Yale Faculty Selected for Projects

The Yale School of Medicine https://medicine.yale.edu faculty have been selected for Demonstration Projects by the National Evaluation System for Health Technology (NEST) established by the Medical Device Innovation Consortium http://mdic.org and funded by FDA www.fda.gov.

The projects will evaluate the quality and use of data obtained from mobile health applications to inform post-market surveillance. The projects would also support NEST’s goal to evaluate timely, reliable, and cost effective development of real world evidence associated with medical devices for both pre- and post-market requirements.

The first project will focus on comparing the quality and reliability of data acquired via a mobile health app to data acquired in an industry-owned post-market surveillance registry. The second project will test the feasibility of using a mobile health app to aggregate multiple sources of health data to support medical device surveillance initiatives.

The projects are also designed to develop methods of evidence, to scale across health systems and device types, to potentially demonstrate impact on patient health, and to identify gaps in strategy.

The Yale-led projects are also partnering with Me2Health, Medtronic, Inc. www.metronic.com  Johnson & Johnson www.jnj.com, Yale-New Haven Health System www.ynhhs.org  Mayo Clinic www.mayoclinic.org , and the FDA Ross project. Support is also coming from the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) https://medicine.yale.edu/core/current_projects/cersi.

 

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