1. HITSP Project Orientation
Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS Vice President, Informatics, HIMSS

2. Agenda
1. Welcome
2. HITSP Charter and Goals 3. Relationship between HITSP, HISPC and CCHIT
4. What is the HITSP process/structure? 5. TC Specific Work:     a) What is a Harmonized Use Case?     b) What is a HITSP Construct?     c) Familiarization with existing HITSP Constructs 6. TC Tools:     a) ANSI Member Library:     b) ANSI Public Library:     c) Standing Meetings and Numbers 7. Questions

3. In 2005, HHS awarded contracts to seed a public-private effort to build a nationwide health information network

4. A public-private “Community” was then established to serve as the focal point for America’s health information concerns and drive opportunities for increasing interoperability
Healthcare Information Technology Standards Panel (HITSP)
Nationwide Health Information Network Architecture Projects (NHIN)
The Health Information Security and Privacy Collaboration (HISPC)
The Certification Commission for Healthcare Information Technology (CCHIT)
American Health Information Community
HITSP includes 372 different member organizations and is administered by a Board of Directors
23 SDOs (6%)
292 Non-SDOs (79%)
31 Govt. bodies (8%)
14 Consumer groups (4%)
12 Project Team (3%)
The Community is a federally-chartered commission and will provide input and recommendations to HHS on how to make health records digital and interoperable, and assure that the privacy and security of those records are protected, in a smooth, market-led way.

5. The HITSP team is charged with completing eleven different tasks, with current efforts focused on the harmonization process
Eleven Tasks are included in this contract:
Comprehensive Work Plan
Conduct a Project Start Up Meeting
Deliver Recommended Use-Cases
Participate in related meetings and activities, including the AHIC Meetings
Develop a Gap Analysis
Standards Selection, Evaluations and Testing
Define a Harmonization Approach
Develop Interoperability Specifications
Develop and Evaluate a Business Plan for the self-sustaining processes
Submit Monthly Reports – ongoing efforts
Assist with communications – ongoing efforts
The Community
HHS Secretary
Mike Leavitt, Chair
HHS ONCHIT1
PO, Dr. John Loonsk
HITSP
Dr. John Halamka, Chair
Member populated Technical Committees
Project Management Team
Executive in Charge, F. Schrotter, ANSI
Program Manager, L. Jones GSI
Deputy PM, J Corley, ATI
Project Manager, Julie Pooley, Booz Allen
Harmonization Process Definition Technical Manager
Michelle Deane, ANSI
Harmonization Process Delivery Technical Manager
Joyce Sensmeier, HIMSS

6. HITSP formed Technical Committees to focus on AHIC breakthrough areas Overview/Structure and Current Use Cases
Care Delivery Technical Committee:
EHR - Lab Reporting -- Deploy standardized, widely available, secure solutions for accessing laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties.
Emergency Responder – EHR -- Covers the use of the ER-EHR from the perspective of on-site care providers and emergency care clinicians. Definitive care clinicians involved in the care and treatment of emergency incident victims, medical examiner/fatality managers investigating cause of death, and public health practitioners using information contained in the ER-EHR, are included because of their interactions with the other portions of this use case.
Medication Management – Focuses on patient medication and allergies information exchange, and the sharing of that information between consumers, clinicians (in multiple sites and settings of care), pharmacists, and organizations that provide health insurance and pharmacy benefits.

7. HITSP formed Technical Committees to focus on AHIC breakthrough areas Overview/Structure and Current Use Cases
Consumer Empowerment Technical Committee:
Consumer Empowerment -- Deploy to targeted populations a pre-populated, consumer-directed and secure electronic registration summary. Deploy a widely available pre-populated medication history linked to the registration summary.
Consumer Access to Clinical Information – Includes three scenarios which describe highlights of the processes, roles and information exchanges which could enable a consumer’s access to clinical information via a personal health record (PHR). The three scenarios are: Consumers receive and access clinical information; Consumers create provider lists and establish provider access permissions; and Consumers transfer PHR information.

