Protocols, resources and best practices for research study compliance.
Guidance document for how the FDA regulates apps requiring clearance, such as Mobile Medical Applications (MMAs) and other mobile device software functions with a clinical application
Information security is an important aspect of any study utilizing mobile technologies because these studies require data to be transferred from a 3rd party into the university computing environment. Transferring data through the firewall creates vulnerabilities that need to be managed appropriately. This article provides information and resources for investigators that will help them navigate the complex and ever-changing landscape of data security at Michigan.
This article provides general IRB guidance for investigators planning to include mobile apps, mobile devices, and other mobile technologies in human health research. It is not intended to address all aspects of an IRB review, only those related to mobile technologies.