Diagnostics: Purpose of my service

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Does the service provide treatment for the individual benefit of a patient?

YES

NO

Practical guide

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Software that is not considered to be for the benefit of individual patients is, for example, software that is intended only to

  • aggregate the data of the population,
  • provide generic diagnostic or treatment recommendations (not addressed to individual patients),
  • produce scientific literature, medical atlases
  • or software intended solely for epidemiological studies or registries.

Examples

  • An algorithm that analyses Facebook posts in a given region to predict a flu epidemic is not a medical device because it does not benefit an individual patient.
  • On the other hand, an algorithm that analyses a person's Facebook posts to establish a diagnosis (e.g. diabetes or depression) is a medical device because it has a diagnostic purpose for a specific patient and uses input data (Facebook posts) to create new medical information (risk of developing diabetes).
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