This interactive course will help students understand the regulations, standards and guidance related to the evolving mobile health technology sector. Mobile health is developing novel technological solutions that span the scope of healthcare, from wellness to patient and clinician support, to chronic disease management to digital therapeutics. Through lectures, case studies, assignments, and in-class games you will learn in a hands-on manner on how to develop and implement a mobile health device regulatory strategy, develop supporting clinical evidence, handle post-market changes to devices, and handle aspects of privacy, confidentiality. The course will extensively review current FDA policies on General Wellness, Mobile Medical Applications, Software as a Medical Device (SaMD) and AI/ML devices.

Learning Outcomes

• Demonstrate knowledge of current framework for FDA regulatory oversight of mobile medical devices and apps
• Demonstrate knowledge of how to develop and execute a mobile medical device regulatory strategy
• Explain regulatory aspects related to privacy, cybersecurity and confidentiality of mobile medical devices
• Develop strategies to handle the regulatory implications of post-market changes for software and AI devices

Topics Include

• Mobile apps, SaMDs
• Devices with AI/ML algorithms
• Bench and clinical performance data to support premarket submissions
• Elements of an SaMD 510(k)s
• Clinical decision support, general wellness, MDDS, cybersecurity
• Post-market, FDA initiatives (PreCert, DHCoE)

Working knowledge of:

Additional Information