achieving breakthroughs towards health information exchange

Achieving Breakthroughs Towards Health Information Exchange

17th Annual Summer Institute in Nursing Informatics

July 20, 2007

Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS

2Healthcare Information Technology Standards Panel

Objectives

Examine the role of standards in providing a foundation for interoperability

Describe the current landscape for health information exchange

Explore the potential impact of the HITSP Interoperability Specifications on consumers and healthcare systems


Globally Recognized Standards: Critical to Improvements in Healthcare Delivery

Standards

– Establish a common terminology

– Facilitate interoperability and integration

– Create structured information models for data structure and interchange

– Enhance security and privacy


Standards: Necessary… not Sufficient

Standards are:

– Foundational - to interoperability and communications

– Broad - varying interpretations and implementations

– Narrow - may not consider relationships between standards domains

– Plentiful - often redundant or disjointed

– Focused - standards implementation guides typically focus on a single standard


The ability of two or more systems or components to exchange information and to use the information that has been exchanged.

Functional Interoperability

Semantic Interoperability

IEEE dictionary

What is Interoperability?


Current Landscape: Disparate vendor systems, applications, and connectivity suites

Historically, “unique” market needs within the healthcare community were addressed with customized systems, applications and standards

More than a dozen standards-setting organizations – from ANSI-accredited bodies to industry consortia and other forums – have developed a plethora of standards to meet the needs of specific sectors within the healthcare IT market

However, the disparate messaging systems, data elements and vocabulary now prevent the cross-system exchange of health information. Content, structure and transmission methods are all in HITSP scope


Impact on Healthcare ITTechnology trends can no longer develop in a void

Systems must connect with each other

– Organizational

– Local

– National

– Global

Public/Private partnerships needed


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

StandardsHarmonization


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

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 351 different member organizations and is administered by

a Board of Directors24 SDOs (7%)

248 Non-SDOs (71%) 30 Govt. bodies (9%)

13 Consumer groups (3%)36 Project Team and Undeclared

(10%)

HITSP includes 351 different member organizations and is administered by

a Board of Directors24 SDOs (7%)

248 Non-SDOs (71%) 30 Govt. bodies (9%)

13 Consumer groups (3%)36 Project Team and Undeclared

(10%)


Presidents Executive OrderFor Immediate Release

Office of the Press SecretaryAugust 22, 2006

Executive Order: Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs

Sec. 3. Directives for Agencies. Agencies shall perform the following functions:

Health Information Technology -

For Federal Agencies. As each agency implements, acquires, or upgrades health information technology systems used for the direct exchange of health information between agencies and with non-Federal entities, it shall utilize, where available, health information technology systems and products that meet recognized interoperability standards.


What is the Healthcare Information Technology Standards Panel?

The Healthcare Information Technology Standards Panel (HITSP) is a volunteer, consensus-driven organization

The Panel brings together experts from across the healthcare community – from consumers to doctors, nurses, and hospitals; from those who develop healthcare IT products to those who use them; and from the government agencies who monitor the U.S. healthcare system to those organizations who are actually writing the standards


The HITSP team is 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, Fran Schrotter, ANSI

Program Manager, Leroy Jones GSIDeputy PM, Jack Corley, ATI

Project Manager, Julie Pooley, Booz Allen

Project Management TeamExecutive in Charge, Fran Schrotter, ANSI

Program Manager, Leroy Jones GSIDeputy PM, Jack Corley, ATI

Project Manager, Julie Pooley, 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

HITSPDr. John Halamka,

ChairMember populated

Technical Committees

Eleven Tasks 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


HITSP Standards Harmonization Process

1. Identify a pool of standards for a general breakthrough area

2. Identify gaps and overlaps for a specific context

3. Make recommendations to the HITSP for resolution of gaps and overlaps

4. Develop interoperability specifications for using the selected standard for a specific context

5. Test the instruction for using the standard

Mission:To harmonize relevant standards in the health care industry to enable

and advance interoperability

The standards harmonization process is an open, inclusive,

collaborative, use case driven process

www.hitsp.org


What is a Standard?A standard specifies a well defined approach that supports a business process

and . . .

