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Update on Current Standards Efforts
              Jitin Asnaani & Rich Elmore
    Office of Standards and Interoperability, ONC
                   November 21, 2011
How do we achieve interoperable
healthcare information systems?



    • EHR Certification                             • HIT Standards
    • Meaningful Use                                  Committee*
                                         Assemble   • Exchange
                            Accuracy &    Team to   • Direct Project
                            Compliance     Solve
                                         Problem
                                                    • S&I Framework


                                  Solutions
                                  & Usability




                          • Nationwide Health
                            Information Network      * Federal Advisory Committee
1
Example: curating incremental standards
to enable health information exchange

    INTEROPERABILITY          STANDARDS & SPECIFICATIONS
         STACK                    (illustrative initiatives)


     Vocabulary &
      Code Sets                             HITSC
                            S&I          ePrescribing             S&I Lab
                       Transitions of    of Discharge             Results
                           Care          Meds Power              Interface
       Content                               Team
       Structure
                                                                                 Potential
                                                                                solution for
      Transport &                                          S&I Certificate        directed
        Security                                          Interoperability      exchange of
                                                                                   clinical
                            Direct Project
                                                                                summaries
                                                            S&I Provider
       Access                                               Directories –
       Services                                         Certificate Discovery
                                                              Use Case

2
HIT Standards Committee




3
Why the HIT Standards Committee?


    • Charged with making recommendations to the
      National Coordinator for Health IT on
      standards, implementation specifications, and
      certification criteria for the electronic exchange
      and use of health information
    • Focused on the implicit and explicit standards
      needs driven by the policies developed by the
      Health IT Policy Committee
    • In developing, harmonizing, or recognizing standards and implementation
      specifications, the Health IT Standards Committee will also provide for the
      testing of the same by the National Institute for Standards and Technology
      (NIST)



4
HITSC Workgroups


     • Clinical Operations Workgroup - make recommendations to HITSC on
       requirements for EHR certification criteria, standards, and implementation
       specifications related to clinical operations
         – Has set up a Vocabulary Task Force to address vocabulary subsets and value
           sets as facilitators and enablers of “meaningful use.”
     • Clinical Quality Workgroup - make recommendations to HITSC on quality
       measures that should be included in the definition of Meaningful Use and
       future EHR certification requirements
     • Privacy & Security Workgroup - make recommendations to HITSC on
       privacy and security requirements that should be included in standards,
       certification criteria, and implementation specifications
     • Implementation Workgroup - bring forward “real-world” implementation
       experience into HITSC recommendations, with special emphasis on
       strategies to accelerate adoption of proposed standards
 5
Summer Camp for HITSC


    • Analyze standards implications of HITPC
      recommendations
       – Prepare for Meaningful Use Stage 2
       – Identify gaps in Standards
       – Triage Standards Work

    • Available tools: Hearings, Federal Register, Wikis,
      working groups, S&I Framework

    • Intense work effort
       – 39 public meetings and hearings over 20
          weeks
       – Approximately 1 meeting every 3.6 days
       – ANPRM from metadata team

6
Summer Camp Power Teams


    • Metadata Analysis Team - Identified metadata elements and standards
      for Patient Identity, Provenance and Privacy. Recommended HL7 CDA R2
      header elements (with modifications)
        – ANPRM published August 9, 2011


    • Patient Matching Power Team - Determined the data that should be
      included in Patient Matching in order to achieve acceptable levels of
      specificity (99.9%) and sensitivity (95%)

    • Surveillance Implementation Guide Power Team - Converged on the use
      of the HL7 2.5.1 standard across lab reporting to public health,
      immunization reporting, and syndromic surveillance
        – Recommended specific HL7 2.5.1 implementation guides



7
Summer Camp Power Teams continued


    • E-prescribing for Discharge Medications - Recommended standards for
      electronic prescription of discharge medications, medication history, and
      eligibility

    • NWHIN Power Team - Evaluated specifications developed for the NwHIN
      Exchange and Direct pilots and made recommendations for specifications
      that could be used to support the secure transport and exchange of
      electronic health information nationally

    • Biosurveillance Power Team - Recommended a core set of 17 elements
      and a set of 16 optional elements for biosurveillance reporting

    • Vocabulary Task Force - Met under the auspices of the parent Workgroup
      (Clinical Operations). Identified acceptable transition vocabularies to
      support Clinical Quality Measure reporting

