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Overview of National HIT Standards
a presentation to the
Seminar Series on Integrated Surveillance
Presented bySteven J Steindel, Ph.D.
National Center for Public Health Informatics (NCPHI), CDC
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Government
Voluntary standards
Consensus standards
Industry standards
Consortia Standards
Etc.
Regulatory standards:
Levels of Protection
Health, Safety Environment
LAWS
Non-Government
MARKET NEEDS
When applicable and appropriate, voluntary standards may be referenced in mandatory regulations.
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Regulations • Based on Health &
Welfare (Legitimate Objectives)
• Development Process (openness, public comment, transparency, timely notification)
• Mandatory
Voluntary Standards• Based on Market and
Business Relevance (Demands or Needs)
• Development Process (much the same as regulatory; regulators are among the participants in standards development bodies)
• Voluntary
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Consideration for Standards
• Flow - where, when, and how data move
• Format - mechanics of data transfer
• Content - which data elements
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Schematic Public Health Data Flow Example: Laboratory Reporting
PathologyLaboratory
Text Report
Encoding
SystematicReport
Standards Standard Codes
H7 Messages
Architecture
ReportableCases
“Public HealthWorld”
Clinical DataUsers
Network Users
Public HealthSystem
NHIN/RHIO
SNOMED, Numbers, Dates, Text
92 Disease specific HL Messages
Public Health
Surveillance
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Acronym Soup!• AHIC
• American Health Information Community
• ONC• Office of the National Coordinator for Health
Information Technology (IT)
• HL7• Health Level 7
• CCHIT• Certification Commission for Health IT
• HITSP• Health IT Standards Panel
• NHIN• Nationwide Health Information Exchange Network
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ONC Major Initiatives
• American Health Information Community
• Standards Harmonization Process
• Certification of HIT• Privacy and Security
Solutions• Nationwide Health
Information Systems Prototypes
• Health Information Technology and Health-care Anti-fraud
• Health IT Adoption Initiative
• Gulf Coast Task Force
• State RHIO Best Practices
In 2004, President Bush called for the widespread use of electronic health records (EHRS) within 10 years. ONC has set the foundation for interoperable EHRs though the following initiatives:
For more information: http://www.hhs.gov/healthit/
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AHIC – a Public and Private Sector Collaborative
• AHIC: American Health Information Community
• HITSP: Health Information Standards Panel
• CCHIT: Certification Commission for Health IT
• NHIN: Nationwide Health Information Community
• HISPC: Health Information Security and Privacy Collaboration
• State-Level HIE Initiatives: State-level Health Information Exchange Initiatives
AHIC is the public-private collaborative that sets priorities and oversees and/or endorses HIT Standards, certification, the NHIN, and polices on a national level.
For More information: http://www.hhs.gov/healthit/community/background/
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AHIC Workgroups (1/07)• Population Health and Clinical Care
• Subsumes work of the Biosurveillance WG• Includes Data Content Steering Group
• Consumer Empowerment• Chronic Care• Electronic Health Records
• Laboratory Reporting• Emergency Preparedness
• Privacy and Security• Quality• Personalized Healthcare
For more information: http://www.hhs.gov/healthit/ahic/index.html
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Health Information Technology Deployment Coordination
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Standards Harmonization Process
• Health Information Standards Panel (HITSP)• Business driven standards harmonization process• Coordinated with AHIC Use Cases• Funded for 3 years by ONC; self-sustaining
