Amia now! session two

Standards Influenced Research Information Systems

Interoperability

Session Two: Interoperability Specifications

AbdulMalik Shakir, Information Management StrategistCity of Hope, Duarte, CA

Standards Influenced Research Information Systems Interoperability Slied: 2 of 29

About Me

Abdul-Malik Shakir

• Information Management Strategist with City of Hope• Principal Consultant with Shakir Consulting• HL7 Member since 1991

– Co-Chair of the HL7 Education Workgroup– Member of the HL7:

• Architectural Review Board• Public Health and Emergency Response Workgroup• Regulated Clinical Research Information Management Workgroup• Modeling and Methodology Workgroup

• Member of the BRIDG Board of Directors since January 2010• Modeling Facilitator for CTR&R, SAP, STDM, and caEHR

May 2010


Research Informatics Systems Engineering

Research Informatics Systems Engineering

Systems Analysis and

Quality Assurance

Solutions Architecture and

Standards

Database Administration and

Inter-system Interface

Solutions Engineering and

Support

Research Informatics Cores

· Biomedical Research Informatics

· Translational Research Informatics

· Clinical Research Informatics

Research Admin/Operations

· Clinical Research Information Mgt

· Clinical Trial Operations

· Cancer Registry

External Research Entities

City of Hope Research

Community

External Research

Community

· National Comprehensive Cancer Network

· National Center for Research Resources

· American Society of Clinical Oncology

Information Technology

Services

Standards Development Organizations

May 2010


Session Overview• Health Information Exchange Standards

• Informatics Standards Coordination

• HITSP Interoperability Specifications

• Leading Standards Developing Organizations

• X12N and Health Level Seven

• HL7 v3 Reference Information Model

• Controlled Clinical Terminologies

• Health Information Integration Infrastructure

• COH Research Information Factory

May 2010

Health Information Exchange (HIE)

Pharmacies

Physicians

Testing OrganizationsLab/Images

Hospitals

Payors

Employers

County/Community Entities

Patients/ConsumersGovernmentMedicare/Medicaid

Lab results

Patient Data

Orders

ResultsImages

Eligibility

Referral ProcessClaim Status

Claims/Prescriptions

Referral Process

Claim/Status

Health InformationInsurance Updates

Eligibility

Medical Records

Enrollment

Mental Health

Family Planning

Medical Society

Public Health

Leading Health Information Exchange Standards

Healthcare Information System

Clinical System

Images, pictures

Bedside Instruments

Billing, claimsreimbursement

Adverse Events Reporting

Immunization Database

MaterialsManagement

Agency Reporting

ProviderRepository

HL7

HL7

HL7, X12N

HL7, X12N

HL7

HL7

DICOM

IEEE MIB,ASTM

X12N / HL7 (Non-US only)

X12N

Waveforms

Retail Pharmacy Orders & Reimbursement

NCPDP

Informatics Standards Coordination Bodies

American National Standards Institute

ANSI

Standard Developing Organizations

SDO


SDO


SDO


SDOs

Accred

its

Healthcare InteroperabilityStandards

Pro

duce

International Standards Organization

ISO / IEC

Liaison

International Healthcare Interoperability

Standards

Acc

redi

ts

Healthcare Information Technology Standards Panel

HITSP

Office of the National Coordinator for Health

Information Technology

ONC

Fo

rmed

Interoperability Specifications

Pro

duce

Adm

inisters

• IS 01 Electronic Health Record Laboratory Results Reporting

• IS 02 HITSP Biosurveillance Interoperability Specification

• IS 03 HITSP Consumer Empowerment and Access to Clinical Information via Networks Interoperability Specification

• IS 04 HITSP Emergency Responder Electronic Health Record Interoperability Specification

• IS 05 HITSP Consumer Empowerment and Access to Clinical Information via Media Interoperability Specification