8. HITSP formed Technical Committees to focus on AHIC breakthrough areas Overview/Structure and Current Use Cases
Population Health Technical Committee:
Biosurveillance -- Transmit essential ambulatory care and emergency department visit, utilization, and lab result data from electronically enabled health care delivery and public health systems in standardized and anonymized format to authorized public health agencies with less than one day lag time.
Quality – This use case depicts two scenarios related to quality measurement, feedback and reporting with respect to a patient’s encounter with the healthcare delivery system: quality measurement of hospital-based care and of care provided by clinicians.

9. Technical Committees Structure/Leadership
Care Delivery – 175 members
Co-chairs
James Ferguson, Kaiser Permanente,
Steve Hufnagel, DoD/Medical Health System (MHS),
Steve Wagner, Department of Veterans Affairs,
Consumer Empowerment – 174 members
Elaine Blechman, PhD, University of Colorado, Boulder
Charles Parisot, EHR Vendor Association,
Scott Robertson, Kaiser Permanente,

10. Technical Committees Structure/Leadership
Population Health – 135 members
Co-chairs
Floyd Eisenberg, MD, MPH, Siemens Medical Solutions,
Peter Elkin, MD, Mayo Clinic College of Medicine,
Shaun Grannis, MD, MS Indiana University School of Medicine & The Regenstrief Institute,
Security and Privacy – 118 members
Glen Marshall, Siemens Medical Solutions,
John Moehrke, GE Healthcare,
Walter Suarez, MD, Institute for HIPAA/HIT Education and Research,
Total Technical Committee Membership – 381 individuals

11. HITSP Coordinating Committees and Leadership
Foundations Committee
Steve Wagner
Bob Dolin
HITSP Process Review Committee
Lynne Gilbertson
Erik Pupo
HITSP-CCHIT Joint Work Group
Jamie Ferguson, Kaiser Permanente
CCHIT Orientation Material
Harmonization Readiness Committee
Lynne Gilbertson
Business Plan Committee
Steve Lieber
International Landscape Committee
Bill Braithwaite
Governance Committee
Michael Aisenberg

12. HITSP project team and staff supports each Technical Committee
HITSP Technical Committee- Care Delivery
Don Van Syckle, DVS Consulting,
HITSP Technical Committee- Consumer Empowerment
John Donnelly, IntePro Solutions, Inc.,
Mike Nusbaum, M.H. Nusbaum & Associates Ltd.,
HITSP Technical Committee- Population Health
Lori Reed-Fourquet, e-HealthSign LLC,
HITSP Cross-Technical Committee Coordination
Bob Yencha, Alschuler Associates,
HITSP Security and Technical Committee
Johnathan Coleman CISM, CISSP, Security Risk Solutions, Inc.,
Sarah Quaynor, ANSI,
HITSP Emergency Responder-EHR
Michael Glickman, Computer Network Architects, Inc.,
Seb Haileleul, Patriot Technology,
HITSP Medication Management
Suzi Hines, Principal, Sage Consulting, LLC,

13. HITSP Technical Committees Terms of Reference
Perform high level Requirements Analysis and Design of HITSP Interoperability Specifications, transaction packages, transactions, components, constructs including requirements analysis, and minimum data set.
Identify and analyze gaps and duplications within the standards industry as they are related to each specific Use Case.
Provide a description of the gaps, including missing or incomplete standards.
Provide a description of the duplications, overlaps, or competition among standards for the relevant Use Case.
Review and scope statements of work for each new use case.
Provide a listing of all standards that satisfy the requirements imposed by the relevant use cases as well as readiness criteria that shall be used to evaluate the standard.
Select and evaluate recommended standards to meet the relevant Use Case.
Develop, review and evaluate ‘interoperability specifications’ for the selected standards.
Submit recommendations to HITSP for review, approval and resolution.
Ensure timely response and disposition of comments.
Ensure on-going process for addressing corrections/change requests and resolutions.

