Structured Data Capture (SDC) Initiative Overview for esMD Community Jenny Brush SDC Project Manager

Agenda Introduction Background Standards Overview: Phase 1 & Phase 2 Implementation Guidance SDC Data Element Framework SDC Pilot Program 2

SDC Background Launched in 2013 in collaboration with other Federal Partners: NIH (NLM, NCI), AHRQ, FDA, CMS & CDC Key area of focus is enabling the collection of structured data within EHRs to supplement data collected for other purposes to include: Clinical research (Patient Centered Outcomes Research/ Comparative Effectiveness Research) (NLM FOCUS) Patient safety event reporting (AHRQ FOCUS) & Adverse Event Reporting (FDA FOCUS) Public Health Reporting (CDC FOCUS) Determination of Coverage (CMS FOCUS) 3

SDC Standards Focus SDC Initiative has identified four areas that specify how EHR systems can capture and store structured data: 1.Standard for the structure/definition of the CDEs that will be used to fill the specified forms or templates 2.Standard for the structure or design of the form (container) 3.Standard for how EHRs interact with the form or template 4.Guidance to pre-populate and auto-populate form or template with existing patient data 4

4 1 5 Sends requested form/template Fills, stores/transmits structured data Sends request for form/template 3 Converts, populates & displays form Extract, Transform, & Load Data by form/ template Forms Manager Forms Filler Actor Key Structured Data Capture Conceptual Workflow 2 xx John Doe x x x x x External Repository SDC Scope

SDC Solution Plan: In Scope Transactions SDC Solution Plan presented in terms of 3 Transactions: Transaction 1A: Form/Template Request and Response without Patient data EHR System sends request for blank form/template to Form/Template Repository Form/template Repository sends requested blank form to EHR System Transaction 1B: Form/Template Request and Response with Patient data EHR System sends request for form/template with relevant patient data to Form/Template Repository Form/Template Repository sends form/template with pre-populated patient data to EHR system Transaction 1C: EHR System sends completed form/template to External Data Repository 6

Phase 1 Solution: SDC IHE Profile SDC standards identified for Phase 1 are not ‘new’; most are mature standards being used across industry to meet specific interoperability specifications SDC Standards are specified via: SDC IHE Profile: Published in Sept df ; tested at January 2015 IHE North American ConnectathonSDC IHE Profile df 7 Content & Structure CDA ISO/IEC ISO/IEC Transport, Security, and Authentication IHE RFD IHE ATNA SOAP TLS v1.0 or higher SAML

Phase 2 Solution: SDC HL7 FHIR Profile Kicked-off in March 2014; intent was to build on emerging ‘content’ standard FHIR and REST interactions Scope was to define HL7 FHIR CommonDataElement Resource that utilizes ISO/IEC syntax with core attributes to facilitate the definition of common data elements Also includes development of a mechanism for clinical systems to expose CDEs for research use leveraging existing FHIR Questionnaire Resource HL7 SDC FHIR Profile Implementation Guide published as ‘draft for comment’ in Aug 2014: Develop/sdc.html Develop/sdc.html – Received 165 votes (75 Affirmative, 35 Negative, 55 Abstain) – Currently in ballot reconciliation phase – HL7 FHIR IG will be balloted as DSTU in April 2015; expected publication date is August 2015

SDC FHIR Implementation Guide: Representation of SDC DE Model SDC DataElementProfile SDC Questionnaire Profile SDC Questionnaire Answers Profile SDC ValueSet Profile DataElement Questionnaire QuestionnaireAnswers ValueSet REST SDC Security Consideration Provide constraints and extensions for each Resource SDC FHIR Data Element Profile serves as the Logical Model

Data Set (grouping) Data Element (semantics) Data Element (semantics) Data Element Attribute (syntax) Data Element Attribute (syntax) Vitals Problems Lab Results Medications Systolic BP Diastolic BP Common DE DE Concept Value Domain SDC Data Element Definition Framework Allergies Height Set of characteristics that describe DE and help define, use and maintain DE using ISO syntax Logical groupings of data elements Unit of data for which the definition, identification, representation, and permissible values are specified by means of sets of attributes. Common Data Elements (CDEs) are those DEs that are developed, maintained and used based on commonly agreed upon principles by the user community. CDEs are reusable across a variety of clinical and non-clinical domains. MU2 Data Set

Common Data Element Attribute Data Element (DE) – A data element is a unit of data for which the definition, identification, representation, and permissible values are specified by means of a set of attributes. Common Data Elements (CDEs) – CDEs are data elements that are developed, maintained and used based on commonly agreed upon principles by the user community. – Another characteristics of CDEs is their reusability across a variety of forms and clinical domain that in turn provides a consistent way to aggregate and analyze data across clinical trials and clinical domains. (Common) Data Element attribute – Attributes are a set of characteristics that describe CDE and help defined, use and maintain CDE.

FHIR SDC Virtual Connectathon Virtual Connectathon Date & Time: April 23, 2015 from 10:00 am – 6:00 pm. The SDC Virtual Connectathon is focused on exercising the two Structured Data Capture implementation guides prior to the publication of the the DSTU version of those guides. Details about the connectathon are on the SDC Wiki: FHIR SDC Profile Implementation Guide(s) – – If you are interested in participating, please send an to indicating: – Name of organization & Number of participants – Which role(s) from the implementation guide would you be interested in testing

FHIR SDC Virtual Connectathon - Kickoff Kickoff / informational meeting scheduled for Wednesday, April 3:00 pm Eastern – Meeting Name: FHIR SDC Virtual Connectathon Kick-Off – Meeting Date/Time: Wednesday, April 1, :00 pm – Dial-In: – Access Code: – URL: If you are interested in participating in the Virtual Connectathon, please send an to – Name of organization & Number of participants – Which role(s) from the implementation guide would you be interested in testing

SDC Leads Contact Information Initiative Coordinator: Evelyn Gallego Federal Lead: Farrah Darbouze Project Manager: Jenny Brush FHIR SME: Lloyd McKenzie CDE SME: Mark Roche Harmonization/Technical Lead: Vijay Shah Standards Development Support: Perri Smith SDC Wiki Page: Weekly All-Hands Meeting Info (Thursdays): Time: 3:25pm – 4:30Ppm Eastern URL: Dial-In Number: Access Code:

Thank you!