So let's take a moment to review the key concepts and terms used when discussing AI model regulations. Many of the terms are used globally. Therefore, it's important to have an understanding of their specific definitions. Let's start with the International Medical Device Regulators Forum or the IMDRF. The IMDRF is an international work group composed of AI regulators that come together to develop a path for standardized AI regulations. Their current efforts focus on the development of standard terminology, a risk based framework, quality management principles, and an approach to making AI solutions clinically meaningful to users. The IMDRF defines Software as a Medical Device, SaMD as and I quote, software intended to be used for one or more medical purposes, that perform these purposes without being part of a hardware medical device. So a medical purpose as they define it is one that is intended to treat, diagnose, cure, mitigate or prevent disease or other conditions. There are two very important components here. First, Software as Medical Devices are not part of hardware. For example, a model that uses signals from a pacemaker to alert an arrhythmia would not be considered a Software as a Medical Device. Second, the purpose of the software must be to treat, diagnose, cure, mitigate, or prevent disease. Previously, we spoke about actions for an AI solution, and some of the actions discussed would not qualify as a Software for Medical Device. For example, if I have an AI model that identifies patients likely to not show up for an MRI appointment, this would not be considered as a Software as a Medical Device. Because the output of this model does not treat, diagnose, cure, mitigate, or prevent disease. However, if I have a model that generates a list of people at high risk for 30 day hospital readmission following a hospitalization for coronary heart disease, for example, this would be considered a Software as a Medical Device. Because I am trying to mitigate a readmission which is highly correlated with disease management. Therefore, it is important to remember that regulations we will discuss in this lecture, apply only to Software as a Medical Device. And Software as a Medical Device must intend to treat, diagnose, cure, mitigate or prevent disease or other conditions, and must not be part of a hardware.