8
Standards & Interoperability
            Framework



9
Why the S&I Framework?



     •    S&I Framework is a forum created by ONC that
          enables a broad, open, transparent community*
          of stakeholders to help guide the development of
          realistic, implementable solutions that meet
          standards needs for health information exchange
     •    Each S&I Initiative focuses on a narrowly-scoped,
          broadly applicable challenge, tackled through a
          rigorous development cycle

     •    S&I Framework supports the HITSC to accelerate the identification, piloting
          and use of a parsimonious set of standards for MU



     * As of 15 Oct 2011, ~900 people had registered on the S&I Framework wiki, and ~400 people representing ~300 organizations had
     committed to specific S&I Framework initiatives
10
Current S&I Initiatives


      • Transitions of Care (ToC) - Creating clear implementation guidance for
        each of the key information exchanges needed in core care transitions
        scenarios
      • Lab Results Interfaces (LRI) - Establishing the nationwide Implementation
        Guide for electronic submission of Lab Results to Ambulatory EHRs
      • Provider Directories (PD) - Establishing a standard for certificate
        discovery, and the minimum data model for broader “electronic service
        information” queries
      • Certificate Interoperability - Investigating architectural and operational
        options for cross-certifying Health ISPs (HISPs) with the Federal Bridge
        Certificate Authority


 11
Current S&I Initiatives continued


      • Query Health - Identifying the standards and services for distributed
        population health queries to certified EHRs and other patient data sources
      • Data Segmentation for Privacy - Focused on standards-driven data
        segmentation to enable privacy of patient data based on consent
        decisions, applicable law and policies
      • Electronic Submission of Medical Documentation (esMD) - Providing a
        new mechanism for submitting medical documentation to Medicare
        Review Contractors; investigates technical transport/authentication and
        proof of document authorship
      • Community-Led Initiatives in Public Health and Longitudinal Coordination
        of Care


 12
S&I Query Health Initiative




13
Query Health: Improve community
understanding of patient population health




                                                  Questions about
                                                 disease outbreaks,
                                             prevention activities, health
     For more information,                             research,
     visit QueryHealth.org                      quality measures, etc.
14
Inside Query Health

     Aggregated Count Data                                                                             Patient Data
                                                          Note: All patient level data stays behind the firewall.

                                                                                       Data Source
                                                                                   1. EHR / Clinical
                                                           Query                        Record
                                                          & Results                 (Patient Data)
                                                          Reviewer
                                                                                             Translate patient
                                   3. Distribute Query to Data Sources                       data to CIM
                                                                                      2. Clinical
            Information                                                              Information
             Requestor                                                               Model (CIM)
                             5. Sends Query Results to Information Requestor
                                                                                                  4. Execute
                                                                                               Query , format
                                                                                               & return Results




                                                               Responding Organization
                                         Firewall
15
Query Health: Voluntary Networks
No Central Planning, No Central DB’s


                    Community of participants that voluntarily
                  agree to interact with each other. There will be
                   many networks; requestors and responders
                      may participate in multiple networks.




                                Query



              Authorized                                  Participating
              Requestors                                  Responders



16
Query Health Scope and Approach



                       Standards &
                          Service




                   Query Health                                 HIT Policy
 EHRs & Other      – Distributed       Public / Private        Committee:
                                        Partnership
Clinical Records
                    Population            Project                 Policy
                      Queries                                  Guideposts


                                                                Practice drives standards
                                                          1.     Rough consensus
                                                          2.     Running code (open source)
                       Community
                         Driven,
                     Consensus-based
                                                          3.     Pilot
                                                          4.     Specifications
17                                                        5.     Standards
Query Health Policy Recommendations


     • Reviews by
        – Privacy and Security Tiger Team
        – HIT Policy Committee

     • Scope: ONC sponsored Query Health pilots

     • Purpose:
        – Policy guardrails for pilots
        – ONC Governance recommendations based on pilot results

     • Link to HIT Policy Committee Recommendations at QueryHealth.org




18
Query Health Policy Recommendations


     • Control of data disclosures by data holder
        – Whether to run a query
        – Whether to release any results

     • Data being disclosed
        – Aggregated de-identified data sets or aggregated limited data sets,
          each with data use agreements (even in circumstances where they are
          not required by law), or
        – Public health permitted use under state or federal law providing the
          minimally necessary and permitted information (which may include
          identifiable information where permitted by law).




19
Query Health Policy Recommendations


     • Data Use Agreement:
        – No re-identification
        – Clarity of purpose (permissible uses)

     • Small cells:
        – Cells with less than 5 observations in a cell shall be blurred by
          methods that reduce the accuracy of the information provided.
        – Exception for regulated / permitted use
        – (The CDC-CSTE Intergovernmental Data Release Guidelines Working
          Group has recommended limiting cell size to three counts presuming a
          sufficiently large population; this is also reflected in guidelines used by
          several states.)



