Software in Medical Devices, by MD101 Consulting

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Inflation of software medical devices - part 3

This article is the last of three articles which deal with the concept of "inflation" of medical devices. The first one was on inflation of standards, the second about inflation of regulations. This one, the most interesting to my eyes, is about multiplication of apps on mobile devices, especially smartphones and tablets.
More that 6000 apps are classified in the "heath", "heathcare" or "medical" categories of the Apple or Android appstores. Many of these apps are classified as medical devices and are in the scope of regulations like FDA and CE Mark. Note that some apps may be regulated the FDA but not the CE Mark or vice-versa.

Medical device apps or not medical device apps

Apps may be categorized in three big sets: encyclopedic apps, health lifestyle apps and real medical devices apps.
Encyclopedic apps are not medical devices, neither for FDA nor for CE Mark. They often contain data or knowledge that can be found in books. They are most of time created by book editors which publish their books in electronic format.
Health lifestyle apps are made for people who are not physicians, for diet, life hygiene or general health condition. These are most of times not medical devices. The frontier between general health and medical devices is sometimes thin. They may fall into the regulations whereas it was not expected by their manufacturers.
Medical devices apps are those with an intended use, which is clearly in the scope of regulations. “Clearly” is not a clear criterion, you may object. That’s true, there is no clear boundary between general health apps and medical devices. A few examples of medical devices are better than endless theoretical explanations:

  • Apps which compute drugs doses or a dose of any pharmaceutical or medical substance, are medical devices.
  • Apps which are connected to Heath IT servers and offer a service higher than simply displaying data are medical devices.
  • A PDF viewer used to read a medical report sent by mail is not a software medical device.
  • A remote DICOM medical imaging viewer is a medical device.
  • An app which lists the defibrillators around you is not a medical device.
  • Apps which give general recommendations, like smoking increase risks of cardiovascular pathologies, are not a medical devices.
  • Apps which contain training information, like memos about first aid are not medical devices.

Smartphones become medical devices

When an app is used to communicate with a peripheral connected to the mobile device, the whole is a medical device. For example, Withings sells a blood pressure monitor, which is connected to a smartphone to measure the blood pressure of patients. In this case, the whole thing (customized smartphone with blood pressure monitor and software) becomes a medical device.
Many new accessories were placed on the market the last two years, to analyse saliva, urine, to measure glycemy ... The possibilities seem to be endless!
Even worse, a physician uses an app which takes photos of the patient's body with the embedded camera of his smartphone to evaluate any medical parameter. In this case, the smartphone (not customized) and the app are a medical device as a whole.

Consumer electronics vs medical device

What an horror, my smartphone is a medical device??? Don’t be afraid. Being a medical device is a transitory state, your smartphone remains the little companion you cherish as soon as you stop the medical device app.
More seriously, there is a kind of contradiction between the level of safety sought in the medical device industry and the non-stopping pace of evolutions of the consumer electronics industry. It takes a long time to design reliable stuff. Smartphones don’t last long (that’s a pity IMHO), smartphone apps don’t either. Developers of smartphone apps may be tempted to ignore mandatory software design activities, event for class I devices.
This is why there is inflation of guidances and standards on standalone software.

PS: Thanks to J. Colombain for its chronicle on France Info about m-santé (sorry, only in French).

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