Structured Data Capture (SDC) Initiative

Overview for esMD Community

Jenny BrushSDC Project Managerjenny.brush@esacinc.com

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Agenda

• Introduction• Background• Standards Overview: Phase 1 & Phase 2 Implementation

Guidance• SDC Data Element Framework• SDC Pilot Program

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 templates2. Standard for the structure or design of the form (container)3. Standard for how EHRs interact with the form or template4. Guidance to pre-populate and auto-populate form or template

with existing patient data

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4

1

5

EHR System

External DataRepository

CDE Library

DisplayedForm

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

Form/ TemplateRepository

SpecifiedForm/Template

2

xx

John Doe x

x x

x x

Structured Captured Data

Form Library

External Repository

MetadataSource

SDC

Scop

e

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

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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 2014

http://ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_SDC.pdf ; tested at January 2015 IHE North American Connectathon

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Content & Structure

• CDA• ISO/IEC 11179• ISO/IEC 19763-13

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 11179-3 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: http://hl7.org/implement/standards/FHIR-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

Content

Transport

Security

SDC ComponentsSDC DataElementProfile

SDC Questionnaire Profile

SDC Questionnaire Answers Profile

SDC ValueSet Profile

DataElement

Questionnaire

QuestionnaireAnswers

ValueSet

REST

SDC Security Consideration

ProfilesProvide constraints and

extensions for each Resource FHIR Resources

SDC FHIR Data Element Profile serves as the Logical Model

Data Set(grouping)

Data Element(semantics)

Data Element Attribute(syntax)

Vitals ProblemsLab

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 ISO1179-

3 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: http://wiki.siframework.org/SDC+FHIR+Virtual+Connectathon

• FHIR SDC Profile Implementation Guide(s)– http://hl7.org/implement/standards/FHIR-Develop//sdc.html– http://hl7.org/implement/standards/FHIR-Develop//sdc-de.html

• If you are interested in participating, please send an email to perri.smith@accenturefederal.com 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 1 @ 3:00 pm Eastern– Meeting Name: FHIR SDC Virtual Connectathon Kick-Off– Meeting Date/Time: Wednesday, April 1, 2015 3:00 pm – Dial-In: 1-650-479-3208– Access Code: 669 321 915– URL: https://siframework2.webex.com

• If you are interested in participating in the Virtual Connectathon, please send an email to perri.smith@accenturefederal.com indicating:– 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 (evelyn.gallego@siframework.org)• Federal Lead: Farrah Darbouze (farrah.darbouze@hhs.gov) • Project Manager: Jenny Brush (jenny.brush@esacinc.com)• FHIR SME: Lloyd McKenzie (lloyd@lmckenzie.com) • CDE SME: Mark Roche (mrochemd@gmail.com) • Harmonization/Technical Lead: Vijay Shah (vshah@jbsinternational.com)• Standards Development Support: Perri Smith (perri.smith@accenture.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!