14. Security and Privacy Technical Committee Terms of Reference/Charter
Harmonize HITSP standards for EHR-Lab reporting, Population Health and Consumer Empowerment with relevant Security and Privacy standards, including the HIPAA Security and Privacy Rules, and basic consents, where appropriate.
Assemble HITSP Security and Privacy Technical Committee (S&PTC) with adequate representation from each TC.
Convene regular meetings of the S&PTC to review current Interoperability Specifications and identify areas of Security and Privacy that were deferred.
Begin work on identifying security standards, approaches, and identifying unresolved issues (e.g. policy issues). Leverage activities of other Security and Privacy related workgroups.
In developing Security and Privacy related content, it will be important to maintain traceability on how existing and emerging HITSP constructs may be affected.

15. Harmonization Process Steps
The actual harmonization process is a series of steps taken by industry stakeholders within the context of HITSP
Harmonization Process Steps
Receive Request I
Harmonization Request 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

16. HITSP 2007/2008 Timeline Overview (as of Oct 2007)
07/09/07
HITSP Board
10/09/07
HITSP Board
WE ARE HERE
2/11/08
HITSP Board
05/11/07
HITSP Panel
07/16/07
HITSP Panel
09/07/07
HITSP Panel
10/15/07
HITSP Panel
12/13/07
HITSP Panel
2/20/08
HITSP Panel
3/27/08
HITSP Panel
MAY
JUNE
JULY
AUG
SEPT
OCT
NOV
DEC
JAN
FEB
MAR
APR
5/08 – 5/10
TC F2F
Arlington VA
6/18 – 6/20
TC F2F
San Diego CA
09/04 – 09/06
TC F2F
Arlington VA
10/29 – 10/31
TC F2F
Lombard IL
1/23 – 1/25
TC F2F
Chicago
3/24 – 3/26
TC F2F
DC Area
Security and Privacy for 2006 Use Cases -- EHR Lab and BIO
S&P v 1.0
EHR and BIO v 3.0
05/17 – 06/14
For major updates only….
Implementation Support, Testing, and Gap Resolution
Public Comment
Inspect Test and Public Comment
Comment Resolution and Panel Approval
Update EHR and BIO constructs
Inspect Test and Public Comment
Comment Resolution and Panel Approval
RDSS
IS Construct Development
07/20 – 08/17
08/20 – 10/15
12/10 – 1/11
1/14 – 3/27
05/17 – 07/19
Consumer Sharing , Quality and ER-EHR Use Cases
ER-EHR, CS Media and Quality v 1.0 and CS Network v 3.0
7/20 – 8/17
Implementation Support, Testing, and Gap Resolution
(with annual updates as required)
Public Comment
Inspect Test and Public Comment
Comment Resolution and Panel Approval
Requirements Design and Stndrds Selection
IS Construct Dev
05/07 – 07/10
7/11 – 9/14
9/17 – 10/12
10/15 – 12/13
Medication Management Use Case
Medications Management v 1.0
9/17 – 10/12
Implementation Support, Testing, and Gap Resolution
Public Comment
Inspect Test and Public Comment
Comment Resolution and Panel Approval
Requirements Design and Stndrds Selection
IS Construct Development
6/18 – 9/14
9/17 – 12/7
12/10 – 1/11
1/14 – 3/27

17. HITSP 2007/2008 Schedule of Meetings
9/29/08
HITSP Board
12/2/08
HITSP Board
10/15/07
HITSP Panel
2/08/08
HITSP Board
3/27/08
HITSP Panel
6/16/08
HITSP Board
10/09/07
HITSP Board
12/13/07
HITSP Panel
2/20/08
HITSP Panel
6/23/08
HITSP Panel
10/6/08
HITSP Panel
12/8/08
HITSP Panel
OCT
DEC
JAN
FEB
MAR
MAY
JUNE
SEP
OCT
DEC
10/29 – 10/31
TC F2F
Lombard, IL
1/23 – 1/25/08
TC F2F
Chicago
3/24 – 3/26/08
TC F2F
DC Area
5/12 – 5/14/08
TC F2F
TBD
9/8 – 9/10/08
TC F2F
TBD
6/11 – 6/13/08
TC F2F
DC Area
10/28 – 10/30/08
TC F2F
Chicago

