Diagnostics: Purpose of my service
Please note that the results correspond to the answers you have ticked. They provide an insight but cannot replace the personalised and in-depth analysis that a legal or regulatory expert can provide.
Does the service transform/analyse entry data to create new medical information?
What is output data for medical purposes?
As a reminder:
Medical device software consists of one or more algorithms that process entry data to create output data for medical purposes.
If your software performs an action on the data, or performs an action other than storage, archiving, communication, simple search, lossless compression (i.e. using a compression procedure that allows exact reconstruction of the original data), it may be a medical device if the creation or modification of that information is driven by a medical purpose.
Practical guide
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Entry data are understood as: Any data provided to software to obtain output data after processing. Examples of entry data formats (not exhaustive):
- Data provided directly by the user through an interface;
- Data provided by voice recognition;
- Digital document: formatted for general purposes such as a Word file or a pdf file or a jpeg image, formatted for medical purposes such as a DICOM file or an ECG record or an electronic health record, or an unformatted document. Note that digital documents must be distinguished from software capable of reading such documents;
- Data received from/transmitted by medical devices.
Output data are understood as: Any data produced by software.
If the processing of your data is limited to:
- Archiving
- E-mail or vocal messaging
- Storage
- Research
- Lossless compression
Then your output data do not constitute "new medical information."
Examples
An application that allows a diabetic to record his or her blood glucose results and formats them to present them more graphically is not a medical device because it is simply an ergonomic presentation.
There is no action performed on the data to create new medical information.
On the other hand, an application that allows a diabetic to record his/her blood sugar results in order to calculate the dose of insulin he/she should inject is a medical device because it has a therapeutic purpose for a specific patient by interpreting the entry data (blood sugar) to create new medical information (insulin dose).