<br />Healthcare is undergoing rapid development thanks to the integration of modern technologies into its core infrastructure. One of the most prominent transformations is the emergence of smart medical systems, which combine artificial intelligence (AI), the Internet of Things (IoT), and big data analytics to provide more accurate and efficient healthcare services. These systems have become a pillar of the digital transformation in medicine, offering promises of improved diagnostic quality, personalized treatments, and continuous patient monitoring. However, despite the significance of this progress, it is not without technical, ethical, and regulatory challenges that hinder the full realization of its potential.<br /><br />Among the most notable opportunities offered by smart medical systems is their ability to enhance diagnostic accuracy through the use of AI algorithms, which have proven capable of analyzing medical images and detecting disease indicators—sometimes surpassing human physicians in performance. These systems also enable personalized healthcare by continuously monitoring patients’ vital signs via wearable smart devices, allowing for early medical intervention and tailored treatments based on individual needs. Additionally, these technologies help reduce administrative and clinical burdens on medical staff by automating many tasks and improving workflow efficiency within healthcare institutions. One cannot overlook their role in expanding access to healthcare, especially through telemedicine technologies, which offer effective solutions for patients in remote areas or regions suffering from a shortage of specialized medical personnel.<br /><br />Nevertheless, this advancement is accompanied by several critical challenges. Chief among them is the issue of data privacy. The use of network-connected devices to collect and analyze health data opens the door to potential cyberattacks and leaks of sensitive information. Furthermore, smart algorithms may suffer from bias in outcomes if they are not trained on diverse and representative datasets, which can lead to inaccurate or unjust treatment decisions for certain population groups. In addition, legislation and regulatory frameworks concerning the use of AI in the healthcare sector remain incomplete in many countries, hindering the widespread adoption of these technologies. Another challenge lies in societal acceptance, as the success of these systems depends on the trust of users—both patients and healthcare providers—and that trust can only be built through awareness, training, and transparency.<br /><br />Progress in this field requires a careful balance between technological innovation on the one hand and the protection of individual rights and ethical standards on the other. The adoption of smart medical systems must not occur in isolation from the development of clear regulatory frameworks, ensuring the inclusivity and fairness of the data used, along <br /><br />Al-Mustaqbal University is the first University in Iraq.