0 CBIIT’s Technology Strategy: Moving to a Semantically-Aware Services-Oriented Architecture...

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CBIIT’s Technology Strategy:Moving to a Semantically-Aware

Services-Oriented Architecture (sSOA)

Charlie Mead, MD, MScChief Technology Officer

Center for Biomedical Informatics & Information Technology

http://www.os.dhhs.gov/




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21st Century Biomedical Paradigm:A “Learning Health System”

Personalized, Predictive, Pre-emptive, Participatory…

Unifies discovery, clinical research, and clinical care (bench-bedside-back) into a seamless continuum

Accelerates the time from discovery to patient benefit

Enables a health care system, not disparate “sectors” or “silos”

Empowers consumers to manage their health over a lifetime

Results in improved clinical outcomes





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The “integrated/linked” NCI-supported Cancer Community:a complex system with diverse information exchange and behavior coordination requirements for interoperability





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Cancer Knowledge Cloud

Consumer

CommunityHospital

ResearchHospital Research

Institution

ComparativeEffectiveness

Quality

Pharmaco-Vigilance

Industry

DecisionSupport

DataAggregators

AnalyticsBiomedicalResearch

Bio-Surveillance

Practice

The “Cancer Knowledge Cloud”





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Focus on Interoperability:Describing Complex Systems

From NCICB caBIG™ to CBIIT BIG Health:– More stakeholders

– More agendas

– More complexity

Multiple vertical levels of organization and horizontal processes which – in order to produce the system’s products-of-value for its stakeholders/user – cross vertical (interface) boundaries. (adapted from Ivar Jacobson)

Experience in multiple domains has repeatedly shown that complexity is most effectively managed through layering and use of standards at the “interface boundaries.”





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Standards Development Organizations

Center for Biomedical

Informatics & Information Technology

Software Development

Companies and Open Source Community

Consume/Contribute Validate Inform

CBIIT Development:Bringing Standards to the Community

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• CBIIT consumes and develops conformant standards-based specifications to resolve business problems

• CBIIT validates the applicability of specifications via reference implementations• CBIIT informs the commercial and open-source vendor communities of the “state of the

art” by deploying/handing off its reference implementations.





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NCI sSOA: Utilizing Standards

NCI Services are based, wherever possible, on existing standards to enhance interoperability

– Payloads are derived from the HL7 v3 Reference Information Model (RIM) wherever possible• BRIDG now formally mapped to RIM

– Attributes bind to ISO 21090 data types

– Utilize standard controlled biomedical terminologies, e.g. LOINC• Mappings maintained via NCI Thesaurus

and the ISO 11179 metadata specification





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1. Enterprise-Level Interoperability– Our applications, data, and analytic services

need the capacity to connect and meaningfully exchange information and coordinate behavior.

CBIIT “BIG 3” Priorities for 2010 - 2011





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2. Enterprise Security– Develop and implement a clear, integrated

enterprise strategy and operational tactics that unify and integrate our approach to security.






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3. Deployment Support– Comprehensively support the requirements of

the 21st-century healthcare community, including• On-going stakeholder identification and

management; and

• Development of technology-independent specifications and reference implementations of software that provides clear benefit to that community.






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Preview/Press Release

Evolution, not Revolution– Architecture must support business

Problem Statement: CBIIT needs to…– define, design, develop, and deploy software

components defined as business capabilities rather than “monolithic applications;”

– certify software components at a more granular level than the current “metal level” approach;

– enable automated/semi-automated certification; and– provide technology-independent specifications that

enable organizations to build software components that will interoperate with CBIIT components.

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Semantically-AwareServices-Oriented Architecture (sSOA)

Semantics are critical to interoperability in the domain of healthcare, clinical research, and life sciences– “bedside-to-bench-and-back-and-beyond” == computable

semantic interoperability

What is a SOA?– “An technology architecture Design Paradigm which can

be applied in the context of Distributed Computing which collectively expresses a set of core Design Principles which collectively realize a set of Design Characteristics?” -- Thomas Erl, “Principles of Service Design”

caBIG 1.x is not an sSOA– Not a value judgment, just a statement of fact– “That was then, this is now…”– “Our baby is not ugly…it’s just growing up.” 12