– has been agreed upon by a group of experts

– has been publicly vetted

– provides rules, guidelines, or characteristics

– helps to ensure that materials, products, processes and services are fit for their intended purpose

– is available in an accessible format

– is subject to ongoing review and revision process

Harmonization is required when a proliferation of standards prevents progress rather than enables it

HITSP Definition


HITSP formed Technical Committees to focus on AHIC breakthrough areas - Initial focus is on 4 use cases

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

Emergency Response EHR – Describes the role that an emergency responder electronic health record, comprising at minimum demographics, medication, allergy and problem list information, can be used to support emergency and routine health care activities.

Current Focus


HITSP Technical Committees and Leadership HITSP Technical Committee - Care Delivery

– James Ferguson, Kaiser Permanente– Steve Hufnagel, Department of Defense/Medical Health System– Steve Wagner, Department of Veterans Affairs

HITSP Technical Committee - Consumer Empowerment– Elaine Blechman, PhD, University of Colorado, Boulder– Charles Parisot, EHR Vendor Association– Scott Robertson, Kaiser Permanente

HITSP Technical Committee- Population Health– Floyd Eisenberg, MD, MPH, Siemens Medical Solutions– Peter Elkin, MD, Mayo Clinic College of Medicine– Shaun Grannis, MD, Department of Family Medicine, Indiana University School of Medicine

HITSP Technical Committee – Security and Privacy– Glen Marshall, Siemens Medical Solutions– John Moehrke, GE Healthcare– Walter Suarez, MD, Institute for HIPAA/HIT Education and Research


Coordinating Committees Harmonization Readiness

– Lynn Gilbertson, convener

– Develop appropriateness criteria Business Sustainability

– Steve Lieber, convener– Develop a business model that will sustain the HITSP for

as long as standards harmonization and coordination is necessary

International Standards Landscape– Bill Braithwaithe, convener– Lessons learned from the UK, Canada, Sweden

Foundations – Steve Wagner & Bob Dolin, conveners– Recommend a long-term direction for achieving standards

harmonization, collaboration and coordination


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


Technical Committees Terms of Reference

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


Security and Privacy Terms of Reference

Harmonize HITSP standards for EHR-Lab reporting, Population Health and Consumer Empowerment Use Cases with relevant Security and Privacy standards, including the HIPAA Security and Privacy Rules, and basic consents, where appropriate.

Review current Interoperability Specifications and identify areas of Security and Privacy that were deferred.

Identify security standards, approaches, and unresolved issues (e.g. policy issues)

Maintain traceability on how existing and emerging HITSP constructs may be affected when developing Security and Privacy content


I

Harmonization Request

II

RequirementsAnalysis

III

Identificationof Candidate

Standards

IV

Gaps,Duplications

and Overlaps

Resolution

V

Standards Selection

VI

Constructionof

InteroperabilitySpecification

VII

InspectionTest

VIII

InteroperabilitySpecification

Releaseand

Dissemination

IX

Program Management

BeginSupport

ReceiveRequest

Harmonization Process Steps


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

Tier 1 Standards Readiness Criteria


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


VocabularyMessaging

www.hhs.gov/fedhealtharch/standards.html

HITSP Interoperability Specifications


Standards Harmonization Objectives In order to achieve the primary goal of full healthcare interoperability,

harmonization must be achieved in five major areas:

– Context/Information Model – establishing a common reference information model to support clinical, public health, financial, and administrative healthcare functions

– Terminology/Content Definition – establishing common reference terminology models and data content specifications that are integrated with the information model

– Privacy and Security – establishing a common security framework

– Methodology – establishing a common methodology/process that all standards organizations and code set maintainers will follow to achieve standards harmonization

– Information Interchange – establishing a common information interchange format and standards-based application roles and interactions in a comprehensive dynamic model

Achievement creates a Common Standards Harmonization Framework


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.


HITSP Framework - Basis for Interoperability Specification Template

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.


