Feasibility Study to Evaluate the use of mHealth as Data Source in Post-Market Surveillance

Overview: This project will compare the quality and reliability of data acquired via the mHealth app (Hugo) to data acquired in an industry-owned post-market surveillance registry, Medtronic’s Product Surveillance Registry (PSR). This study is enrolling 30 patients from Yale New Haven hospital who are also registered in Medtronic’s PSR.

Impact for NESTcc: The systematic process used to test and validate the mHealth app and validate its feasibility of use will provide insight and produce a framework for future use of mHealth apps in the post-market setting. Learnings will be extendable to pre-market evidence generation use-cases in the future.

Organization(s): Medtronic, Yale University, Me2Health

Principal Investigator(s): Rachael Lampert, MD (Yale)