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SOA Strategic Goals(CBIIT “semantics” frame these Goals)

Intrinsic Interoperability– Interoperability vs Integration

Increased Federation– Common endpoint and local governance

Increased business/technology alignment– Linear “degree of difficulty” for change

Increased vendor neutrality options– Specifications at a logical level (ECCF PIM)

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-- Thomas Erl, “Principles of Service Design”





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SOA Strategic Benefits (CBIIT “semantics” frame these Benefits)

Increased ROI– Reuse vs inconsistent Redundancy– Applications as “compositional aggregations”

Increased Organizational Agility– Business evolution aligned with technology flexibility

Reduced IT footprint– Elimination of redundancy and inconsistency– Elimination of one-off integration activities– Decreased governance burden

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SOA Design Principles (CBIIT “semantics” frame these Principles)

Standardized Service Contracts

Service Loose Coupling

Service Abstraction

Service Reusability

Service Autonomy

Service Statelessness

Service Discoverability

Service Composability15






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Design Principles vs Strategic Goals and Benefits– Thomas Erl, “Principles of Service Design”

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Intrinsic Inter-operability

IncreasedFederation

IncreasedBusiness/Technology Alignment

IncreasedVendor Diversification Options

IncreasedROI

IncreasedOrganiza-tionalbAgility

DecreasedIT Burden

Standard Service Contracts

Service Loose Coupling

Service Abstraction

ServiceReusability

Service Autonomy

Service Statelessness

Service Discoverability

Service Composability





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SOA Challenges

SDP increased design complexity

SDP need for Design Standards (informational, behavioral)

SDP top-down delivery requirements

SDP “counter-agile” (contract-first) design/delivery

SDP new organizational roles, relationships, responsibilities

SDP governance requirements

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Preview/Press Release

Advantages gained from sSOA: CBIIT users will realize benefits from the solution to each aspect of the Problem Statement:…– focus on business capabilities increased agility– fine-grained certification increased predictability and

reliability– automated certification increased responsiveness to

change and evolution of software components– technology-independent specifications increased vendor

participation and cross-vendor interoperability

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sSOA ServiceTaxonomy (1)

NCI uses a version of the CBDI taxonomy– Placement of a given service is purely for classification

purposes

Infrastructure/Utility– Perform “background” essential functions required

by most other services• Security• Transaction management/Auditing• Terminology Management

Core– Provide information components to Capability and

Process services• Person, Organization, Relationship management





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sSOA Service Taxonomy (2)

Capability– Provide “business atoms” from which more complex

business processes/workflows are constructed• Image Management• Lab Management

Process– Arbitrarily complex services that utilize the other

three service types to carry out business functions• Adverse Event Management• Outcomes Management





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sSOA ServiceTaxonomy (3)

Each service exposes multiple– Functional Profiles (collections of operations) bound to– Semantic Profiles (specifics of data exchanged)– Together, the F and S profiles are linked to traceable business

processes or requirements

All specifications are documented via a series of artifacts collected in a SAIF construct called the Enterprise Conformance and Compliance Framework (ECCF)– Actual “collector” is called a “Specification Stack”– A component of the HL7 Services-Aware Interoperability

Framework(SAIF)





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CBIIT Road Map to sSOA

Adoption/adaption of HL7 Services-Aware Interoperability Framework (SAIF)– CBIIT SAIF Implementation Guide (SAIF IG)

Standardization of enterprise-level components will be required– However, standardization can be viewed as “layered”

depending on its “breadth” of required interoperability• ECCF “Stairway to Heaven” quantifies degree-of-difficulty

required to achieve interoperability• Industry standards and CBIIT Design Standards Governance

Known standards that will form the basis for CBIIT-focused interoperability tapestry (e.g. caBIG®, caEHR, BIG Health)– Existing caBIG® concepts and terminologies– 21090 data types

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The SAIF/ECCF Value Proposition: (layered) Working Interoperability

Working Interoperability

“The deterministic exchange of data/information in a manner that preserves shared meaning (static & behavioral semantics)”

A − F: Trading Partners

Two trading partners interoperate based on a certified level of shared compliance to interoperability specifications/standards.

Certified level-of-conformance determines the possible degree of automated interoperability and/or the difficulty of the transformations that are required to enable interoperability.





