Introduction to Medical Software

In this course, we provide a broad overview of the medical software field. You will learn from Yale professors and a range of industry experts who connect course concepts to their real-world applications. We begin by discussing the regulatory landscape of medical devices, data privacy and cybersecurity regulations, and key enabling technologies such as quality management and risk management systems. We then take a detailed look at the medical software lifecycle, from identifying user needs, mapping them to system requirements, and continuing through the process of developing, coding, testing, and validating the software. Next, we consider issues related to the use of machine learning techniques in medical applications, from both a software engineering and regulatory perspective. Finally, we discuss business and management issues in this field, focusing on the impact of digital health on modern healthcare and the challenges associated with creating new businesses. This course is designed for third- or fourth-year students studying computer science, biomedical engineering, and related fields, as well as aspiring software engineers working in or interested in moving into the medical device industry.