Structured Data Capture (SDC) The Use of Structured Data Capture for Clinical Research March 2016 S&I Initiative Coordinator: Ed Hammond HHS/ONC Sponsor: Farrah Darbouze DRAFT: Not for distribution

What is Structured Data Capture (SDC)? The SDC Initiative defines the necessary requirements (including metadata) to facilitate the collection of supplemental EHR-derived data. The SDC standards and guidelines are explained in two Implementation Guides – IHE SDC Profile and FHIR SDC Profile Defines a structured form definition model Template that can be used for creating forms for different domains making them interoperable Guidance for structured Data Element definition model SDC is not creating new Data Elements, however it defines structure (provides template) to create / edit Data Elements SDC extends the value of EHRs by using Health IT systems’ data and interoperability standards to facilitate reporting

SDC Overview Launched in 2013 in collaboration with NIH (NLM, NCI), AHRQ, FDA, CMS and CDC Uses the structured data within EHRs to supplement data collected for other purposes, such as: Clinical research (Patient Centered Outcomes Research/ Comparative Effectiveness Research) (NLM) Patient safety event reporting (AHRQ) & Adverse Event Reporting (FDA) Public Health Reporting (CDC) Determination of Coverage (CMS) 3 DRAFT: Not for distribution

Value and Benefits Reduce the data collection burden on health care providers. Improve clinical research by leveraging data already in EHRs. Implement published interoperability standards. Contribute to and encourage the use of learning health systems. Improve comparability of data to better inform research, quality reporting and ultimately, improve patient care. Contribute to the Public Health, Patient Safety Reporting, Adverse Event Reporting, and Clinical Research communities by identifying trends, predicting outcomes, influencing patient care, drug development and therapy choices. Contribute to projects which support more effective use of informatics (e.g. registries, cohort identification, and shared data across multiple sites to provider larger research cohorts).

SDC Standards Focus SDC Implementation Guidance SDC Initiative has adopted and enhanced existing standards for: Forms (also called templates) Data Elements on those forms Pre-population / Auto-population of the forms Transport (how EHRs exchange forms) These standards/guidelines are explained in two Implementation Guides: IHE SDC Profile FHIR SDC Profile Standard for the structure/definition of the Data Elements (DEs) that will be used to fill the specified forms or templates Standard for the structure or design of the form or template (container) Standard for how EHRs exchange the form or template Guidelines to pre-populate and auto-populate form or template with existing patient data There are two version of this group of standards. SDC IHE Profile SDC FHIR Profile The structured standard for the DE’s is based on ISO/IEC 11179-3 (and is also part of the IHE SDC Profile); the FHIR SDC Profile includes a NEW DataElement Profile based on DataElement Resource The structured standard for the FORM is based on ISO/IEC 19763 (and is included in the IHE SDC Profile); however the FHIR SDC Profile uses Questionaire/Answer Resource which are based on the same SDC conceptual model The standard for how EHRs exchange the form is in BOTH the IHE and the FHIR profile, but is different in each The guidelines for pre-populating / auto-populating the form is in BOTH the IHE and the FHIR profiles 5 DRAFT: Not for distribution

Structured Data Capture Structured Data Capture Workflow Metadata CDE Library Sends request for form/template 1 Form/Template Repository Form Library Metadata Source Sends requested form/template 2 SDC Scope EHR System Specified Form/Template 3 Converts, populates and displays form 4 Fills, stores/transmits structured data External Data Repository Displayed Form Actor Key Extract, Transform, and Load Data by form/ template 5 Forms Filler Structured Data Capture Forms Manager External Repository DRAFT: Not for distribution

SDC Transactions There are 3 Form Transaction Options: Blank Form EHR System sends a request for a blank form/template to the Form/Template Repository Form/Template Repository sends requested blank form back to the EHR System Partially Completed Form EHR System sends a request for the form/template with relevant patient data to the Form/Template Repository Form/Template Repository sends the form/template with pre-populated patient data back to the EHR system Completed Form EHR System sends a completed form/template to an External Data Repository 7 DRAFT: Not for distribution

SDC Roles and Descriptions Profile Role Description Business Role Form Filler Retrieves forms from a Form Manager as and when required. When requesting a form, the Form Filler can optionally provider EHR context information by providing pre-population xml data in the request for use by the Form Manager. Health IT System (EHR/EMR) Form Manager Supplies forms to Form Fillers based upon form retrieval requests. In some cases, may return a form whereas in other cases the returned form may be selected or constructed based upon context information supplied in the form retrieval request. Form Repository Form Receiver Receives and processes completed or partially completed forms instance data from a Form Filler. External Data Repository DRAFT: Not for distribution

Published in September 2014 IHE SDC Profile IHE SDC Profile Published Guidance Part of IHE’s Quality, Research and Public Health Technical Framework (Revision 0.1) Published in September 2014 Provides specifications to enable an Electronic Health Record (EHR) system to retrieve a form, populate it with existing data, add additional data, then submit the completed form. DRAFT: Not for distribution

IHE SDC Profile Milestones Balloted IHE SDC Profile through QRPH – Aug 2014 Published – September 2014 http://ihe.net/Technical_Frameworks/#qrph IHE Connectathon Participation – January 2015 HIMSS Participation – March 2015 Change Proposals Approved – July 2015 Form Definition Schema Updates – Sept 2015 http://wiki.siframework.org/Structured+Data+Capture+Form+Definition+Schema+Updates Revised IHE SDC Profile Published – October 2015 IHE SDC Pilots kickoff – October 2015 IHE Connectathon Participation – January 2016 HIMSS Participation – March 2016