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CBIIT Road Map to sSOAvia SAIF/ECCF

Some things will stay the same:– CBIIT focus: Support for the ongoing goals supporting

information and functional integration across and throughout the Translational Medicine Continuum…

“from bedside to bench and back…and beyond”

– Oversight of CBIIT-funded software development

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Some things will evolve:– Static data, metadata, terminology representations,

and tooling

– Application development from monolithic to service composition

– Increased emphasis on enterprise architecture

– Increased emphasis on Continuous Integration (aka BDA)

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Some things will be new:– Behavioral metadata that is defined and captured

– Artifacts that define ECCF Specification Stack instances

– Increased emphasis on automated testing/certification

– Tooling to support new data/metadata and processes

– Focus on software contracts as basis for Computable Semantic Interoperability (CSI)

– Formal requirements traceability

– Formal project and architecture governance

– Some aspects of software engineering process

– Some aspects of contracts for development organizations

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The ECCF Specification Stack





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Conformance Certification

Conformance Statements for a given SS are shown in horizontal black arrows.

Conformance Assertions for a given Technology Binding in vertical red arrows.

Conformance Statements ==Testable Requirements

Conformance Assertions ==Implementer claims

Testable via a Test Harness defined by Conformance Statements

Abstraction Layers

CIM

Technology Binding

Specification Stack

Conformance Statements




PIM PSM





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The CBIIT ECCF Implementation Guide (IG)

What it is: CBIIT’s implementation details of the HL7 “SAIF Book” (referred to as “Implementation Guide(s)” (IGs))– Information Framework– Behavior Framework– Governance Framework (reuse of standards)– Enterprise Conformance and Compliance Framework

When– ECCF IG is first

• Draft available ~May 15• Full operationalization by Fall 2010

– Semantic Infrastructure (v2) will include IF and BG IGs– Enterprise architecture governance SAIF GF IG

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Compatibility: the suggestion that one behavior may align with another

Interoperability: the predictable/reliable exchange or coordination of meaning

Guideline: a informal indication of how things should be done which can be contextually modified

Specification: an unambiguous definition of how things must be done which can be modified based on explicit rules

Compatibility vs InteroperabilityGuideline vs Specification





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Scope & Highlights Platform Specific artifacts Annotated Models (CDE’s and EVS concepts) Service Interfaces

caBIG Silver Level Compatibility Reviews 12 required artifacts 4 optional artifacts

caBIG Compatibility Guidelines:Today





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Silver Compatibility

Required Artifacts

1. PPT Presentation for Review Team (General description)

2. UML Model

3. Graphic representation of UML model

4. Semantically Annotated XMI file

5. Error Log from SIW (Semantic Integration Workbench)

6. UML Model submission form (Proof loaded into caDSR)

7. Vocabulary Report (Proof used Standard Vocabs)

8. Standards Report (Proof re-used CDE Standards for interoperability)





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Silver Compatibility (2)

Required Artifacts (continued)

9. Full CDE use report (Proof of CDEs in caDSR)

10. API description Doc (eg, Java Docs)

11. Test Scripts of API

12. Test logs of Interface/API functions

Optional Artifacts

1. Use case Document

2. Requirements/specification document

3. Implementation/Design Document

4. Test Approach Document





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caBIG Compatibility Guidelines: Today

Compatibility Guidelines Today• Platform Specific• Annotated Models

(CDE’s)• Service Interfaces





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ECCF “bullets” Layered Specification Testable Conformance (Boolean) Computable Behavioral and Static Semantics Requirements Traceability to explicit service

specifications Binding to standards when applicable

Future CBIIT Conformance Guidelines: Submission Package Non-computable artifacts (links to documents, etc.) Computable artifacts

Service Metadata (BVP, IVP, CVP, EVP) Conformance Statements (testable requirements)

CBIIT Interoperability Specifications: Tomorrow





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CBIIT Interoperability Specifications: Tomorrow Conformance Guidelines Tomorrow

• Layered Specifications• Testable Conformance• Behavioral Semantics• Traceability• Binding to standard models and data

types





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ECCF Guidelines & Artifacts: Tomorrow

Analyst/Architect

BPEL CONSOLE

ECCF Specification

ECCF Registry(Service Specifications)

Models & Bindings & Rules

CIMPIM

PSM

Wiki(Non Computable)

Automated Conformance Testing

SI Tooling SI Tooling

LoB ArtifactsProfiles/Models





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Summary: The Value of an ECCF

The enemy of Working Interoperability is implicit assumptions.– Implicit assumptions are always explicitly realized in an

implementation.

