structured data capture (sdc) kick off document & draft charter january 23, 2013
TRANSCRIPT
Structured Data Capture (SDC) Kick Off Document & Draft Charter
January 23, 2013
Meeting Etiquette
• Remember: Please keep your phone on mute• Do not put your phone on hold. If you need to take a
call, hang up and dial in again when finished with your other call o Hold = Elevator Music = frustrated speakers and
participants• This meeting is being recorded
o Another reason to keep your phone on mute when not speaking
• Use the “Chat” feature for questions, comments and items you would like the moderator or other participants to know.o Send comments to All Panelists so they can be
addressed publically in the chat, or discussed in the meeting (as appropriate).
From S&I Framework to Participants:Hi everyone: remember to keep your phone on mute
All Panelists
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• Opening Remarks – Doug Fridsma, MD, PhD Director, Office of Standards and Technology, ONC
• The Standards & Interoperability Framework - Doug Fridsma
• Patient-Centered Outcomes Research: Lisa Lang, MPP, Assistant Director, Health Services Research Information and Head, NICHSR, NLM, NIH
• Patient Safety Event Reporting: Amy Helwig, MD, MS, Medical Officer, Center for Quality Improvement and Patient Safety, AHRQ
• Initiative Introduction and Draft Charter – Evelyn Gallego-Haag, Initiative Coordinator, Structured Data Capture Initiative
• Next Steps/Call for Participation – Jenny Brush, Project Manager, Structured Data Capture Initiative
• Questions and Resources
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Agenda
Standards & Interoperability (S&I) Framework
Dr. Doug Fridsma, OSI, ONC
Teams convened to solve
problems
Solutions& Usability
R&D
Curate a portfolio of standards, services, and policies that accelerate information exchange
Support Innovation through SHARP program, Innovation/Challenge Grants, and interfacing with international Standards community
Enable stakeholders
to come up with simple,
shared solutions to
common information
exchange challenges
Office of Science & Technology
Coordinate Federal Partners
Collaborate with federal agencies to coordinate federal health IT priorities as manager of Federal Health Architecture
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S&I Framework Overview
• Specific health interoperability initiatives guide the design and development of a fully integrated and connected health information system.
• An S&I Initiative focuses on a single challenge with a set of value-creating goals and outcomes, and the development of content, technical specifications and reusable tools and services.
• Call for Participation: The overall success of the S&I Framework is dependent upon volunteer experts from the healthcare industry and we welcome any interested party to get involved in S&I Framework Initiatives, participate in discussions and provide comments and feedback by joining the Wiki: http://wiki.siframework.org
S&I Framework Coordination
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ONC Programs & Grantees
Community S&I Framework
FACAs
SDOs
• State HIE Program & CoPs• SHARP Program• REC Program & CoPs• Beacon Program
• Technology Vendors• System Integrators• Government Agencies• Industry Associations• Other Experts
• HL7• IHE• CDISC• NCPDP• ASC X12• ASTM• WEDI
• HIT Standards Committee• HIT Policy Committee• Tiger Team
• ISO/TC 215• IHTSDO• NLM• NQF• Regenstrief• Other health IT
standards related organizations
The Big Picture…
Federal
Responsibility Private SectorJoint Efforts
NwHINExchange
OperationsS&I PilotsS&I
Framework
ATCBs and Testing
Infrastructure
NWHIN Implementation & Pre-Certification
TestingStandards DevelopmentUse Cases Harmonization
S&I Framework
eHealth Exchange
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Our Missions» Promote a sustainable ecosystem that drives increasing interoperability and standards adoption» Create a collaborative, coordinated, incremental standards process that is led by the industry in solving
real world problems» Leverage “government as a platform” – provide tools, coordination, and harmonization that will support
interested parties as they develop solutions to interoperability and standards adoption.
