The National Evaluation System for health Technology Coordinating Center (NESTcc) has established a Data Quality Subcommittee and a Methods Subcommittee to support its efforts to conduct efficient, timely, and high-quality real-world evidence studies for medical devices. These subcommittees will develop data quality and methodological standards for NESTcc Network Collaborators – the organizations partnering with NESTcc to generate and analyze real-world data (RWD). Subcommittees will also be charged with designing processes for demonstrating conformance to the standards and will make recommendations for their implementation. Standards will build upon existing bodies of work and will leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, Sentinel, and MDEpiNet.
The subcommittees are comprised of members with a diverse set of stakeholder perspectives, including FDA, academia, industry, and society registries, who bring expertise from other national data initiatives and device-specific partnerships.