When expressed explicitly prior to the actual code, these assumptions are referred to as conformance statements.– Implementations can then make pair-wise conformance

assertions against conformance statements

– Conformance is thus testable, verifiable, and certifiable.

The ECCF provides a framework for collecting the set of artifacts with explicitly define the complexity inherent in software components.





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The BRIDG Model, V3.0

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Applying Standards for Collaboration:Clinical Research Filtered Query Service

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Evolution – not Revolution

Data Elements to Business-Level

InformationI

Business-Level Information provides

Mature Business Capabilities

IIMature Business

Capabilities organize the Knowledge Cloud

III

Data services Business Capability Services

Data models Semantic Profiles bound to service Functional Profiles





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NCI Enterprise sSOA Periodic Table of Services

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RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit

RaReferral andAuthorization

HxHx and Physical

VaValidation

EvEnterpriseVocabulary

OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management

AaAuthorization Authentication

PyPolicy





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NCI sSOA Periodic Table of Services: Infrastructure

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RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit


HxHx and Physical

VaValidation


OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management


PyPolicy

Trust Management establishes verifiable and explicit relationships between technology endpoints in the deployed architecture

Identity Management deals with identities of specific entities of interest to the organization

Authorization and Authentication Management provides a means of testing an identity against a set of credentials and explicit policy within a deployed architecture

Policy Management exposes elaborated, well-formed policies and rules that manifest the organization's permissions, prohibitions, and obligations





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NCI sSOA Periodic Table of Services: Infrastructure

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RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit


HxHx and Physical

VaValidation


OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management


PyPolicy

Service Contract Management represents a series of capabilities around the storage, versioning, and expression of the contract semantics supporting interoperability

Knowledge Management represents a series of capabilities around the storage, versioning, and expression of the semantics supporting key capabilities

Enterprise Vocabulary Management supports the management, storage, and mapping of terminologies and value sets

Validation Management verifies structural and semantic consistency across messages used in interoperability scenarios

Transformation Management provides a functional end point to manage and enact mappings between syntactically disparate information types

Auditing Management provides an interface that captures auditing information around the access to sensitive data





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NCI sSOA Periodic Table of Services:Core

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RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit


HxHx and Physical

VaValidation


OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management


PyPolicy

Organization Management establishes a central service of record for the Organization information type

Correlation Management establishes a central service of record for relationships between core information components (Persons to Organizations, etc.)

Person Management establishes a central service of record for the Person Information

Protocol Abstraction Management establishes a central service of record for non-annotated, "flat" information about Protocols and their relation to trials

Disease Management establishes a central service of record for information about various diseases found in trials

Agent Management establishes a central service of record for information about various agents found in trials





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NCI sSOA Periodic Table of Services: Capability

46

RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit


HxHx and Physical

VaValidation


OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management


PyPolicy

Specimen Management provides the core specification for specimen management from both the clinical and research perspectives regardless of the nature of specimen transactions that occur or the type of specimen

Credentialing Management allows the credentials of a given investigator to be enumerated and validated by a trusted third party

Treatment Plan Management provides the ability to create and update Treatment Plan templates, generate and view prospective calendars of patient activities, track activities as they occur, and manage patient calendars as they change during a plan

Image Management includes the ability to manage image, including intersections with order reporting.

