1. FDA Data Management Council
May 16, 2007
United States Health Information Knowledgebase Meeting the Challenge of Health Care Information Integration
Laura Reece, Ph.D.
FDA Data Management Council
May 16, 2007

2. What is national health information?
National health information is information that either is national in coverage or has national relevance and relates to:
the health of the population
the determinants of the population’s health, including external factors and those internal to individuals
health programs or health services, covering information on the nature of the services provided and their management, resourcing, accessibility, use and effectiveness
the relationships among these elements

3. Why is it needed? To enable informed decision making
To guide consumers’ decisions
To provide needed information about the needs of the populations, the effectiveness of their interventions and for whom, and the acceptability of these interventions
To compare the effectiveness and efficiency of healthcare
To make decisions in health industry and governments need information about how to provide services equitably, efficiently and effectively

4. Introduction Background Standards Capabilities & Value Accomplishments
Content
Introduction
Background
Standards
Capabilities & Value
Accomplishments
Questions
How describing data using common characteristics promotes ease of comparison and interchange,
How the ISO/IEC metamodel is used to both separate and share metadata between organizations, and
How independently-developed registries can be semantically consistent when based on a common standard.

5. Introduction USHIK Goals:
To provide and maintain a metadata registry of health information data element definitions, values, and information models which will enable browsing, comparison, synchronization, and harmonization within a uniform query and interface environment.
Build, populate, demonstrate, and make available for general use a data registry to assist in cataloging and harmonizing data elements across multiple organizations.
First version of USHIK—one of the first—clean uncluttered look and integrated functionality. Based on the AIHW Australian Knowledgebase.

6. Facilitate comparison and crosswalk with existing standards and development of new metrics

7. Background Nearly a decade in existence
Collaborative effort from a changing mix of federal organizations
Based on earlier implementations
Based on national and international standard

9. USHIK Registry Contents
ANSI HL7 2.4, 2.5
ANSI X12N
ANSI ASTM
NCPDP SCRIPT, Batch, Data Dictionary
American Dental Association Specif. 2000
HIPAA
MHS Functional Area Model (FAM-A)
Public Health Care Data Standards  
IEEE: Medical Device Communications Industry Group (IEEE 1073)
NCVHS
Clinical Care Classification (Nursing Taxonomy)
DICOM (Imaging)

10. ISO/IEC 11179 a standardized way of describing information.
The USHIK is an Implementation of ISO/IEC – Information technology--Metadata registries (MDR)
ISO/IEC a standardized way of describing information.
Data Elements and their component parts
Relationships among Data Elements
Includes both Conceptual and Logical (Representational) level objects
USHIK as implementation of standard
Not all features of standard implemented – chose what was most important and applicable
Some structures added not in standard – extensions encouraged and do not invalidate “standardness”

11. ISO/IEC 11179 Data Element (DE) Standard Attributes & Relationships
Important for Semantic Understanding
Preferred Name/Context/Language
Alternative Names/Context/Language
Preferred Definition/Context/Language
Alternative Definitions/Context/Language
Example
Related Data Elements
Derived and Composite Data Elements
Registration Information
Registration Authority, Registrar
Unique Registration ID
Reg. Authority, Data ID, Version ID
Registration Status
Submitter Org, Submitter
Assigned Steward
Administrative Status and Notes
Data Element Concept
Conceptual Domain
Classification Scheme
Related Documents and URLs
Value Domain
Data Type
Min/Max Length
Low/High Value
Format
Unit of Measure
Precision
Valid Values –Value Meanings
Features of registry shown through attributes which describe data in a standardized way
We hear a lot about “Semantic Interoperability”. This slide illustrates some of the features of USHIK that are important for improving semantic understanding, data exchange, and data governance.
Important for Data Interoperability
Important for Data Governance

12. ISO/IEC 11179 Core Meta-Model
Object
Class
Property
Data
Element
Concept
Conceptual
Domain
Perception
4 corners – major AI’s in USHIK
Others – minor AI’s in USHIK
Representation
Data
Element
Value
Domain
Represen-
tation