20
Questions



     Learn more at:
     ONC website: http://www.healthit.gov/
     HIT Standards Committee:
        http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__health
        _it_standards_committee/1271
     S&I Framework wiki: http://wiki.siframework.org
     Query Health Homepage: http://www.queryhealth.org


     Contact us:
     Jitin Asnaani                           Rich Elmore
     jitin.asnaani@siframework.org           richard.elmore@hhs.gov

21

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Current ONC Standards Activities

  • 1. Update on Current Standards Efforts Jitin Asnaani & Rich Elmore Office of Standards and Interoperability, ONC November 21, 2011
  • 2. How do we achieve interoperable healthcare information systems? • EHR Certification • HIT Standards • Meaningful Use Committee* Assemble • Exchange Accuracy & Team to • Direct Project Compliance Solve Problem • S&I Framework Solutions & Usability • Nationwide Health Information Network * Federal Advisory Committee 1
  • 3. Example: curating incremental standards to enable health information exchange INTEROPERABILITY STANDARDS & SPECIFICATIONS STACK (illustrative initiatives) Vocabulary & Code Sets HITSC S&I ePrescribing S&I Lab Transitions of of Discharge Results Care Meds Power Interface Content Team Structure Potential solution for Transport & S&I Certificate directed Security Interoperability exchange of clinical Direct Project summaries S&I Provider Access Directories – Services Certificate Discovery Use Case 2
  • 5. Why the HIT Standards Committee? • Charged with making recommendations to the National Coordinator for Health IT on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information • Focused on the implicit and explicit standards needs driven by the policies developed by the Health IT Policy Committee • In developing, harmonizing, or recognizing standards and implementation specifications, the Health IT Standards Committee will also provide for the testing of the same by the National Institute for Standards and Technology (NIST) 4
  • 6. HITSC Workgroups • Clinical Operations Workgroup - make recommendations to HITSC on requirements for EHR certification criteria, standards, and implementation specifications related to clinical operations – Has set up a Vocabulary Task Force to address vocabulary subsets and value sets as facilitators and enablers of “meaningful use.” • Clinical Quality Workgroup - make recommendations to HITSC on quality measures that should be included in the definition of Meaningful Use and future EHR certification requirements • Privacy & Security Workgroup - make recommendations to HITSC on privacy and security requirements that should be included in standards, certification criteria, and implementation specifications • Implementation Workgroup - bring forward “real-world” implementation experience into HITSC recommendations, with special emphasis on strategies to accelerate adoption of proposed standards 5
  • 7. Summer Camp for HITSC • Analyze standards implications of HITPC recommendations – Prepare for Meaningful Use Stage 2 – Identify gaps in Standards – Triage Standards Work • Available tools: Hearings, Federal Register, Wikis, working groups, S&I Framework • Intense work effort – 39 public meetings and hearings over 20 weeks – Approximately 1 meeting every 3.6 days – ANPRM from metadata team 6
  • 8. Summer Camp Power Teams • Metadata Analysis Team - Identified metadata elements and standards for Patient Identity, Provenance and Privacy. Recommended HL7 CDA R2 header elements (with modifications) – ANPRM published August 9, 2011 • Patient Matching Power Team - Determined the data that should be included in Patient Matching in order to achieve acceptable levels of specificity (99.9%) and sensitivity (95%) • Surveillance Implementation Guide Power Team - Converged on the use of the HL7 2.5.1 standard across lab reporting to public health, immunization reporting, and syndromic surveillance – Recommended specific HL7 2.5.1 implementation guides 7
  • 9. Summer Camp Power Teams continued • E-prescribing for Discharge Medications - Recommended standards for electronic prescription of discharge medications, medication history, and eligibility • NWHIN Power Team - Evaluated specifications developed for the NwHIN Exchange and Direct pilots and made recommendations for specifications that could be used to support the secure transport and exchange of electronic health information nationally • Biosurveillance Power Team - Recommended a core set of 17 elements and a set of 16 optional elements for biosurveillance reporting • Vocabulary Task Force - Met under the auspices of the parent Workgroup (Clinical Operations). Identified acceptable transition vocabularies to support Clinical Quality Measure reporting 8
  • 11. Why the S&I Framework? • S&I Framework is a forum created by ONC that enables a broad, open, transparent community* of stakeholders to help guide the development of realistic, implementable solutions that meet standards needs for health information exchange • Each S&I Initiative focuses on a narrowly-scoped, broadly applicable challenge, tackled through a rigorous development cycle • S&I Framework supports the HITSC to accelerate the identification, piloting and use of a parsimonious set of standards for MU * As of 15 Oct 2011, ~900 people had registered on the S&I Framework wiki, and ~400 people representing ~300 organizations had committed to specific S&I Framework initiatives 10
