• Integrating the Healthcare Enterprise (IHE) Cardiology Profiles
• National Cardiovascular Data Registry® (NCDR) Implantable Cardioverter Defibrillator (ICD) Registry™ V2.1 Coder’s Data Dictionary
• ACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the Cardiac Catheterization Laboratory: A Report of the American College of Cardiology Clinical Quality Committee
• ACCF/AHA 2011 Key Data Elements and Definitions of a Base Cardiovascular Vocabulary for Electronic Health Records: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards
• Most Frequent Operating Room Procedures Performed in U.S. Hospitals, 2003-2012

• Integrating the Healthcare Enterprise (IHE) Quality, Research, and Public Health Technical Framework Supplement: Structured Data Capture (SDC)
• Office of the National Coordinator (ONC) Structured Data Capture (SDC) Initiative
• Clinical Data Interchange Standards Consortium, Inc. (CDISC) Healthcare Link Profiles

• Kaiser Permanente National Total Joint Replacement Registry: Aligning Operations With Information Technology

• AccessGUDID
• Global Unique Device Identification Database
• Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence-Based Regulatory Science and Public Health Surveillance: Implementation of Unique Device Identification Demonstration Projects Lessons Learned
• Mercy SUDID Data
• Unique Device Identifiers (UDIs): A Roadmap for effective implementation
• Premier Research Institute – Unique Device Identifier: Implementation Guide
• Learning UDI Community

Device Data Capture Efforts

• Promoting the capture of unique device identification in health care data sources
• Using automated methods and electronic systems for capturing detailed information on medical devices through the Unique Device Identifier
• Acquiring and analyzing data collected and stored within medical devices.
• Developing and implementing databases of clinical attributes for a deeper understanding of medical device design characteristics
• Communicating lessons learned/best practices  to inform National Medical Device Evaluation System

FAQs

• Can the device identifier (DI) portion of a Unique Device Identifier (UDI) be part of a limited or de-identified data set as defined under HIPAA? Yes. Please find additional information at https://www.hhs.gov/hipaa/for-professionals/faq/2071/can-device-identifier-di-portion-unique-device-identifier-udi-be-part-limited-or-de-identified/index.html

• National Medical Device Surveillance System (MDS) Action Plan
• Office of the National Coordinator (ONC) – Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap

• Evaluating  selected medical devices based on public health importance/need and availability of existing data sources
• Obtaining safety and effectiveness estimates throughout the total product life cycle
• Developing and applying modeling techniques to enhance understanding and context of medical device benefit/risk balance
• Translating the results of modeling for regulators, physicians and patients and disseminate the results
• Communicating lessons learned/best practices  to inform National Medical Device Evaluation System

• Adapting existing patient centered total product life cycle framework to evaluate selected medical devices
• Accounting for comparator selection, device characteristics, operator characteristics, procedure/intervention characteristics, intervention setting characteristics, patient characteristics and appropriate outcome measures selection
• Communicating lessons learned/best practices  to inform National Medical Device Evaluation System

• Developing scientifically valid analytical methods for evaluating medical device exposure and clinical outcome characteristics across multiple data sets across different types of data systems
• Utilizing appropriate statistical techniques to compare performance and clinical outcomes between comparator or exposure groups and translate the modeling results for regulators, physicians and patients and publicize the results
• Evaluating  existing gaps in approaches to medical device studies of approved medical devices by developing innovative methodologies using existing data sources and infrastructure
• Identifying  and describing unique challenges and gaps in studying various classes of medical devices
• Identifying sustainable data and methods for evaluation of selected classes of medical devices
• Validating endpoints/outcomes using variety of data sources
• Communicating lessons learned/best practices  to inform National Medical Device Evaluation System