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

Evelyn Gallego, MBA, CPHIMSOffice of Science & Technology (OST)Office of National Coordinator for Health IT

September 25, 2013

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

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Agenda

S&I Framework: The Value of Community Participation

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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

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?

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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)

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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

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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 templates2. Standard for the structure or design of the form or template

(container)3. Standard for how EHRs interact with the form or template4. Standard to auto-populate form or template

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* SDC standards identified are not ‘new’; most are mature standards being used across industry to meet specific interoperability specifications

End User

Stores/ transmits data

Structured Data Capture - Conceptual Workflow

xx

John Doe xx x

x x

Selects

form/te

mplat

e

Inputs data

Finds form/template

Caches data

Converts, populates & displays form

Extract, Transform,

& Load Data by form/ template

EHRSystem

Provider/End User

Actor Key

Provider

External Data Repository

Displayed FormStructured Captured Data

Specified Form/Template

EHR System1

2

3

5

4

6

7Template Library

CDE Library

Clinical Research

AHRQ CDEs[Common Formats]

CDEs

Other DomainCDEs

Form Library

Patient SafetyForms [Common Formats]

Other domain-specified Forms

Domain-specified Templates

Structured Data Capture - Conceptual Workflow

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Pilots &Testing …Standards & HarmonizationUse Case &

FunctionalRequirementsPre-Discovery

Structured Data Capture (SDC) Initiative:Standards & Harmonization WGs and Timeline

FEB 13 JUN 13MAR 13 APR 13 MAY 13 JUL 13 AUG 13 SEP 13 OCT 13 NOV 13

Kick Off1/23/13

Evaluation...

TechnicalWork Stream

Standards SWG3. EHR Interaction Standard4. Auto-populate standard

SDC All-Hands Work Group

Use Case WG

Forms SWG1. CDE Structure Standard2. Container/Template Standard

Standards & Harmonization WG

ContentWork Stream

Common Formats/AE SWG…AHRQ/FDA Lead

PCOR Content SWG…NLM Lead

PH Tiger TeamCDC Lead

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

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Legend

Authentication& Authorization

IHE RFDTLS 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 higherII01

II03

EHR System Form/Template Repository

IHE RFDTLS 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 System Form/Template Repository

1. IHE RFD REQUEST [ Form ID ]2. pre-population data

3. Privacy Consent Directive Document*

EHR System External Data Repository

IHE RFD-Submit FormSOAP-or-

REST

TLS v 1.0 or higherII05

1. Form Data [XML Name-Value pairs]2. Privacy Consent Directive Document*

Form/Template Exchange Form/Template Exchange with Patient Data

Completed Form/Template Structured Data

A A

B B

C

Service

Transport

Security

Items Metadata

Item Payload

SAML -or

OAuthRequest a Form, Mapping File and Compliance Rule

SAML*-or-

OAuth*

IHE DEX*

* Optional

SAML -or

OAuth

SAML -or

OAuth

Transaction Details

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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

SDC ‘Base Standard’ Approach

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• 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)

SDC ‘Base Standard’ Outline

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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 ENHANCEMENTS4.0 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

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

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✔✔✔

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)

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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

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− National Minority Quality Forum

− Cerner− CRG Medical− University Health Center

SDC Community Participation

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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

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