Joyce Sensmeier MS, RN, BC, CPHIMS, FHIMSSHIMSS Vice President Informatics

August 25, 2006

Healthcare Information Technology Standards Panel (HITSP) Overview

HIMSS Advocacy & Public Policy Steering Committee

2

The purpose of this presentation is to orient the Committee by providing. . .

Information about the formation of HITSP

An overview of the HITSP Harmonization Process

Schedule and next steps

3

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

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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)

National Health Information

Network (NHIN) Architecture

Projects

The Health Information Security and

Privacy Collaboration

(HISPC)

The Certification Commission for

Health Information Technology

(CCHIT)

American Health

Information Community

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.

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.

HITSP includes 206 different member organizations and is administered by

a Board of Directors17 SDOs (8%)

161 Non-SDOs (79%) 18 Govt. bodies (8%)

10 Consumer groups (5%)

HITSP includes 206 different member organizations and is administered by

a Board of Directors17 SDOs (8%)

161 Non-SDOs (79%) 18 Govt. bodies (8%)

10 Consumer groups (5%)

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The Community formed workgroups to focus on four breakthrough areas

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.

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.

Electronic Health Record Exchange -- Deploy standardized, widely available, secure solutions for accessing laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties.

Chronic Care – Ensure that widespread use of secure messaging, as appropriate, is fostered as a means of communication between clinicians and patients about care delivery

HITSP Focus

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The HITSP team was charged with completing eleven different tasks, with current efforts focused on the harmonization process

The CommunityHHS Secretary

Mike Leavitt, Chair

Project Management TeamExecutive in Charge, F. Schrotter, ANSI

Program Manager, L. Jones GSIDeputy PM, J Corley, ATI

Project Manager, C Fantaskey, Booz Allen

Project Management TeamExecutive in Charge, F. Schrotter, ANSI

Program Manager, L. Jones GSIDeputy PM, J Corley, ATI

Project Manager, C Fantaskey, Booz Allen

Harmonization Process Delivery

Technical Manager

Joyce Sensmeier, HIMSS

Harmonization Process Delivery

Technical Manager

Joyce Sensmeier, HIMSS

Harmonization Process Definition

Technical Manager

Michelle Deane, ANSI

Harmonization Process Definition

Technical Manager

Michelle Deane, ANSI

HHS ONCHIT1 PO, Dr. John Loonsk

HHS ONCHIT1 PO, Dr. John Loonsk HITSP

Dr. John Halamka, ChairMember populated

Technical Committees

Eleven Tasks are included in this contract:

1. Comprehensive Work Plan

2. Conduct a Project Start Up Meeting

3. Deliver Recommended Use-Cases

4. Participate in related meetings and activities, including the AHIC Meetings

5. Develop a Gap Analysis

6. Standards Selection, Evaluations and Testing

7. Define a Harmonization Approach

8. Develop Interoperability Specifications

9. Develop and Evaluate a Business Plan for the self-sustaining processes

10. Submit Monthly Reports – ongoing efforts

11. Assist with communications – ongoing efforts

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The HITSP process is an open, inclusive, and collaborative process

The Community selects breakthrough areas to be worked across ONC contracts

The HITSP then charters Technical Committees to address each break through

– Identify a pool of standards for a general breakthrough area

– Identify gaps and overlaps for a specific context,

– Make recommendations to the HITSP for resolution of gaps and overlaps

– Develop instructions for using the selected standard for a specific context

– Test the interoperability specifications for using the standard

A call for participation is announced to all HITSP members

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HITSP Technical Committees Overview

•Biosurveillance

•63 members

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.

Floyd P. Eisenberg, MD MPH, SIEMENS Medical Solutions Health Services

Peter L. Elkin MD FACP, Mayo Clinic College of Medicine

Shaun Grannis, MD, The Regenstrief Institute, Indiana University School of Medicine

•Consumer Empowerment

•61 members

Allow consumers to establish and manage permissions access rights and informed consent for authorized and secure exchange, viewing, and querying of their linked patient registration summaries and medication histories between designated caregivers and other health professionals. 

Elaine A. Blechman PhD, Professor, Univ. of Colorado-Boulder

Charles Parisot, EHR Vendor Association

•Electronic Health Record

•77 members

Allow ordering clinicians to electronically access laboratory results, and allow non-ordering authorized clinicians to electronically access historical and other laboratory results for clinical care.

Jamie Ferguson, Kaiser- Permanente

John Madden, MD, PhD, SNOMED Intl

Steve Wagner, Department of Veterans Affairs

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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 & Tier 2 Harmonization Readiness Criteria.

