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Structured Data Capture (SDC) Overview for HL7 Clinical Quality Information WG

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. Agenda. Purpose: Why are we here today? SDC Background & Overview

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Structured Data Capture (SDC) Overview for HL7 Clinical Quality Information WG

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

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

  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: • Standard for the structure of the CDEs 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 interact with the form or template • Standard to auto-populate form or template * SDC standards identified are not ‘new’; most are mature standards being used across industry to meet specific interoperability specifications 7

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

  9. Structured Data Capture - Conceptual Workflow

  10. Structured Data Capture (SDC) Initiative:Standards & Harmonization WGs and Timeline FEB 13 MAR 13 APR 13 MAY 13 JUN 13 JUL 13 AUG 13 SEP 13 OCT 13 NOV 13 Use Case & Functional Requirements Standards & Harmonization Pilots & Testing … Kick Off 1/23/13 Pre-Discovery Evaluation... SDC All-Hands Work Group Use Case WG Standards & Harmonization WG Technical Work Stream • Forms SWG • CDE Structure Standard • Container/Template Standard Standards SWG EHR Interaction Standard Auto-populate standard Content Work Stream PH Tiger Team CDC Lead Common Formats/AE SWG… AHRQ/FDA Lead PCOR Content SWG… NLM 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. Form/Template Exchange Form/Template Exchange with Patient Data EHR System Form/Template Repository EHR System Form/Template Repository A A II01 II02 TLS v 1.0 or higher TLS v 1.0 or higher SAML -or OAuth SAML* -or- OAuth* IHE RFD-Retrieve Form [Form ID &Patient Data] SOAP -or- REST SOAP -or- REST IHE RFD-Retrieve Form [Form ID] 1. IHE RFD REQUEST [ Form ID ] 2. pre-population data 3. Privacy Consent Directive Document* Request a Form, Mapping File and Compliance Rule IHE DEX* TLS v 1.0 or higher B B IHE RFD-Submit Form SOAP -or- REST II04 TLS v 1.0 or higher II03 TLS v 1.0 or higher SAML -or OAuth IHE RFD SAML* -or- OAuth* IHE RFD SOAP -or- REST SOAP -or- REST 1. Partially completed MFI-compliant Form [XML, HTML, URI] 2. Privacy Consent Directive Document* MFI-compliant Form [XML, HTML, URI]; DataElement-FormElement Mapping (XML); Compliance Rule Completed Form/Template Structured Data EHR System External Data Repository Legend Transport Items Metadata C II05 SAML -or OAuth Security Item Payload IHE DEX* Authentication & Authorization 1. Form Data [XML Name-Value pairs]2. Privacy Consent Directive Document* Service * Optional

  13. Transaction Details Transaction Detail 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 Patient Data [Only applicable for II05] XML Name-Value pairs 13

  14. SDC ‘Base Standard’ Approach Phase 1 (OCT 13) Phase 2 ( DEC 2013) • 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 • 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 14

  15. SDC ‘Base Standard’ Outline 2.0 IMPLEMENTATION APPROACH 2.1 Solution Plan Overview 2.2 Actors 2.3 Transaction Overview 2.3.1Transport, Security, Authentication 2.3.2 Transaction Document “Payload” 2.4 Transaction Document Sections 2.4.1Form 2.4.2 Context 2.4.3 Privacy and Consent 2.4.4 Patient Data 2.4.5 Signature 2.5 Transaction Details 2.5.1Request 2.5.2 Response 2.5.3 Submission 2.6 SDC Data Element Definition 2.6.1Overview 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 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 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 15

  16. Structured Data Capture Immediate & Long-Term Outcomes ✔ • Use Case(s) and Functional Requirements • 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 • ‘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 • Pilots to evaluate use of the specified form standard for CER and patient safety event reporting • Proliferation and use of NIH-identified and curated CDEs for PCOR and AHRQ ‘Common Formats’ for patient safety event reporting • Alignment and integration to other health IT infrastructure to support effective maintenance, distribution, and use of specified forms or templates • Enhancement of patient care through improvements in quality and safety interventions, population health and research • Improvement in provider experience and workflow when using EHRs for patient care and other purposes ✔ ✔ 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 & esMDeDoC 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 • National Minority Quality Forum • Cerner • CRG Medical • University Health Center 18

  19. SDC Community Participation 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 19

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

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