- Explain the regulatory requirements of research that involve mobile medical applications such as web-based software executed on a server and mobile platforms with or without wireless connectivity.
- Describe the requirements of a mobile medical application manufacturer.
- Determine whether use of a mobile platform or mobile application constitutes a regulated medical device.
- Determine whether a mobile medical application is subject to the IDE requirements.
- Describe instances in which the mobile application is not a medical device, is a mobile application in which the FDA will use enforcement discretion, and is a mobile medical application that the FDA will enforce oversight, along with examples.
- Provide a regulatory framework for conducting human subjects’ research involving mobile medical applications.
Richard Ramdeo, CIP, and Dorean Flores, CIP, of the Human Research Protection Program
The Public Research Education Program (PREP) is a series of courses developed by various research support offices in conjunction with other health system offices. The courses offer CME credits and are designed to increase quality of research throughout the health system and streamline the process of conducting research.
PREP courses also aim to enhance and expand investigator capacity to conduct research. PREP courses are free and open to all Northwell Health employees, students, and volunteers. In addition, interested research collaborators and community partners are welcome to attend.
Light refreshments will be served at the courses held at the Goldman B Conference Room.
Don’t forget to check out select videos of PREP courses online.