1September, 2005 What IHE Delivers

ITI - Overview of Cross ITI - Overview of Cross Enterprise Document SharingEnterprise Document Sharing

(XDS) and Related Profiles(XDS) and Related Profiles(XDR, XDM)(XDR, XDM)

Emmanuel CORDONNIER (ETIAM)Emmanuel CORDONNIER (ETIAM)

IHE-Europe Booth, World of Health IT, 2006IHE-Europe Booth, World of Health IT, 2006

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User RequirementsUser Requirements

Beyond the inter-applications Beyond the inter-applications structured structured messagesmessages and and informal textual interchangesinformal textual interchanges between healthcare professionals, there is an between healthcare professionals, there is an increasing need for increasing need for interchange of medical interchange of medical documentsdocuments (structured or not) (structured or not)

Complementary to Complementary to EHR managed by healthcare EHR managed by healthcare professionalsprofessionals inside care facilities (acute and inside care facilities (acute and ambulatory care), there is an emerging need for ambulatory care), there is an emerging need for sharing medical documentssharing medical documents among these among these professionals, and with the patientprofessionals, and with the patient

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Patient « envelope » approachPatient « envelope » approach

Electronic document is the Electronic document is the intermediate intermediate objectobject enabling to manage the link enabling to manage the link between between non structured informationnon structured information (letters, dictated reports…) and (letters, dictated reports…) and the one the one managed inside medical databasesmanaged inside medical databases (EHR) (EHR)

A A patient centricpatient centric « envelope » approach « envelope » approach enables to manage the documents enables to manage the documents interchangeinterchange as well as their as well as their sharingsharing, with , with an an easy and structuring implementationeasy and structuring implementation

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HL7 Attachements (US claims)HL7 Attachements (US claims)

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DICOM E-mail (started in Germany)DICOM E-mail (started in Germany)

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Merit-9 CD in JapanMerit-9 CD in JapanHospital Clinic

Home care

CD CD

DICOMImages

Lab/HospitalDoctorsdistribution

IHE-PDI

MERIT-9

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EDISanté « MMF/MXF » in FranceEDISanté « MMF/MXF » in France

.rtf

.txt

.xml

Letter or Report with the presentation

Textual Note or ASCII encoded message (HL7…)

Structured document [with included files] (CDA…)

Other files, included into documents (XSLT…)

Tile of medical images (DICOM)

Vocal comment or physiological signal

John Smith12/30/1957

Envelope header: patient identity, documents description,author, sender, recipient…

Envelope header: patient identity, documents description,author, sender, recipient…

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Document SharingDocument Sharing

Before to address the EHR itself, the IHE Before to address the EHR itself, the IHE community has decided to work on the community has decided to work on the cross-enterprise clinical document cross-enterprise clinical document sharingsharing

This document sharing IHE XDS This document sharing IHE XDS Integration Profile is referenced in Integration Profile is referenced in numerous emerging projects around the numerous emerging projects around the World, at different levels (healthcare World, at different levels (healthcare centers and local / specialized / regional / centers and local / specialized / regional / state health networks)state health networks)

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Implementing IHE XDS in regional & national Implementing IHE XDS in regional & national projects…Todayprojects…Today

Canada Infoway

IHE InteroperabilityShowcase ‘06

Denmark (Funen)Italy (Veneto)Spain (Aragon)

Austria

THINC- New YorkNCHICA – N. Carolina

Italy (Conto CorrenteSalute)

MA-Share – MAIHIE – INMendicino - CA

FranceNational

PHR

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Acute Care (Inpatient)

GPs and Clinics (Ambulatory)

Long Term Care

Other Specialized Care(incl. Diagnostics Services)

Continuity of Care: Patient Longitudinal RecordPatient Longitudinal Record

Typically, a patient goes through a sequence of encounters in different Care Settings

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community

Clinical Encounter

Clinical IT System

RecordsRecordsSentSent

Laboratory Results Specialist Record

Hospital Record

Finding the records of a patient-Manual & tediousFinding the records of a patient-Manual & tedious

The challenge: Finding and accessing easilydocuments from other care providers In the community.

