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Aug 18 2011   6:34AM GMT

FDA’s classification of mHealth apps as medical devices: ECG in your hand

Posted by: Jenny Laurello
FDA, Medical device regulation, mhealth apps, mHealth devices, mHealth regulation, Smartphones

Guest post by: Wendy Whittington, MD, MMM, Chief Medical Officer, Anthelio Healthcare Solutions, Inc.

In the July 21, 2011 Federal Register, the FDA released new guidance on the use of smartphone apps as medical devices. The guidance is to let users know how the FDA intends to apply its regulatory authority to smartphone apps that may pose the same or similar potential risks as other medical devices.   The public has 90 days in which to comment.

While there’s no doubt that smartphone usage among physicians has really picked up in recent years,  the idea of using mHealth devices to expand the continuum of care is nothing new. Physicians have been using apps to view digital medical information and patient records from hospital web portals long before hospitals sanctioned that use.  News analysts predict that by 2015, there will be 500 million smartphone users accessing and utilized health care apps, though the FDA seeks to regulate only those apps that pose the greatest risk to patients and play a direct role in providing clinical decision support.

The FDA states that the guidance pertains to an app that cause the smartphone to meet the definition of a “device” AND:

  • Is used as an accessory to a related medical device; or
  • Transforms a mobile platform into a regulatory medical device (such as an ECG).

One of the use cases mentioned by the FDA is in regards to an app displaying an image from a PACS (Picture Archival and Communication System), such as a radiology image.  If the user performs an analysis of the image for patient care, then it meets the definition of a device.  It will be interesting to see how the FDA draws the line between a radiologist interpreting an image and a primary care physician who just wants to look at it.

We all remember Schoolhouse Rock, with “Conjunction Junction” and “Lolly, get your adverbs here!”  For verbs, Schoolhouse Rock came up with “A verb tells it like it is!”  In similar fashion, the FDA has used verbs to depict the application’s guidance, and has done so with great style.  Here are some of the verbs that trigger the guidance that an app may qualify as a medical device:

Analyze Interpret Assess
Alarm Monitor Program
Control Calculate Convert
Attach Trend Manipulate
Measure Amplify Cure
Treat Detect Diagnose

The FDA also gave some examples of things that specifically don’t count:

  • An electronic or personal health record (EHR or PHR)
  • An electronic copy of a medical textbook or other materials for clinician training
  • A general function such as note-taking, logging or office functions

The FDA has already cleared a handful of mobile medical apps used by health care professionals, such as a smartphone-based ultrasound and an application for iPhones and iPads that allows doctors to view medical images and X-rays. Additionally, two other fairly well-known examples of FDA cleared apps are AirStrip, a cross-platform app for live fetal and ICU vital sign remote monitoring, and MobileMIM, an iOS app for viewing CT & MRI images.

If you think everything you need to know is becoming more difficult to remember every day, don’t worry; there’s probably an app for that!

For more information on the National Library of Medicine’s Gallery of mobile apps, please visit

And please visit Anthelio Healthcare Solutions Inc. for more information on Dr. Whittington and the Anthelio blog.

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