Sanket Dhruva, MD, MHS
Assistant Professor of Clinical Medicine, UCSF School of Medicine
Cardiologist, San Francisco VA Medical Center
Using a Novel mHealth Platform to Obtain Real-World Data for Post-Market Surveillance: A NEST Demonstration Project
Real world data; Post-market surveillance; Clinical data; National Evaluation System for Health Technology; NEST Coordinating Center; Medical device; Mobile health; Patient-generated data
- In an effort to ensure the continued safety and effectiveness of medical devices after they are on the market, the NEST demonstration project evaluated an mHealth platform to obtain real-world data for post-market surveillance.
- The NESTcc demonstration project provides an opportunity for surmounting the challenges of longitudinal clinical data and addressing the limitations of current paradigms for medical device research in the post-market setting.
Sustaining high levels of patient engagement with participants can be challenging when the trial is conducted virtually. Shorter follow-up periods, building a “community” of patients, and helping patients understand the potential link to clinical care are a few of the ways patient engagement can be supported.
The NESTcc demonstration project is not yet in the analysis phase, so a common data model has not been established for the analysis of electronic health record (EHR) data. The challenges are recognized because of all the different data sources that will have to be linked.
Sync for Science and CMS Blue Button 2.0 share a similar model to that of the NESTcc demonstration project. The premise is that patients should be able to receive their data. Whenever patients obtain more information about their data, it’s good for both patients and researchers.
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