18. HITSP Definition of a Standard
A standard specifies a well-defined approach that supports a business process and: (1) has been agreed upon by a group of experts; (2) has been publicly vetted; (3) provides rules, guidelines, or characteristics; (4) helps to ensure that materials, products, processes, and services are fit for their intended purpose; (5) is available in an accessible format; and (6) is subject to an ongoing review and revision process.

19. Tier 1 Standards Readiness Criteria
The standards required to support each major Use Case event were organized within an agreed upon standards taxonomy
The standards selected for inclusion in the pool were examined using ‘HITSP approved’ Tier 1 and Tier 2 Harmonization Readiness Criteria

20. Tier 2 Standards Readiness Criteria
Suitability
The standard is named at a proper level of specificity and meets technical and business criteria of use case
Compatibility
The standard shares common context, information exchange structures, content or data elements, security and processes with other HITSP harmonized standards or adopted frameworks as appropriate
Preferred Standards Characteristics
Approved standards, widely used, readily available, technology neutral, supporting uniformity, demonstrating flexibility and international usage are preferred
Standards Development Organization and Process
Meet selected criteria including balance, transparency, developer due process, stewardship and others.
Total Costs and Ease of Implementation
Deferred to future work

21. HITSP Framework Basis for Interoperability Specification Template
HITSP receives Use Cases and Harmonization Requests from external sources, such as AHIC and ONC.
The Use Case or Request defines scenarios, business actors, and business and functional/interoperability requirements.
HITSP decomposes the Use Case requirements into scenario(s) and then into transactions providing context: technical actors, actions and content. It may create or reuse a transaction or a grouping of transactions (transaction package) based on commonality at this level.
Transactions are logical groupings of actions that are decomposed into components, which are groupings of base standards that work together, such as message and terminology.
Each HITSP construct, i.e., transaction package, transaction or component, may constrain the construct or standard below it. Constraints follow a strict hierarchy and are only imposed by the next higher construct.
Transaction packages, transactions and components all are potential candidates for reuse if a new set of requirements and context are successfully fulfilled by the existing construct.
While reuse is a HITSP goal, it is established in the context of a Use Case and its functional/interoperability requirements.
HITSP constructs are version controlled and, if reused, will be uniquely identified.

22. HITSP Framework

23. Definitions and Rules Level Definition Example Rules
Use Case or Harmonization Request
Defines business/functional requirements
Sets Context
ONC EHR- Lab Use Case
Interoperability Specification
Models business/ functional/ interoperability requirements
Identifies technical/system requirements to meet use-case
Identifies how to use one or more HITSP constructs to meet use-case requirements
HITSP EHR – Lab Interoperability Specification (IS01)
Based on UML diagram to identify technical actors and actions
Sets context
Testable functional requirements
Ids transactions or transaction packages
Transaction Package
Defines how two or more transactions are used to support a stand-alone information interchange within a defined context between two or more systems
Record Locator Service
Entity Identification Service
Thin context and interoperability requirements
Testable
Based on analysis of like technical actors, context and content harmonized across transactions
May be fulfilled by one or more transactions or composite standard
Expresses constraints on the transactions or composite standard
Transaction
Logical grouping of actions, including necessary content and context, that must all succeed or fail as a group.
Query lab result
Send lab result
Fulfills all actions between two or more systems needed to meet one or more interoperability requirements
May be fulfilled by components or composite standard
Expresses constraints on components or composite standard

