regulatory initiatives in hl7 using xml and structured documents

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Regulatory Initiatives in HL7 Using XML and

Structured Documents

Regulatory Initiatives in HL7 Using XML and

Structured Documents

Liora AlschulerCDISC Interchange

BethesdaSeptember 30, 2003

2

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

• Liora Alschuler• Current

– alschuler.spinosa, consultants– Co-chair HL7 Structured Documents TC & Marketing

Committee– Co-editor, Clinical Document Architecture– liora@the-word-electric.com

• Background– Broadcast engineering– Semi-conductor industry– Electronic text: 1986 -- 1998– Helped bring XML to HL7 in 1997

3

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Outline• XML +• HL7

+• CDA

+• CDISC________Starbrite Single-source trial

4

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Two observations:

• applications need to change

• data needs to persist

5

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Application-based interoperabilty

• as systems evolve, data lost, recreated or converted

6

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Information-based interoperability

• as systems evolve, data persists

7

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Two observations: corollary

• applications need to change

• data needs to persist

depreciate

appreciate

8

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Impact on Healthcare and Drug Information

• Steve Ruberg, Applied Clinical Trials, February, 2002: “The essential kernal of the whole

clinical development processs is the data… Thus, without a data-centric approach to developing any e-clinical solution, we are unlikely to be fully successful. The data is the foundation on which we build our entire effort.”

9

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

XML

• XML is about investing in information– writing code still important, but– information design should outlive system

design– information outlives the system on which it is

created

• Research and patient care share this perspective

10

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

• XML: Extensible Markup Language (www.w3.org)

• Platform and vendor independent• Data in XML persists over time• Data in XML can move between

applications

How XML puts info at the center

11

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

How XML puts info at the center

• XML makes all types of information both human readable and machine processible:

Allergies and adverse reactions:

Penicillin - hives

12

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

XML-encoded info <Section>

<code code="10123-x" codeSystem="LOINC">Allergies and Adverse Reactions</code>

<text>

<list>

<item><content>Penicillin - Hives</content></item> </list>

</text>

<component>

<Observation>

<code code="G-1001" codeSystem="SNOMED" displayName="Prior dx"/> <value xsi:type="CD" code="DF-10074" codeSystem="SNOMED"

displayName="Allergy to penicillin"/>

<pertinentInformation typeCode="MFST">

<Observation>

<code code="G-1001" codeSystem="SNOMED" displayName="Prior dx"/>

<value xsi:type="CD" code="D0-00165"

codeSystem="SNOMED" displayName="Hives"/>

</Observation>

CDA Release 2.0: Draft

human readable

machine processible

13

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

XML-encoded information

• With a few simple tags, and controlled

vocabulary, XML can describe anything• but…• the tags need to be defined:

<orderNum> : HL7: order placed<orderNum> : CDISC: visit sequence

14

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Health Level Seven

• ANSI-accredited Standards Development Organization

• Established 1987• Approx. 2000 members• 22 affiliates in Europe,

Asia-Pacific, South America, Africa

15

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

16

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

HL7• Working group meetings

– 3 times each year– about 500 attendees

Technical Steering CommitteeTechnical affairs

Appointed officers plus chairsof the committees & SIGs

Technical CommitteesCreate normative specifications

or chapters in the standard

Special Interest GroupsCollaborate in area of interest tocontribute to the work of the TCs

The Working GroupThe working HL7

Any member can registerfor any committee or SIG

Board of DirectorsBusiness affairs

Elected

The MembershipThe "real" HL7

Any member can registerfor any committee or SIG

17

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

a few of the HL7 TCs

• Modeling & Methodology• Patient Care• Orders & Observations• Structured Documents: Clinical

Document Architecture (CDA, SPL)• RCRIM: Regulated Clinical Research

Information Management• CCOW: Context Management

18

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

a few of the HL7 SIGs

• XML• Genomics• Clinical Guidelines• Electronic Health Record• JAVA• Imaging Integration• Medication

19

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

HL7 Standards

• Informative or normative• Balloting (normative)

