TM Overview of National HIT Standards a presentation to the Seminar Series on Integrated Surveillance Presented by Steven J Steindel, Ph.D. National Center for Public Health Informatics (NCPHI), CDC

TM 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.

TM 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

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

TM Schematic Public Health Data Flow Example: Laboratory Reporting Pathology Laboratory Text Report Encoding Systematic Report Standards Standard Codes H7 Messages Architecture Reportable Cases “Public Health World” Clinical Data Users Network Users Public Health System NHIN/RHIO SNOMED, Numbers, Dates, Text 92 Disease specific HL Messages Public Health Surveillance

TM 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

TM 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:

TM 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:

TM 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:

TM Health Information Technology Deployment Coordination

TM 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:

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

TM I Harmonization Request Harmonization Process Steps II Requirements Analysis III Identification of Candidate Standards IV Gaps, Duplications and Overlaps Resolution V Standards Selection VI Construction of Interoperability Specification VII Inspection Test VIII Interoperability Specification Release and Dissemination IX Program Management Begin Support Receive Request HITSP Harmonization Process

TM HITSP Framework

TM JANFEBMARAPRMAYJUNJULAUGSEPOCTNOVDEC 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 – 08/1608/17 – 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

TM Coordinated Timeline Two Years We are here

TM 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:

TM 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

TM 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 Finalize Launch Certification Program

TM CCHIT Myths and Realities MythReality 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 basic criteriaCertification 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.

TM 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:

TM Key Terminologies LOINC Lab Result Names SNOMED Clinical Terminology Organisms Both distributed free for use

TM Get Involved! No restrictions – just join: HL7 HITSP Selected Membership CCHIT NCVHS Open Meetings AHIC NCVHS CCHIT Town Halls Registration LOINC SNOMED (IHTSDO)

TM 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 (tel)