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Mobile Health: The Evolving Industry and Regulatory Landscape | MEDD.X404

Mobile Health: The Evolving Industry and Regulatory Landscape | 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.

Necessary Knowledge


  • To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and an essential understanding of Canvas.

Learning Outcomes


At the conclusion of the course, you should be able to
  • Demonstrate knowledge of current framework for FDA’s 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
  • Elements of a mobile health FDA 510(k)s
  • Post Market, FDA initiatives

Additional Information


Instructor will share articles and related material as a PDF or via website links
Have a question about this course?
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Call (408) 861-3860
FAQ
ENROLL EARLY!
This course is related to the following programs:

Prerequisite(s):

Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Quarter Units Cost Instructor
01-28-2023 to 01-29-2023 1.0 $700

Prabhu Raghavan

Enroll

Final Date To Enroll: 01-28-2023

Schedule

Date: Start Time: End Time: Meeting Type: Location:
Sat, 01-28-2023 10:00 a.m. 4:00 p.m. Live-Online REMOTE
Sun, 01-29-2023 10:00 a.m. 4:00 p.m. Live-Online REMOTE