thereafter
• Published Implementation Guidance 10/06• Consumer Empowerment• Biosurveillance• EHR: Laboratory Reporting
For more information: http://www.ansi.org/standards_activities/standards_boards_panels/hisb/hitsp.aspx?menuid=3
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HITSP Technical Committees
• Cross-Technical Committee Coordination
• Care Delivery• Consumer Empowerment• Population Health• Security and Privacy • Emergency Responder-EHR
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I
Harmonization Request
Harmonization Process Steps
II
RequirementsAnalysis
III
Identificationof Candidate
Standards
IV
Gaps,Duplications
and Overlaps
Resolution
V
Standards Selection
VI
Constructionof
InteroperabilitySpecification
VII
InspectionTest
VIII
InteroperabilitySpecification
Releaseand
Dissemination
IXProgram Management
BeginSupport
ReceiveRequest
HITSP Harmonization Process
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Use Case/Modification Request
Interoperability Specification
Transaction1… n components or composite standards
Component1... n base standards or composite standard
Base Standard
#1
Base Standard
#2
Base Standard
#3
Transaction Package1…n transactions or composite
standards
Package (Composite)
Standard
Component (Composite)
Standard
Transaction(Composite)
Standard
Pot
entia
l for
Reu
se in
Oth
er C
onte
xt
Defines and N
arrow
s Context
Policy Makers and Industry
Base Standard
#4
HITSP
Base Standard
#6
Base Standard
#7
Base Standard
#8
Base Standard
#9
Base Standard
#5
HITSP Framework
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JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
HITSP 2007 Timeline 02/05/07
HITSP Board04/23/07
HITSP Board07/09/07
HITSP Board10/09/07
HITSP Board
03/19/07HITSP Panel
05/11/07HITSP Panel
09/07/07HITSP Panel
03/06 – 03/08TC Face to Face
Chicago IL
5/08 – 5/10TC Face to Face
Arlington VA
6/18 – 6/20TC Face to Face
San Diego CA
09/04 – 09/06TC Face to Face
Arlington VA
Public Comment
Inspect Test and Public Comment
Implementation Support and Testing
(with annual updates as required)
Comment Resolution and Panel Approval
02/15 – 05/16
04/13 – 05/16
IS Construct Development
05/17 – 07/19 07/20 – 08/16 08/17 – 10/15
Implementation Support and Testing(includes minor document updates)
EHR, CE and BIO v 2.0
Activity 1 – Version 2.0 of Existing EHR, CE, BIO ISs
Activity 2 – Security and Privacy for All Use CasesActivity 3 – New Emergency Responder EHR Use Case
On-going Support
10/15/07HITSP Panel
07/16/07HITSP Panel
02/12/07HITSP Panel
Activity 4 –New Use Cases from AHIC
Detail Schedule to be Established Upon Review of the Use Cases
Work Plan and Schedule Overview
S&P and EHR-ER v 1.0
Requirements, Design, Standards Selection
Public Input on S&P
05/17 – 06/14
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2006 2008Timeline (Calendar Year)
2007 2009 2010
2006 Use Cases
· Consumer Empowerment
· EHR· Biosurviellance
HITSP RDSS & ConstructsRelease 1
HITSPRelease 2
Accepted by Sec.
CCHIT 2008 Certification
CCHIT 2008 Criteria Development
Recognized by Sec.
New Federal Systems and Upgrades
HITSPRelease 2
AHIC Medication Management, Quality
and Consumer Access to Clinical Information Use Cases Published New Federal Systems and Upgrades
NHIN Trial Implementations
2008Use Cases
· Consutations and Transfer of Care
· Remote Monitoring
· Remote Consultation
· Public Health Case Reporting
· Immunization and Response Management
· Personalized Healthcare
AHIC Use Cases Published
CCHIT 2009 Certification
CCHIT 2009 Criteria Development
NHIN Trial Implementations
HITSP Medication
Management, Consumer
Access and Quality
RDSS and Constructs Release 1
Accepted by Sec.
Recognized by Sec.
2007Use Cases
· Emergency Responder EHR
· Medication Management
· Quality· Consumer
Access to Clinical Information
HITSPEmergency
Responder EHRRDSS and
Constructs r1
AHIC Emergency Responder EHR Use
Case Published
Accepted by Sec.
New Federal Systems and UpgradesHITSPRelease 2
Recognized by Sec.
2011AHIC Use Cases
Accepted by Sec. Recognized by Sec.
