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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.
- 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.
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
- Mobile apps, SaMDs
- Elements of a mobile health FDA 510(k)s
- Post Market, FDA initiatives
Instructor will share articles and related material as a PDF or via website links
- Save Your Seat
Help us confirm course scheduling. Enroll at least seven days before your course starts.
- Accessing Canvas
Learn more about gaining access to your course on Canvas in our FAQ section.
Accessibility and Accommodation
For accessibility questions or to request an accommodation, please visit Access for Students with Disabilities or email the Extension registrar.
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Sections Open for Enrollment:
|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|