• IS 06 HITSP Quality Interoperability Specification

• IS 07 HITSP Medication Management Interoperability Specification

• IS 08 Personalized Healthcare Interoperability Specification

• IS 09 Consultations and Transfers of Care Interoperability Specification

• IS 10 Immunizations and Response Management Interoperability Specification

• IS 11 Public Health Case Reporting Interoperability Specification

• IS 12 Patient-Provider Secure Messaging Interoperability Specification

• IS 77 Remote Monitoring (RMON) Interoperability Specification

• IS 91 Maternal and Child Health Interoperability Specification

• IS 92 Newborn Screening Interoperability Specification

• IS 98 Medical Home Interoperability Specification

• IS 107 EHR Centric Interoperability Specification

• IS 158 Clinical Research Interoperability Specification

HITSP Interoperability Specifications

IEEEInstitute of Electrical and Electronic

Engineers

NCPDPNational Council for Prescription

Drug Programs

X12NInsurance Subcommittee of X12

ASTMAmerican Society for Testing and

Materials

DICOMDigital Imaging and Communications

in Medicine

HL7Health Level Seven

Leading HIE Standards Developing Organizations (SDO)

Leading Healthcare Data Interchange SDOs

IEEEInstrumentation communication

standards and generalized information interchange standards

NCPDPStandards for communication of

prescription, billing, and other pharmacy material

X12NStandards for exchange of healthcare

insurance and billing information

ASTMLab reporting standards and standard

guide for content and structure of computer-based patient records

DICOMStandards for exchanging digital

radiology images and other waveform data

HL7Inter-application interoperability

standards for healthcare

• X12N and HL7 are standards development organizations accredited by the American National Standards Institute (ANSI).

• Each organization adheres to a strict and well-defined set of operating procedures that ensures consensus, openness and balance of interest.

• X12N develops specification that enable the electronic interchange of healthcare insurance and claims processing data.

• HL7 develops standards that enable disparate healthcare applications to exchange key sets of clinical and administrative data.

X12N and HL7

HL7Clinical / Administrative

X12NInsurance / Billing

ASC X12 brings together business and industry professionals in a cross-industry forum to develop and support electronic data exchange standards and related documents for the national and international marketplace to enhance business processes, reduce costs and expand organizational reach

ASC X12 Organization

X12 HIPAA Transactions• Health Claims or Equivalent Encounter Information Standard Transaction Form: X12-837 -

Health Care Claim

• Claims Payment and Remittance Advice Standard Transaction Form: X12-835 - Health Care

Claim Payment/Advice Standard

• Healthcare Claims Status Standard Transaction Form: X12-276/277 - Health Care Claim Status

Request and Response

• Coordination of Benefits Standard Transaction Form: X12-837 - Health Care Claim

• Referral Certification and Authorization Standard Transaction Form: X12-278 - Health Care

Services Review - Request for Review and Response

• Enrollment and Disenrollment in a Health Plan Standard Transaction Form: X12-834

• Premium Payments Standard Transaction Form: X12-820

• Eligibility for a Health Plan Standard Transaction Form: X12-270/271

• First Report of Injury Standard Transaction Form: X12-148

• Claims Attachments Standard Transaction Form: X12-275

Health Level Seven

• Health Level Seven (HL7) is an American National Standards Institute (ANSI) Accredited Standards Developer.

• The mission of HL7 is to provide standards for interoperability that improve care delivery, optimize workflow, reduce ambiguity and enhance knowledge transfer among its stakeholders, including healthcare providers, government agencies, the vendor community, fellow SDOs and patients.

