The National Evaluation System for health Technology’s (NESTcc) Active Surveillance Roadmap summarizes progress made to date and describes forward-looking plans and activities needed to develop NESTcc’s active surveillance capabilities. The Roadmap details the technical characteristics of a cloud-based, federated learning environment to perform safety signal refinement and signal detection using real-world data via a planned data network. Additionally, the document describes planned research methods and procedures to ensure data quality along with guiding principles around signal management and communications to ensure active surveillance capabilities are scalable, secure and equitable to all stakeholders.
NESTcc seeks public comment on the draft Active Surveillance Roadmap to ensure the stated capabilities and strategy meets the needs of the medical device ecosystem.
View the full draft Roadmap here.
Comments may be submitted through the online submission portal here. The public comment period will be open for 60 days, closing on Monday, October 11 at 5:00 p.m. ET.
An informational webinar on the Roadmap was held on Thursday, September 23 from 2:00 p.m. to 2:30 p.m. ET. A recording of the webinar is available here.
Please contact firstname.lastname@example.org with any questions regarding the Roadmap or public comment period.