13. ISO/IEC 11179 Core Meta-Model
Object
Class
Property
Person
Sex
1..1
1..1
0..*
0..*
Data
Element
Concept
Conceptual
Domain
Sexes
Male
Female
Other
0..*
1..1
Person.Sex
Hypothetical
Example
1..1
Perception
1..1
Representation
Sex_Code (Census)
01 – Male
02 - Female
0..*
0..*
Gender_Code (HHS)
M - Male
F – Female
O - Other
Person.Sex:Code
Data
Element
Value
Domain
Person.Gender:Code
1..1
Gender_Type (NIH)
XY - Male
XX – Female
XXY – Underdeveloped Male
XYY – Overdeveloped Male
X – Underdeveloped Female
0..*
Person.Gender:Type

14. ISO/IEC 11179 a standardized way of describing information.
The USHIK is an Implementation of ISO/IEC – Information technology--Metadata registries (MDR)
ISO/IEC a standardized way of describing information.
Data Elements and their component parts
Relationships among Data Elements
Includes both Conceptual and Logical (Representational) level objects

15. Capabilities Data elements are described in common format
High Level Information Model Assists in Grouping Data Elements
Data Elements are Linked to Model Views
Data Elements Linked by Different Organizations Appear Together
Uniform, objective comparison across multiple standards
Comparison Matrix Aids in Harmonizing Data Elements
Data Element Usage Shows Linkages Between Data Elements

16. New Capabilities
Related Data References shows relationships among data elements
Links to external sources for immediate reference and viewing “native” format
Pre-built downloadable query results updated regularly
Examples illustrating data element usage provided by the SDOs (in process)

17. Data Registry Overview
Methods of Finding Data Elements
References to Authoritative Sources
A data registry is a place to keep facts about characteristics of data that are necessary to clearly describe, inventory, analyze, and classify data.
A data registry supports data sharing with cross-system and cross-organization descriptions of common units of data.
A data registry assists users of shared data to have a common understanding of a unit of data’s meaning, representation, and identification.
Data Elements
NCPDP (National Council for Prescription Drug Program)
ABCDEFGH..
Initiatives
Data Element
Identifying and Definitional Attributes:
Data Element ID : v1
Name : Gender Code
Context : X12 Data Dictionary
Definition : Code indicating the sex of the individual
Status : Received as of 01/19/1999
Example :
Synonyms/Keywords :
Comment :
Data Collection Methods :
Relational and Representational Attributes:
Data Type : ID
Representational Form :
Representational Layout :
Minimum Size : 1
Maximum Size : 1
Unit Of Measure :
Precision :
Minimum Range :
Maximum Range :
Data Domain:
Permissible value Domain Meaning Name Domain Meaning
Definition Text
A Not Provided
B Not Applicable
F Female
M Male
N Non-sexed
U Unknown
X Unsexable
Related Data References:
Object Relationship Related Item Type
Gender Code is composite part of X12 Data Dictionary Standards
Alternate Names and Contexts:
Name Context
Gender Code X12 Data Dictionary
X12 Data Element Number
X12 (American Standards Committee)
Health Insurance Portability and Accountability Act...
Transaction Set
-Data Element
-Composite Data Element
Data Collections …
Birth Date
Hair Color
Eye Color
Sex
... …
Person_Sex
Gender
Sex_Category Code
...
HCFA Long Term Care
BRFSS
HL7 (Health Level Seven)
Reference Information Model
-Subject Area
-Class
-Attributes
Data Agreements
X12
NCVHS Core Data
NCPDP
What data elements are used?
Where are data elements defined?
AIHW (Australian Institute of Health and Welfare)
Medical Banking Architecture & Technology Project Medical Banbking Information Sharing and Analysis Center (MBISAC).
Organizations
Model -Model Subtype -Information Model
Subtype
-Data Element
-Data Concept
-Composite Data
Element
-Derived Data
CDC
AHCPR
NCVHS
Models
HL7-RIM
DoD HA FAM-D
AIHW
Data elements are described in common format.
Codes can be downloaded for use in applications.

