HL7 Version 3: Driving Interoperability & Transforming Healthcare Information Management Charles Mead, MD, MSc Director, Healthcare Information Architecture

HL7 Version 3:Driving Interoperability & Transforming

Healthcare Information Management

Charles Mead, MD, MSc

Director, Healthcare Information Architecture

Oracle Healthcare

[email protected]

BCIG Seminar

National Institutes of Health

October 14, 2004

“The great thing about standards is that there are

so many to choose from.” --- anonymous

Slide 2BCIG Seminar October 14, 2004

A Framework for Change:Bits vs Atoms

(“Being Digital,” Nicholas Negroponte)

• Atoms– Occupy proportional physical space– Cost money to move or replicate– Take time to move or replicate– Atom processing today vs 2000BC is order-of-magnitude unchanged

• Bits– Occupy disproportionately small physical space– Cost of replication not related to number of replications– Transport times virtually identical regardless of distance

• Healthcare has traditionally used atoms (paper) to move bits (information)


A Second Framework:Process vs Implementation

• Process Description: “An implementation-independent description of an activity or sequence of activities focused on accomplishing a specific goal.”

– e.g. ‘Communicate a message from Party A to Party B’

• Implementation Solution: “An implementation-specific mechanism whereby a given process is realized and achieves its stated goal. Every implementation is a set of compromises on the original Problem statement”

– e.g. Face-to-face conversation vs email vs voicemail vs US Mail

• Healthcare personnel (clinical, administrative, and financial) often confuse the (historical) paper implementation as the essential care delivery / management process.


A Third Framework:Complex Systems

• Complex System: A system composed of multiple vertical organizational levels engaged in horizontal processes that cross vertical organizational boundaries

– Problems occur at the interchange boundaries/interfaces• Duplication/redundancy of effort• Inefficiency/variability of process


The Computer-Based Patient Record• Described by 1991 IOM report: “The Computer-Based Patient Record: An Essential

Technology for Health Care”– 180 features in 12 categories. “The CPR should support…”

• direct data entry by all persons caring for a patient• measurement of health status and function (outcomes of care)• support for co-managing cost and quality of care• documentation of clinical reasoning and rationale• clinical problem solving/decision support• Problem/Condition Lists• relevant and timely linkage with all relevant patient information• layered confidentiality and audit trails• continuous (ad hoc) (authorized) user access• simultaneous user views• local and remote information access to relevant resources• existing and evolving specialty needs


What Makes the CPR so Difficult?

• Complexity of purpose

• Requirement for (computable semantic) interoperability

• Historic lack of standards facilitating (computable semantic) interoperability

– ‘Best of Breed’

• E.g. Medication allergy– Initial text capture in an anesthetic setting– Need for machine processing and decision

support in an ER setting


The National Health Information Infrastructure (NHII)

• 2004 Announcement: “An initiative set forth to improve the effectiveness, efficiency, and overall quality of healthcare in the US through the development of a comprehensive knowledge-based network of interoperable systems of clinical, public health, and personal health information that will improve decision-making by making the information available when and where it is needed. The NHII includes the set of technologies, standards, applications, systems, values, and laws that currently or will be needed to support all facets of individual health, personal healthcare, and public health.”


The Continuity of Care Record (CCR)

• 2003 initiative: “developed in response to the need to organize and make transportable a sete of basic information about a patient’s healthcare accessible to all clinicians and patients. The CCR is intended to foster and improve the continuity of care, reduce medical errors, and ensure a minimum standard of secure health information transportabiliity. Adoption of the CCR by the medical community and IT vendors will be the first step in achieving interoperability of medical records.”

• CCR is being developed by the AAFP, the Massachusetts Medical Society, the AMA, the AAP, HIMSS, American Health Care Association, and ASTM Committee E31.


