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Introduction
The Office of the National Coordinator for Health IT (ONC) has demonstrated its value as a forum for addressing complex data architecture challenges, particularly as a means to publicly develop and test alternatives in advance of their inclusion in the regulations implementing the 2009 Health Information Technology and Economic and Clinical Health (HITECH) Act. The Structured Data Capture Initiative built on both the results of and lessons learned in prior efforts to bring consensus to this next critical aspect of our collective health data infrastructure.
Initiative Overview and Scope
For detailed information on initiative goals, objectives and intended outcomes, please see the SDC Project Charter.
Summary: The Structured Data Capture (SDC) initiative will develop and validate a standards-based data architecture so that a structured set of data can be accessed from EHRs and be stored for merger with comparable data for other relevant purposes to include:
- The electronic Case Report Form (eCRF) used for clinical research including Patient Centered Outcomes Research (PCOR)
- The Incident Report used for patient safety reporting leveraging AHRQ ‘Common Formats’
- The Surveillance Case Report Form used for public health reporting of infectious diseases
- The collection of patient information used for determination of coverage, as resources permit.
Following is a visual conceptualization of the initiative workflow.
The proposed infrastructure will consist of four new standards that will enable EHRs to capture and store structured data. These will consist of: a standard for the CDEs that will be used to fill the specified forms or templates; a standard for the structure or design of the form or template (container); a standard for how EHRs interact with the form or template; and a standard to enable these forms or templates to auto-populate with data extracted from the existing EHR. The standards will facilitate the collection of data in such a way that any researcher, clinical trial sponsor and/or reporting entity can access and interpret the data in electronic format. For more information about this initiative, please see the
Structured Data Capture Charter.