Feasibility Study to Evaluate the use of mHealth as Data Source in Post-Market Surveillance
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.
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.
Medtronic, Yale University, Me2Health
Rachael Lampert, MD, Yale