Comment sécuriser les données des patients dans le contexte du développement de l'intelligence artificielle ?

FDA clearance and CE marking are both essential for market access and regulatory compliance of AI radiology tools. These evaluations confirm that a device is safe, performs as intended, and complies with required quality standards. Yet, in practice, these approvals tell only half the story. That’s because they don’t guarantee that the AI tool will fit into your workflow, be used by your radiologists, and give you a good ROI. So the real question is no longer “Is it cleared?” but “Does it work in my practice, for my patients, with my team?” In this blog, we’ll cover what these approvals mean and five things to consider when evaluating FDA or CE-marked AI tools.  We’ll also highlight how tools within the  Rayvolve® AI Suite meet these expectations while also making sure they perform well in real-world settings.

At AGAPLESION ELISABETHENSTIFT, the AI deployment occurred not because of curiosity but because of a need for an additional layer of oversight for supervising the patient throughput. The number of specialists varies. The senior consultant in the surgical outpatient department of trauma surgery, orthopedics, and sports medicine, Dr. Sabine Geck, shared this comment: “We perform imaging day and night, but a radiologist is not always available 24 hours a day to interpret the studies”.

A inteligência artificial (IA) na detecção de imagens torácicas transformou os fluxos de trabalho diários das radiografias torácicas (CXRs). As CXRs ainda representam cerca de 40%¹ de todas as imagens capturadas nas unidades de radiologia hospitalar. O processo de interpretação das CXRs é complexo porque diferentes patologias² apresentam características radiográficas sobrepostas, enquanto as estruturas anatômicas se sobrepõem umas às outras. A combinação do aumento do volume de imagens dificulta a redução do tempo de resposta dos laudos e aumenta o potencial de variabilidade diagnóstica³.