Lab Management includes the ability to order, track, and manage laboratory orders from a clinical perspective, including intersections with specimen management and pathology reporting

Pharmacy Management includes the ability to order, track, and manage prescriptions from a clinical perspective

Scheduling Management provides the capabilities associated with scheduling a particular appointment for a particular encounter





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NCI sSOA Periodic Table of Services: Capability

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RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit


HxHx and Physical

VaValidation


OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management


PyPolicy

Data Query Management provides a consistent mechanism to query and retrieve information from information systems

SDTM Management provides a data structure that is reused in regulatory reporting

Master Problem Management establishes a central service of record for the Problems tied to patients

Allergy Management establishes a central service of record for the Allergies tied to patients





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NCI sSOA Periodic Table of Services: Process

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RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit


HxHx and Physical

VaValidation


OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management


PyPolicy

History and Physical Management provides access to patient's History and Physical document. This service will facilitate requests for and provision documents that capture the clinical history of the patient during a specific encounter

Adverse Event Management provides queries, reports adverse events and the associated work flows

Discharge Note Management provides access to a patient's Discharge Notes for a given encounter

Decision Support provides an algorithmically-neutral way to manage decision support services for patients

Referral is Management provides core capabilities needed by health care organizations to facilitate the business process of patient referrals and consultations among providers





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NCI sSOA Periodic Table of Services: Process

49

RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit


HxHx and Physical

VaValidation


OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management


PyPolicy

Protocol Management supports creation of a Study Protocol by providing a capability to create a computable part of the protocol

Trial Registration Managment provides investigators with the ability to submit descriptive information about a clinical trial. It also provides the ability to search registered trials based on various criteria

Study Outcomes Management establishes a set of reporting patterns for collecting data and validating it in order to report on a particular intervention outcome

Patient Outcomes Management provides clinicians or administrators at clinicians' offices with the ability to submit outcome data for the cancer patients. It also provides them with the ability to query the outcomes data they submitted

Eligibility Management provides the capabilities associated with establishing eligibility for a patient to register on a Study based on criteria specified in the Study Protocol





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NCI Enterprise sSOA:Periodic Table of Services

50

RRegistration

AeAdverse

Event

PtProtocol

“PR

OC

ES

S”

“CO

RE

”“C

AP

AB

ILIT

Y”

SSpecimen

ScScheduling

TxTranslation

AuAudit


HxHx and Physical

VaValidation


OOrganization

PPerson

AAgent

DDisease

CCorrelation

PaProtocol

Abstraction

DxDischarge

Note

PoPatient

Outcomes

TpTreatment

Plan

DsDecisionSupport

IImage

LLab

RxPharmacy

“Inf

ra /

UT

ILIT

Y”

CmContract

Management

MpMaster

Problem List

AyAllergy

SdSDTM

EEligibility

KmKnowledge

Management

CrCredentialing

OcStudy

Outcomes

QrData

Query

IdId

Management

TrTrust

Management


PyPolicy

NCI is continually refining our periodic table of services to reflect the needs of the cancer

research and care community





513/31/2010 51

Current State of All Services

Service # Service Name Short Description Current StatusProduct Team

Implemented

CFSS Complete

PIM Complete

PSM Complete

CFSS Complete

PIM Complete

PSM Complete

Scope Approved

CFSS Complete

PIM Complete

Scope Approved

CFSS Complete

PIM Complete

BS06 Accrual This service will support publishing/reporting requirements for both single-site and multi-site studies. I t will have separate functional profiles for each reporting destination (e.g. Coordinating Center, Regulatory Agency).

Assigned CTRP

BS07 History and Physical

The History and Physical service provides access to patient's History and Physical document. This service will facilitate requests for and provision documents that capture the clinical history of the patient during a specific encounter.

CFSS Complete caEHR

BS08 Discharge Summary

Provides access to a patient's Discharge Notes for a given encounter.

CFSS In-Progress caEHR

BS09 Consult Note Provides access to a patient's History from another Organization. CFSS In-Progress caEHR

BS10 Order Request Management

Order Request Management provides capability to manage requests for clinical services (such as Labs and Images). Part of the Request / Fulfillment Pattern.

CFSS Complete caEHR

1. Business Process Services

C3PRBS05 Randomization Randomization service provides capability to randomize a subject according to one of the predefined randomization algorithms.

Assigned

BS03 Adverse Event The Adverse Event service manages, queries, reports adverse events and the associated work flows.

caAERS

BS04 Subject Registration

The Subject Registration service provides a means to establish a subject on a trial.

C3PR

BS01 Trial Registration Service

The Trial Registration service provides investigators with the ability to submit descriptive information about a clinical trial. I t also provides the ability to search registered trials based on various criteria.