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community

Clinical Encounter

Clinical IT System Index of patients records(Document-level)

1-Patient Authorized

Inquiry

Temporary Aggregate Patient History

4-Patient data presented to

Physician

Sharing SystemSharing System

3-Records3-RecordsReturnedReturned

Referenceto records

Laboratory Results Specialist Record

Hospital Record

2-Referenceto Records for Inquiry

Sharing records that have been publishedSharing records that have been published

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Acute Care (Inpatient)

PCPs and Clinics (Ambulatory)

Long Term Care

Other Specialized Careor Diagnostics Services

Building and accessing DocumentsBuilding and accessing Documents

EHR-CR: EHR-CR: Care RecordCare Record systems systemssupportingsupporting care delivery care delivery

Documents Registry

DocumentRepository

EHR-LR:EHR-LR:Longitudinal RecordLongitudinal Recordas usedas usedacross-encountersacross-encounters

Submission of Document References

Retrieve of selected Documents

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XDS – Value PropositionXDS – Value PropositionFoundation for Health IT Infrastructures: Shared Electronic Health Record, in a community, region, etc.

Effective means to contribute and access clinical documents across health enterprises.

Scalable sharing of documents between private physicians, clinics, long term care, pharmacy, acute care with different clinical IT systems.

Easy access: Care providers are offered means to query and retrieve clinical documents of interest.

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XDS - Value PropositionXDS - Value PropositionDistributed: Each Care delivery organization “publishes” clinical information for others. Actual documents may remain in the source EHR-CR.

Cross-Enterprise: A Registry provides an index for published information to authorized care delivery organizations belonging to the same clinical affinity domain (e.g. an LHII).

Document Centric: Published clinical data is organized into “clinical documents”. using agreed standard document types (HL7-CDA, ASTM-CCR, PDF, DICOM, etc.)

Document Content Neutral: Document content is processed only by source and consumer IT systems.

Standardized Registry Attributes: Queries based on meaningful attributes ensure deterministic document searches.

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XDS DocumentXDS Document

XDS Submission SetXDS Submission Set

XDS FolderXDS Folder

IHE XDS Integration Profile: Key ConceptsKey Concepts

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SubmissionSet

Folder

XDS : conceptsXDS : concepts

DocumentDocument

Document

FolderFolder

Documents server (registry-repository)

Submission

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XDS DocumentXDS Document

A set of attested clinical information (structured or not) which A set of attested clinical information (structured or not) which form an element of a patient record to be shared. It may form an element of a patient record to be shared. It may already exist within the source IT system.already exist within the source IT system.

XDS Submission SetXDS Submission Set

A set of documents related to a patient that a (team of) A set of documents related to a patient that a (team of) clinician(s) in the same source system have decided to make clinician(s) in the same source system have decided to make available to potential consumers.available to potential consumers.

XDS FolderXDS FolderA means to group documents for a number of other reasons:A means to group documents for a number of other reasons:

Team work across several physicians,Team work across several physicians,

Episode of care, Episode of care,

Emergency information for a patient, etc.Emergency information for a patient, etc.

XDS leaves open the use of folders to affinity domain clinicians.XDS leaves open the use of folders to affinity domain clinicians.

IHE XDS Integration Profile: Key ConceptsKey Concepts

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Cardiac Care Scenario (1)Cardiac Care Scenario (1)

PCP

Cardiologist

Laboratory

Radiology

Folder

SubmissionSet

XDSDocument

CardiacCardiacAssessmentAssessment

3&9

2 4

1

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Cardiac Care Scenario (2)Cardiac Care Scenario (2)

PCP Ward

Lab

Cardiologist

Local Hospital

Emergency Room

Cath Lab

Laboratory

Radiology

Folder

SubmissionSet

XDSDocument

RehabTherapist Cardiac

Assessment

3&9

2 4

Cardiac treatment

86&8

710

1

5

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Document Source

Document Registry

Document Repository

Provide&Register Document Set

Register Document Set

XDS : diagramXDS : diagram

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Document Consumer

Retrieve Document

Query Documents

Document Source

Document Registry

Document Repository

Provide&Register Document Set

Register Document Set

XDS : diagramXDS : diagram

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Document Consumer

Retrieve Document

Query Documents

Patient Identity Source

Patient Identity Feed

Document Source

Document Registry

Document Repository

Provide&Register Document Set

Register Document Set

XDS : diagramXDS : diagram

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XDS: standards usedXDS: standards used

ebXML Registry ServicesebXML Registry Services

SOAP with attachments et ebXML SOAP SOAP with attachments et ebXML SOAP Messaging ServicesMessaging Services

Méta-data based on HL7 CDA with HL7 v2.5 Méta-data based on HL7 CDA with HL7 v2.5 content for ids (patient, prof/org)content for ids (patient, prof/org)

On line (HTTP) or optional off-line (SMTP) On line (HTTP) or optional off-line (SMTP) submission of documentsubmission of document

On-line (HTTP) SQL query with recent stored On-line (HTTP) SQL query with recent stored queries on Web Servicesqueries on Web Services

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XDS: meta-dataXDS: meta-data

