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From smartwatch apps and telehealth to artificial intelligence and machine learning, digital health is revolutionizing the practice of medicine. In some instances, medical software is not only increasing access to data but also diagnosing and treating diseases. For all its potential, digital health is not without risks, though. This seminar is for students who want to explore the promise that digital health devices offer and investigate the legal, quality, and safety protections in place to help ensure responsible and high-quality innovation. Students will explore key digital health terminology and trends and examine the regulatory pathways to usher medical software devices from bench to bedside. Goals: At the end of this course, you will be able to: 1. Define key terminology relevant to the fields of digital health law and medical device regulation. 2. Discuss the relationships between regulators, technology developers, healthcare providers, and patients. 3. Describe the requirements for digital health technology to be considered software as a Medical Device (SaMD) by the FDA 4. Identify the various regulatory pathways for SaMD and the main considerations.