The Continuity of Care Record (CCR)

• Contexts of application include– Referral– Transfer– Discharge

• Proposed components of the CCR include– Dx, Problems, and Conditions– Adverse Reactions/Alerts– Current Medications and Immunizations– VS– Lab results– Procedures and Assessments– “Extensions”


The Cancer Bioinformatics Grid (caBIG)

• 2003-04 initiative: “…An informatics infrastructure that will connect teams of cancer and biomedical researchers together to enable them to better develop and share tools and data. Standards for common vocabularies and data elements will be an integral part of the caBIG infrastructure.”


A caBIG Example(from Covitz et al, Bioinformatics, V19, N18, P2404)

• Patient presents with headache, focal weakness, history of seizures• Workup reveals glioblastoma multiforma subtype astrocytoma

• Is this tumor histology is associated with gene expression abnormalities?– Yes, in the p53 signaling pathway including BCL2, TIMP3, GADD45A, CCND1

• Is there documented evidence of aberrant expression of (e.g.) CCND1?– Yes, SAGE tags for cyclin D1 appear with 3x greater frequency in cancerous vs normal

brain tissue• Are any gene products of the p53 signaling pathway known targets for therapeutic agents?

– Yes, TP53, RB1, BCL2, CDK4, MDM2, CCNE1• Are any of the agents known to target these genes being specifically tested in glioblastoma

patients?– Yes, trials xxx and yyy are currently underway

• Research data at the point of care, Clinical data at the point of research


“Interoperability”

• Everyone in healthcare seems to want it (at least in some sense)

• What does it mean?

• Is it obtainable?

• If so, at what cost ($$, effort, etc.)?


Clinical Data Interchange Standards Consortium (CDISC)

• CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.

• CDISC’s mission is to lead the development of global, vendor-neutral, platform-independent standards to improve data quality and accelerate product development in our industry.

Protocol Std

ClinicalDocument

Architecture

DICOM

The “World of Clinical Trial Standards” (circa 2004)

International Conference on Harmonization (ICH)

U.S. Dept. of Health and Human Services(HHS)

Health Level 7 (HL7)

U.S. FDA

CDISC

TC:RCRIM

NIH/NCI NLM

EFPIA

EMEA MHLWKIKO

PhRMAJPMA

CDC

Reference Information Model

RIM

LAB

eCTD

LOINC

ISO/ANSI

SNOMED

MedDRA ODMSDS

= Organization= Dictionary, Codelist = Standard = Model = Document Standard,

or Architecture

ADaM


Health Level Seven (HL7)

• “HL7 develops specifications that enable the semantically interoperable exchange of healthcare data. ‘Data’ refers to any subject, patient, or population data required to facilitate the management or integration of any aspect healthcare including the management, delivery, evaluation of and reimbursement for healthcare services, as well as data necessary to conduct or support healthcare-related research. HL7 Specifications are created to enable the semantically interoperable interchange of data between healthcare information systems across the entire healthcare continuum.”

(C Mead paraphrase of HL7 Mission Statement)


HL7: A Brief History(www.hl7.org)

• Founded in 1987• Produced Version 1.0 and 2.0

in ‘87 and ‘88• Approved HL7 message

standards - –2.1, 2.2, 2.3, 2.3.1 and 2.4 in ‘90, ‘94, ‘97, ‘99 and ‘00

• Approved CCOW standards–1.0, 1.1, 1.2, 1.3 in ’99, ’00 and ‘01

• Approved Arden Syntax standard in ’99

• Approved XML-based Clinical Document Architecture standard in ‘00

• Accredited as an SDO by ANSI in 1994–All HL7 approvals since ‘94 are “American National Standards”

• Published implementation recommendations for:–Object broker interfacing ‘98–Secure messaging via e-mail ‘99

–HIPAA Claims attachments ‘99–XML encoding of Version 2 ’00


Syntax vs Semantics

• The dog eats red meat.• The dog eats blue trees.

• Give the patient pain medication.• Give the patient medication for pain.

