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Interoperability Framework
                       Overview
                        HIT Standards Committee

                        June 24, 2010




Presented by:

Douglas Fridsma, MD, PhD
Acting Director, Office of Interoperability & Standards
ONC
Goals of the Standards and Interoperability
Framework
» Move toward more “computational” implementation specifications (IS)
    • Scalable processes
    • Ability to develop tools to increase the efficiency of IS development and
      maintenance
    • The importance of developing IS that are explicit and subject to less
      interpretation
» Link use cases and standards from inception to certification
    • Keep the certification processes tightly linked to the standards and IS
      processes
    • Support tool development for certification testing
    • Develop the testing for compliance at the same time as developing the
      standards and IS
» Integrate multiple SDOs with different expertise across the process
    • Transport packages
    • Vocabulary
    • Value sets
    • Security
  6/25/2010
Bottom up use case development within a top-
down coordination framework

NHIN Direct + Interoperability Framework = Focused Collaboration
        High




                                   Focused       CORE PRINCIPLES
                 Command         Collaboration
                and Control
                                                   Prioritization
Focus
                                                   Transparency
                               A Thousand
                              Flowers Bloom
                                                   Engagement
        Low




               Low                        High
                                                   Rapid Results
                          Participation
Bottom Up Innovation within a
Coordination Framework




                                Standards                                        Pilot Demonstration
                               Development                                             Projects




 Use Case Development        Harmonization of
                                                         Implementation              Reference                 Certification
     and Functional        Core Concepts (NIEM
                                                          Specifications           Implementation              and Testing
     Requirements               framework)




                                                    Tools and Services
          (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
Use Case Development                             Use Case Development and
    and Functional
    Requirements                                 Functional Requirements

                                    Standards                                        Pilot Demonstration
                                   Development                                              Projects

                                                                                                                                   The process should
   Use Case Development          Harmonization of
                                                                                                                                   » Engage a wide community in
       and Functional
       Requirements
                               Core Concepts (NIEM
                                   framework)
                                                             Implementation
                                                              Specifications
                                                                                         Reference
                                                                                       Implementation
                                                                                                                   Certification
                                                                                                                   and Testing
                                                                                                                                     defining the use cases
                                                                                                                                   » Focus on solving a real problem
                                                    Tools and Services
          (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)                  • Determines scope
                                                                                                                                       • Able to “test” if the use case
                                                                                                                                          solves the problem
      » Example of a use case                                                                                                          • Prevents “analysis paralysis”
          • provider wants to send a referral                                                                                          • Does not model in the abstract
             to a specialist electronically                                                                                            • Open, transparent process
      » Use case describes                                                                                                         » Establish a “use case steward” to
          • Services                                                                                                                 shepherd the use cases through the
          • Standards (package)                                                                                                      entire process
          • Business rules, trust, policies                                                                                        » Output is a clear description (in a
      That are necessary to satisfy the use                                                                                          computable form) that describes the
        case                                                                                                                         standards, services and policies
                                                                                                                                     necessary to describe the use case
Harmonization of
Core Concepts (NIEM
     framework)
                                                Harmonization of Core Concepts

                                   Standards                                        Pilot Demonstration
                                  Development                                              Projects

                                                                                                                                  » Need to have a strong
                                                                                                                                    harmonization framework that
  Use Case Development          Harmonization of
                                                            Implementation              Reference                 Certification
                                                                                                                                    spans different standards
                                                                                                                                    organizations
      and Functional          Core Concepts (NIEM
                                                             Specifications           Implementation              and Testing
      Requirements                framework)



                                                                                                                                      • XML/UML computational
                                                   Tools and Services
         (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
                                                                                                                                        descriptions of the use cases
                                                                                                                                      • Strong governance and
                                                                                                                                        transparent processes
                                                                                                                                      • Use-case driven (bottom up)
     » Multiple use cases might                                                                                                         with top down coordination
       have overlapping standards,                                                                                                » Harmonization processes need
       services or policies                                                                                                         to describe
        • E-prescribing and adverse                                                                                                   • Standards
                                                                                                                                      • Services
          event reporting
                                                                                                                                      • Policies
        • Clinical care summary and                                                                                                 In standard ways
          quality reporting
        • Laboratory data exchange
          and clinical decision
          support
Harmonization of
Core Concepts (NIEM
     framework)
                                                Harmonization of Core Concepts

                                   Standards                                        Pilot Demonstration
                                  Development                                              Projects