Tier 1 Readiness Criteria

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Tier 2 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

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Current Work Technical Committees assigned to harmonize

standards that support the Community’s breakthroughs– Biosurveillance– Consumer Empowerment– Electronic Health Record exchange

Status of work productsUse Cases documented Gap and Overlap Analysis completed Standards Selection completed Interoperability Specifications – In Progress –

due Sept 29th

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The purpose of this presentation is to orient the Committee by providing. . .

Information about the formation of HITSP

An overview of the HITSP Harmonization Process

Schedule and next steps

13

I

Harmonization Request

Harmonization Process Steps

II

RequirementsAnalysis

III

Identificationof Candidate

Standards

IV

Gaps,Duplications

and Overlaps

Resolution

V

Standards Selection

VI

Constructionof

InteroperabilitySpecification

VII

InspectionTest

VIII

InteroperabilitySpecification

Releaseand

Dissemination

IXProgram Management

BeginSupport

ReceiveRequest

The actual harmonization process is a series of steps taken by industry stakeholders within the context of HITSP

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HITSP FrameworkBasis for Interoperability Specification Development

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.

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HITSP FrameworkBasis for Interoperability Specification Development

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 successful 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. The first objective for September is meeting Use Case functional/interoperability requirements.

HITSP constructs are version controlled and, if reused, will be uniquely identified.

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Use Case/Modification Request

Interoperability Specification

Transaction1… n components or composite standards

Component1... n base standards or composite standard

Base Standard

#1

Base Standard

#2

Base Standard

#3

Transaction Package1…n transactions or composite

standards

Package (Composite)

Standard

Component (Composite)

Standard

Transaction(Composite)

Standard

Pot

entia

l for

Reu

se in

Oth

er C

onte

xt

Defines and N

arrow

s Context

Policy Makers and Industry

Base Standard

#4

HITSP

Base Standard

#6

Base Standard

#7

Base Standard

#8

Base Standard

#9

Base Standard

#5

HITSP Framework

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Level Definition Example Rules

Use Case or Harmonization Request

Defines business/functional requirements

Sets Context

ONC Harmonized EHR 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 Interoperability Specification

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

Testable May be fulfilled by components or

composite standard Expresses constraints on components or

composite standard

HITSP Framework Definitions and Rules

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HITSP Framework 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

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Current HITSP Document InventoryHITSP

document number

Construct Name Type TC

02 Interoperability Specification BIO IS BIO03 Interoperability Specification CE IS CE01 Interoperability Specification EHR. IS EHR

13 Manage Sharing of Docs TP BIO, CE, EHR14 Send Lab Result Message to Ordering Clinician and Providers of Care TP BIO, EHR

18 View lab results from a web application TP EHR

24 Pseudonymize Tx BIO25 Anonymize Tx BIO

22 Patient ID Cross Referencing (IHE PIX) Tx BIO, CE, EHR23 Patient Demographics Query (IHE PDQ) Tx BIO, CE, EHR29 Notification of lab report availability Tx BIO, EHR19 Patient Registration Information Update Tx CE

41 Radiology Results Message C BIO

47 Resource Utilization Message C BIO39 Encounter Message - HL7 ADT C BIO, CE

45 Acknowledgements C BIO, CE, EHR36 Lab Report Message - HL7 2.5 (as constrained by ELINCS, etc.) C BIO, EHR37 Lab Report Document Structure C BIO, EHR32 Registration and Med History Document(s) Content C CE33 Map x12 Registration to Reg/Med Document C CE34 Map NCPDP 8.1 to Reg/Med Doc C CE35 EHR Lab Terminology C EHR44 Secure Web Connection C EHR

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The Harmonization Process – Inspection Testing

I

Harmonization Request

Harmonization Process Steps

II

RequirementsAnalysis

III

Identificationof Candidate

Standards

IV

Gaps,Duplications

and Overlaps

Resolution

V

Standards Selection

VI

Constructionof

InteroperabilitySpecification

VII

InspectionTest

VIII

InteroperabilitySpecification

Releaseand

Dissemination

IXProgram Management

BeginSupport

ReceiveRequest

We are here

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The Inspection Test is just one in a series of tests that will be performed to validate the utility of the specification

The HITSP harmonization process results in an interoperability specification that will be widely disseminated

A series of tests is required to validate the quality and usability of the specification