HITSP Framework

Use Case

Interoperability Specification

Transaction

Component

Base Standard

#1

Base Standard

#2

Base Standard

#3

Transaction Package

Package (Composite) Standard

Component (Composite) Standard

Transaction(Composite) Standard

Po

ten

tial f

or

Re

use

in O

the

r C

on

text

De

fi nes a

nd

Na

rrow

s Co

nt e

xt

Policy Makers and Industry

Base Standard

#4

HITSP

Base Standard

#6

Base Standard

#7

Base Standard

#8

Base Standard

#9

Base Standard

#5


Level Definition Example Rules

Use Case or Harmonization Request

Defines business/functional requirements

Sets Context

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

Definitions and Rules


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


Harmonization Initiatives: Laying the Foundation for the NHIN

HITSP members and experts have committed themselves to setting and implementing standards that will ensure the integrity and interoperability of health data– In some cases, redundant or duplicative

standards will be eliminated– In other cases, new standards may be

established to span information gaps– In all cases, the resulting standards serve the

consumer and other healthcare stakeholders by addressing issues such as data accessibility, privacy and security


What did HITSP do in 2006?Established the HITSP Organization and its Committees

Created the standards harmonization process including all coordinating committee sub-processes

Harmonized 3 Use Cases and resolved three controversies along the way

– To resolve CCR v. CDA, the CCD was successfully balloted

– To resolve the need for Interim standards we accelerated CCD

– To resolve HL7 2.4 v. 2.5, ELINCS will be maintained by HL7 and an HL7 2.51 version of ELINCS will be completed by Summer 2007

To align HITSP interoperability specifications with CCHIT functional criteria, the CCHIT/HITSP Joint Working group is establishing a joint timeline for the next 3 years


Interoperability Specification Process

The specifications are intended to be used by architects and system designers as a way to guide future implementation efforts based on health IT

The specifications represent an ongoing effort to create a framework/template that represents a solution set for solving the known problems related to a Use Case


EHR- Lab Results Reporting Interoperability Specification


Biosurveillance Interoperability Specification


Consumer Empowerment Interoperability Specification


HITSP Recommended Standards – Electronic Health Record

– Clinical Laboratory Improvement Amendments (CLIA)– Health Insurance Portability and Accountability Act (HIPAA)– Health Level Seven (HL7) CDA R2 – HL7 Clinical Document

Architecture Release 2– Health Level Seven (HL7) v. 2.5, 3.0– Hypertext Transfer Protocol Secure (HTTPS)– IHE-XDS Lab – IHE Laboratory Report Document Sharing– IHE-PIX – IHE Patient Identification Cross-Referencing– IHE-PDQ – IHE Patient Demographics Query– International Organization for Standardization (ISO) ebXML– Logical Observation Identifiers Names and Codes (LOINC)– Systematized Nomenclature of Medicine –

Clinical Terms (SNOMED – CT)– Unified Code for Units of Measure (UCUM)


HITSP Recommended Standards - Biosurveillance

– Clinical Care Classification (CCC) formerly Home Healthcare Classification System

– Clinical Laboratory Improvement Amendments (CLIA)

– Current Procedural Terminology (CPT-4)

– Federal Information Processing Standards (FIPS)

– Healthcare Common Procedure Coding System (HCPCS)

– Health Insurance Portability and Accountability Act (HIPAA)

– Health Level Seven (HL7) v. 2.5

– Health Level Seven (HL7) Version 3.0 Clinical Document Architecture (CDA)

– ICD-9CM – International Classification of Diseases v. 9 Clinical Modifications & ICD-10 CM – Diagnoses and Procedures

– IHE-XDS – Integrating the Healthcare Enterprise (IHE) Cross-Enterprise Document Sharing

– IHE-XDS Lab – IHE Laboratory Report Document Sharing


HITSP Recommended Standards - Biosurveillance

– IHE-RFD – IHE Retrieve Form for Data Capture

– IHE-PIX – IHE Patient Identification Cross-Referencing

– IHE-RAD – XDS-I – IHE Cross-Enterprise Sharing of Images

– IHE-NAV – IHE Notification of Document Availability

– IHE-XDS-MS – IHE Medical Summary Document Sharing

– ISO/TC215 -DTS 25237 - Health Informatics Pseudonymization

– LOINC – Logical Observation Identifiers Names and Codes

– National Uniform Billing Committee (NUBC) UB-92 Patient Discharge Status

– NCCLS – National Committee for Clinical Laboratory Standards

– OASIS – Emergency Data Exchange Language (EDXL)

– RxNorm – National Library of Medicine (UMLS)

– Systematized Nomenclature of Medicine – Clinical Terms (SNOMED – CT)

– Unified Code for Units of Measure (UCUM)