– committee-level: 65%– membership level 90%– ANSI-certification– ISO fast track

• New: Draft Standard for Trial Use (DSTU)

20

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

HL7 Standards• Version 2.x

– used worldwide, 90% of US hospitals– “pipe & hat”: HL7-proprietary, EDI-like PID||2247^^^Primary|098018500^^^MRN||FIX-INTF^PAT||19650618|Female|

• Version 2.XML– a normative XML encoding for V2<PatientGroup>

- <PID PID07_DateOfBirth="19650618" PID08_Sex="Female"

21

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

HL7 Standards

• Version 3– based on Reference Information

Model (RIM)– technology independent: so far,

developing XML schemas, JAVA API

• RCRIM/CDISC lab reporting is a V3 draft standard, as is SPL

• First normative V3 spec was CDA

22

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

• Clinical Document Architecture• ANSI/HL7 CDA R1.0-2000• first certified XML spec for

healthcare• first balloted portion of HL7’s “V3”• first RIM-based specification• created & maintained by HL7

Structured Documents Technical Committee (SDTC)

CDA

23

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

• The scope of the CDA is the standardization of clinical documents for exchange.

• CDA enables, but does not constrain:– authoring– document management– storage– distribution– display

CDA: scope

24

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

• priority is patient care, other applications facilitated

• minimize technical barriers to implementation

• promote longevity of clinical records• scoped by exchange, independent of

transfer or storage• enable policy-makers to control

information requirements

CDA: Release 1.0

25

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Applications of the CDA…or

What can you dowith a few tags?

• access/portability/exchange– query/locate by patient, provider, practioner,

setting, encounter, date

• integration– multiple transcription systems– with EHR records

• re-use/derivative data– summaries – billing

26

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Applications of the CDA…or

What can you dowith a few tags?

• access– web portal, CCOW

(Orion, Sybase, IBM)

• integration– import into EMR (Epic)

• re-use/derivative data– V3 Rx order (MS)– ADT (Orion, Epic)– OBX (Orion, TheraDoc)

27

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

CDA: Major Implementations• PICNIC (European Union)• SCIPHOX (Germany)• HYGEIAnet/WebOnColl (Greece)• NHS South Staffordshire (United Kingdom)• Aluetietojärjestelmä (Finland)• MERIT-9 (Japan)

• e-Claims Supporting Doc Arch (Canada); HIPAA Claims Attachments (US, proposed)

• Mayo Clinic (US)• Buenos Aires project (Argentina)• Dalhousie U, QEII Health Sci Ctr (Canada)

28

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

SCIPHOX, GermanyK

ai Heitm

ann

29

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Seamless Care and CDA, FinlandAluetietojärjestelmä

• PICNIC project: integrated access

30

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

The CDA document definedANSI/HL7 CDA R1.0-2000, section 1.1:

A clinical document ... has the following characteristics: Persistence Stewardship Potential for authentication Wholeness Human readability

A CDA document is a defined and complete information object that can include text, images, sounds, and other multimedia content.

(material in blue is quoted from theClinical Document Architecture Release 1.0)

(material in blue is quoted from theClinical Document Architecture Release 1.0)

ANSI/HL7 CDA R1.0-2000, section 1.1:

A clinical document ... has the following characteristics: Persistence Stewardship Potential for authentication Wholeness Human readability

A CDA document is a defined and complete information object that can include text, images, sounds, and other multimedia content.

31

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

The CDA document defined

(material in blue is quoted from theClinical Document Architecture Release 1.0)

(material in blue is quoted from theClinical Document Architecture Release 1.0)

CDA Release 2 (draft), section 2.1:

A clinical document ... has the following characteristics: Persistence Stewardship Potential for authentication Context Wholeness Human readability

“Context - Contents of a clinical document share a common context unless all or part of that context is overridden or nullified.”