New Federal Systems and Upgrades
CCHIT 2010 Certification
CCHIT 2010 Criteria Development
HITSP RDSS and ConstructsRelease 1
HITSPRelease 2
NHIN Trial Implementationsand Initial Production Capabilities
Coordinated Timeline
Two Years
We are here
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Certification of EHRs
• Certification Commission for Health IT (CCHIT)• Privately founded and funded 11/04• ONC funding for three years• First certified Ambulatory EHRs 7/06
• 37 systems certified: 1/07
• Inpatient EHR Certification 6/07• Network Certification 6/08
For more information: http://www.cchit.org/
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CCHIT History and Status
• Sept 2004: AHIMA, HIMSS, and the Alliance partner to launch CCHIT
• June 2005: Eight organizations add $325k funding support
• Sept 2005: CCHIT awarded 3-year, $7.5M HHS contract to develop compliance criteria and inspection process• Ambulatory EHRs (2006)
• Inpatient EHRs (2007)
• Infrastructure and Networks through which EHRs interoperate (2008)
• July 18, 2006: First batch of certified
ambulatory EHRs announced
Goals of Product Certification
• Reduce the risks of investing in HIT
• Facilitate interoperability of HIT products
• Enhance availability of adoption incentives
• Ensure that the privacy of personal health information is protected
Goals of Product Certification
• Reduce the risks of investing in HIT
• Facilitate interoperability of HIT products
• Enhance availability of adoption incentives
• Ensure that the privacy of personal health information is protected
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• Stakeholder priorities
• Availability in vendor marketplace
• Practicality of certification
• Release for public comment
CCHIT Development Process
• Call for participants
• Random selection for each market segment
• Conduct pilot
• Release for public comment Results Final criteria Final test
process and scripts
Certification handbook and agreement
• Criteria for next year Functionality Security/
reliability Interoperability
• Roadmap for• Next year + 1• Next year + 2
• Release for public comment
• Methods Self-attestation Juror
observation Laboratory
testing
• Test scenarios
• Step-by-step test scripts
• Release for public comment
• Respond to comments
• Final adjustments
• Commission review and approve
• Publish final materials
Gather Data
Develop Criteria
Develop Inspection Process
Pilot Test FinalizeLaunch
Certification Program
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CCHIT Myths and Realities
Myth RealityCCHIT is a government agency
• CCHIT is an independent, voluntary, private-sector initiative organized as a limited liability corporation. CCHIT will transition from HHS funding to a self-sustaining model.
CCHIT is a standards development organization
• CCHIT develops criteria based on commonly available standards developed by SDOs.
Certification could stunt innovation and competition in the HIT marketplace
• Certification is a pass/fail indication that the product meets basic criteriabasic criteria in every area. It provides a baseline above which HIT vendors may innovate and compete.
CCHIT will only be certifying EHRs for the physician practice
• Work groups are already developing criteria for inpatient EHR certification.
• In 2007, the effort will expand to the networks and technology components through which EHRs interoperate.
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HL7 Groups of Importance• New
• Public Health and Emergency Response• Patient Safety
• Established• Vocabulary• Government Projects• Laboratory• Attachments• Structured Documents (CDA/Templates)
For more information: http://www.hl7.org/
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Key Terminologies
• LOINC• Lab Result Names
• SNOMED• Clinical Terminology• Organisms
• Both distributed free for use• http://www.regenstrief.org/medinformatics/loinc/• http://www.nlm.nih.gov/research/umls/Snomed/
snomed_main.html
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Get Involved!
• No restrictions – just join:• HL7• HITSP
• Selected Membership• CCHIT• NCVHS
• Open Meetings• AHIC• NCVHS• CCHIT Town Halls• Registration
• LOINC• SNOMED (IHTSDO)
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Contact Information
Steven J Steindel, Ph.D.Director, Data Standards and VocabularyCenters for Disease Control and
PreventionNational Center for Public Health
InformaticsU.S. Department of Health and Human
Services1600 Clifton Road, MS E-78Atlanta, GA 30333(tel) [email protected]