HITSP Recommended Standards – Consumer Empowerment

– American Standards Committee (ASC) X12 Insurance/financial– CDC Race and Ethnicity Code Sets– Federal Medication Terminologies– Healthcare Provider Taxonomy– IHE-XDS – IHE Cross-Enterprise Document Sharing– IHE-PIX – IHE Patient Identification Cross-Referencing– IHE-PDQ – IHE Patient Demographics Query– Health Level Seven (HL7) CDA R2 – HL7 Clinical Document

Architecture Release 2– HL7 CCD – HL7 Clinical Document Architecture Release 2 and

ASTM E 2369-05 Standard Specification for Continuity of Care Record (CCR)

– HL7 v. 2.5, 3.0– HL7 EHR Systems Functional Model Draft Standard for

Trial Use (DSTU)– Logical Observation Identifiers Names and Codes

(LOINC)– National Council for Prescription Drug Programs (NCPDP)


HHS Secretary Michael Leavitt..

- “Accepted” all three HITSP Interoperability Specifications – December 2006

- Will “recognize” them in December 2007 assuming “minor changes of a technical nature”

- “Recognition” triggers Executive Order expectations

- Several states including Texas have introduced laws to require implementation of HITSP Interoperability Standards

Impact of 2006 HITSP Interoperability Specifications


For Federal Agencies – As each agency implements, acquires, or upgrades health information technology systems used for the direct exchange of health information between agencies and with non-Federal entities, it shall utilize, where available, health information technology systems and products that meet recognized interoperability standards.

For Contracting PurposesEach agency shall require in contracts or agreements with health care providers, health plans, or health insurance issuers that as each provider, plan, or issuer implements, acquires, or upgrades health information technology systems, it shall utilize, where available, health information technology systems and products that meet recognized interoperability standards.

August 22, 2006 President’s Executive Order

GEORGE W. BUSH, THE WHITE HOUSE


2007 – The second turn of the crank

Privacy and Security standards

Emergency First Responder– Emergency summary record

exchange– Provider authentication,

authorization and credentialing

Consumer Access to Clinical Information– Lab results as needed by

patient– List of conditions and allergies– Health problems– Diagnosis codes

Medication Management– Medication reconciliation– Pharmacy/Allergy– Monitoring of medications

Quality – Inpatient Quality Measures

(core set)– Ambulatory measures (core set)– Clinician access (self-

assessment)– Public reporting


JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

HITSP 2007 Work Plan and Schedule Overview (as of May 2007) 02/05/07

HITSP Board04/23/07

HITSP Board07/09/07

HITSP Board10/09/07

HITSP Board

03/19/07HITSP Panel

05/11/07HITSP Panel

09/07/07HITSP Panel

03/06 – 03/08TC Face to Face

Chicago IL


Arlington VA


San Diego CA


Arlington VA

Public Comment

Inspect Test and Public Comment

Implementation Support and Testing

(with annual updates as required)

Comment Resolution and Panel Approval

02/15 – 05/16

04/13 – 05/16

IS Construct Development

05/17 – 07/19 07/20 – 08/16 08/17 – 10/15

Implementation Support and Testing(includes minor document updates)

EHR, CE and BIO v 2.0

Activity 1 – Version 2.0 of Existing EHR, CE, BIO ISs

Activity 2 – Security and Privacy for All Use CasesActivity 3 – New Emergency Responder EHR Use Case

On-going Support

10/15/07HITSP Panel

07/16/07HITSP Panel

02/12/07HITSP Panel

Activity 4 –New Use Cases from AHIC

Detail Schedule to be Established Upon Review of the Use Cases

S&P and EHR-ER v 1.0

Requirements, Design, Standards Selection

Public Input on S&P

05/17 – 06/14


Resources

www.hitsp.orgwww.hhs.gov/healthit/

3 Interoperability Specifications:

IS-01 v2.0 EHR-Lab-Result-Reporting

IS-02 v2.0 Biosurveillance

IS-03 v2.0 Consumer Empowerment

ER-EHR Requirements, Design and Standards Selection (RDSS)

Security and Privacy Requirements, Design and Standards Selection (RDSS)

High Level Executive Summary


Questions?

Thank you!


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

[email protected]

achieving breakthroughs towards health information exchange

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