Smartphone based software with automatic "rating" from remote servers

S

SmallD

#1
Situation: a smartphone is used as a medical monitor (with added HW) but the supporting software immediately sends test results to a remote backend, which in turn sends in real-time the supporting software with a rating of the test results (good, bad, normal, abnormal, etc.).

My question is, the backend is considered a diagnostic device but does the smartphone change status from a monitor to a diagnostic device because it is supplying the user with a medical analysis of the test he has just performed?

Or is the display of the rating on the smartphone just a reflection of the backend diagnostic ability which does not affect the smartphone status?

Really need help thinking this out, any references would be great. :bonk:
 
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Marcelo

Inactive Registered Visitor
#2
Situation: a smartphone is used as a medical monitor (with added HW) but the supporting software immediately sends test results to a remote backend, which in turn sends in real-time the supporting software with a rating of the test results (good, bad, normal, abnormal, etc.).

My question is, the backend is considered a diagnostic device but does the smartphone change status from a monitor to a diagnostic device because it is supplying the user with a medical analysis of the test he has just performed?

Or is the display of the rating on the smartphone just a reflection of the backend diagnostic ability which does not affect the smartphone status?

Really need help thinking this out, any references would be great.
Usually this depends on what you (I´m assuming you are the manufacturer) defines all parts of the "system". For example, the smartphone could be an accessory of the device and thus it would not be a medical device (the software is).

Another possibility is that both the software and smartphone are medical devices.
 

c.mitch

Quite Involved in Discussions
#3
Hi,
About the software:
It depends on the regulation of each country. The main criterion is the intended use.
If the device is for diagnosis or treatment purposes, or drives or influences a diagnosis or treatment, then the probabilities are high to qualify it as a medical device.

To help you in the decision:

The EU released a MEDDEV in feb 2012: Public Health

And the FDA released a draft guidance about mobile apps with interesting examples: http ://www. fda. gov /medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm - DEAD (404) LINK UNLINKED

Hope it helps.

Mitch.
 
Last edited by a moderator:
S

SmallD

#4
Thanks for the answer. To better explain the situation is we know the software (backend and smartphone app) are medical devices, no problem there. The smartphone test results (seen by the user) are just a reflection of the backend processing (diagnostic), so is the smartphone also giving a diagnosis (as per a medical device with measuring function) or can it be categorized as a MDDS (per FDA definition)?
Sorry I cannot give more details, very complicated (and first of its kind) system and is coming to close soon.
 
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