• Time flies like an arrow• Fruit flies like a banana.

• Syntax Structure• Semantics Meaning• ….and then there’s Context

– ‘he threw his hat into the ring….’– ‘he’s got a chip on his shoulder…’


The Semiotic Triangle:How Humans Communicate

ThingSymbol“Shark”

(Concept)

Symbol“Shark”

Thing

Concept

“Delicious with cabernet.”

Symbol“Shark”

Thing 1

Concept 1

“A predator.”

“A guy who hustled me.”Concept 2

Thing 2


Interchange vs Interoperability

• Main Entry: in·ter·op·er·a·bil·i·ty: ability of a system ... to use the parts or equipment of another system

Source: Merriam-Webster web site

• interoperability : ability of two or more systems or components toexchange information and to predictably use the information that has been exchanged.

Source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990]

Semanticinteroperability

Syntacticinteroperability

(interchange)

Syntax Structure

Semantics Meaning


The Pillars of(Semantic) Interoperability

Necessary but not Sufficient

• Common model across all domains-of-interest– Information model vs Data model

• Model grounded on robust data type specification

• Methodology for binding terms from concept-based terminologies

• A formally defined process for defining specific structures to be exchanged between machines, i.e. a “messaging standard”

The Version 3 Tool Kit


Pillar #1: A Common Model

• The HL7 Reference Information Model (RIM) (ANSI)

• RIM203.pdf


Pillar #2: A Data Type Specification

• The HL7 Version 3 Data Type Specification (ANSI)


Data Types

• Design Goals for HL7 Data Type Specification– Coherence– Parsimony– Stability– Completeness– Simplicity

• HL7 Data Type Specification as an interoperability standard– ANSI approved– Currently in ISO process– Endorsed by CEN


Pillar #3: A Methodology for Binding to Concept-Based Terminologies

• The HL7 Version 3 Vocabulary Technical Committee

• Concept-based terminologies are essential for capturing the complexity of healthcare delivery in the context of the CPR and its derivative products

Taxonomy of Terminologies(from Ingenerf, MEDINFO Proceedings, 1995)

Dictionaries and Thesauri

Collections of terms, definitions, associations, synonyms, etc.

Classification Systems

Exhaustive concept identification

Hierarchical structure

Disjunctive

Derived from / serve a particular perspective

ICD-9

CPT

NANDA

Taxonomy of Terminologies(from Ingenerf, MEDINFO Proceedings, 1995)

Nomenclatures

Multi-axial

Combinations of atomic terms used to build complex terms

No formal grammar

C/C fx of L femur

C/C/fx of R eye

Formal Terminologies

Nomenclature + associated formal grammar

Requires tool support to enforce grammar rules during both construction and interpretation

SNOMED-CT

Grail (Galen Project, Rector et al)


Pillar #4: A Messaging Model

• The HL7 Version 3 Messaging Specifications (including Clinical Document Architecture, Release 2)

• HL7 is an ANSI Standards Development Organization

• HL7 v3 ‘Early Adopters’ Program


The HL7 V3 Messaging Standard

• Focused on information exchange that enables semantic interoperability

• All “message structures” are derived from the RIM

• Message structures defined using HL7-defined process

• Message content defined using HL7-supplied tools

• Message implementation to multiple technologies– XML– Java


Pillar #1: A Common Model

• The HL7 Reference Information Model (RIM) (ANSI)

• RIM203.pdf


What’s the RIM ‘About?’

• The set of concepts, attributes, and relationships needed to describe any aspect of healthcare

– Clinical• Patient Care• Aggregated Populations• Non-person domains-of-interest

• Veterinary• Genomics




– Administrative• Scheduling• Materials Management• Personnel Management

• Credentialing and Privileging




– Financial• Reimbursement model neutral• Supports ‘supply-chain’ approaches to patient care

(‘inventory-to-bedside’)


How Can the RIM be All Things to All Parties?

