Mobile Health, SaMD, and AI/ML Devices | MEDD.X404

Mobile Health, SaMD, and AI/ML Devices | MEDD.X404

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

At the conclusion of the course, you should be able to
  • 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

Please review section notes to view the full schedule.

Instructor will share articles and related material as a PDF or via website links

Formally Titled: Mobile Health: The Evolving Industry and Regulatory Landscape
Have a question about this course?
Speak to a student services representative.
Call (408) 861-3860
This course is related to the following programs:


Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Quarter Units Cost Instructor
02-21-2024 to 03-20-2024 1.0 $700

Prabhu Raghavan


Final Date To Enroll: 02-21-2024


Date: Start Time: End Time: Meeting Type: Location:
Wed, 02-21-2024 5:30 p.m. 8:00 p.m. Live-Online REMOTE
Wed, 02-28-2024 5:30 p.m. 8:00 p.m. Live-Online REMOTE
Wed, 03-06-2024 5:30 p.m. 8:00 p.m. Live-Online REMOTE
Wed, 03-13-2024 5:30 p.m. 8:00 p.m. Live-Online REMOTE
Wed, 03-20-2024 12:01 a.m. 11:59 p.m. Online Traditional ONLINE