• Sven Jungmann

Clinical data

Clinical data is information regarding the performance, effectiveness, and/or safety of a medical product or device. This data is generated from clinical investigations and trials, from scientific reports about the device in question or a comparable device, or from sources of clinical experience (e.g., medical records, medical incident databases, and patient registries).


Important note about biases in clinical data: Innovators need to be aware and minimize biases. Historical data often misses certain population groups, thus using it for AI solutions can potentially perpetuate health inequities. Be sure to design clinical trials in a way that reduces or eliminates bias (e.g., blind or randomized studies) and consider weaknesses of chosen training data (lack of diversity in patient groups).


Source: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n55.pdf

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