                                                                                                                                  » Standards harmonization
  Use Case Development          Harmonization of
                                                                                                                                     • Leverage best practices
                                                                                                                                     • Use the NIEM processes
                                                            Implementation              Reference                 Certification
      and Functional          Core Concepts (NIEM
                                                             Specifications           Implementation              and Testing
      Requirements                framework)




                                                                                                                                     • Create explicit data
                                                   Tools and Services
         (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)                    exchange package that
                                                                                                                                        describe the data elements,
                                                                                                                                        vocabularies and value sets
     » Three parts to harmonization                                                                                               » Service harmonization
                                                                                                                                     • Information model
        • Description of the standards                                                                                               • Services description
          (the data that is exchanged)                                                                                               • Conformance description
        • Description of the services                                                                                                • Governance (business rules)
          (the functions that will be                                                                                                   descriptions
          supported in the exchange)                                                                                              » Policy descriptions
                                                                                                                                     • Harmonization of policies is a
        • Description of the policy                                                                                                     challenge
          (trust, business rules, etc)
Harmonization of
Core Concepts (NIEM
     framework)
                                                What is the NIEM process?

                                   Standards                                        Pilot Demonstration
                                  Development                                              Projects


                                                                                                                                  » National Information Exchange
  Use Case Development
      and Functional
                                Harmonization of
                              Core Concepts (NIEM
                                                            Implementation
                                                             Specifications
                                                                                        Reference
                                                                                      Implementation
                                                                                                                  Certification
                                                                                                                  and Testing
                                                                                                                                    Model
      Requirements                framework)


                                                                                                                                  » Started as a DoJ initiative, but the
                                                   Tools and Services
         (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
                                                                                                                                    processes have been generalized
                                                                                                                                      • Supported data integration
                                                                                                                                        and reporting for
                                                 Patient
                                                                                                                                        Recovery.gov
                                                                                                                                      • Used by HHS to support child
                                                Discovery
                         Lab data                                      E-prescribing
                         exchange

                Provider                                                                       Future                                   and family services
             address lookup                                                                   Domains

                                                 Common                                                                               • Recommended by OMB as
               Discharge                          Core
               Summary                                                            Quality
                                                                                 reporting
                                                                                                                                        best practice
                       PHR
                                                                         Child and                                                    • Used by state and local
                                                                          Family
                     exchange
                                          Patient summary
                                                                         Services
                                                                                                                                        governments
Harmonization of
Core Concepts (NIEM
     framework)
                           What is the NIEM framework?


                                                                  » A common core of concepts,
                                                                    explicitly defined, that are shared
                                                                    across different use cases or
                          Patient
                         Discovery
                                                                    domains
           Lab data                     E-prescribing
           exchange                                               » Naming and modeling
      Provider
   address lookup
                                                         Future     conventions that allow different
                                                        Domains
                          Common
                                                                    groups to work independently but
     Discharge             Core
                                              Quality               harmonize the work together
     Summary
                                             reporting
                                                                  » Based on the ISO-11179 metadata
                                         Child and
          PHR                             Family
                                                                    standard used by the NCI, NLM,
        exchange
                      Patient summary
                                         Services                   and standards organizations.




      6/25/2010
Standards
  Development
                                              Standards Development

                                 Standards                                        Pilot Demonstration
                                Development                                              Projects


                                                                                                                                » Gaps in existing standards
Use Case Development
    and Functional
    Requirements
                              Harmonization of
                            Core Concepts (NIEM
                                framework)
                                                          Implementation
                                                           Specifications
                                                                                      Reference
                                                                                    Implementation
                                                                                                                Certification
                                                                                                                and Testing
                                                                                                                                    • Data package
                                                                                                                                    • Value sets
                                                                                                                                    • Services
                                                 Tools and Services
       (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)




                                                                                                                                » Can be identified as part of the
                                                                                                                                  use case development and
                                                                                                                                  harmonization process
                                                                                                                                » Work with SDOs (NLM, HL7
                                                                                                                                  etc) to fill in gaps
                                                                                                                                » Allows the standards work to
                                                                                                                                  proceed in parallel with
                                                                                                                                  development of the
                                                                                                                                  implementation specifications
Implementation
 Specifications
                                              Implementation Specifications

                                 Standards                                        Pilot Demonstration
                                Development                                              Projects


                                                                                                                                » If the standards, services and
Use Case Development
    and Functional
                              Harmonization of
                            Core Concepts (NIEM
                                                          Implementation              Reference                 Certification
                                                                                                                                  policies are the ingredients,
                                                           Specifications           Implementation              and Testing
    Requirements                framework)
                                                                                                                                  then the implementation
                                                 Tools and Services
                                                                                                                                  specification is the recipe
       (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)




