SaMD (Software as a Medical Device)

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2026: Noninvasive sepsis SAMD developed at Johns Hopkins offers early warnings
AI tools include computational technology integrated within devices or platforms as well as stand-alone AI technologies such as SaMD, risk assessment and prognosis algorithms, and software for informing health care used in the cure, mitigation, treatment, recovery, or prevention of health conditions without being part of a hardware medical device.
Digital Health Technologies (DHT) that can be adopted and implemented for clinical and translational research. These technologies and approaches enable generation of novel data types that can give a more robust assessment of human health as well as subsequent perturbations due to disease and/or therapeutic intervention. DHTs include: wearables, mobile health (mHealth apps), ambient sensors, health information technology (IT), and other software as a medical device (SaMD) solutions. Digital health approaches incorporate any combination of computing platforms, connectivity, software, and/or sensors to generate digital biomarkers.
Other potential areas of interest: Intelligent neuromodulation protocols guided by AI/ML methods to minimize drug craving, improve impulse control, enhance executive function, reduce dysphoria, etc., for long-term recovery Combinatorial approaches designed through computational modeling and directed at multiple treatment targets simultaneously, combining different treatment modalities or different medications with synergistic effects on sustained drug abstinence Implementation of AI/ML algorithms to augment existing digital and sensor-based technologies monitoring stress, craving, drug relapse, or overdose AI/ML-based software as a medical device (SaMD) to support recovery, prevent relapse and improve treatment outcomes

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