NIST AI 600-1 provides a Generative AI Profile for the AI Risk Management Framework, identifying key GAI risks and suggested actions to govern, map, measure and manage them.

NIST has published a news release on a mathematical proof supporting the transition from a “one and done” AI security model to continuous monitoring and updating.

NIST has published the Initial Public Draft of SP 800-213r1, updating IoT product cybersecurity guidelines for the US Federal Government and introducing a product-focused approach with direct implications for medical device and IVD manufacturers.

FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.

A nova orientação da FDA sobre cibersegurança na produção de dispositivos médicos alerta para os riscos associados à tecnologia operacional (OT) utilizada em ambientes industriais. A FDA recomenda o mapeamento das redes conectadas, a implementação de arquiteturas seguras e a integração de normas como IEC 62443 e NIST SP 800-82.

The new Revision 3 of NIST SP 800-61, published in April 2025, redefines incident response as an integral part of cyber risk management, now aligned with the Cybersecurity Framework 2.0. The guide covers everything from preparation and detection to recovery and continuous improvement. Smart MDR supports medical device manufacturers and SaMDs in implementing incident response processes in line with the requirements of the MDR, IVDR, FDA and international standards such as NIST.