changes to apps will also fall to app makers: "Developers have to make sure that the changes don’t affect performance of MobMed app," Patel tweeted.

Unlike a pacemaker or hip-implant maker, just about anyone with a computer and some time can cobble together an app, which means the field of "manufacturers" has expanded exponentially. "If anyone is making a MobMed app, they would be considered a manufacturer," Patel explained.

The agency says that the guidelines so far do not promise enforcement. "We will have an appropriate enforcement strategy once the guidance is finalized," Patel wrote.

As with other medical devices, the agency’s future regulatory strategy will be risk-based, Patel noted during the chat. So under the current proposed guidelines, apps that have the most potential for harm would be more likely to face the strictest regulation. By that logic, apps that provide more consumer-oriented advice, such as dietary recommendations or first aid tips, would probably not be evaluated before hitting the app store. The types of apps that would be considered for regulation, the FDA has suggested, include ones that transmit information from a blood glucose monitor, record sound for use as a stethoscope, measure movement to diagnose sleep cycles, administer cognitive tests or calculate medication dosing for patients.

And as with analog devices, the new guidelines would require makers of medical apps to inform the FDA of any injuries or deaths related to their product.

How do you think health and medical apps should be regulated? The FDA’s draft guidelines are open for public comment until October 19. And share your comments below.

Image courtesy of iStockphoto/inhauscreative





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  1. 1. Jesse_EngAmer 1:35 pm 07/26/2011

    This is completely fiscally irresponsible. Larger proportions of our medical devices are in greater risk yet resources are being driven away from regulation them.

    Part of the reason why this isn’t a good idea has to do with financials. 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

    Link to this

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