2. 2Some Slides Reproduced withPermission fromDr. Supachai Parchariyanon@supachaiMDProfile:Dr. Supachai Parchariyanon is a medical doctorwhos passionate about information technology andturn himself to be informatician and serialentrepreneurs.Hes also earned Business Management degreefrom Ramkamhaeng university and BiomedicalInformatics degree from the US. He led the team tocertify both HL7 Reference Information Model (RIM)and Clinical Document Architecture (CDA). Hisinterest is now on standards and interoperability,clinical informatics and project management.Keep in touchsupachaimd@gmail.comhttp://www.facebook.com/supachaiMDSlide reproduced/adapted from Dr. Supachai Parchariyanon 3. 3Thailands HL7Certified SpecialistsKevinAsavanantHL7 V3 RIM (2009)SupachaiParchariyanonHL7 CDA (2010)NawananTheera-AmpornpuntHL7 CDA (2012)SireeratSrisiriratanakulHL7 V3 RIM (2013) 4. 4Standards Are Everywhere 5. 5Standards: Why? The Large N ProblemN = 2, Interface = 1# Interfaces = N(N-1)/2N = 3, Interface = 3N = 5, Interface = 10N = 100, Interface = 4,950 6. 6Health Information Exchange (HIE)Hospital A Hospital BClinic CGovernmentLab Patient at Home 7. 7Why Health Information Standards?Objectives Interoperability Inter-operablesystemsUltimate Goals Continuity of Care Quality Safety Timeliness Effectiveness Equity Patient-Centeredness Efficiency 8. 8What is interoperability?It is the ability of two or more systemsor components to exchange information,and to use the information that has beenexchanged predictably (IEEE StandardComputer Dictionary)Slide reproduced/adapted from Dr. Supachai Parchariyanon 9. 9Levels of InteroperabilityFunctionalSemanticSyntactic 10. 10Goal of interoperability HL7s key goal of interoperability hastwo aspects: Syntactic interoperability has to do withstructure Semantic interoperability has to do withmeaningSlide reproduced/adapted from Dr. Supachai Parchariyanon 11. 11Things that can go wrong inmessage exchangeSlide reproduced/adapted from Dr. Supachai Parchariyanon 12. 12Standards are not equalInteroperabilityStandards only create the opportunityfor interoperability and are not equal tointeroperabilitySlide reproduced/adapted from Dr. Supachai Parchariyanon 13. 13Various Kinds of Standards Unique Identifiers Standard Data Sets Vocabularies & Terminologies Exchange Standards Message Exchange Document Exchange Functional Standards Technical Standards: Data Communications,Encryption, Security 14. Functional Standards (HL7 EHRFunctional Specifications)Vocabularies, Terminologies,Coding Systems (ICD-10, ICD-9,CPT, SNOMED CT, LOINC)Information Models (HL7 v.3 RIM,ASTM CCR, HL7 CCD)Standard Data SetsUnique IDExchange Standards (HL7 v.2,HL7 v.3 Messaging, HL7 CDA,14How Standards Support InteroperabilityFunctionalSemanticSyntacticDICOM)Technical Standards(TCP/IP, encryption,security)Some may be hybrid: e.g. HL7 v.3, HL7 CCD 15. 15What is HL7? HL7 is an ANSI-accredited StandardsDevelopment Organization (SDO)operating in the healthcare arena. It is a non-profit organization made up ofvolunteers providers, customers,vendors, government, etc.Slide reproduced/adapted from Dr. Supachai Parchariyanon 16. 16What is HL7? (Cont.) HL7 is an acronym for Health Level Seven Seven represents the highest, or applicationlevel of the International StandardsOrganization (ISO) communications model forOpen Systems Interconnection (OSI) networks.Slide reproduced/adapted from Dr. Supachai Parchariyanon 17. 17OSI ModelSlide reproduced/adapted from Dr. Supachai Parchariyanon 18. 18What HL7 does? HL7 focuses on the clinical and administrativedata domains. It defines data exchange standards for thesedomains called messages or messagingspecifications (aka HL7 messages) Messages are developed by technical committees andspecial interest groups in the HL7 organization. HL7 organization defines 2 versions of themessaging standard: HL7 v2.x (syntactic only) HL7 v3.0 (semantic capability added)Slide reproduced/adapted from Dr. Supachai Parchariyanon 19. 19What HL7 does?Slide reproduced/adapted from Dr. Supachai Parchariyanon 20. 