                                                                                                                                » Packaged together to support
   » An implementation                                                                                                            use cases
     specification becomes a                                                                                                    » Guides development of
     explicit description of the                                                                                                  reference implementation
      • Standards                                                                                                               » Interim Final Rule requires
      • Services                                                                                                                  creation of Implementation
      • Policies                                                                                                                  Specifications where they don’t
                                                                                                                                  exist
   » That conform to adopted
     standards and have sufficient
     detail to be implemented
Reference
Implementation
                                              Reference Implementation

                                 Standards                                        Pilot Demonstration
                                Development                                              Projects


                                                                                                                                » Specification must be tested to
Use Case Development
    and Functional
                              Harmonization of
                            Core Concepts (NIEM
                                                          Implementation
                                                           Specifications
                                                                                      Reference
                                                                                    Implementation
                                                                                                                Certification
                                                                                                                and Testing
                                                                                                                                  make sure they can be
    Requirements                framework)

                                                                                                                                  implemented
                                                 Tools and Services
       (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
                                                                                                                                » Can be used by others to help
                                                                                                                                  guide their own implementation
                                                                                                                                  or find problems with
   » Example: CONNECT                                                                                                             specifications
     software could potentially be                                                                                              » Encourages feedback to ONC
     the reference implementation
     of NHIN specifications and
     standards
Pilot Demonstration
      Projects
                                               Pilot Demonstration Projects

                                  Standards                                        Pilot Demonstration
                                 Development                                              Projects


                                                                                                                                 » Reference implementation in
 Use Case Development
     and Functional
                               Harmonization of
                             Core Concepts (NIEM
                                                           Implementation
                                                            Specifications
                                                                                       Reference
                                                                                     Implementation
                                                                                                                 Certification
                                                                                                                 and Testing
                                                                                                                                   use by stakeholders
     Requirements                framework)


                                                                                                                                 » Confirms use case is being
                                                  Tools and Services
        (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
                                                                                                                                   supported
                                                                                                                                 » ONC should provide
                                                                                                                                   coordination of pilot
    » NHIN Trial Implementations                                                                                                   demonstrations
    » NHIN Limited Production
      Exchange
    » NHIN Direct Project
Certification
   and Testing
                                              Certification and Testing

                                 Standards                                        Pilot Demonstration
                                Development                                              Projects


                                                                                                                                » Culmination of prior activities
Use Case Development
    and Functional
    Requirements
                              Harmonization of
                            Core Concepts (NIEM
                                framework)
                                                          Implementation
                                                           Specifications
                                                                                      Reference
                                                                                    Implementation
                                                                                                                Certification
                                                                                                                and Testing
                                                                                                                                » NIST can help create test
                                                                                                                                  harnesses to ensure
                                                 Tools and Services
       (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
                                                                                                                                  conformance with
                                                                                                                                  specifications

   NIST Conformance tools
   Tools and resources for
     certification processes
Tools and Services

                                 Standards                                        Pilot Demonstration
                                Development                                              Projects


                                                                                                                                » Make the process as
Use Case Development
    and Functional
                              Harmonization of
                            Core Concepts (NIEM
                                                          Implementation
                                                           Specifications
                                                                                      Reference
                                                                                    Implementation
                                                                                                                Certification
                                                                                                                and Testing
                                                                                                                                  automated and self-serve as
    Requirements                framework)

                                                                                                                                  possible
                                                 Tools and Services
       (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
                                                                                                                                » Leverage tools & services in
                                                                                                                                  future efforts
Bottom Up Innovation within a
Coordination Framework


                                Standards                                         Pilot Demonstration
                               Development                                              Projects




 Use Case Development        Harmonization of
                                                         Implementation                  Reference               Certification
     and Functional        Core Concepts (NIEM
                                                          Specifications               Implementation            and Testing
     Requirements               framework)




               Information Model,           Harmonized/                                           Integration Testing
                                                                           Reference
                  Services, and            Implementation                                                 and
                                                                           Code Set
                   Value Sets               Specification                                           Implementation



                                                    Tools and Services
          (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
NHIN Direct Example

 J            J         A     S               O           N               D               J               F             M               A              M                 J   J      A      S   O                     N




                                                                                                                                                                                                                    S&I and HITSC NHIN Direct
                                                                                                                                                                                                                                   Activities
 Implementation                Reference                          Pilot Demonstration
  Specifications             Implementation                              Projects




