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News Members Get Involved Upcoming Events Fundamentals of Digital Health Regulation Successfully Navigating Your Product Through FDA Digital health including software mobile health applications machine learning and artificial intelligence AI wearables and personalized medicine has created opportunities to improve patient health and provider efficiency. This course will explore the essentials of FDA regulation of innovative medical device technologies. In this course youll learn whether and how these categories of products are regulated as medical devices. Then the course will cover the various regulatory pathway options for getting a technologically focused product on the market current FDA premarket review initiatives AImachine learning regulations and cybersecurity considerations.