Patient:Patient: Affinity domain Affinity domain id, demographics (id, id, demographics (id, name, birthdate…) « as viewed by the source »name, birthdate…) « as viewed by the source »

Origin:Origin: ( (authorauthor, , institutioninstitution, validator), validator)

Identification:Identification: ( (ID indexID index, , repositoryrepository URIURI, , unique unique idid, dates of , dates of creationcreation et et start /end of medical actstart /end of medical act, , title, title, sizesize, , hashhash, , statusstatus, parent document), parent document)

Classification:Classification: ( (classeclasse, , typetype, , formatformat, , MIME typeMIME type, , typetype and and specialty ofspecialty of institutioninstitution and and authorauthor, , medical codes, medical codes, confidentiality levelconfidentiality level)) RequiredRequired, , if knownif known, , generated by repositorygenerated by repository, Recommended, Recommended

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XDR / XDMXDR / XDM Uses CasesUses Cases

Specialist, Radio or LabGP / PCP Doctor A

Care Facility Hospital Acute

Care / ED

Patient TransferPatient Transfer

Personal Health Record (PHR)Personal Health Record (PHR)to ED/Primary Care EMRto ED/Primary Care EMR

Acute Care DischargeAcute Care Dischargeto Extended Care Facility (ECF)to Extended Care Facility (ECF)

Remote adviceRemote advice

Consulting to referring physicians Consulting to referring physicians

Hospital-doctorHospital-doctor communicationcommunication

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XDR / XDM Value propositionXDR / XDM Value proposition

Complementary to sharing documents (XDS), Complementary to sharing documents (XDS), point-to-point communication of documentspoint-to-point communication of documents

Both transports: secured mail & media (CD…)Both transports: secured mail & media (CD…)

As XDS, “document content agnostic”As XDS, “document content agnostic”

Maximal re-use of XDS objects & meta-dataMaximal re-use of XDS objects & meta-data

Compatible with exchange of images (PDI…)Compatible with exchange of images (PDI…)

All XDS “content profiles” applyAll XDS “content profiles” apply

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XDR / XDM ScopeXDR / XDM Scope

Interchange of patient centered documentsInterchange of patient centered documents

Transmission of results, discharge letters or Transmission of results, discharge letters or patient referrals (not the "workflow" itself but patient referrals (not the "workflow" itself but all the medical information associated with - all the medical information associated with - e.g. reports, results, images, signals…)e.g. reports, results, images, signals…)

Personal Health Record medical information Personal Health Record medical information (history, etc), snapshots of clinical information (history, etc), snapshots of clinical information (medication list, immunization records, etc), (medication list, immunization records, etc), current observations from home care medical current observations from home care medical devices (e.g. blood pressure, blood sugar devices (e.g. blood pressure, blood sugar level, etc). level, etc).

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XDR / XDM Key Technical XDR / XDM Key Technical PropertiesProperties

Re-uses XDS approach for documentsRe-uses XDS approach for documents SubmissionSet, DocumentEntrySubmissionSet, DocumentEntry ebRS based XML meta-data w. limited extensionsebRS based XML meta-data w. limited extensions

Secure e-mail (ebMS over SMTP, S/MIME)Secure e-mail (ebMS over SMTP, S/MIME)

Optional on-line protocol (similar to XDS)Optional on-line protocol (similar to XDS)

PDI like media profile with XDS meta-dataPDI like media profile with XDS meta-data

Potential association of XDS and PDI at the actor Potential association of XDS and PDI at the actor level (Document Source…)level (Document Source…)

Further evolution possible for direct interchange Further evolution possible for direct interchange over web services (MTOM…) over web services (MTOM…)

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XDR DiagramXDR Diagram

Provide and Register Document Set [ITI-15]

Document Source Document Recipient

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XDR in conjunction with XDSXDR in conjunction with XDS

Document Source

Document ConsumerDocument Repository

Document Registry

Document Recipient

XDR

Document Recipient

Document Source

XDR

XDS

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XDR off-line messageXDR off-line messageProtocol encapsulation in SMTP/ESMTP

SOAP with MIME attachments (multipart/related)

text/xml SOAP:Envelope

SOAP:Header, with Service=LifeCycleManager and Action=submitObjects

SOAP:Body, with Manifest=list of attachments (e.g. ebXML Reg. Msg + Documents)

Part 1 (start)Part 1 (start)

text/xml SubmitObjectRequest (ebXML Registry Message)Part 2Part 2

Document 1 Part 3Part 3

Document n

.

.

.

