Project Summary for Structured Data Capture (SDC) FHIR Profile
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Project Details
Number | 1104 View Ballot Items List (with NIBs) |
---|---|
Name | Structured Data Capture (SDC) FHIR Profile |
Sponsor(s) | FHIR Infrastructure Work Group |
Co-Sponsor(s) | Clinical Genomics Work Group, Clinical Interoperability Council Work Group, Healthcare Standards Integration, Patient Care Work Group, Terminology Infrastructure Work Group |
Steering Division | Infrastructure |
Description | This project aims to create a new DataElement resource, update as needed the Questionnaire and QuestionnaireAnswer resources, and create an implementation guide on the use of Fast Healthcare Interoperability Resources (FHIR) Profile(s) for Structured Data Capture (SDC) on the new DataElement resource and on the existing Questionnaire and QuestionnaireAnswers resources. These profiles will be used to meet SDC project objectives of: - encouraging consistency around how common data elements are captured and used in healthcare systems - allowing data elements to be clearly identified in forms for the purpose of auto-population and data-extraction - allowing definition of standard data elements to improve consistency of data representation in CDA template and FHIR resource design The implementation guide (IG) will explain how the 3 resources (using the defined profiles) can be used to support auto-population of forms and data extraction. The IG will also describe secure interaction specifications using Representational State Transfer (REST) services to allow access, display, populate and saving of the resources. For this project, Data Element (DE) is defined as a named (identified) definition for a single piece of data (e.g. systolic blood pressure). The new DataElement resource will: - Define a common syntax referencing ISO/IEC 11179-3 to allow unambiguous interpretation of DEs. The syntax will be bound to controlled terminologies such as SNOMED CT, LOINC, RxNorm where appropriate. The SDC profiles on the resources will identify the resource elements and extensions that must be supported to meet SDC use cases as well as constraints on their use. The use cases for SDC interaction specifications are: - Retrieve data elements from a DE repository - Retrieve a form from a form repository with or without pre-populated data - Provide patient data (CCD or its FHIR equivalent) as part of the query to the form repository. The retrieved form should be a fully/partially filled form instance - Submit a completed form to an intended recipient The SDC Profile(s) will build from the existing work of the Standards & Interoperability (S&I) Structured Data Capture (SDC) Initiative. Out of scope for this implementation guide: - Defining DEs (semantics and their associated value sets) |
Project Facilitator | Ed Hammond |
Status | Archived |
SD Approval Date | May 23, 2014 |
TSC Approval Date | Jul 28, 2014 |
Type | Ballot - STU to Normative |
Objectives / Deliverables | Complete analysis, design, draft specification work on SDC FHIR Profile - Target: 2014 Jul Submit for Draft for comment - Target: 2014 Sept Submit for DSTU - Target: 2015 Jan Ballot Comments Reconciliation - Target: 2015 Feb 28 DSTU Period - 24 months - Target: 2015 March- 2017 March |
Next Milestone Date | 2019 May WGM |
Project End Date | 2019 May WGM |
Project Intent | Implementation Guide |
Project Need | The SDC initiative was created to 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 such as clinical research, patient safety event reporting, adverse event reporting and quality reporting. This project is focused on the capture, store and sharing of structured data among EHRs and other systems. The use case will consist of a mechanism by which Data Sets and CDEs can be shared across multiple perspectives and organizations. The mechanism 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. This project aims to drive adoption of FHIR Profiles for SDC as industry trend moves toward adoption of FHIR. Additionally, this project will define REST interactions that enable definitions of CDEs to be shared across disparate systems. |
Implementers | 1) US National Institutes of Health National Library of Medicine 2) US Centers for Medicare and Medicaid 3) EHR Vendor(s): Cerner, also in discussion with additional EHR vendors |
Security Risks | |
External Drivers | |
Common Names / Keywords/ Aliases | |
Lineage | |
Dependancies | 1. New resource for Data Element syntax (DataElement) 2. FHIR Questionnaire and QuestionnaireAnswers resources 3. Existing FHIR Resources to support identified data sets 4. FHIR's publication mechanism - FHIR Profiles for SDC may require publication separate from the FHIR specification |
Project Document Repository |
http://wiki.siframework.org/Structured+Data+Capture+IG+Development FHIR's SVN repository |
Backwards Compatibility | N/A |
External Vocabularies | |
Products | |
Joint Copyright? | No |
External Pjt Collaborators | This project is based on community input from a group of experts and stakeholders across the public, private and academic sectors in the United States. These broad stakeholder groups confer, convene and collaborate as part of the ONC S and I Framework, while offering guidance consistent with their policy making responsibilities. Collaborations: - HL7 International Affiliates - Governments: United States - Federal Agencies: Office of the National Coordinator for Health IT, National Institutes of Health, Agency for Healthcare Research and Quality, Food and Drug Administration, Centers for Medicare and Medicaid Services, Center for Disease Control |
Realm | Universal |
HL7 Affiliate | |
Stakeholders | Clinical and Public Health Laboratories, Immunization Registries, Regulatory Agency, Payors, Other (specify in Misc. Notes below) |
Vendors | Pharmaceutical; EHR, PHR; Equipment; Health Care IT; Clinical Decision Support Systems |
Providers | Clinical and Public Health Laboratories; Emergency Services; Local and State Departments of Health; Medical Imaging Service; Healthcare Institutions (hospitals, long term care, home care, mental health) |
Ballot Cycle Info | 2016 Sept Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 16 Negatives to reconcile Document Name: HL7 FHIR; Implementation Guide: Structured Data Capture (SDC), Release 1 2015 May Ballot Cycle Info: DSTU Ballot results: Did not meet basic vote requirements Document Name: HL7 FHIR; Implementation Guide: Structured Data Capture (SDC), Release 1 2014 Sept Ballot Cycle Info: COMMENT ONLY Ballot results: Met basic vote requirements. 36 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Structured Data Capture (SDC), Release 1 - US Realm Submitted By: Hans Buitendijk |
Misc Notes | 2021 December: LMcKenzie: Project 1104 was superseded by 1390; PMO archiving 1104. 2018 May: RMerrick: SDC project got moved from OO to FHIR-I Mar 2017: TSC approved STU publication request for HL7 FHIR® Implementation Guide: Structured Data Capture (SDC), Release 2 STU at TSC Tracker 13116 for 24 months through 2019-03-28. Sept 2015: TSC approved publication of HL7 FHIR® Implementation Guide: Structured Data Caputre (SDC), Release 1 at TSC Tracker 8717 through 2017-09-23 WGM Jan2015: Still have several ballot comments to reconcile July 2014: Per LMcKenzie: The intention is that we're balloting a single implementation guide which includes profiles of 3 resources. The IG will pass or fail as a whole and will be balloted together - for comment in Sept, DSTU in Jan. For that reason, we've gone ahead and updated the existing PSS. There's no concern about the draft IG content being ready for the Sept. ballot. PMO removed the 5/23/2014 SD approval date as the revised PSS is going through SD review Removed the Federal Agencies: Office of the National Coordinator for Health IT, National Institutes of Health, Agency for Healthcare Research and Quality, Food and Drug Administration, Centers for Medicare and Medicaid Services, Center for Disease Control While US-sponsored, the artifacts produced are expected to have universal applicability. Development will build on existing standards and will include engagement of international SDOs and will welcome feedback from other jurisdictions. |
U.S. Govt Interest? | Yes |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | May 13, 2014 |
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