• Constructs– High-level abstract structures– Well-defined set of data types– Well-defined interfaces to terminologies

• Healthcare Domains (clinical, administrative, financial) are defined by the combination of common structures and unique terminologies


The HL7 Reference Information Model

• Motivated by need for standard to facilitate semantic interoperability

– HL7 2.x is an interchange standard

– “Too technical and abstract for domain experts (‘I can’t find the things I need to describe my domain’)”

– “Too abstract and not detailed enough for the technology cognoscenti (‘No methods, no foreign keys…worthless as a data model.’)”


The RIM BackboneEssential Structures of Healthcare

Party 1..*

0.. *Healthcare

Action

Is involved inIs involved in

involvesinvolves

• A Party (Person or Organization) is involved in zero-to-many Healthcare Actions

• A Party (Person or Organization) is involved in zero-to-many Healthcare Actions

• A Healthcare Action involves one-to-many Parties (Persons or Organizations)

• A Healthcare Action involves one-to-many Parties (Persons or Organizations)

• How do we represent a Person as both a Patient and a Clinician?

• How do we represent a Person as both a Patient and a Clinician?



Party1..* 0..* Healthcare

Actionplaysplays involvesinvolves

• A Party (Person or Organization) plays zero-to-many Roles


• How do we represent a Clinician who is a Consultant in one Healthcare Action and a Supervisor in another?

• How do we represent a Clinician who is a Consultant in one Healthcare Action and a Supervisor in another?

Role

• A Party (Person or Organization) in Role is involved in zero-to-many Healthcare Actions

• A Party (Person or Organization) in Role is involved in zero-to-many Healthcare Actions

1 0..*


Party0..*

1Role

1..*

10..*

1Participation

HealthcareAction




• A Party (Person or Organization) in a Role may assume zero-to-many Participations

• A Party (Person or Organization) in a Role may assume zero-to-many Participations

• A Party (Person or Organization) in Role assuming a Participation is involved in zero-or-one Healthcare Action

• A Party (Person or Organization) in Role assuming a Participation is involved in zero-or-one Healthcare Action


‘Collections’ using RIM Structures

• A Healthcare Action can be the source of zero-to-many Healthcare Relationships, each of which relate the source Healthcare Action to one-and-only one other Healthcare Action (the target action).

• A Healthcare Action can be the source of zero-to-many Healthcare Relationships, each of which relate the source Healthcare Action to one-and-only one other Healthcare Action (the target action).

OBS:Temp 101F

OBS:Abnormal

CXR

OBS:Elevated

WBC

AR:“is supported

by”

AR:“is supported

by”

AR:“is supported

by”

has target has target

has targethas target


OBS:Dx Pneumonia

is source foris source for

is source for

is source for

is source for

is source for

•NOTE: Each Observation is ‘Attributed’


The HL7 Reference Information Model

• Referral• Transportation• Supply• Procedure• Consent• Observation• Medication• Administrative act• Financial act

• Organization• Place• Person• Living Subject• Material

• Patient• Member• Healthcare facility• Practitioner• Practitioner assignment• Specimen• Location

Entity

1

0..*

1

0..*

Role Link

0..*

1Role

1

0..*

1

0..*

ActRelationship

1..*

10..*

1Participation Act

• Author• Reviewer• Verifier• Subject• Target• Tracker

• Has component• Is supported by

•ReducedShakespeare.ppt

State

– Definition: “A named stage in the lifecycle of an instance of a concept”

• Washing Machine• Stopped, Running (Filling, Spinning, Emptying)

• Lab order• New, Active, Suspended

– The lifecycle of a concept (i.e. valid states and transitions) is shown in a State Diagram (a visual representation of a State Machine)

• A single instance of a concept may take on one-to-many states over its ‘lifetime’

• An instance does not have to pass through all possible states in its lifetime

The State Diagram for the Act Class

Mood

– Definition: “A named description – from the perspective of a single concept – of one stage of a business cycle”

