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Is the Smartphone a Medical Device Accessory?

Written by Karl Larsson on . Posted in Tips & Tricks.

Last week I attended the Inartis Network seminar "E-connected Healthcare - Innovation Made in Switzerland in Digital Health and Telemedicine" that covered the latest developments in the eHealth market. The eleven speakers provided some very interesting input on their take on the problems and solutions in this domain. The common denominators were:

  • Health-related wearables connected to the "cloud" are here to stay. The sensors will become even more advanced in the next years.
  • Digitalization of Patient records is still progressing really slow even though everyone understands the potential benefits.
  • Where patient data and wearables meet there is still an integrity issue
  • There are numerous "new" players entering this health-related field coming from other industries (logistics-, telecom-, energy-companies)

The seminar was utterly silent on the regulatory aspect of all these developments. There was only one point where this came up: as Mark-Eric Jones, the CEO of Leman Micro Devices was presenting the company's smartphone blood pressure solution, he got the question if this "did not make the smartphone a medical device"?

We can all imagine where this could lead. If the smartphone becomes a medical device then it needs to be developed and documented accordingly. Who would do this work? I cannot imagine that Apple and Samsung are particularly keen on the idea. 

Mr. Jone's ingenious answer was to declare the smartphone as a medical device accessory "..like a battery. If your device needs a battery, you don't need a special medical device documented battery. You can take any battery as long as they fulfill the specifications you set up as a medical device manufacturer. It's the same with the smartphone. We define the required specifications and you can then use any smartphone that suits these specs."

Mr. Jones claimed that Lemans had worked closely with the regulatory authorities on this issue and had received acceptance of this approach provided that "additional software safety measures are put in place."

A very interesting approach. It remains to see if this is a viable approach for other manufacturers.

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