Nestcc.org
NESTcc Developing RWE for the Medical Device Ecosystem
WebNESTcc posts Request for Proposal (RFP) 23-AS1001 July 18, 2023 / in News. National Evaluation System for health Technology Coordinating Center (NESTcc) Releases a Request for Proposal Relating to its Medical Device Active Surveillance …
Actived: 9 days ago
URL: https://nestcc.org/
Collaborative Community
WebA Coordinating Center and a Collaborative Community. The National Evaluation System for health Technology Coordinating Center (NESTcc) is an independent organization tasked with driving quality and efficiency in the use of real-world data (RWD) to inform medical …
Mohamed Salama, M.D.
WebMohamed Salama, M.D. Dr. Salama became chief medical officer of Sonic Healthcare USA in December 2021. Previously, Dr. Salama was a professor of Pathology at Mayo Clinic and the chief medical officer for Mayo Clinic Laboratories, as well as a consultant in Mayo’s …
David Rhew, M.D.
WebDavid Rhew, M.D. Dr. David C. Rhew is the Global Chief Medical Officer (CMO) and Vice President (VP) of Healthcare for Microsoft. He is the Chairman of the Health and Fitness Technology Division for the Consumer Technology Association and serves on CTA’s …
NESTcc Medical Device Research Frequently Asked Questions
WebThe National Evaluation System for health Technology (NEST) is a voluntary data network of collaborators able to efficiently consolidate Real-World Evidence (RWE) from clinical registries, electronic health records, medical billing claims, patient-mediated data, and …
NESTcc One of the First Collaborative Communities with FDA
WebCDRH identified participation in collaborative communities as a strategic priority for 2018 to 2020. The purpose of a collaborative community is to bring together medical device stakeholders in a continuing forum of private- and public-sector …
NESTcc UDI Playbook
WebIn this setting, the UDI Playbook was created for NESTcc health system research network collaborators (and more broadly, for all health systems) to advance UDI implementation at the POC and UDI availability in RWD sources in their respective health systems. This …
Achieving Unique Device Identifiers in Real World Data Sources:
Web4 called for a robust system for postmarket medical device evaluation.4 Subsequent FDA reports focused on strengthening medical device postmarket surveillance5,6 that included establishing a UDI system and incorporating UDIs into …
Juan Espinoza, M.D.
WebJuan Carlos Espinoza Salomon, MD, is the Chief Research Informatics Officer at Ann & Robert H. Lurie Children’s Hospital of Chicago and Associate Director of the Center for Biomedical Informatics and Data Science at Northwestern University. He is also the …
Diane Pickles, BA
WebDiane Pickles is the American Heart Association’s Program Director for One Brave Idea, an $85 million coronary heart disease research initiative based in Boston, which was co-founded by the American Heart Association and Verily with significant support from …
Focusing on heart health with real-world evidence research
WebHeart disease continues to be the leading cause of death for men and women in the U.S., as well as a significant driver of health costs – over $200 billion each year from 2014 to 2015 – including the cost of health care services, medicine and lost productivity.. As American …
Lisa Weiss PhD, MPH
WebLisa Weiss is the Senior Director of Evaluation and Surveillance and currently leads our work on Active Surveillance within the NEST initiative. Lisa brings over twenty-five years of research experience in surveillance, epidemiology and real-world evidence (RWE) …
NESTcc Research Methods Framework
WebNESTcc Research Methods Framework. The NESTcc Research Methods Framework promotes overall study design, outlining key principles and evidentiary requirements for disease and device information, target population and patient selection, study outcomes …
Final Report on Lessons from the NESTcc Test-Cases
WebRAND has developed a final report for the independent assessment, covering 18 of the 21 Test-Cases and builds on the interim report published in December 2021, which described lessons learned from the first 14 Test-Cases. The remaining three Test-Cases were …
Real-world evidence landscape review: Insights on the use of
WebThe RAND Corporation (RAND) has published a manuscript in the December 2021 issue of Value in Health based on a landscape review of perceptions about real-world evidence (RWE) for medical devices and its use in regulatory and coverage decisions.
Infographic: Examples of real-world evidence used in medical …
WebAcknowledgment: Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant [U01FD006292]. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official …
Methodological Considerations in Medical Device Evaluations
WebNESTcc Methods Framework 1 NE 1 Methodological Considerations in Medical Device Evaluations 2 A Report from the National Evaluation System for health Technology 3 Coordinating Center’s Methods Subcommittee 4 Preamble 5 The National …
Aggregating Multiple Real-World Data Sources Using a Patient
WebStudy Illustrates Key Potential of mHealth for Postmarket Device Evaluation. The CERSI project found the innovative Hugo platform helps to obtain comprehensive, longitudinal data to understand the safety and effectiveness of a specific medical device …
Randomized Controlled Trial Examining Real-World Effectiveness …
WebLeveraging patient-generated health data, this project is assessing the impact of a mobile-delivered, prescription digital therapeutic (PDT) (Somryst) delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) for real-world patients with chronic insomnia.
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