HL7 International Affiliates

1. Affiliates Council 2. Anatomic Pathology 3. Architectural Review Board 4. Arden Syntax 5. Attachments 6. Child Health 7. Clinical Context Object Workgroup 8. Clinical Decision Support 9. Clinical Genomics 10. Clinical Interoperability Council 11. Clinical Statement 12. Common Message Element Types 13. Community Based Collaborative Care14. Domain Experts Steering Division 15. Dynamic Model 16. Education 17. Electronic Health Records 18. Electronic Services 19. Emergency Care20. Financial Management 21. Foundation and Technology Steering Division 22. Generation of Anesthesia Standards23. Governance and Operations Government Projects 24. Health Care Devices 25. Imaging Integration 26. Implementable Technology Specifications27. Implementation / Conformance

28. Infrastructure and Messaging 29. International Mentoring Committee 30. Marketing Modeling and Methodology 31. Orders and Observations 32. Outreach Committee for Clinical Research33. Patient Administration 34. Patient Care 35. Patient Safety 36. Pharmacy 37. Process Improvement 38. Project Services 39. Public Health and Emergency Response 40. Publishing 41. Regulated Clinical Research Information Management 42. RIMBAA 43. Scheduling and Logistics 44. Security 45. Services Oriented Architecture 46. Structure and Semantic Design Steering Division 47. Structured Documents 48. Technical and Support Services Steering Division 49. Technical Steering Committee 50. Templates 51. Terminfo Project 52. Tooling 53. Vocabulary

As of January 2009

HL7 Workgroups

The Family of HL7 Standards

• Standardization of knowledge representation (Arden / GELLO) • Specification of components for context management (CMA)• Standardization of clinical document structures (CDA)• Electronic Health Record System Functional Model (EHR-S)• Application protocol for electronic data exchange in healthcare

environments (messages)• Support for use of healthcare services in a Service Oriented

Architecture (SOA)• Specification of robust vocabulary definitions for use in clinical

messages and documents• Work in the area of security, privacy, confidentiality, and

accountability

Divide and Conquer / Component Reuse

DATA

Next of Kin (NK 1)

Insurance (IN1)

Patient Visit ( PV1) Patient

Demographics ( PID)

Guarantor( GT 1)

NK 1

IN1

PV1

PID

GT 1OBR

OBX

Next of KIN(NK 1)

Patient Visit(PV1)

Patient Demographics

( PID)

Abstract Message Specification

MSH Message HeaderEVNEvent TypePID Patient Identification [PD1] Additional Demographics[ { NK1 } ] Next of Kin /Associated PartiesPV1 Patient Visit[ PV2 ] Patient Visit - Additional Info.

…[ { GT1 } ] Guarantor[ { IN1 Insurance [ IN2 ] Insurance Additional Info. [ IN3 ] Insurance Add'l Info - Cert. } ]

…

[ ] optional

{ } may repeat

Segment ID Segment Name

MSH Segment DefinitionSEQ LEN DT OPT RP/# TBL# ITEM # ELEMENT NAME

1 1 ST R 00001 Field Separator2 4 ST R 00002 Encoding Characters3 180 HD O 00003 Sending Application4 180 HD O 00004 Sending Facility5 180 HD O 00005 Receiving Application6 180 HD O 00006 Receiving Facility7 26 TS O 00007 Date/Time Of Message8 40 ST O 00008 Security9 7 CM R 00009 Message Type10 20 ST R 00010 Message Control ID11 3 PT R 00011 Processing ID12 8 ID R 0104 00012 Version ID13 15 NM O 00013 Sequence Number14 180 ST O 00014 Continuation Pointer15 2 ID O 0155 00015 Accept Acknowledgment Type16 2 ID O 0155 00016 Application Ack. Type17 2 ID O 00017 Country Code18 6 ID O Y/3 0211 00692 Character Set19 60 CE O 00693 Principal Language Of Message

MSH Segment DefinitionSEQ LEN DT OPT RP/# TBL# ITEM # ELEMENT NAME

1 1 ST R 00001 Field Separator2 4 ST R 00002 Encoding Characters3 180 HD O 00003 Sending Application4 180 HD O 00004 Sending Facility5 180 HD O 00005 Receiving Application6 180 HD O 00006 Receiving Facility7 26 TS O 00007 Date/Time Of Message8 40 ST O 00008 Security9 7 CM R 00009 Message Type10 20 ST R 00010 Message Control ID11 3 PT R 00011 Processing ID12 8 ID R 0104 00012 Version ID13 15 NM O 00013 Sequence Number14 180 ST O 00014 Continuation Pointer15 2 ID O 0155 00015 Accept Acknowledgment Type16 2 ID O 0155 00016 Application Ack. Type17 2 ID O 00017 Country Code18 6 ID O Y/3 0211 00692 Character Set19 60 CE O 00693 Principal Language Of Message