20HL7 Standards HL7V2.x Defines electronic messages supporting hospitaloperations HL7V3 HL7 Clinical Document Architecture(CDA) Releases 1 and 2 HL7 Arden Syntax Representation of medical knowledge HL7 EHR & PHR Functional Specifications Etc. 21. 21The Industry StandardHL7 version 2 (HL7 v2) Not Plug and Play - it provides 80 percent of theinterface and a framework to negotiate the remaining 20percent on an interface-by-interface basis Historically built in an ad hoc way because no otherstandard existed at the time Generally provides compatibility between 2.X versions Messaging-based standard built upon pipe and hatencoding In the U.S., V2 is what most people think of when peoplesay HL7Slide reproduced/adapted from Dr. Supachai Parchariyanon 22. 22HL7 version2 HL7 v2 is still the most commonly used HL7standard Over 90% of US hospitals have implemented someversion of 2.x HL7 messages The HL7 v2 messaging standard is considered: The workhorse of data exchange in healthcare The most widely implemented standard for healthcareinformation in the world HL7 v2.5 was approved as an ANSI standard in2003Slide reproduced/adapted from Dr. Supachai Parchariyanon 23. 23Part of Sample HL7 v.2 Message(Lab Result)OBX|1|NM|10839-9^TROPONIN-I^LN||5|ng/ml|0-1.3|H||H|F|19980309Slide reproduced/adapted from Dr. Supachai Parchariyanon 24. 24HL7 v2 Message Messages composed of Segments composed of Fields composed of Components Delimiters Field separator: | Component separator: ^ Repetition separator: ~ Escape character: Subcomponent: & Segment terminator: Slide reproduced/adapted from Dr. Supachai Parchariyanon 25. 25Message Header Segment - MSHSendingUnitReceivingUnit DateTimeMessagetypeTriggerIDMSH|^~|&|SMS|OR2|TMR|SICU|201010191535|password|ADT^A01|MSG1632|P|2.7SendingPlace ReceivingPlaceMessageNumberversionDelimitersproductionSlide reproduced/adapted from Dr. Supachai Parchariyanon 26. 26PID Segment 1/3Check digitPatient IDMethodLast nameFirst nameMiddleInitialSuffixPID|Z12345^5^M11||||PATIENT^JOSEPH^M^IV|Patient nameNull fieldsData fieldField delimiterSlide reproduced/adapted from Dr. Supachai Parchariyanon 27. 27PID Segment 2/3Mothersmaiden nameDate of birth RaceMAIDEN|19610605|M||C|1492 OCEAN STREET^GenderStreetaddressData component ComponentdelimiterSlide reproduced/adapted from Dr. Supachai Parchariyanon 28. 28PID Segment 3/3CityStateZip CodeCountyTelephoneDURHAM^NC^27705|DUR|(919)684-6421Segment terminatorSlide reproduced/adapted from Dr. Supachai Parchariyanon 29. 29PV1 SegmentPV1|1|1|N2200^2200|||OR^02|0846^WELBY^MARCUS^G||SURPatient locationAttendingServiceSequencenumberPatientclassSlide reproduced/adapted from Dr. Supachai Parchariyanon 30. 30OBR SegmentPlacer ordernumberFiller ordernumberUniversalservice IDTextorder Local setOBR|1|330769.0001.001^DMCRES|0000514215^RADIS1|77061^U/S PEVLIC^L||201010211145|||||||||||||0491909||||U999|M||||||^FIBROIDS, R/O|207484^CARROLL&BARBARA&A|||089657&BROWN&JOANNERequesteddate-time ofserviceReason forstudyPrincipal resultsinterpreterSlide reproduced/adapted from Dr. Supachai Parchariyanon 31. 31Typical Result Message -ORUMSH|^~&|||||19981105131523||ORU^R01PID|||100928782^9^M11||Smith^John^JOBR||||Z0063-0^^LNOBX||XCN|Z0063-0^^LN||2093467^Smits^J^OBX||Z0092-0^^LN||203BE0004Y^^X12PTXData fieldData componentsegmentAgain, this slide shows a typical order result message. In this case, thesegments include the header, the patient identifier, the order request,and two result segments. The OBX segment is examined in detail inthe next slide. The last OBX shows the hierarchical nature of thesegment. The test ID data field is broken into the triplet of code (withcheck-digit), text name, and vocabulary source (LOINC).Slide reproduced/adapted from Dr. Supachai Parchariyanon 32. 32Problems with HL7v2 HL7 v2 cannot support all this! Ad Hoc design methodology Ambiguous lacking definition Complicated, esoteric encoding rules. Artifacts left to retain backward compatibility Too much optionality Cant specify conformance No standard vocabularySlide reproduced/adapted from Dr. Supachai Parchariyanon 33. 