# Presentation: 282635

## 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

## Government

_**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.

## Regulations 
Based on Health & Welfare (Legitimate Objectives)

Development Process (openness, public comment, transparency, timely notification)

Mandatory

- 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

## Consideration for Standards

- Flow - where, when, and how data move
- Format - mechanics of data transfer
- Content - which data elements

## Schematic Public Health Data Flow Example: Laboratory Reporting

- Text Report

- Encoding

- Systematic
- Report

**Standards**

**Standard Codes****H7 Messages**

**Architecture**

## 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

## 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/

## 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/

## 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

## Health Information Technology Deployment Coordination

- Health Information Technology Deployment Coordination

## 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

## HITSP Technical Committees

**Cross-Technical Committee Coordination **
**Care Delivery**
**Consumer Empowerment**
**Population Health**
**Security and Privacy **
**Emergency Responder-EHR**

## HITSP Harmonization Process

- Harmonization Request

**Harmonization Process Steps**

**II **
- RequirementsAnalysis

**III **
- Identificationof CandidateStandards

**IV  **
- Gaps,Duplicationsand Overlaps Resolution

**V **
- Standards Selection

**VI **
- ConstructionofInteroperabilitySpecification

**VII **
** **InspectionTest

**VIII**InteroperabilitySpecificationReleaseandDissemination

**IX**Program Management

- BeginSupport

- ReceiveRequest

## HITSP Framework

**HITSP** **Framework**

## HITSP 2007 Timeline 

**JAN**

**FEB**

**MAR**

**APR**

**MAY**

**JUN**

**JUL**

**AUG**

**SEP**

**OCT**

**NOV**

**DEC**

- HITSP 2007 Timeline

*02/05/07*
*HITSP Board*

*04/23/07*
*HITSP Board*

*07/09/07*
*HITSP Board*

*10/09/07*
*HITSP Board*

*03/19/07*
*HITSP Panel*

*05/11/07*
*HITSP Panel*

*09/07/07*
*HITSP Panel*

*03/06 – 03/08*
*TC Face to Face*
*Chicago IL*

*5/08 – 5/10*
*TC Face to Face*
*Arlington VA*

*6/18 – 6/20*
*TC Face to Face*
*San Diego CA*

*09/04 – 09/06*
*TC 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 Cases**
**Activity 3 – New Emergency Responder EHR Use Case**

**On-going Support**

*10/15/07*
*HITSP Panel*

*07/16/07*
*HITSP Panel*

*02/12/07*
*HITSP 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***

## Coordinated Timeline

- Coordinated Timeline

## 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/

## 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

## CCHIT Development Process

- Availability in vendor marketplace
- Practicality of certification
- Release for public comment

- 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**

**Finalize**

**Launch Certification Program**

## CCHIT Myths and Realities

| Myth | Reality |
| --- | --- |
| CCHIT 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 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. |

## 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/

## Key Terminologies

- LOINC
- Lab Result Names
- SNOMED
- Clinical Terminology
- Organisms
- Both distributed free for use
- _[http://www.regenstrief.org/medinformatics/loinc/](http://www.regenstrief.org/medinformatics/loinc/)_
- http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html

## Get Involved!

- No restrictions – just join:
- HL7
- HITSP
- Selected Membership
- CCHIT
- NCVHS

- Open Meetings
- AHIC
- NCVHS
- CCHIT Town Halls
- Registration
- LOINC
- SNOMED (IHTSDO)

## Contact Information

**Steven J Steindel, Ph.D.**
**Director, Data Standards and Vocabulary**
**Centers for Disease Control and Prevention**
**National Center for Public Health Informatics**
**U.S. Department of Health and Human Services**
**1600 Clifton Road, MS E-78**
**Atlanta, GA 30333**
**(tel) 404-498-2444**
**sns6@cdc.gov**