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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) 404-498-2444sns6@cdc.gov