S&I Framework Phases & Likely Structured Data Capture Activities
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Phase Planned Activities Pre-Discovery Development of Initiative Synopsis
Development of Initiative Charter Definition of Goals & Initiative Outcomes
Discovery Creation/Validation of Use Cases, User Stories & Functional Requirements Identification of interoperability gaps, barriers, obstacles and costs Review of Vocabulary
Implementation Creation of aligned specification Documentation of relevant specifications and reference implementations such as
guides, design documents, etc. Validation of Vocabulary Development of testing tools and reference implementation tools
Pilot Validation of aligned specifications, testing tools, and reference implementation tools Revision of documentation and tools
Evaluation Measurement of initiative success against goals and outcomes Identification of best practices and lessons learned from pilots for wider scale
deployment Identification of hard and soft policy tools that could be considered for wider scale
deployments
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You are here
Structured Data CaptureSuccess Metrics
SDC will focus on solving a specific interoperability challenge through the development of four new standards that will enable EHRs to capture and store structured data:1. Standard for 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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Goal is to address this challenge in terms of the structured data requirements needed in: • Research• Patient-Safety Event Reporting
Patient-Centered Outcomes Research
Lisa Lang, NLM, NIH
Patient-Centered Outcomes Research
• 2010 Patient Protection and Affordable Care Act: established funding for Comparative Clinical Effectiveness Research with focus on Patient-Centered Outcomes Research (PCOR)
• Majority of this funding designated to establish a non-profit corporation, the Patient Centered Outcomes Research Institute (PCORI)– charged with assisting patients, clinicians, purchasers, and policy-makers in
examining the "relative health outcomes, clinical effectiveness, and appropriateness" of different medical treatments by evaluating existing studies and supporting additional research
• Remaining funds were designated to Federal Health programs to, a key purpose of which was to build data capacity for PCOR, including development of clinical registries and health outcomes research data networks, so that research data could be captured, aggregated and analyzed from multiple sources including EHRs
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The Assistant Secretary for Planning and Evaluation (ASPE) awarded National Library of Medicine (NLM) and ONC S&I Framework funds to establish
infrastructure for the use of EHRs for PCOR
NLM and ONC Project to support PCOR
• Web Portal page to existing HHS-supported CDEs and patient assessment instruments (PAIs) and definitions relevant to PCOR
• Technical design for storage of and access to CDEs and PAIs
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Project Goal: Improve the efficiency, comparability, and utility of PCOR studies, the aggregation of PCOR data from EHRs, and the ease of translation of research results
into practice by associating research- relevant CDEs with consensus-determined health data standards, standard terminology value sets and common interfaces.
Collaborating with relevant NIH-wide committees and other stakeholders including other HHS agencies (AHRQ, FDA, CMS, CDC) and standard development organizations (CDISC)
• Community-based S&I Initiative using S&I platform
• New standard that will embed structured electronic forms with CDEs within the EHR to facilitate collection of research data
NLM Common Data Element (CDE) Resource Portal
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http://cde.nih.gov
• Provides single point-of-entry for information about NIH-supported CDE initiatives and CDE tools & resources
• Enables browsing of descriptive summaries of the CDE initiatives and of the subject areas to which they apply
• Links out to repositories containing the data elements themselves.
• Version 1.0 launched in January 2013• Contains information on 16 NIH-supported initiatives• Future enhancements: additional NIH and HHS initiatives,
improved navigation
Repository of CDEs and PAIs (under development)
• NLM, working with NIH and others, will develop a means of providing easy access and searching capability for standardized representations of CDEs and PAIs that have been specified using consensus data standards and terminologies
• Approach will capitalize on attributes, capabilities of existing distribution systems, such as FITBR, CaDSR, NLM Value Set Authority Center and others
• Resulting repository will serve as a resource for efforts to further standardize and harmonize CDEs and PAIs
• Initial development: 2013
Patient-Safety Event Reporting
Dr. Amy Helwig, AHRQ
The Patient Safety andQuality Improvement Act of 2005
• Creates “Patient Safety Organizations” (PSOs)• Establishes “Network of Patient Safety
Databases” (NPSD)• Authorizes establishment of “Common
Formats” for reporting patient safety events• Requires reporting of findings annually in
AHRQ’s National Health Quality/Disparities Reports
Common Formats
• Common language for patient safety event reporting– Common language & definitions
– Standardized rules for data collection
• Standardize the patient safety event information collected
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Unique Role of Common Formats
• Only patient safety reporting scheme designed to meet three goals:– Provide information on harms from all causes
– Support local quality/safety improvement
– Allow the end user – to collect it once & supply it to whoever needs it
• Designed to serve IOM goals for national patient safety measurement
How do Common Formats work?
