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National Evaluation System for health Technology (NEST)

Overview

NEST is a voluntary network of health organizations aiming to efficiently develop Real World Evidence (RWE) using Real World Data (RWD) to inform medical device evaluation and support regulatory decision-making throughout the total product life cycle. In September 2016, FDA awarded a grant for the NEST Coordinating Center (NESTcc) to the Medical Device Innovation Consortium (MDIC), a public-private partnership organization based in the Washington, DC area.

NESTcc has established relationships with 12 network collaborators to date, including Yale-New Haven Hospital, to advance the use of RWE generation and foster collaboration with stakeholders across the medical device field. Together, the network collaborators represent more than 195 hospitals and 3,942 outpatient clinics, with nearly 500 million patient records. In order to demonstrate proof‐of‐concept for the generation of robust RWE, NEST is funding several rounds of test cases, aka projects. Yale-New Haven Hospital is the lead network collaborator for 3 test cases and a participating network collaborator for 2 test cases. These test cases aim to explore the use of health system data to generate high-quality evidence for medical devices needed for regulatory decision-making in both the pre- and post-market spaces.

Harlan M. Krumholz, MD, SM is a member of the NEST Governing Committee.

Joseph S. Ross, MD, MHS is a member of the NEST Data Quality Subcommittee.