CTRP

BS02 Patient Outcomes Data Service

The Patient Outcomes Data service provides healthcare consumers, clinicians or administrators at clinicians' offices with the ability to submit outcome data for the cancer patients. I t also provides them with the ability to query the outcomes data they submitted.

CTRP





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CBIIT Service Inventory

Service # Service Name Short Description Current Status Product Team

BS11 Fulfillment Management

Fulfillment Management provides access to fulfillment of clinical services (such as Labs and Images). Part of the Request / Fulfillment Pattern.

CFSS Complete caEHR

BS12 Referral Referral is intended to provide core capabilities needed by health care organizations to facilitate the business process of patient referrals and consultations among providers.

CFSS Complete caEHR

BS13 Immunizations Immunization service establishes a central service of record for the immunizations tied to patients.

Assigned caEHR

BS14 Procedure History This service provides access to a patient's History of Procedures from another Organization.

Assigned caEHR

BS15 Decision Support This service provides an algorithmically-neutral way to manage decision support services for patients.

Assigned caEHR

BS17 Study Outcomes Study Outcomes establishes a set of reporting patterns for collecting data and validating it in order to report on a particular study's outcomes.

Not Assigned

BS19 Protocol Life Cycle Management

This service will capture protocol state modifications for a study protocol whereas Protocol Life Cycle service will support key reporting requirements as well as support other services such as Subject Registration.

Not Assigned

BS20 Eligibility Eligibility service provides the capabilities associated with establishing eligibility for a patient to register on a Study based on criteria specified in the Study Protocol.

Assigned ESST

BS21 Recruitment This is a higher level business service to identify potential candidates for a study based on high-level demographic criteria.

Not Assigned

BS22 IRB Management This will support the interactions between an Institutional Review Board and Study Coordinating Centers. This service will have interfaces with Protocol Management and Subject Management services.

Not Assigned

C3DBS18 Clinical Research Query

Clinical Research Query is based on HL7's Clinical Research Functional Query specification, I t provides an interface to an algorithm to run rules based on clinical research inclusion and exclusion criiteria.

Assigned

BS16 Protocol Management

The Protocol Management service will support creation of a Study Protocol by providing a capability to create a computable part of the protocol.

Assigned CTRP





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Scope Approved

CFSS Complete

PIM Complete

CS05 Treatment Plan Management

The Treatment Plan service provides the ability to create and update Treatment Plan templates, generate and view prospective calendars of patient activities, track activities as they occur, and manage patient calendars as they change during a plan.

CFSS Complete caEHR

CS08 Medication Medications service establishes a central service of record for the Medications tied to patients.


CS09 Clinical Statements

Clinical Statements provides an semi- or non-structured note capturing resource to coordinate patient care.

Assigned caEHR

CS10 Laboratory Management

Lab Management service includes the ability to order, track, and manage laboratory orders from a clinical perspective, including intersections with specimen management and pathology reporting.

Assigned caEHR

2. Capability Services

Scope ApprovedCFSS CompletePIM Complete

Scope ApprovedCFSS CompletePIM Complete

Image Management

Image Management service includes the ability to manage image, including intersections with order reporting.

Assigned

Specimen Management

Specimen Management Service will provide the core specification for specimen management from both the clinical and research perspectives regardless of the nature of specimen transactions that occur or the type of specimens involved in the transaction.

CFSS In-Progress

caEHR

CS07 Image Study Management

Imaging Study Management service includes the ability to order, track, and manage imaging orders, including intersections with order reporting.


CS06

CS04 Scheduled Calendar

The purpose of this service is to provide a set of interfaces to enable the creation and management of subject specific Scheduled Calendars. Combining the template with the Subject's start date allows the creation of a personalized calendar.

PSC

caEHR

CS03 Planned Calendar The purpose of this service is to provide a set of interfaces to enable the creation and management of calendar templates. A calendar template is composed of Arms, epochs, periods and activities. Activities can be scheduled to occur relative to the start of a period.

PSC

CS02

CS01 Subject Management

This service will support creation, updating, querying and deactivation of a study subject.

C3PR





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CS11 Pharmacy Pharmacy Management service includes the ability to order, track, and manage prescriptions from a clinical perspective.

Assigned caEHR

CS12 Scheduling The Scheduling service provides the capabilities associated with scheduling a particular appointment for a particular encounter.