• Comprehensive modules cover all types of events:– Incidents, near misses and unsafe conditions
– Common events
– Rare events (includes NQF Serious Reportable Events)
• Modular design allows for expansion– Addition of new topics
– Expansion to new settings
Value of the Common Formats
Supports ongoing data-driven quality assessment, regardless of hospital complexity, organization or services provided• Focused on indicators related to improved health outcomes,
processes of care, and the prevention and reduction of medical errors.
• Applicable to high risk, high volume problems as well as less common events
• Standardized reports allow for tracking and measuring improvements
• Reports provide rich detail for areas hospitals select as priorities in patient safety
Data Flow: Provider to NPSD to User
User: Researchers and
Policy Makers
Privacy Protection
Center (PPC)
Other Qualified Sources
Network of Patient Safety
Databases (NPSD) User:
Provider
User:AHRQ National
Quality Reports
User: Patient Safety Organization
(PSO)
Patient Safety Organization
(PSO)
EHR
Incident Reporting System
Structured Data
Capture
Patient Safety Work Product
Provider Environment
Structured Data Capture Initiative
Evelyn Gallego-Haag, ONC
Why Focus on Structured Data Capture?
• Exponential growth in volume and detail of information captured by healthcare organizations
• Strong public and private interest in leveraging clinical data captured in the health record during episodes of care (EOC) and using this data to supplement data collected for other purposes including:– Research– Patient-safety event reporting– Public Health Reporting
• Eventually, such data could be used to enhance EHR data collected during EOC– Enhanced data would be valuable to health organizations for quality and
performance improvement
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Aggregated and analyzed EHR data can be used to identify trends, predict outcomes and influence patient care, drug development and therapy choices.
Challenge & Opportunity of Using EHRs
• EHRs are recognized as the data source with the highest potential to provide timely and relevant data in a form that is quickly usable for quality and safety improvement, population health, and research
• Linking EHR data with other data in a uniform and structured way could accelerate the utility of EHR data for supplemental purposes
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The utility of EHR data for supplemental purposes has been limited due to a lack of uniformity in the terminology and definitions of data elements across EHRs. This limitation is compounded by the fact that clinician workflow often
records patient information in unstructured free-text data well after the episodes of care.
The Value of SDC within EHRs
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Advances Stage 3 MU vision to design trusted infrastructure to enable patient information to flow securely from EHRs to other systems, such as research consortia, registries, and bio repositories
Stage 3 MU Learning Health
System
Reduces Data Collection Burden
Improves Comparability of
Data
Reduces need for site-specific EHR enhancements
Reduces burden on health care providers by enabling secure, single-point data entry that populates to multiple systems
Aggregated patient data is more comparable and will better inform research, quality reporting and ultimately, influence patient care
Reduces the need to make site-specific modifications to EHR system capabilities in order to enable participation in important reporting and research activities
Structured Data Capture Initiative Some S&I Principles
• This is not a government initiative, or it is not a government-only initiative – this is an open, collaborative opportunity for public and private volunteers working towards shared objectives
• Leverage existing, widely used, and openly available standards and services.