The first test in the series of tests is the Inspection Test

The objective of the Inspection Test is to ensure that the IS meets the requirements of the Use Case and can be used to implement the requirements

Title Due to HHS Stakeholders

Inspection Test Sept 29, 06 HITSP, EHRVA, IHE, Gov’t, others

Plan for interoperability testing

Sept 29, 06 HITSP, NIST, NLM, others

Third party testing 2007 HITSP, NIST, CCHIT

Orchestration and implementation test

2007 HITSP, IHE, FHA, EHRVA, NHIN

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The purpose of the inspection test is to ensure the Interoperability Specifications meet the following objectives

Conforms to Style and Editorial Guidelines

(Note that this will primarily be the responsibility of the HITSP project team and not the testers)

Ensure the integrity of document pieces – that all the cascading documents are present

Validate grammar, spelling, and consistency of terminologyValidate that it follows the style guide for text and graphics

Contains Accurate References and Data

Validate the references to other documents and data sources are valid and that data in tables is accurate.

Meets Use Case Requirements

Validate that the IS when implemented will meet the specific requirements as defined in the use case

Is Technically Valid Check the specification to determine the existence of the following:• Ambiguities/ lack of specificity• Inconsistencies• Gaps and overlaps• Testability• Completeness• Internal consistency• Ability to implement

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There are 8 major steps to complete the Interoperability Specification (IS) inspection test process

1. Identify and engage key volunteer test resources

2. Develop the tools and procedures for gathering and responding to test findings

3. Assign testers to IS documents

4. Distribute Interoperability Specifications to the assigned testers

5. Conduct the test and hold test monitoring sessions– including a test kickoff, mid-point test monitoring session, IS specific walkthrough sessions, and final test debrief

6. Consolidate and document test results

7. Writers analyze and disposition test defects, updating IS documents as appropriate

8. Wrap up testing and prepare for posting to HITSP.org for public comment

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The purpose of this presentation is to orient the Committee by providing. . .

Information about the formation of HITSP

An overview of the HITSP Harmonization Process

The schedule and next steps

25

Meeting Schedule

Activity Description of Activity Responsible Dates

Meetings

TC Face to Face I TC’s meet to draft Interoperability Specifications

Four Points Sheraton - Baltimore

TCs and Performance Team

TC Leadership: July 17TC: July 18 - 20

TC Face to Face II TC’s meet to finalize Interoperability Specifications

Chicago Hilton Garden Inn

TCs and Performance Team

TC Leadership: August 14TC: August 15 – 17Project team only August 18

TC Face to Face III TC’s meet to update Interoperability Specifications post Test and Comment

Crystal City Marriott at Reagan National Airport

TCs and Performance Team

TC: September 6-8

Board Meeting Board meets to review HITSP progress

Design Team Lead September 8

Panel Meeting Panel meets to approve Interoperability Specifications

Design Team Lead September 20

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Other Deliverables

Activity Description of Activity Responsible Dates

Draft Interoperability Specifications

Technical Committees meet to finalize the draft IS for inspection testing

TCs & Performance Team

July 5 – August 17 COBAugust 18 – Project team

Panel Review I: Comment and/or Inspection Test of IS

Interoperability Specification is reviewed and inspection tested by the HITSP Panel and public

Design Team Lead Posts, Performance Team manages comments

August 18 - 30

Update I: Address Comments from Review / Inspection Test

Technical Committees update Interoperability Specifications

TCs & Performance Team

August 31 – September 12

Panel Review II: Review and comment of IS updates

Posted to www.HITSP.org and review and comment thru the 19th – comment review period closes the 20th

Design Team Lead Posts, Performance Team manages comments

September 13 – 19

Panel Approval: Approval IS HITSP Panel Approves IS Panel September 20

Update II: TCs Finalize Interoperability Specifications

TC’s finalize IS for delivery to ONC TCs & Performance Team

September 20 – 25 COB

Finalize Interoperability Specifications

TCs update based on panel comments

Project Management Team

September 26 – 28 COB

Deliver Interoperability Specifications

SOW Ref # 9 Project Management Team

Friday, September 29, 2006

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Lab

Emergency

Surgical

Pharmacy

Copyright © 2002 College of American Pathologists

Building a Nationwide Health Information Network

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Contact Information

Joyce Sensmeier MS, RN, BC, CPHIMS, FHIMSS

Vice President, Informatics

Healthcare Information and Management Systems Society (HIMSS)

230 East Ohio, Suite 500

Chicago, IL 60611

312-915-9281

jsensmeier@himss.org