In the EU context, a software to be used at home that aggregates data (e.g. vital signs) from different sources (not from the same manufacturer) and processes that information to provide real-time warnings to a healthcare professional if those data are outside the normal threshold is considered a medical device, as the data processing is not limited to storage, archival, communication or simple search.
A) Concerning the data collected and used for a real-time warning to a healthcare professional, if it is collected from a non-medical device (e.g. wearable not certified as a medical device for no medical purpose), how to deal with it? Would the manufacturer of the software need to validate that the data collected complies with certain requirements? Or would an indication that the data collected is coming from a device not certified be enough mitigation?B) What if the data is coming from Google Fit or Healthkit, where no indication of the provenance of the data or its precision?
C) What if the data collected is coming from a manual insertion?
Would love to hear your thoughts for this situation.
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