SEQ - position within segment

LEN - length of field

DT - data type for field

OPT - optionality for field

RP/# - repeatability

TBL# - table number for codes

ITEM# - HL7 element number

ELEMENT NAME - name

Standards Moving in Ever-Increasing CirclesInternational

National

Inter-Enterprise

Enterprise

InstitutionSource: Gartner

HL7 v3.0 Foundational Artifacts

ReferenceInformationModel

ReferenceInformationModel

DatatypeSpecificationDatatypeSpecification

VocabularySpecificationVocabularySpecification

The HL7 Reference Information Model is the information model from which all other information models and message specifications are derived.

The HL7 Vocabulary Specification defines the set of all concepts that can be taken as valid values in an instance of a coded attribute or data type property.

The HL7 Datatype Specification defines the structural format of the data carried in an attribute and influences the set of allowable values an attribute may assume.

HL7 RIM Class Diagram

• Entitya physical thing or an organization/group of physical things capable of participating in Acts. This includes living subjects, organizations, material, and places.

• Acta discernible action of interest in the healthcare domain. An instance of Act is a record of that action. Acts definitions (master files), orders, plans, and performance records (events) are all represented by an instance of Act.

RIM Entity and Act

Entity Act

RIM Core Classes

Entity

classCode : CSdeterminerCode: CScode: CEstatusCode : CSid : II

Role

classCode : CScode: CEeffectiveTime : IVL<TS>statusCode : CSid : II

Participation

typeCode : CStime : IVL<TS>statusCode : CS

Act

classCode : CSmoodCode: CScode: CDstatusCode : CSeffectiveTime : GTSid : II

0..1

0..*1

0..*

1

0..*

Role Link

typeCode : CSeffectiveTime : IVL<TS>

Act Relationship

typeCode : CS

0..1

0..*

plays

scopes

1 1

0..* 0..*

1 1

0..* 0..*

Definition of RIM Core Classes• Act – a discernible action of interest in the healthcare domain. An instance of Act is a

record of that action. Acts definitions (master files), orders, plans, and performance records (events) are all represented by an instance of Act.

• Act relationship – an association between two Acts. This includes Act to Act associations such as collector/component, predecessor/successor, and cause/outcome. The semantics of the association is captured by the Act Relationship attributes.

• Entity - a physical thing or an organization/group of physical things capable of participating in Acts. This includes living subjects, organizations, material, and places.

• Participation – an association between a Role and an Act representing the function assumed by the Role within the context of the Act. A single Role may participate in multiple Acts and a single Act may have multiple participating Roles. A single Participation is always an association between a particular Role and a particular Act.

• Role – a classification/specialization of an Entity defined by the relationship of the playing Entity to a scoping Entity. An example of Role is “Employee”. An employee is a classification attributed to a person which has an employment relationship with an organization (Employer).

• Role Link – An association between two Roles. It is used to capture relationships that exists between Entities other than the scoping relationships. A single Role may have a Role Link with multiple other Roles. A single Role Link is always between two distinct instances of Role.

HL7 RIM Class Diagram

Controlled Clinical Terminologies

“…Behold, they are one people, and they have all one language; and this is only the beginning of what they will do; and nothing that they propose to do

will now be impossible for them.” ~ Genesis 11:6

Controlled Clinical Terminologies

• In addition to standards for data interchange, it is essential to employ a common set of clinical terminology and ontology systems.

• Clinical problems and diagnoses are usually coded with International Classification of Diseases Coding Systems (ICD-9 or ICD-10)

• Medical procedures are commonly designated using Current Procedural Terminology Codes (CPT).

• Clinical observations procedures and observation result values are encoded using a variety of standard, proprietary, and locally defined code. LOINC and SNOMED are widely utilized clinical coding schemes.