SDC Participation at the IHE NA Connectathon 2016 SDC community stakeholders successfully tested the SDC IHE Profile (current published version) at the IHE NA Connectathon 2016. Forms prepared for NA Connectathon 2016 testing Demographic Form (successfully tested through complete workflow) Adrenal Form (unable to test due to time constraints) Medwatch 3500 Form (unable to test due to time constraints) Organization Role Form Successfully Transmitted Epic Form Filler Demographic Form NextTrials Form Manager CDC (eMaRC Plus) Form Receiver CA DoH

FHIR SDC Profile Based on the HL7 FHIR 1.0.2 / DSTU 2 Standard. Published Guidance Based on the HL7 FHIR 1.0.2 / DSTU 2 Standard. Published in October 2015 Supports clinical systems in the creation and population of forms with patient-specific data. Defines a mechanism for linking questions in forms to pre-defined data elements and enables systems to automatically populate portions of the form based on existing data (from an EHR or other system). DRAFT: Not for distribution

FHIR SDC Profile Milestones Kickoff for FHIR SDC Profile – May 2014 Draft for Comment Ballot – September 2014 1st Virtual Connectathon – April 2015 DSTU Ballot – May 2015 2nd Virtual Connectathon – August 2015 DSTU published – September 2015 http://www.hl7.org/fhir/iglist.html Test track in the FHIR Connectathon – October 2015 FHIR Connectathon Participation – January 2016 HIMSS Participation – March 2016 FHIR SDC Pilots will kick off – Spring of 2016

SDC Participation at the HL7 FHIR Connectathon (Jan 2016) SDC Community members participated in and successfully tested the SDC FHIR Profile (DSTU v2.1) at the HL7 FHIR Connectathon in January 2016. Forms prepared for FHIR Connectathon 2016 testing FHIR Test Form - Demographic (successfully tested through complete workflow) Lung Cancer Form (successfully tested through complete workflow) Organization Role(s) Forms Transmitted? CCO (Cancer Care Ontario) Form Designer Yes NCI (caDSR) Form Designer / Form Manager N/A JBS Form Manager / Form Receiver Lloyd McKenzie Form Filler CDC (eMaRC Plus) Form Receiver

SDC IHE Profile vs. SDC FHIR Profile Which standard is best suited to your needs? Part of IHE’s QRPH Technical Framework (Revision 0.1) Published in September 2014 Enables systems to retrieve a form, populate it with existing data from EHRs or other clinical systems, add additional data, then submit the completed form. Content & Structure Standards: ISO/IEC 11179 (data elements) ISO/IEC 19763-13 (forms) Transport, Security & Authentication Standards: IHE RFD IHE ATNA SOAP TLS v1.0 or higher SAML Based on the HL7 FHIR 1.0.1 / DSTU 2 Standard. Published in September 2015 Enables systems to create a form, link questions on the form to pre-defined data elements and populate portions of the form based on existing data. Content & Structure Standards: FHIR Data Element Resource FHIR Questionnaire Resource FHIR QuestionnaireAnswer Resource FHIR ValueSet Resource Transport & Security Standards REST SDC Security Consideration

SDC Pilot Activities Current IHE pilot participants include: (UCSF) University of California San Diego (CAP) College of American Pathologists (DCG) Data Consulting Group (CCR) California Cancer Registry (CDC) Center for Disease Control Expected Completion Date: August 2016 In the process of kick starting FHIR Pilots Currently have proposals – hope to make decision in next week Expected Completion Date: September 2016

SDC Participation Opportunities HealthCa.mp On FHIR Code-a-thon April 1-2, 2016 (Washington, DC) http://healthca.mp/onfhir We will be in attendance to support participants who will be testing the FHIR SDC Profile. IHE F2F Meeting April 25-29, 2016 (Oak Brook, IL) http://wiki.ihe.net/index.php?title=Quality,_Research_and_Public_Health_Technical_Committee We will be working on updating the IHE SDC Profile to include updated version of the form definition model and have the profile ready for public comments HealthDataPalooza 2016 May 8 – 11, 2016 (Washington, DC) http://healthdatapalooza.org/ We will support any SDC related activities during this event. HL7 Working Group Meeting 2016 May 8 – 13, 2016 (Montreal) http://www.hl7.org/events/wgm052016/ We will be participating in and supporting the SDC track during the HL7 FHIR Connectathon.

Contact Information Initiative Coordinator: Dr. Ed Hammond (william.hammond@duke.edu ) Federal Lead: Farrah Darbouze (farrah.darbouze@hhs.gov) Federal Lead: Mera Choi (mera.choi@hhs.gov) Project Manager: Jenny Brush (jenny.brush@esacinc.com) Technical and Harmonization Lead: Vijay Shah (vshah@jbsinternational.com) Harmonization Support: Perri Smith (perri.smith@accenturefederal.com ) CDE Subject Matter Expert: Robert Hausam (rrhausam@gmail.com) FHIR Subject Matter Expert: Lloyd McKenzie (lloyd@lmckenzie.com) SDC Wiki Page: http://wiki.siframework.org/Structured+Data+Capture+Initiative Weekly All-Hands Meeting Info (Thursdays): Time: 3:25pm – 4:30Ppm Eastern URL: https://siframework1.webex.com/ Dial-In Number: 1-650-479-3208 Access Code: 663 397 496

Thank you! DRAFT: Not for distribution