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From here on, we are discussing the DRAFT charter – objectives, use cases, scope statements, and work groups – all will be up for the community to
review and formulate on the wiki
Structured Data Capture CharterScope Statement
• Define the necessary requirements which will drive the identification and harmonization of standards that will facilitate the collection of supplemental EHR derived data
• 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’– The Surveillance Case Report Form used for public health reporting of
infectious diseases
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Draft Charter for S&I Community Review on
the Wiki
Structured Data Capture CharterData Architecture
Infrastructure will consist of four new standards that will enable EHRs to capture and store structured data:1. Standard for 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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Draft Charter for S&I Community Review on
the Wiki
• Standards will facilitate the collection of data so that any researcher, clinical trial sponsor, reporting and/or oversight entity can access and interpret the data in electronic format
• Will leverage existing standards such as XML and CDISC Retrieve Form for Data Capture (RFD)
Form Library5
2
xx
John Doe x
x x
x x 6
1
4Provider
EHR System
External DataRepository
SpecifiedForm/Template
CDE Library
AHRQ CDEs[Common Formats]
Clinical ResearchCDEs
DisplayedForm
Structured Captured Data
Selects
form
/template
Inputs data
Stores/ transmits data
Finds form/template
Caches data
3Converts, populates & displays form
7Extract, Transform,
& Load Data by
form/ template
EHRSystem
Provider/End User
Actor Key
End User
Structured Data Capture Conceptual Workflow
Other domainCDEs
Patient SafetyForms
Other domainForms
Form Library5
2
xx
John Doe x
x x
x x 6
1
4Provider
EHR System
External DataRepository
SpecifiedForm/Template
CDE Library
AHRQ CDEs[Common Formats]
Clinical ResearchCDEs
DisplayedForm
Structured Captured Data
Selects
form
/template
Inputs data
Stores/ transmits data
Finds form/template
Caches data
3Converts, populates & displays form
7Extract, Transform,
& Load Data by
form/ template
EHRSystem
Provider/End User
Actor Key
End User
Structured Data Capture Standards Overlay
Other domainCDEs
Patient SafetyForms
Other domainForms
1. CDE Standard
2. Structure Standard
4. Pre-populate Standard
3. EHR InteractionStandard:Find, display, cache, store/transmit
Timelines for Consideration: MU Stage 3, SDO Ballot Cycles
Structured Data CaptureS&I Phases Roadmap
Dec ‘12 Apr ‘13Jan ‘13 Feb ‘13 Mar ‘13 May ‘13 Jun ‘13 Jul ‘13 Aug ‘13 Sept ‘13
Pilots & Testing
• Pilot site readiness• Implementation of solution• Test User Stories and Scenarios• Monitor Progress & Outcomes• Utilize Requirements Traceability Matrix
Evaluation
• Evaluate outcomes against Success Metrics and Criteria
Use Case & Functional Requirements
• Develop, review, and finalize the Use Case and Functional Requirements
Pre-Planning
• Call for Participation
• Conduct Environmental Scan
• Success Criteria• Stakeholder
Engagement Standards & Harmonization
• Finalize Candidate Standards• Standards Gap Analysis• Technical & Standards Design• Develop Requirements Traceability
Matrix• Develop Implementation Guide
Pre-Discovery
• Launch initiative• Review and Finalize
Charter• Review initial
Candidate Standards
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Initiative Kick Off: 1/23/13
Draft Charter for S&I Community Review on
the Wiki
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Structured Data CaptureInitiative Work steams
Pilots & TestingUse Case & Functional Requirements
Pre-DiscoveryStandards & Harmonization
Technical Work stream
Content Work stream
Timelines for Consideration: MU Stage 3, SDO Ballot Cycles
Dec ‘12 Apr ‘13Jan ‘13 Feb ‘13 Mar ‘13 May ‘13 Jun ‘13 Jul ‘13 Aug ‘13 Sept ‘13
Evaluation
Pre-Planning
SDC All-Hands WG - TBD LeadUse Case WG:API Functionality
Technical SWGTBD Lead
Common Formats SWGAHRQ Lead
PCOR Content SWGNLM Lead
Pilots WG
Standards & Harmonization WG
Initiative Kick Off: 1/23/13
Draft Charter for S&I Community Review on
the Wiki
Structured Data Capture CharterExisting Efforts to Consider
• NLM/NIH repository of PCOR-related projects: e.g. NCI, NINDS, Patient Reported Outcomes Measurement Information System (PROMIS), PhenX Toolkit
• Other Projects using CDEs and standardized assessment tools:
• AHRQ Common Formats for Patient Safety Event Reporting within USHIK
• Other AHRQ funded projects: EDM Forum, DARTNet, DEcIDE Network
• Other NIH funded projects: eMERGE, HMORN