• e.g. Order/Request vs Event• In order to completely describe a business cycle (from the

perspective of a single concept), multiple instances of that concept – each with their own mood designation – must be instantiated

– The term ‘mood’ is used based on its meaning in formal grammar, where it is used to describe certain characteristics of verbs relative to time

– A concept instance can have many state (aka status) values in its life; it can have one and only one mood

Mood in HL7 V3

– Specified by the value of the ‘moodCode’ attribute in the Act class

– All instances of Act (or its subtypes) must have a value for moodCode attribute

• Once assigned (at creation time), the value of moodCode never changes

– moodCode value set is controlled by HL7

– Examples include…• Define• Order/Request• Event• Goal

Mood: Example 1– The Concept: Penicillin VK 500mg IV

– In Master Service Catalogue (orderable) DEFINE– Ordered or patients ORDER/REQUEST

• Mr. Brown TID x 10 days• Mrs. Smith QID x 7 days• Mr. Jones 2 doses STAT

– Given to patients based on order EVENT• Mr. Brown 3 x 10 = 30 events• Mrs. Smith 4 x 7 = 28 events• Mr. Jones 1 (or 2) events

– State describes single instance; mood describes multiple instances in a business process

Mood: Example 2– The Concept: Observation (Ambulatory Assessment)

– 03.06.03: “Pt will walk 20 ft without assistance in 3 weeks.”

– 03.27.03: “Pt walked 15 ft with assistance.”– 03.27.03: “Pt did not meet ambulatory goal.”

AR:“has outcome”

AR:“has explanation”

Is source for Is source for


OBS:Date: 03.27.03Goal Assmt.

moodCode: EVTValue: DNM

is source for

is source for

Is target for

Is target for

OBS:Date: 03.27.03

Amb Asmt.moodCode: EVT

Value: 15 w

OBS:Date1: 03.06.03Date2: 03.27.03

Amb. Asmt.moodCode: GOAL

Value: 20 w/o

Mood: A Final Implication

– Because an instance in ORDER mood is different from an instance in EVENT mood, it follows that the ORDER mood instance will not have any ‘value’ associated with it, while the instance in the EVENT (or GOAL) mood will have a ‘value’ associated with it.

– It follows (after a bit of thought) that Documents are collections of values which can be represented as instances of Acts in the EVENT mood

• A document instance may have a complex structure which requires consider use of ActRelationship instances

• Documents have additional semantics (discussed later)

RMIM – Specifications vs Constraints


`

The Communication Pyramid

Communication

Free-text Documents

Structured Documents

ad hoc Drawings

Non-standard Graphics

Discussions

Standardized Models (UML)Pro

blem

Probl

em

Space

Space

Solution

Solution

Space

SpaceIm

plem

enta

tion-

Inde

pend

ent

Implem

entation-Specific

Source: Charlie Mead, MD, HL7


Standards Development

XML message spec

Specification Development

HL7Documentation

Domain Experts

ICH

Requirements

CDISCSEND

FDA

Other..

HL7 RCRIM

R. Levin, EuroInterchange, May 2004 (modified by Med, Oct 2004

Implementation

FDAVendors

SROs

other


Requirements Documentation:The Problem Space Model

The “Problem Space” is defined using a combination of visual models and a rigorously-defined and linked Glossary

RequirementsDocumentation

Requirements Specification

1. Document Domain Process Flow: UML Activity Diagram

2. Capture Domain Structure: UML Class Diagram and Glossary

3. Capture Business Rules: Relationships, Triggers, and Constraints

4. Harmonize the resulting Problem Space Model with HL7 RIM etc.

Mission StatementAnd

Goals


Healthcare information management technology that supports:• Comprehensive view across entire community • Data reuse and portability• Analysis and control of patient care processes• Management of healthcare transactions




Standards-based (including HL7 v3 and RIM) application development platform to enable:

