Method
Live-Online
Term
WINTER
Units
1.0 QUARTER UNITS
Cost
$700

Skills you will gain

  • 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

Course Description


This 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, and assignments, 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.

 


 

Topics

  • 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)

 

Additional Information

Formally Titled: Mobile Health: The Evolving Industry and Regulatory Landscape

 

 

Professional Credit

Approved for 9.25 RAC recertification credits

Jan. 24 - Feb. 14, Saturday, 9:00am - 12:00pm
  • Live-Online Attend via Zoom at scheduled times.
MEDD.X404.(6)
Schedule
Date Start Time End Time Meeting Type Location
Sat, 01-24-2026 9:00am 12:00pm Live-Online REMOTE
Sat, 01-31-2026 9:00am 12:00pm Live-Online REMOTE
Sat, 02-07-2026 9:00am 12:00pm Live-Online REMOTE
Sat, 02-14-2026 9:00am 12:00pm Live-Online REMOTE
 

11/19/2025: Instructor TBA.

This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.

To see all meeting dates, click "Full Schedule" below.

You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.

This course applies to these programs:

Demo