HL7 Clinical Document Architecture (CDA)

Transcription

1 HL7 Clinical Document Architecture (CDA) and its Sciphox implementation in Germany Dr. Kai U. Heitmann M.D. University of Cologne (Germany) Institute for Medical Statistics, Informatics und Epidemiology Heitmann Consulting and Services, The Netherlands Vice Chair HL7 Deutschland Director International Affiliates - Board of Directors HL7 USA Manager SCIPHOX GbR mbh Working Group Germany HL7 Roadshow International Meeting EuroMISE 2004 Prague, CZ, April 2004

2 Agenda HL7 Version 3 Projects Objectives of (early) implementers projects Challenges Multiple entry points of HL7 Version 3 Implementation The Clinical Document Architecture Sciphox: making CDA feasible Results and Discussion 2

3 Common objectives of projects To enhance the exchange of health information patients (quality of care, better surveillance) providers (discharge/referral, orders, observations, Health Record ) organizations (lab, radiology, pharmacies, prenatal screening, vaccination, medication ) in a way that our experiences and models can be used in general or in other medical domains retro-filled into the HL7 standard development process 3

4 Challenges within the projects Plan the plan! Clearly defined steps, deliverables and time lines Concept Phase Information analysis based on care chains, treatment flow Models for the specific domain Create, refine or choose models How to deal with localization Implementation Phase Creation of R-MIMs and specific constraints for specific communication scenarios XML Schemas Implementation Guideline with Example Messages How to securely transport the information Ensure that investments survive 4

5 Version 3 Projects HL7 Version 3 Project Entry Points develop use implement Domain Analysis Models Messages/ Documents Implementation Guidelines <xml> <xml> <xml>

6 Clinical Document Architecture CDA = International Standard a development of Health Level Seven (HL7) CDA is ANSI-Std a document markup standard for the structure and semantics of exchanged clinical documents a defined and complete information object for storage and exchange can include text, images, sounds and other multimedia content documentation of observations and other services a part of the HL7 Version 3 family of standards Standard as of Release 1, Release 2 in ballot process 6

7 Clinical Document Architecture Interoperability Human The paper world with documents, forms... Application Storage, management of clinical data Context driven analysis Reusability Stepwise approach to application interoperability Immediate human interoperability (compliant users) Approach to iteratively add more markup in order to get more application interoperability 7

8 Some key aspects of CDA Patient Care Strategy Technique Persistence Human readability Context preservation Potential for Authentication Clinicians are used to create documents Acceptance by clinicians CDA Use rich-featured subset of the family of XML standards Levels are a step-wise approach Low costs for first steps, shrink-to-fit Bound to the RIM and family 8

9 Implementations Examples of current CDA projects The Clinical Notes II Project at Mayo Clinic in Rochester, Minnesota (USA) The PICNIC project, mainly from Finland, Denmark, Greece and Ireland The CDA-Compliant Middleware for Integrated Medical Records by IBM, Israel. The SCIPHOX discharge and referral letter project in Germany 9

10 CDA Implementation SCIPHOX Nationwide German Project Standardization of Communication between Information Systems in Physician Offices and Hospitals using XML Phase II+III Long term disease documentation (Disease Management Projects initiated by insurance companies) Electronic prescription Conformance testing using XSLT transforms Transport and Security Issues Status Phase III started, supported by multiple national organizations implementation documents and implementations available second ballot round for specifications 10

11 CDA = International Standard National Standardization means actually: Adoption and refinement of a global standard considering local (national) requirements based on use cases and national legislation publish adequate implementation guidelines... but also means understand and accept global concepts with generic approaches Make concessions towards standards (and against proprietary solutions) Assuring access, availability and continuity of definitions (investment incentive and protection) 11

12 The SCIPHOX project and CDA uses CDA model(s) as a start framework for basic shared information (CDA Header) sender, recipient, patient, event etc. definition of structures and entries (CDA Body) information units based on analysis story boards discharge/referral documents, long term diabetes documentation, emergency info, prescription localization Complementary local requirements 12

13 SCIPHOX and CDA framework framework for basic shared information (header) sender, recipient, patient, event etc. <clinical_document_header > <id EX="..." RT="..."/> <document_type_cd V=" " S=" " DN="Koloskopie-Bericht "> <NOTE V="Version 1.00"/> </document_type_cd > <origination_dttm V="..."/> <provider >... </provider > <patient >... </patient > <local_header ignore ="all" descriptor ="sciphox "> <sciphox:sciphox-ssu type="software_de " country ="de" version="v1">... </sciphox:sciphox-ssu > </local_header > </clinical_document_header > XML-Code 1 - clinical_document_header <nm> <GIV V="Ernst August "/> <FAM V="Oberberg "/> <PFX V="Dr. med." QUAL="AC"/> <PFX V="Graf von" QUAL="NB"/> </nm> XML-Code 1 - nm (Beispiel Arzt) 13

14 Structures and Entries (Body) 14

15 CDA and forms DMP Documentation background SCIPHOX / CDA foreground Usual Form View 15

16 Challenge Constraints/Conformance W3C XML schema v2.xml XML instance Wellformed HL7 / domain business rules validation constraints Valid Conformant 16

17 Challenge Implementation Implementation Guidelines SCIPHOX recommendation v1.0 (Phase I) Excerpt, translation and adoption of original CDA standard Document structure, SSUs Close collaboration with vendors CDA spec describes a general way of doing it Implementation constraints that narrows the generic CDA approach Added local vocabulary 17

18 Challenge Localization Rule driven SCIPHOX Header small semantic units SSU (information blobs) Body Narrative text allowed as stated in the standard Also SSUs for diagnoses, procedures, medication, lab results Sections identified by LOINC codes (<caption>) SSU Based on SCIPHOX schema definitions, SSU has to validate against the schema in instances: imports own namespace Uses CDA building blocks (structures, data types) 18

19 SCIPHOX SSUs (instance) Localization <patient>... <birth_dttm V=" "/> <administrative_gender_cd V="M" S=" "/> <local_header ignore="all" descriptor="sciphox"> <sciphox:sciphox-ssu type="insurance" country="de" version="v1"> <sciphox:gesetzlichekrankenversicherung> <sciphox:kostentraegerbezeichnung V="AOK Köln"/> <sciphox:vertragskassennummer V="27101"/> <sciphox:institutionskennzeichen V=" "/> <sciphox:versichertennummer V=" "/> <sciphox:versichertenstatus V="F" S=" "/> <sciphox:kvkgueltigbis V=" "/> </sciphox:gesetzlichekrankenversicherung> </sciphox:sciphox-ssu> </local_header> </patient> 19

20 Challenge Survive Organization of SCIPHOX (under German law) now a legal structure under German law co-operation contract: partnership between HL7.de and a large GP system vendors association rules and procedures, especially for balloting Intensification of SCIPHOX applications Broader spectrum of use cases Developed Business Cases Collaboration with Ministry of Health Initiatives Public presence (politics, SDOs) 20

21 Results and Discussion I Sciphox (CDA in Germany) Started with CDA R 1 model and two use case scenarios Created Implementation Guidelines Established an organization to ensure longevity of activities and specifications Current and future tasks National telematics framework (government initiative) Electronic prescription Embedded in transport and security framework 21

22 Results and Discussion II Early implementor projects Build solutions on artefacts that are not finally balloted Standards are a never ending story Start: Define Use Evaluate Accept Refine HL7 = Potential for good models internationally comparable verifiable by domain experts verifiable by vendors (programmers) Stable models means: stable investments 22

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