Uso di sensori indossabili in studi clinici: aspetti regolatori

This is a guideline document that the DARE consortium produced to assist the Italian Ethics Committees called to evaluating clinical studies involving wearable devices. As the level of certification depends on the context of use, this guideline became necessary as we submit to various Italian Ethics Committees the many clinical studies the DARE project involves. We hope it can help the Ethics Committees to have a more uniform evaluation of these and other similar studies.

Keywords

medical device, wearable sensors, regulatory, Italian Ethics Committees

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