Healthcare information management technology supporting:• Comprehensive view across entire community • Data reuse and portability• Analysis and control of patient care processes• Management of healthcare transactions

HTB is a platform/framework

HTB is not an application

HTB Product Vision


Healthcare Transactions

RIM-basedEnterprise Object

Model

Check EquipmentAvailability

PerformProcedure

I need aChest X-ray

for Mr. Smith

OrderChest X-ray

ReportResult

Place Image in

RadiologistQueue

InterpretStudy

Check TechnicianAvailability

ScheduleChest X-ray


Oracle E-Business Platform

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Oracle E-Business PlatformOracle E-Business Platform

Hea

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Hea

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Clin

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Ad

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Clin

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Healthcare Transaction BaseAn interoperability framework


• Terminology Mediation• Person Services• Auditing and Security• Configuration• Workflow Integration• Message Management

• Terminology Mediation• Message Management• Security and Auditing• Person Services• Configuration• Workflow Integration

Core Services


• All terminologies managed by HTB are Concept-based – Unique internal ID– ‘Standard’ and ‘homegrown’ terminologies

managed identically

• Intra-terminology version management

• Inter-terminology cross mapping– Equivalence– Other semantic relationships (e.g. SNOMED-CT set)

Terminology Services


Message ServicesInbound

v2.x v3.0

Repository(RIM)

ApplicationProgramming

Interface

LegacySystem

InboundMessage

Processing

HL7 IFEngine

Oracle

Customer

Responsibilities

App. Dev.

HTB Applications

HL7 IFEngine


Messaging Services DetailsInbound Message Processor

AncillarySystem

v2.X

pipe&bar

InterfaceEngine(iHub)

API Based HTB Services

Configuration

Inbound Message Processor • Cross referencing external Ids• Mapping and domain validation via

Enterprise Terminology Services• Extracting data from v3XML to Value

Objects using mapping routines• Message Acknowledgement

Repository

Bu

sin

es

s A

PIs

DatabaseEntry Vehicle

PostUpdate

Workflow

CustomAcknowledge

OutboundMessageProcessor

Kickoff

V3.0

XML


Services

Mechanisms E-Signature

• Digital Signature• Message integrity• Non-repudiation• User authentication

• Integrity control• Message authentication• Access control• Encryption• Alarm• Audit control• Entity authentication• Event reporting

Services

• Emergency access• User/role/context-based access• Audit control• Consent/authorization control• Data authentication• Automatic logoff• Unique user identification

Security and AuditingHIPAA Requirements


Security and Auditing Authorization policy engine

2. HTB compiles policy rules into DB constraints

3. DB constraints associated with tables

1. Security Administrator defines policy

4. Application invokes security services

5. DB constraints attached to application queries

6. DBMS executes extended queriesData Model

HTB Applications

Security MgmtApplication

Management API Service API

Enterprise Object Model


Internet

BusinessIntelligence

DataMining

Healthcare Transaction BaseA healthcare Interoperability platform

ExternalWarehouse

DataAccess

Registries

Clinical TrialSystem (OC)

ClinicalInformation

Systems

LaboratoryInformation

Systems

HL7 IFEngine

Data Warehouse

Providers Patients Administrators Researchers

Healthcare Transaction Base

ClinicalData

Repository

• Messaging Services• Person Services• Terminology Management• Security and Auditing

NewApplications

Point of CareAppliances


• Semantic interoperability is essential if we are to solve the myriad of problems facing the healthcare delivery system

• Semantic interoperability is difficult

• Semantic interoperability is possible if the ‘Four Pillars’ are addressed

• HL7 Version 3 and the associated RIM provide a framework satisfying the ‘Four Pillars’

• Oracle is building HTB, a standards-based interoperability platform based on HL7 v3, the RIM, and the ‘Four Pillars’

Summary


AQ&Q U E S T I O N SQ U E S T I O N S

A N S W E R SA N S W E R S