1. Structured Data Capture (SDC) Overview for HL7 Clinical Quality Information WG Evelyn Gallego, MBA, CPHIMS Office of Science & Technology (OST) Office of National Coordinator for Health IT September 25, 2013

2. Purpose: Why are we here today? SDC Background & Overview SDC Solution Plan & ‘Base Standard’ Outline Next Steps 2 Agenda

3. S&I Framework: The Value of Community Participation 3 ONC Programs & Grantees Community S&I Framework FACAs SDOs State HIE Program & CoPs REC Program & CoPs Beacon Program Technology Vendors System Integrators Government Agencies (National & International) Industry Associations Other Experts HL7 IHE CDISC Other SDOs HIT Standards Committee HIT Policy Committee Tiger Team ENABLING

4. Why are we here today? Provide high-level overview of SDC Initiative and draft ‘base standard’ Identify potential HL7 CQI WG interest in SDC ‘base standard’ Does the SDC base standard compliment existing CQI quality reporting and quality improvement projects? Is the CQI looking into similar projects that focus on extending the functionality of EHRs? 4

5. SDC Background One of 11 active Initiatives under the ONC S&I Framework Launched on January 23, 2013 in partnership with NIH NLM and AHRQ Key area of focus is enabling the collection of structured data within EHRs to supplement data collected for other purposes specific to: Clinical research (Patient Centered Outcomes Research/ Comparative Effectiveness Research) (NLM FOCUS) Patient safety event reporting (AHRQ FOCUS) 5

6. Scope of Work 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 PCOR – The Incident Report used for patient safety reporting leveraging AHRQ ‘Common Formats’ and FDA form 3500/3500a – 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 6

7. SDC Standards Focus and Success Metrics SDC will identify, evaluate and harmonize four *standards that will enable EHRs to capture and store structured data: 1.Standard for the structure of the CDEs that will be used to fill the specified forms or templates 2.Standard for the structure or design of the form or template (container) 3.Standard for how EHRs interact with the form or template 4.Standard to auto-populate form or template 7 * SDC standards identified are not ‘new’; most are mature standards being used across industry to meet specific interoperability specifications

8. End User Stores/ transmits data Structured Data Capture - Conceptual Workflow xx John Doe x x x x x Selects form/templat e Inputs data Finds form/template Caches data Converts, populates & displays form Extract, Transform, & Load Data by form/ template EHR System Provider/ End User Actor Key Provider External Data Repository Displayed Form Structured Captured Data Specified Form/Template EHR System 1 2 3 5 4 6 7 Template Library CDE Library Clinical Research AHRQ CDEs [Common Formats] CDEs Other Domain CDEs Form Library Patient Safety Forms [Common Formats] Other domain- specified Forms Domain-specified Templates

9. Structured Data Capture - Conceptual Workflow

10. Pilots & Testing … Standards & Harmonization Use Case & Functional Requirements Pre-Discovery Structured Data Capture (SDC) Initiative: Standards & Harmonization WGs and Timeline FEB 13JUN 13MAR 13 APR 13MAY 13JUL 13AUG 13SEP 13OCT 13NOV 13 Kick Off 1/23/13 Evaluation... Technical Work Stream Technical Work Stream Standards SWG 3.EHR Interaction Standard 4.Auto-populate standard SDC All-Hands Work Group Use Case WG Forms SWG 1.CDE Structure Standard 2.Container/Template Standard Standards & Harmonization WG Content Work Stream Content Work Stream Common Formats/AE SWG… AHRQ/FDA Lead PCOR Content SWG… NLM Lead PH Tiger Team CDC Lead

11. SDC Solution Plan: In Scope Transactions SDC Information Interchange (II) requirements defined in terms of 5 Transactions: II01: EHR System sends request for empty form/template to Form/Template Repository II02: EHR System sends request for form/template with relevant patient data to Form/Template Repository II03: Form/Template Repository sends empty form/template to EHR System II04: Form/Template Repository sends form/template with pre- populated patient data to EHR System II05: EHR System sends completed form/template to External Data Repository 11

12. Legend Authentication & Authorization IHE RFD TLS v 1.0 or higher MFI-compliant Form [XML, HTML, URI]; DataElement-FormElement Mapping (XML); Compliance Rule SOAP -or- REST SAML* -or- OAuth* IHE RFD-Retrieve Form [Form ID] SOAP -or- REST TLS v 1.0 or higher II01 II03 EHR SystemForm/Template Repository IHE RFD TLS v 1.0 or higher 1. Partially completed MFI-compliant Form [XML, HTML, URI] 2. Privacy Consent Directive Document* SOAP -or- REST IHE RFD-Retrieve Form [Form ID &Patient Data] SOAP -or- REST TLS v 1.0 or higher IHE DEX* II02 II04 EHR SystemForm/Template Repository 1. IHE RFD REQUEST [ Form ID ] 2. pre-population data 3. Privacy Consent Directive Document* EHR SystemExternal Data Repository IHE RFD-Submit Form SOAP -or- REST TLS v 1.0 or higher II05 1. Form Data [XML Name-Value pairs] 2. Privacy Consent Directive Document* Form/Template ExchangeForm/Template Exchange with Patient Data Completed Form/Template Structured Data AA BB C Service Transport Security Items Metadata Item Payload SAML -or OAuth Request a Form, Mapping File and Compliance Rule SAML* -or- OAuth* IHE DEX* * Optional SAML -or OAuth SAML -or OAuth