                                                                          Standards
                                                                         Development                                                                                         NHIN Inclusion
                                                                                              HIT Standards Committee Review




                                                                                                                                                                                                                      Activities
                                                                                                                                                                              Evaluation


                                         Use Case Development          Harmonization of
                                                                                                   Implementation              Reference                 Certification
                                             and Functional
                                             Requirements
                                                                     Core Concepts (NIEM
                                                                         framework)
                                                                                                    Specifications           Implementation              and Testing         Other Standards
                                                                                                                                                                               Governance
                                                                                                                                                                               Evaluations
                                                                                          Tools and Services
                                                (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)




                                                                                                                                                                                                   HITPC Activities
                   HITPC P&S Tiger Team Policy
                           Framework



                            HITPC + HITSC
                      Specification Policy Review

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Interoperability framework overview

  • 1. Interoperability Framework Overview HIT Standards Committee June 24, 2010 Presented by: Douglas Fridsma, MD, PhD Acting Director, Office of Interoperability & Standards ONC
  • 2. Goals of the Standards and Interoperability Framework » Move toward more “computational” implementation specifications (IS) • Scalable processes • Ability to develop tools to increase the efficiency of IS development and maintenance • The importance of developing IS that are explicit and subject to less interpretation » Link use cases and standards from inception to certification • Keep the certification processes tightly linked to the standards and IS processes • Support tool development for certification testing • Develop the testing for compliance at the same time as developing the standards and IS » Integrate multiple SDOs with different expertise across the process • Transport packages • Vocabulary • Value sets • Security 6/25/2010
  • 3. Bottom up use case development within a top- down coordination framework NHIN Direct + Interoperability Framework = Focused Collaboration High Focused CORE PRINCIPLES Command Collaboration and Control Prioritization Focus Transparency A Thousand Flowers Bloom Engagement Low Low High Rapid Results Participation
  • 4. Bottom Up Innovation within a Coordination Framework Standards Pilot Demonstration Development Projects Use Case Development Harmonization of Implementation Reference Certification and Functional Core Concepts (NIEM Specifications Implementation and Testing Requirements framework) Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
  • 5. Use Case Development Use Case Development and and Functional Requirements Functional Requirements Standards Pilot Demonstration Development Projects The process should Use Case Development Harmonization of » Engage a wide community in and Functional Requirements Core Concepts (NIEM framework) Implementation Specifications Reference Implementation Certification and Testing defining the use cases » Focus on solving a real problem Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) • Determines scope • Able to “test” if the use case solves the problem » Example of a use case • Prevents “analysis paralysis” • provider wants to send a referral • Does not model in the abstract to a specialist electronically • Open, transparent process » Use case describes » Establish a “use case steward” to • Services shepherd the use cases through the • Standards (package) entire process • Business rules, trust, policies » Output is a clear description (in a That are necessary to satisfy the use computable form) that describes the case standards, services and policies necessary to describe the use case
  • 6. Harmonization of Core Concepts (NIEM framework) Harmonization of Core Concepts Standards Pilot Demonstration Development Projects » Need to have a strong harmonization framework that Use Case Development Harmonization of Implementation Reference Certification spans different standards organizations and Functional Core Concepts (NIEM Specifications Implementation and Testing Requirements framework) • XML/UML computational Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) descriptions of the use cases • Strong governance and transparent processes • Use-case driven (bottom up) » Multiple use cases might with top down coordination have overlapping standards, » Harmonization processes need services or policies to describe • E-prescribing and adverse • Standards • Services event reporting • Policies • Clinical care summary and In standard ways quality reporting • Laboratory data exchange and clinical decision support