18. Accomplishments
HIPAA – The Health Insurance Portability and Accountability Act
CHI – Consolidated Health Informatics
HITSP - Healthcare Information Technology Standards Panel
Shortened version of previous slide

19. Initiatives
HIPAA – The Health Insurance Portability and Accountability Act
Title II of HIPAA requires the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers.
CHI – Consolidated Health Informatics
Adopts a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to “speak the same language” based on common enterprise-wide business and information technology architectures.
HITSP - Healthcare Information Technology Standards Panel - The mission is to serve as a cooperative partnership between the public and private sectors for the purpose of achieving a widely accepted and useful set of standards specifically to enable and support widespread interoperability among healthcare software applications, as they will interact in a local, regional and national health information network for the United States.

20. Value Government programs can use this tool:
To compare their data elements with those in USHIK for harmonization
To develop data elements for new programs based on those in USHIK, and
To stay current with standards developing organizations (SDO’s) changes in their standards
To aid in harmonization among States & Territories
Certification authorities can use this tool:
To verify that data elements in a given EHR system are interoperable with the data elements in:
A specific interoperability criterion,
A specified data standard, or
Another specific system

21. USHIK Strategic Federal & Business Use
Contributes to President’s eGov initiative support (Consolidated Health Informatics initiative-CHI)
Value to Health Information Technology Standards Panel (HITSP)
Using USHIK in each HITSP lifecycle Phase 1: Gap Analysis & Standards Selection Phase 2: Standard Specificity Phase 3: Interoperability Specifications
Clinger-Cohen Act mandates facilitation of eGovernment – Citizen business relationships
USHIK is a focal point to publish federally designated health standards, data elements and definitions (metadata) online

22. USHIK use by HITSP Technical Committees
USHIK use by HITSP Technical Committees
To support a mapping analysis
E.g., do two standards have the same demographic variables and representations
To support the gap analysis after the standards have been selected by the Technical Committee
For comparing the required data elements of the use case with what the chosen standard contains
To objectify the standards selection process by providing a neutral, identical presentation of the candidate standards
To support giving feedback to the SDOs for improving a standard to fit the needs of the use case
Ask the SDO if some specific changes are possible to improve interoperability (cross-organizational, cross-system data sharing)
Publish choices and document for long-term maintenance

23. Viewpoint for the implementation of HITSP and ANSI Technical Committee use case
Focal point to examine Technical Committee standards, data model relationships
Uniform environment to compare, synchronize, harmonize standards overlaps – gaps

24. How AHRQ and CMS Support HITSP
By providing a USHIK health information specialist assigned to the Technical Committee for one use case
To learn the standards selection process of the HITSP TC
To provide expertise at using USHIK to answer TC questions
To provide expertise at using USHIK to present comparisons across standards requested by the TC
To display choices made by the TC in a standard metadata registry format

25. How AHRQ and CMS Support HITSP (cont.)
By providing a potential method for comparing the standards choices made by a HITSP TC with those choices made by another HITSP TC
By providing an opportunity for helping HITSP to streamline the processes of standards screening, selection, and gap analysis

26. Comparison Matrix Aids in Harmonizing Data Elements

27. Summary
USHIK
Is a Well-advanced Metadata Registry for Healthcare Information Standards
Provides Opportunity to “manage” a myriad of Standards Data Elements
Offers a Platform from which to closely examine Relationships, Overlaps, Gaps
Forms a Navigable Platform for Browsing and Viewing
Has demonstrated utility for integrating and harmonizing healthcare information standards
Built to an internationally-recognized standard

28. Demonstration Model-based navigation Comparison matrix tool
Linkage to SDO sites
Show model-drill-down
Comparison matrix
AND a new tack—linking USHIK copies of elements to SDOs live sites in order to view
a. more information
USHIK not trying to replace the SDOs.
b. “native” format of the SDO
more familiar
has more information

29. Contacts for www.USHIK.org
Michael Fitzmaurice, PhD, AHRQ
Senior Science Advisor for Information Technology Office of the Director, Agency for Healthcare Research and Quality
Laura J. Reece, Ph.D. 29

30. Discussion

31. Links to external sites by individual element

32. Links to parent generic element on WPC site

33. Related Data References example

34. Administration screen

35. Relationships to other models, agreements, collections, initiatives

36. Role-based Access

37. Secure Administrative Interface

38. Easy editing interface