LOINC

www.regenstrief.org/loinc [GO]

http://www.regenstrief.org/loinc

SNOMED

HL7 Common Terminology Services Project Scope

• Establish a common model for terminology, and how it is related to meta-data (models of data) and data (the information itself)

• Specify both an information and functional model that addresses the relationships and use of terminology in data – how data elements are constrained to ranges of possible codes, how selection lists built and queried, how terminological information is validated.

• Specify the interactions between terminology providers and consumers – how users can submit unambiguous requests for corrections and extensions and how revisions to content are identified, distributed and integrated into running systems.

• Specify how mapping between compatible terminologies and data models is defined, exchanged and revised.

• Specify how logic-based terminologies can be queried about subsumption, classification and inferred relationships.

HL7 CTS II Conceptual Data Model

Standards Influenced Research Information Systems Interoperability

CTS II Simplified View

May 2010 Slied: 36 of 29

ParentConcept

VocabularyDomain

name : Stringdescription : String

CodedConcept

conceptCode : StringconceptDesignation : String

0..*0..*

ValueSet

name : Stringdescription : StringdefiningExpression : String

0..*

0..*

0..*

0..*0..*

0..*0..*

0..*

includes

CodeSystem

identifier : OIDname : Stringdescription : String

0..*0..*

0..*

0..1

0..*

0..1

based on

ValueSetContext

contextExpression : String

Standards Influenced Research Information Systems Interoperability

Vocabulary Binding

May 2010 Slied: 37 of 29

Vocabulary TermsVocabulary BindingInformation Model

Class

Attribute

Vocabulary Domain

Value Set CodedConcept

CodeSystem

1

0..* 0..*

0..1

0..10..*

0..*

0..*

0..* 0..*

0..*

1

0..*

0..1

Healthcare Information Integration Infrastructure

DataCollection

InboundInformationProcessing

Quality AssuranceServices

OutboundInformationProcessing

Source HealthcareInformation System

Case ManagementInformation System

CaseManagement

Information Transformation

Services

Analysis, Visualization,And Reporting

Integrated Data Repository

Business Intelligence

Environment


MetadataServices

TerminologyServices

HL7 ReferenceInformation Model

Electronic Data Interchange

DataCollection





CaseManagement


Services


Syntactic Interoperability

DataCollection






CaseManagement


Services


MetadataServices

Semantic Interoperability

DataCollection






CaseManagement


Services


MetadataServices

TerminologyServices

Semantic Data Integration

DataCollection






CaseManagement


Services



MetadataServices

TerminologyServices


Semantically Sound Business Intelligence

DataCollection






CaseManagement


Services

Analysis, Visualization,And Reporting


Business Intelligence

Environment


MetadataServices

TerminologyServices


COH Research Information Factory(Current State)

Information Technology Services Research Information Factory

COH Clinical and Administrative

Systems

Enterprise Data Warehouse

ETL

Interface Engine

Research Information

Systems

Reporting Services

COH Research Information Factory(Future State)



Systems


ETL

Interface Engine

Research Integrated Data

Repository

Research Information Systems and

Services

Research Business Intelligence

RIF Architectural Redesign

• Research Information Systems and ServicesReduce redundancies and inefficiencies in the existing application portfolio by adopting a multi-tiered service oriented architectural pattern

• Integrated Data RepositoryImplement an operational data store and data access services for shared research related data based upon the HL7 Reference Information Model

• Research Business IntelligenceExpand research analytic capabilities by implementing star schema dimensional datamart databases, data access services, and information delivery applications.

COH Research Information Factory(Future State)



Systems


ETL

Interface Engine

Research Integrated Data

Repository

Research Information Systems and

Services

Research Business Intelligence

AbdulMalik ShakirInformation Management Strategist

City of Hope1500 E. Duarte Road

Duarte, CA 91010

Office: (626) 256-4673 x63160 Mobile: (626) 644-4491Email: [email protected]