Establishment of the National Evaluation System for health Technology Coordinating Center (NESTcc)

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Project Summary/Abstract The Medical Device Innovation Consortium (MDIC), a 501(c)3 Public-Private Partnership will continue its work in bringing together device manufacturers, payers, regulatory agencies, patient groups, physicians, providers and other relevant stakeholders to develop a National Evaluation System for health Technology Coordinating Center (NESTcc). Our approach is to develop a CC that oversees the development and operations of a collective modernized decentralized medical device evidence generation system. We leverage and develop standards for data procurement, signal detection, data processing, and reporting. The CC and governance system will be anchored on diverse stakeholder inclusion, highest ethical standards, patient-centered outcomes, and a business culture of efficiency and accountability to create the foundational principles of trust, transparency, scalability, sustainability and accountability. AIM 1: Launch the inaugural 15-member multi-stakeholder, patient-focused, expert, Governance Committee to provide direction and support for the NESTcc. AIM 2: Continue to establish scope, strategy (decentralization, stakeholder engagement, independence from bias, open science and data sharing, objective prioritization), structure (primary data processes and secondary data and results dissemination), standards (data, methods, reporting, and data access, audit and certification), in a decentralized and federated NEST that will be built around a sustainable business model. AIM 3: Manage NEST demonstration projects that develop, verify and operationalize methods of evidence generation and data use, demonstrate scalability across healthcare systems and device types and manufacturers, and prove out principles of NEST sustainability. AIM 4: Lead state-of-the-art methods development work in critical areas for uses of patient-centered Real World Data and Real World Evidence that are inclusive of the latest technological developments (mHealth etc.) MDIC will continue to establish the NESTcc and create a sustainability plan for continued operations. This will allow the use of real-world data in an efficient manner to accelerate patient access to safe and effective devices quickly identify new safety problems for devices on the market and optimally and appropriately rely on real-world evidence to support product approvals of public health importance, to potentially shift premarket data collection to the postmarket setting, and to meet postmarket data collection commitments through a modern system that leverage electronic health information generated in the clinical and home setting.