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Mobile Health: Industry Overview and Evolving Regulatory Framework

This online CERSI mini-course is a primer on the regulatory framework for mobile health. We will both chart the evolution of the regulatory framework in this sector, and review the latest guidelines and legislation. The course also covers advanced topics, such as the role of the Federal Trade Commission; the latest regulatory trends in health management software; and privacy and data security considerations for mobile health apps. 

Download the  pdf version of the flyer

 

About the Course

Introduction to the course by Dr. Marta Gaia Zanchi

Format

Online, self-paced learning consisting of video recorded lectures, readings and a culminating activity.

Learning Objectives

At the end of this course, you will be able to discuss the regulatory approach, priorities and relevant guidances that the Food and Drug Administration has developed to clarify the scope of its regulations and to further promote development of mobile health products.

Intended Audience

This mini-course is designed for regulatory professionals, academicians, researchers, scientists and other innovators who understand the role of regulators in the medical device industry and who are interested in learning more about the regulatory requirements specifically for mobile health technologies in the United States.

Prerequisites

There are no prerequisites for this course.

Instructor

Dr. Marta Gaia Zanchi is an Adjunct Professor at Stanford University with the Stanford Byers Center for Biodesign.  Dr. Zanchi is engaged in various roles with organizations in the United States both public and privately-held that have a stake in advancing technology for health and medicine.

2019 Dates and Registration Links

January 14 to February 15, 2019: Registration open

April 1 to May 3, 2019: Registration open

FAQs

In which session should I enroll?

All sessions cover the same content, so you can enroll in any session.

What is the registration fee for this course?

Click on the registration link above to see registration fees.

How can I contact the organizer with any questions?

Send your questions to education@ucsfstanfordcersi.org

How do I access online materials for the course?

Approximately three days before the course start date, you will receive an email with instructions. If you are having technical problems, contact us by sending an email to education@ucsfstanfordcersi.org

Do I need to complete all the modules in the course?

While the lessons contained in each of the five modules are intended to stand alone, we strongly encourage all participants to complete all modules sequentially.

Do you offer a Statement of Accomplishment for completing the course?

Students who complete the culminating course activity will be provided with a Statement of Accomplishment by the UCSF-Stanford CERSI.  The statements will be emailed approximately 3-4 business days after the last day of the mini-course.

Do you offer CE Credit?

CE credits not available for this course.

Do I need to buy a textbook?

There is no required textbook associated with this course.

How long will it take to complete this course?

The mini-course lasts 4 weeks.  We expect that you will spend between 3 to 4 hours each week.

Do you offer group discounts?

Depending on the space availability, we do.  Please, contact education@ucsfstanfordcersi.org for more information.