Raw data retention for Diagnosis Results

#1
Hello,

My question is related to the retention of raw data and diagnosis results based on this raw data. Our medical device is a "Medical Device Software" falling under the new EU MDR regulation. The software uses raw data from another medical device and computes a diagnosis that influences treatment given to a patient.

It is unclear to me if 1/ we need to keep the raw data and/or the diagnosis 2/ if so, for how long.

Any pointers, insights would be great.

Thanks.
 
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Ninja

Looking for Reality
Trusted Information Resource
#3
Howdy Ernesto,

I am not in medical...and not in the EU...so understand that up front.
I do, however, work in data, data storage and data integrity...

Simply from a CYA standpoint, if you are going to store the diagnosis, you should also store the data that diagnosis was based upon...helps immensely for the lawsuits later.
There's a balance between cost, speed and lowering risk. (Speed comes in since copying data takes longer than RAM access of data via query).

There may be regulations at play as well, as you ask in the first place...but others here can answer that one.
 

yodon

Staff member
Super Moderator
#5
In theory, when you validate your system, you have high assurance that the results are (always) accurate (your diagnosis is correct based on the data). Thus, you shouldn't have to keep any of the data. Regarding the CYA tack @Ninja suggested, maybe you can add something to the report that supports the diagnosis (some or all of the raw data values)?

Managing what I presume would be protected health information (albeit probably de-identified) brings a heavy legal burden and greatly increases the controls needed to protect. Make sure you understand that first before saving any. (I tend to be quite paranoid regarding health info.)
 
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