  • 12. Current S&I Initiatives • Transitions of Care (ToC) - Creating clear implementation guidance for each of the key information exchanges needed in core care transitions scenarios • Lab Results Interfaces (LRI) - Establishing the nationwide Implementation Guide for electronic submission of Lab Results to Ambulatory EHRs • Provider Directories (PD) - Establishing a standard for certificate discovery, and the minimum data model for broader “electronic service information” queries • Certificate Interoperability - Investigating architectural and operational options for cross-certifying Health ISPs (HISPs) with the Federal Bridge Certificate Authority 11
  • 13. Current S&I Initiatives continued • Query Health - Identifying the standards and services for distributed population health queries to certified EHRs and other patient data sources • Data Segmentation for Privacy - Focused on standards-driven data segmentation to enable privacy of patient data based on consent decisions, applicable law and policies • Electronic Submission of Medical Documentation (esMD) - Providing a new mechanism for submitting medical documentation to Medicare Review Contractors; investigates technical transport/authentication and proof of document authorship • Community-Led Initiatives in Public Health and Longitudinal Coordination of Care 12
  • 14. S&I Query Health Initiative 13
  • 15. Query Health: Improve community understanding of patient population health Questions about disease outbreaks, prevention activities, health For more information, research, visit QueryHealth.org quality measures, etc. 14
  • 16. Inside Query Health Aggregated Count Data Patient Data Note: All patient level data stays behind the firewall. Data Source 1. EHR / Clinical Query Record & Results (Patient Data) Reviewer Translate patient 3. Distribute Query to Data Sources data to CIM 2. Clinical Information Information Requestor Model (CIM) 5. Sends Query Results to Information Requestor 4. Execute Query , format & return Results Responding Organization Firewall 15
  • 17. Query Health: Voluntary Networks No Central Planning, No Central DB’s Community of participants that voluntarily agree to interact with each other. There will be many networks; requestors and responders may participate in multiple networks. Query Authorized Participating Requestors Responders 16
  • 18. Query Health Scope and Approach Standards & Service Query Health HIT Policy EHRs & Other – Distributed Public / Private Committee: Partnership Clinical Records Population Project Policy Queries Guideposts Practice drives standards 1. Rough consensus 2. Running code (open source) Community Driven, Consensus-based 3. Pilot 4. Specifications 17 5. Standards
  • 19. Query Health Policy Recommendations • Reviews by – Privacy and Security Tiger Team – HIT Policy Committee • Scope: ONC sponsored Query Health pilots • Purpose: – Policy guardrails for pilots – ONC Governance recommendations based on pilot results • Link to HIT Policy Committee Recommendations at QueryHealth.org 18
  • 20. Query Health Policy Recommendations • Control of data disclosures by data holder – Whether to run a query – Whether to release any results • Data being disclosed – Aggregated de-identified data sets or aggregated limited data sets, each with data use agreements (even in circumstances where they are not required by law), or – Public health permitted use under state or federal law providing the minimally necessary and permitted information (which may include identifiable information where permitted by law). 19
  • 21. Query Health Policy Recommendations • Data Use Agreement: – No re-identification – Clarity of purpose (permissible uses) • Small cells: – Cells with less than 5 observations in a cell shall be blurred by methods that reduce the accuracy of the information provided. – Exception for regulated / permitted use – (The CDC-CSTE Intergovernmental Data Release Guidelines Working Group has recommended limiting cell size to three counts presuming a sufficiently large population; this is also reflected in guidelines used by several states.) 20
  • 22. Questions Learn more at: ONC website: http://www.healthit.gov/ HIT Standards Committee: http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__health _it_standards_committee/1271 S&I Framework wiki: http://wiki.siframework.org Query Health Homepage: http://www.queryhealth.org Contact us: Jitin Asnaani Rich Elmore jitin.asnaani@siframework.org richard.elmore@hhs.gov 21

Notas del editor

  1. (1) We are actively involved in the programs themselves (e.g., through the Direct Project Boot Camp);(2) We attend, participate and occasionally facilitate their CoPs (e.g., the REC FI-HIE CoP, the State HIE Provider Directory and Lab CoPs, etc);(3) We bring the CoPs to the table when S&I initiatives need input that will affect them, etc.