  • 7. Harmonization of Core Concepts (NIEM framework) Harmonization of Core Concepts Standards Pilot Demonstration Development Projects » Standards harmonization Use Case Development Harmonization of • Leverage best practices • Use the NIEM processes Implementation Reference Certification and Functional Core Concepts (NIEM Specifications Implementation and Testing Requirements framework) • Create explicit data Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) exchange package that describe the data elements, vocabularies and value sets » Three parts to harmonization » Service harmonization • Information model • Description of the standards • Services description (the data that is exchanged) • Conformance description • Description of the services • Governance (business rules) (the functions that will be descriptions supported in the exchange) » Policy descriptions • Harmonization of policies is a • Description of the policy challenge (trust, business rules, etc)
  • 8. Harmonization of Core Concepts (NIEM framework) What is the NIEM process? Standards Pilot Demonstration Development Projects » National Information Exchange Use Case Development and Functional Harmonization of Core Concepts (NIEM Implementation Specifications Reference Implementation Certification and Testing Model Requirements framework) » Started as a DoJ initiative, but the Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) processes have been generalized • Supported data integration and reporting for Patient Recovery.gov • Used by HHS to support child Discovery Lab data E-prescribing exchange Provider Future and family services address lookup Domains Common • Recommended by OMB as Discharge Core Summary Quality reporting best practice PHR Child and • Used by state and local Family exchange Patient summary Services governments
  • 9. Harmonization of Core Concepts (NIEM framework) What is the NIEM framework? » A common core of concepts, explicitly defined, that are shared across different use cases or Patient Discovery domains Lab data E-prescribing exchange » Naming and modeling Provider address lookup Future conventions that allow different Domains Common groups to work independently but Discharge Core Quality harmonize the work together Summary reporting » Based on the ISO-11179 metadata Child and PHR Family standard used by the NCI, NLM, exchange Patient summary Services and standards organizations. 6/25/2010
  • 10. Standards Development Standards Development Standards Pilot Demonstration Development Projects » Gaps in existing standards Use Case Development and Functional Requirements Harmonization of Core Concepts (NIEM framework) Implementation Specifications Reference Implementation Certification and Testing • Data package • Value sets • Services Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) » Can be identified as part of the use case development and harmonization process » Work with SDOs (NLM, HL7 etc) to fill in gaps » Allows the standards work to proceed in parallel with development of the implementation specifications
  • 11. Implementation Specifications Implementation Specifications Standards Pilot Demonstration Development Projects » If the standards, services and Use Case Development and Functional Harmonization of Core Concepts (NIEM Implementation Reference Certification policies are the ingredients, Specifications Implementation and Testing Requirements framework) then the implementation Tools and Services specification is the recipe (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) » Packaged together to support » An implementation use cases specification becomes a » Guides development of explicit description of the reference implementation • Standards » Interim Final Rule requires • Services creation of Implementation • Policies Specifications where they don’t exist » That conform to adopted standards and have sufficient detail to be implemented
  • 12. Reference Implementation Reference Implementation Standards Pilot Demonstration Development Projects » Specification must be tested to Use Case Development and Functional Harmonization of Core Concepts (NIEM Implementation Specifications Reference Implementation Certification and Testing make sure they can be Requirements framework) implemented Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) » Can be used by others to help guide their own implementation or find problems with » Example: CONNECT specifications software could potentially be » Encourages feedback to ONC the reference implementation of NHIN specifications and standards
  • 13. Pilot Demonstration Projects Pilot Demonstration Projects Standards Pilot Demonstration Development Projects » Reference implementation in Use Case Development and Functional Harmonization of Core Concepts (NIEM Implementation Specifications Reference Implementation Certification and Testing use by stakeholders Requirements framework) » Confirms use case is being Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) supported » ONC should provide coordination of pilot » NHIN Trial Implementations demonstrations » NHIN Limited Production Exchange » NHIN Direct Project
  • 14. Certification and Testing Certification and Testing Standards Pilot Demonstration Development Projects » Culmination of prior activities Use Case Development and Functional Requirements Harmonization of Core Concepts (NIEM framework) Implementation Specifications Reference Implementation Certification and Testing » NIST can help create test harnesses to ensure Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) conformance with specifications NIST Conformance tools Tools and resources for certification processes
  • 15. Tools and Services Standards Pilot Demonstration Development Projects » Make the process as Use Case Development and Functional Harmonization of Core Concepts (NIEM Implementation Specifications Reference Implementation Certification and Testing automated and self-serve as Requirements framework) possible Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) » Leverage tools & services in future efforts
  • 16. Bottom Up Innovation within a Coordination Framework Standards Pilot Demonstration Development Projects Use Case Development Harmonization of Implementation Reference Certification and Functional Core Concepts (NIEM Specifications Implementation and Testing Requirements framework) Information Model, Harmonized/ Integration Testing Reference Services, and Implementation and Code Set Value Sets Specification Implementation Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc)
  • 17. NHIN Direct Example J J A S O N D J F M A M J J A S O N S&I and HITSC NHIN Direct Activities Implementation Reference Pilot Demonstration Specifications Implementation Projects Standards Development NHIN Inclusion HIT Standards Committee Review Activities Evaluation Use Case Development Harmonization of Implementation Reference Certification and Functional Requirements Core Concepts (NIEM framework) Specifications Implementation and Testing Other Standards Governance Evaluations Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) HITPC Activities HITPC P&S Tiger Team Policy Framework HITPC + HITSC Specification Policy Review