32

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

CDA documents::HL7 messages

Messages

can be the same

differ

Messages

can be the same

differ

Documents

can be the same

differ

Documents

can be the same

differ

Content

Intent & use cases

33

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

CDA documents::HL7 messages

Messages

temporary

system-to-system

... not messages

signed?legally accepted?

designed per use case

must be defined in each segment

Messages

temporary

system-to-system

... not messages

signed?legally accepted?

designed per use case

must be defined in each segment

Documents

persistent

human-to-human

care-givers are trained to create documents ...

have legal standing

defined by precedent

document as a whole

Documents

persistent

human-to-human

care-givers are trained to create documents ...

have legal standing

defined by precedent

document as a whole

Lifetime

Communication

Relationto caregivers

Legalaspects

Source

Context

34

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

• CDA documents are “human readable” =– This principle means that CDA documents

are human readable using: a) widely-available and commonly deployed

XML-aware browsers and print drivers and b) a generic CDA style sheet written in a

standard style sheet language.

• CDA documents are also “machine processable” to the degree that markup has been added– required markup provides initial

functionality– optional markup can augment processing

CDA::Readability

35

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

CDA & CDISC• eSource & electronic data capture

– redundant with creation of clinic note– require information reside in EMR/EHR– proprietary data formats

• CDA & CDISC in “single-source”– capture trial data, merge it into clinic note

(re-use)– work with current technology, workflow– open, non-proprietary data formats

36

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

CDA & CDISC in Starbrite Trial• Participants:

– CDISC– Duke Clinic– Duke Clinical Research Institute (DCRI)– Technology partners: Microsoft,

Arbortext, Topsail– Investigators

• Liora Alschuler, Landen Bain, Rebecca Kush, MD, Meredith Nahm

37

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

dblab, ADT, meds, source documents

display manual entry to CRF

re-key CRF

lab, ADT, meds, source documents

display dictate chart note

LIS

LIS

HIS

HIS

Manual creation and re-entry of CRF

Redundant creation of chart note

CLINIC CRO

validation

Current processes (dual source)

CDA & CDISC in Starbrite Trial

38

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

db

LIS

HIS

lab, ADT, meds, source documents

display eCRF

dictate chart note

Merged workflow: electronic CRF re-used in chart note

validation

Proposed processes (single source)

CLINIC ARO

CDA/ ODM

CDA & CDISC in Starbrite Trial

39

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

40

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Use of ODM & CDA in Single-source

ODM

Initiate document

Complete study-required data entry

Complete data entry for patient chart

Finalize, sign and archive

Clinical trial management

Clinical document repository (EHR)

CDA

41

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

• features:– eSource contributes to patient chart,

not the reverse– no requirement to create/extract from

EMR– fewer privacy and regulatory issues– can be driven from electronic protocol– uses HL7 CDA and CDISC ODM

CDA & CDISC in Starbrite Trial

42

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

• status:– initial study design and information

analysis complete– information design, in progress– technology design launch October 14– prototype implementation by 2/04

CDA & CDISC in Starbrite Trial

43

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

The Universal “need a hub”diagram

Shared care

Clinical trials

Public health

Orders

Quality improvement

Reimbursement

Diagnostic imaging

Pathway, guidelines

Decision support

44

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

Clinical documents are the core of healthcare information

Documenting patient care

Shared care

Clinical trials

Public health

Orders

Quality improvement

Reimbursement

Diagnostic imaging

Pathway, guidelines

Decision support

Relationships:

• Equal

• Derive

• Incorporate

• Link

• Transform

45

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

ler

selected references• Information on HL7: www.HL7.org• On SDTC: HL7.org -> TCs -> SDTC -> “Documents &

Presentations”• CDA Release One: Dolin RH, Alschuler L, Beebe C, Biron PV, Boyer

S, Essin D, Kimber E, Lincoln T, Mattison JE. The HL7 Clinical Document Architecture. J Am Med Inform Assoc. 2001;8:552-569.

• CDA Draft Release 2.0: • Paper on CDA Implementations & the EHR:

ttp://www.hl7.org/Library/Committees/structure/CDA_in_context_withpics.zip

• Recent presentations on CDA: http://www.hl7.de/cdaiw200305/• First International Conference on CDA:

http://www.hl7.de/cda2002/index.html

46

alschuler.spinosa

c op

y r igh

t 20

03

, Li o

ra A

l sc hu

lerThank you!

any questions?Thank you!

any questions?