13. Transaction Details 13 Transaction Detail Patient Data [Only applicable for II05] XML Name-Value pairs Form Description, Serialization, and Actions [ Only applicable to II02 and II04] ISO/IEC 19763-13, ISO 16262-2011, HTML5 Context [only applicable for II02,II04, and II05] CDA R2, CDA Consent Directive IG Privacy & Security [only applicable for II02,II04, and II05] XaDES, CDA Consent Directive IG

14. SDC ‘Base Standard’ Approach 14 SOAP/SAML Ballot Package Base Standard Document – EHR Interaction guidance Information interchange transactions System requirements – Form Standard/Definition CDE Definition – Introduction to Schema – Instance document XML Schema REST/OAuth Ballot Package Base Standard Document – EHR Interaction guidance Information interchange transactions System requirements – Form Standard/Definition CDE Definition – Introduction to Schema – Instance document XML Schema Phase 1 (OCT 13)Phase 2 ( DEC 2013)

15. SDC ‘Base Standard’ Outline 15 1.0 INTRODUCTION 1.1 Purpose 1.2 Intended Audience 1.3 Organization of This Guide 1.4.1 Conformance Verbs (Keywords) 1.4.2 Cardinality 2.0 IMPLEMENTATION APPROACH 2.1 Solution Plan Overview 2.2 Actors 2.3 Transaction Overview 2.3.1 Transport, Security, Authentication 2.3.2 Transaction Document “Payload” 2.4 Transaction Document Sections 2.4.1 Form 2.4.2 Context 2.4.3 Privacy and Consent 2.4.4 Patient Data 2.4.5 Signature 2.5 Transaction Details 2.5.1 Request 2.5.2 Response 2.5.3 Submission 2.6 SDC Data Element Definition 2.6.1 Overview 2.6.2 SDC Data Element Definition 2.6.3 SDC CDEs and SDC Forms 2.6.4 Version Control 2.7 Structure and Overview of MFI Form Model Definition 2.7.1 Scope and Approach 2.7.2 SDC Form Definition 2.7.3 Administrative Document 2.8 Pre-conditions and Post-conditions 3.0 SUGGESTED ENHANCEMENTS 4.0 APPENDICES Appendix A: Acronyms and Key Terms Appendix B: Conformance Statements List Appendix C: Templates List Appendix D: Specifications References Appendix E: SDC Form Attributes

16. 1.Use Case(s) and Functional Requirements 2.Identification of National standards for the structure of CDEs, structure for forms used to capture those CDEs and standardized functions for how EHRs interact with those standards and forms 3.‘Base Standard’ or Guidance to assist researchers, patient safety personnel, software vendors and others in apply technical requirements for the customized use of structured forms/ templates 4.Pilots to evaluate use of the specified form standard for CER and patient safety event reporting 5.Proliferation and use of NIH-identified and curated CDEs for PCOR and AHRQ ‘Common Formats’ for patient safety event reporting 6.Alignment and integration to other health IT infrastructure to support effective maintenance, distribution, and use of specified forms or templates 7.Enhancement of patient care through improvements in quality and safety interventions, population health and research 8.Improvement in provider experience and workflow when using EHRs for patient care and other purposes Structured Data Capture Immediate & Long-Term Outcomes 16 ✔ ✔ ✔

17. Next Steps Develop final ‘Base Standard’ for SOAP/SAML exchange (OCT) Begin development of ‘Base Standard’ for REST/OATH exchange (NOV) Launch SDC Pilot Phase – Stand-up SDC Content Work streams: Common Formats/Adverse Event (AHRQ/FDA) SWG (OCT 2013) PCOR (NIH) SWG (OCT 2013) – Integrate CDC Public Health Tiger Team & esMD eDoC WG related Pilot activities – Begin Pilot Projects using SDC ‘Base Standard’ (DEC) Ballot SDC Base Standards (2014) 17

18. SDC Pilot Candidates SDC Pilot Interest Survey Respondents: – Oz Systems – Dept. of Health, State of Washington – National Health Data Systems, Inc. – College of American Pathologists (CAP) – CDISC 18 −National Minority Quality Forum −Cerner −CRG Medical −University Health Center

19. SDC Community Participation 19 In addition to NIH/NLM and AHRQ participation in the SDC Initiative, other key stakeholders include: FDA CMS CDC DoD/VA IPO ASPE PCORi CDISC IHE EHR Vendors: Allscripts, McKesson, Cerner, Greenway

20. SDC Leads Contact Information Initiative Coordinator: Evelyn Gallego (evelyn.gallego@siframework.org)evelyn.gallego@siframework.org Project Manager: Jenny Brush (jenny.brush@esacinc.com)jenny.brush@esacinc.com Use Case/Requirements Lead: Jennifer Sisto (jennifer.t.sisto@accenturefederal.com)jennifer.t.sisto@accenturefederal.com Standards Development Lead: Hector Cintron (hector.cintron@accenture.com)hector.cintron@accenture.com Harmonization Support Lead: Vijay Shah (vshah@jbsinternational.com)vshah@jbsinternational.com SDC Wiki Page: http://wiki.siframework.org/Structured+Data+Capture+Initiativehttp://wiki.siframework.org/Structured+Data+Capture+Initiative Weekly All-Hands Meeting Info (Thursdays): Time: 3:25pm - 5:00pm Eastern URL: https://siframework1.webex.com/https://siframework1.webex.com/ Dial-In Number: 1-650-479-3208 Access Code: 663 397 496