Terrie Reed

Director, Partner Relationships

MSIE, Industrial Engineering
Symmetric Health Solutions

Terrie Reed, independent regulatory and policy consultant, is a visionary health informatics professional with 20+ years of progressive success in building and leading interdisciplinary teams that address healthcare policy and technical challenges, especially those related to the capture of core procedure and device data linked to patient outcomes. She has been continually relied upon by senior executives as a unique device identification and health IT strategic and technical expert both nationally and internationally. Her areas of expertise include:
• Strategic planning assistance in the design and execution of IT solutions and programs that navigate the device ecosystem - patients, regulators, healthcare policy makers, standards developers, and supply chain
• Guidance on optimizing and infusing user-centered design and informatics principles into healthcare products and services
• Designing/Developing/Implementing training and tools that support adoption of innovative structured data capture solutions that meet short term business requirements and align with current and near-term regulatory and public health requirements
• Partnering with clients to identify and rally key stakeholders/customers to create sources of feedback for ongoing product/program improvement

Relevant Experience
• Developed and led the US FDA UDI program and team that designed, developed, and successfully implemented the 2013 US FDA UDI regulation including the creation and roll out of the premier UDI database, the Global Unique Device Identification Database (GUDID) with the expectation to harmonize across all global jurisdictions.
• Partnered with National Library of Medicine to design and successfully implement AccessGUDID, the publicly available version of GUDID.
• Researched and advocated for the use of an online UDI helpdesk with the plan to roll out the platform across CDRH offices and use the knowledge gained to improve the long-term usability of AccessGUDID and the UDI regulations.
• Collaborated with other government agencies, jurisdictions and standards development groups to meet long term goal that US FDA UDI regulations are referenced in ONC Health IT regulations placed on certified EHR vendors, in CMS common clinical data set requirements and in corresponding HL7, ANSI X12 and IMDRF requirements.

SCAN Health Portals