Part n+2Part n+2

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XDR Actors and OptionsXDR Actors and Options

Actor Options Vol &Section

Document Source Multiple Document Submission

ITI TF-1:15.2.1

On-Line Mode ITI TF-1:15.2.2

Document Recipient On-Line Mode ITI TF-1:15.2.2

Note 1: At least one of these options is required for each Actor.Note 1: At least one of these options is required for each Actor.

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XDR Integration Profile OptionsXDR Integration Profile Options

Multiple Documents Submission Option Multiple Documents Submission Option Offers the ability to include multiple documents in Offers the ability to include multiple documents in

a single Submission Requesta single Submission Request

On-Line Mode Option On-Line Mode Option Offers the ability to send the set of documents to Offers the ability to send the set of documents to

one unique recipient, using a HTTP web-service one unique recipient, using a HTTP web-service based on-line transmission mode. based on-line transmission mode.

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Diagramme XDMDiagramme XDM

Portable Media Importer

Portable Media Creator

Distribute Document Set on Media [ITI-32]

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XDM Actors and OptionsXDM Actors and Options

Actor Options Vol &Section

Portable Media Creator USB (Note 1) ITI TF-1:15.2.3

CD-R (Note 1) ITI TF-1:15.2.4

ZIP e-mail (Note 1) ITI TF-1:15.2.5

Portable Media Importer

USB (Note 1) ITI TF-1:15.2.3

CD-R (Note 1) ITI TF-1:15.2.4

ZIP e-mail (Note 1) ITI TF-1:15.2.5

Note 1: At least one of these options is required for each Actor.Note 1: At least one of these options is required for each Actor.

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XDM Integration Profile OptionsXDM Integration Profile Options

Multiple Documents Submission Option Multiple Documents Submission Option Offers the ability to include multiple documents in a single Offers the ability to include multiple documents in a single

Submission RequestSubmission Request

ZIP email Mode Option ZIP email Mode Option Offers the ability to send the set of documents to one unique Offers the ability to send the set of documents to one unique

recipient, using a ZIP over email. recipient, using a ZIP over email.

USB Option USB Option Portable Media Creator writes a set of documents on USB Portable Media Creator writes a set of documents on USB

mediamedia

CD-R Option CD-R Option Portable Media Creator writes a set of documents on CD-R Portable Media Creator writes a set of documents on CD-R

media. media.

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XDM media StructureXDM media Structure

Entry for the web content

Entries for the content the submissions sets

Other content not covered by the profile

XDS Metadata

Other file ignored by the metadata

Simple part document

Multi part document

XDS Metadata

Other file ignored by the metadata

Simple part document

Multi part document

Other part (file)

Start part (main file)

Other part (file)

Start part (main file)

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XDM combined with PDIXDM combined with PDI

XDM content:XDM content:

Additional PDI content:Additional PDI content:

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Security considerationsSecurity considerations (1) (1)

Use of S/MIME encryption and signature for off-line network Use of S/MIME encryption and signature for off-line network transfer (integrity, privacy)transfer (integrity, privacy)

Encryption, with TLS authentication of both hosts, for on-Encryption, with TLS authentication of both hosts, for on-line transfers across secure domainsline transfers across secure domains

Actors need to protect themselves against confidentiality Actors need to protect themselves against confidentiality and integrity related risks and integrity related risks

XDR / XDM grouped with ATNA (access control/audit)XDR / XDM grouped with ATNA (access control/audit)

Import operations need to be further protected (hash and Import operations need to be further protected (hash and size to detect corruption with metadata assurance)size to detect corruption with metadata assurance)

Media must be securely managed (respect of privacy, Media must be securely managed (respect of privacy, proper identification, and corruption checking)proper identification, and corruption checking)

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Security considerationsSecurity considerations (2) (2)

Additionally, parties are recommended to have a Additionally, parties are recommended to have a mutual agreement:mutual agreement: Management of Patient identification in order to avoid/limit Management of Patient identification in order to avoid/limit

identification errors. The metadata includes a patient id identification errors. The metadata includes a patient id shared by both the Document Source and the Document shared by both the Document Source and the Document Recipient as well as id and associated patient info as known Recipient as well as id and associated patient info as known by the Document Source.by the Document Source.

Measures taken to avoid/limit loss of email by using Measures taken to avoid/limit loss of email by using acknowledgements.acknowledgements.

Management of personnel and the organizations Management of personnel and the organizations identification and access control mechanisms.identification and access control mechanisms.

Codes set and vocabulary used enabling a consistent Codes set and vocabulary used enabling a consistent management of the metadata on both side.management of the metadata on both side.

In addition both organizations shall have mutually In addition both organizations shall have mutually acceptable audit trail mechanisms.acceptable audit trail mechanisms.

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