24. Definitions and Rules (cont.)
Level
Definition
Example
Rules
Component
An atomic construct used to support an information interchange or to meet an infrastructure requirement (e.g., security, logging/audit)
Lab result message
Lab result context
Typically will use one “primary” standard and may have other “secondary” standards
Expresses constraints on base or composite standards
Base Standard
A standard capable of fulfilling a discrete function within a single category produced and maintained by a single standards organization.
Messaging standard
Security standard
Code set.
Per HITSP definition the term “standard” refers, but is not limited to,:
Specifications
Implementation Guides
Code Sets
Terminologies
Integration Profiles
Composite Standard
Grouping of coordinated base standards, often from multiple standards organizations, maintained by a single organization. In HITSP, it can serve as a component, transaction or transaction package functional requirements..
Integration profiles
Implementation guides
Health transaction services
Per Definition above

25. Familiarization with existing HITSP Constructs
Document Naming Convention: [Document Type]_HITSP_[Document Number]_[Version]_[year]_[Short_Title]_[Date]
Example: IS_HITSP_02_v1.2_2006_Biosurveillance_ pdf
Document Type: IS (Interoperability Specification)
Document Number: 02
Version: 1.2
Year: 2006
Short Title: Biosurveillance
Date: October 20th, 2006
Document Types:
IS: Interoperability Specification ISTP: Transaction Package IST: Transaction ISC: Component 
Collectively known as “Constructs”

26. Familiarization with existing HITSP Constructs
There are three approved Interoperability Specifications:
IS-01 v1.2 EHR-Lab-Result-Reporting
IS-02 v1.2 Biosurveillance
IS-03 v1.2 Consumer Empowerment
There is also a high-level Executive Summary of the three main ISs
Each IS has a number of HITSP Constructs which it calls upon to describe the implementation of lower level, specific interactions
The beginning of each IS contains a diagrammatic overview of the lower level constructs it calls upon and their relationship to the IS

27. Technical Committee Resources
The ANSI Public Document Library is used for publicly posting completed works and related materials. It can be found on the “Document Library” links from the main HITSP site:
HITSP Interoperability Specifications (ISs) and Executive Summary can also found at which links to them directly.
The Use Cases are located in the Public Document Library in the following link:
AHIC Harmonized Use Cases
The Members Document Library is used for works in progress and can be found at:
Login using: ANSI_Membership\{your ANSI assigned user ID}
Password: {your ANSI assigned password}
Technical Committees have standing meeting times with dedicated conference bridge lines supported by various web-based collaboration tools including:
GoToMeeting: Up to 26 participants; “Meet Now” capability
GoToWebinar: Up to 1001 participants; Survey, Poll and Q &A Capabilities

28. Technical Committee Resources
Standing Conference Calls all scheduled for the TCs and Work Groups as follows:
For all standing meetings: Dial in:
Consumer Empowerment: Every Monday 12:00pm to 1:00 pm EST
Participant code:
Care Delivery: Every Monday from 3:00 -5:00pm EST.
Participant code:
Population Health: Every Monday from 1:00 -3:00 pm EST.
Participant code:
Security and Privacy: Every Thursday from 1-2pm EST
Participant code:

29. Troubleshooting
For Technical Committee related questions please contact your TC facilitators or:
Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS Vice President, Informatics HIMSS 230 East Ohio, Suite 500 Chicago, IL Phone:
Theresa Wisdom, MBA, RHIA Manager, Standards Harmonization HIMSS East Ohio, Suite 500 Chicago, IL Phone:
Jessica Kant Coordinator, Standards Harmonization Healthcare Information & Management Systems Society 230 E. Ohio St., Suite 500 Chicago, IL Phone: Fax:
For ANSI Document Library related questions please contact:
Alison Ziegler Program Administrator, Standards Panels American National Standards Institute 25 West 43rd Street New York, NY Phone:

30. Questions?
Thank you for volunteering to participate in HITSP. We cannot succeed without you!