• NCI Biomedical Research Integrated Domain Group (BRIDG)
• FDA mini-Sentinel
• Patient Centered Outcomes Research Institute (PCORI) Projects
• CDISC Clinical Data Acquisition Standards Harmonization (CDASH)
• IHE/CDISC Retrieve Form for Data Capture (RFD) Profile
• IHE Clinical Research Data Capture (CRD) and Retrieve Clinical Knowledge (RCK) Profile
• Value Sets derived from accepted Meaningful Use Standards
• Other S&I Initiatives: e.g. Public Health Reporting Initiative (PHRI), Query Health
• Standards identified through the S&I Framework’s Standards Catalog: e.g. ONC DIRECT
• Standards and approaches identified through related ONC Grant Programs: e.g. SHARP, HIE Challenge Grants
34And we welcome consideration of other efforts and standards suggested by the community
Draft Charter for S&I Community Review on
the Wiki
Next Steps & Call for Participation
Jenny Brush, ONC
Structured Data Capture InitiativeCall for Participation
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• To make this initiative a success, we need the help of volunteers who are eager to make rapid progress on this important project
• We need experts to develop standards, test beds ready to pilot new tools, innovators to push the envelope, and patients and providers willing to provide feedback
• Minimum commitment: regular participation in community meetings (1-2 hours / week) and active contribution to one or more workgroups (1-3 hours / month). It is okay to participate in one phase and not another.
• There will be opportunities for your organization to o Pilot new ways to give consumers access to information o Hear about and provide input to the latest policy and standard issues
affecting information exchange and consumer accesso Directly contribute to a potential game-changer for health care
Structured Data Capture InitiativeWiki Page
http://wiki.siframework.org/Structured+Data+Capture+Initiative
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Structured Data Capture InitiativeNext Steps
• The Structured Data Capture Initiative is open for anyone to join.
• This community will meet frequently by webinar and teleconference
• We use Wiki pages to facilitate discussion
• Information on how to join the Community can be found on the Structured Data Capture Sign Up Wiki:
• http://wiki.siframework.org/Join+Structured+Data+Capture+Initiative
• In order to ensure the success of our initiative and the subsequent pilot, we encourage broad and diverse participation from the community.
• This is your chance to have an impact on the creation and implementation of a pilot program in this important area of health IT development.
• Please review the Proposed Project Charter
• http://wiki.siframework.org/http://wiki.siframework.org/Structured+Data+Capture+Project+Charter 38
• Use Case(s) and Functional Requirements
• National standards for CDEs, structured forms for capturing those CDEs and standardized functions for how EHRs interact with those standards and forms
• Implementation 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 NLM-hosted CDEs for PCOR and AHRQ ‘Common Formats’ for patient safety event reporting
Structured Data Capture CharterExpected Deliverables
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Draft Charter for S&I Community Formulation and Review on the Wiki
• Over the next 2 weeks, we will hold All Hands Meetings to finalize the project charter– All Hands Meetings will be held Thursdays from 3:30 to 4:30pm
Eastern
– SDC wiki page will be updated with meeting information
• In Week 4, we will launch workgroups as agreed by the community, beginning with Use Case development
• We are planning to host a series of presentations from related projects and initiatives– Similar to ‘concert series’ hosted by other S&I Initiatives
– If you have an interest in participating, please contact the support team: Evelyn Gallego ([email protected] ) and Jenny Brush ([email protected] )
Structured Data Capture Initiative Schedule
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Structured Data Capture Initiative Resources and Questions
Please feel free to reach out to any member of the SDC Initiative team:
• ONC Leads– Doug Fridsma ([email protected]) – Farrah Darbouze ([email protected])
• Teaming Partner Leads– Lisa Lang ([email protected])– Amy Helwig ([email protected])
• Initiative Coordinator– Evelyn Gallego-Haag ([email protected])
• Project Management– Jennifer Brush ([email protected])– Zachary May ([email protected])
• Use Case & Functional Requirements Development– Presha Patel ([email protected]) – Jennifer T. Sisto ([email protected])
• Standards Development Support– Caryn K. Just ([email protected])