Assigned caEHR

CS14 Clinical Data Management

CRF-based data service supporting Management and Query functional profiles for CDMS data.

Not Assigned

CS15 Prescription Prescription Management Service includes the ability to order, track and manage prescriptions from a clinical perspective.

Not Assigned

CS16 Lab Result Grading Service

This service will assess lab values against allowed range specified in the study protocol to come up with a grade for lab results. I t will support different functional profiles such as Lab, Tissue, Imaging.

Not Assigned

Specimen ID Management

This service will manage relationships between specimens and their related entities across multiple sites/applications to facilitate interoperability.

Assigned caTissue

CS17 Credentialing Credentialing Management allows the credentials of a given investigator to be enumerated and validated by a trusted third party.

Not Assigned

CS13





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CO01 Correlation Correlation Service establishes a central service of record for relationships between core information components (Persons to Organizations, etc.)

Implemented CTRP

CO04 Protocol Abstraction

The Protocol Abstraction Service establishes a central service of record for non-annotated, "flat" information about Protocols and their relation to trials.

Implemented CTRP

CO07 Master Problem List

Master Problem service establishes a central service of record for the Problems tied to patients.

Assigned caEHR

CO08 Allergy Allergy service establishes a central service of record for the Allergies tied to patients.

Assigned caEHR

CO09 Drug Drug service establishes a central service of record for the Drugs that may be tied to patients.


CO10 Agent The Agent service establishes a central service of record for information about various agents found in trials.

Not Assigned

CO11 Disease The Disease service establishes a central service of record for information about various diseases found in trials.

Not Assigned

CO12 SDTM SDTM Represents a key data structure that is reused in regulatory reporting.

Not Assigned

CO13 Mobile Services This is a service or a group of services enabling the use of mobile infrastructure for clinical trial management.

Not Defined

CO06 CRF Data Management

The CRF Data Management service manages the life cycle of templated CDA (Clinical Document Architecture) instance data. I t provides capability to instantiate, populate, submit and validate CDA-based CRFs.

Assigned

ESST

3. Core services

Implemented

Implemented CTRP

CO02 Organization Organization Service establishes a central service of record for the Organization information type.

CTRP

ESST, C3D

CO05 CRF Template Management

The Case Report Form (CRF) Template Management service manages the life cycle of CRF templates by providing capability to create, aggregate, migrate, publish and query CRF Templates.

Assigned

CO03 Person Person Service establishes a central service of record for the Person Information.





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IS01 Notification Management

Notification Management service will provide capability to create, manage and send event-based notifications to other applications and services.

Assigned caBIG Integration Hub

IS02 Messaging Messaging service will provide capability to exchange messages with other services / applications.

Assigned caBIG Integration Hub

IS03 Global Unique Identifier

This service provides capability to uniquely identify all objects (e.g. Persons, Organizations, Studies).

Scope In-Progress ESST

IS05 Id Management Identity Management deals with identities of specific entities of interest to the organization.


IS06 Trust Management Trust Management establishes verifiable and explicit relationships between technology endpoints in the deployed architecture.


IS07 Authorization Authentication

Authorization and Authentication service provides a means of testing an identity against a set of credentials and explicit policy within a deployed architecture.


IS08 Policy The Policy service exposes elaborated, well-formed policies and rules that manifest the organization's permissions, prohibitions, and obligations.


IS09 Validation The Validation service verifies structural and semantic consistency across messages used in interoperability scenarios.

Not Assigned

IS10 Transformation The Transformation service provides a functional end point to manage and enact mappings between syntactically disparate information types.

Not Assigned

IS11 Knowledge Management

Knowledge Management service represents a series of capabilities around the storage, versioning, and expression of the semantics supporting key capabilities.

Not Assigned

IS12 Service Contract Management

Service Contract Management service represents a series of capabilities around the storage, versioning, and expression of the contract semantics supporting interoperability.

Not Assigned

IS13 Enterprise Vocabulary

Enterprise Vocabulary services support the management, storage, and mapping of terminologies and value sets.

Not Assigned

IS04 Audit Management The Auditing service provides an interface that captures auditing information around the access to sensitive data.

Assigned caBIG Integration Hub, caCore

4. I nfrastructure Services





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