33Whats Different About v3? Conceptual foundation A single, common reference information model to be used acrossHL7 Semantic foundation Explicitly defined concept domains drawn from the bestterminologies Abstract design methodology That is technology-neutral Able to be used with whatever is the technology de jour XML, UML, etc. Maintain a repository Database of the semantic content Ensures a single source and enable development of supporttoolingSlide reproduced/adapted from Dr. Supachai Parchariyanon 34. 34How is v3 different than v2? v3 is approaching Plug and Play v2 uses pipe and hat messaging, while v3uses the Reference InformationModel(RIM) and XML for messaging v3 is a brand new start it is NOTbackward compatible with v2Slide reproduced/adapted from Dr. Supachai Parchariyanon 35. 35Sample HL7 v.3 Message(Patient Registration)...NawananTheera-Ampornpunt...Message source adapted from Ramathibodi HL7 Project by Supachai Parchariyanon,Kavin Asavanant, Sireerat Srisiriratanakul & Chaiwiwat Tongtaweechaikit 36. 36HL7 V3 Standards A family of standards based on V3information models and developmentmethodology Components HL7 V3 Reference Information Model (RIM) HL7 V3 Messaging HL7 Development Framework (HDF) 37. 37How HL7 V3 Works Message sent from sending application toreceiving application Mostly triggered by an event Typical scenario portrayed in a storyboard Message in XML with machine-processableelements conforming to messagingstandard Data elements in message conform to RIM Not designed for human readability 38. 38v3 Messaging Standard Based on an object informationmodel, called the ReferenceInformation Model, (RIM)Slide reproduced/adapted from Dr. Supachai Parchariyanon 39. 39HL7 V3 Messaging V3 provides messaging standards for Patient administration Medical records Orders Laboratory Claims & Reimbursement Care provision Clinical genomics Public Health Etc. 40. 40HL7 v3 ReferenceInformation ModelActRelationship Referral Transportation Supply Procedure Consent Observation Medication Administrative act Financial act Organization Place Person Living Subject Material Has component Is supported by0..* 1 Patient Member Healthcare facility Practitioner Practitioner assignment Specimen LocationEntity0..*1Role10..*10..*1..*1Participation Act Author Reviewer Verifier Subject Target TrackerSlide reproduced/adapted from Dr. Supachai Parchariyanon 41. 41HL7 v3 Components and Process: RIM UML InstanceScenarioEntity Role Participation ActJohn Doe Patient SubjectDr. Smith Classes are color coded: Green = Entity, Yellow = Role, Blue = Participation, Red/Pink = Act, Purple = Infrastructure, Lilac = messagecontroller.HealthCareProvider SurgeonJohn Doe Patient SubjectHas PertinentAct Relationship Information(Clinical Trial Act)Protocol ECOG1112XYZHospitalHealthCareFacility Location(Procedure Act)ProstectomySlide reproduced/adapted from Dr. Supachai Parchariyanon 42. 42Reference Information Model (RIM)42 43. 43V3 Messaging Concerns Difficult to implement No one understands v3 Overhead too much 1% of message is payload compared to v2 (delimiters)is about 90-95% No one understands what implementation of v3messaging means Need stability, clarity, definition of v3 messagingSlide reproduced/adapted from Dr. Supachai Parchariyanon 44. 44Additional Information Health Level Seven www.hl7.org HL7 Reference Information Model https://www.hl7.org/library/data-model/RIM/C30202/rim.htm HL7 Vocabulary Domains http://www.hl7.org/library/data-model/RIM/C30123/vocabulary.htm HL7 v3 Standard http://www.hl7.org/v3ballot/html/welcome/environment/index.htm HL7v3: Driving Interoperability & Transforming Healthcare InformationManagement by Charles Mead, MD, MSc. http://www.healthcare-informatics.com/webinars/05_20_04.htmSlide reproduced/adapted from Dr. Supachai Parchariyanon 45. 45HL7 Clinical DocumentArchitecture (CDA)Nawanan Theera-Ampornpunt, M.D., Ph.D.Department of Community MedicineFaculty of Medicine Ramathibodi HospitalCertified HL7 CDA SpecialistSome slides reproduced & adapted with permission fromDr. Supachai ParchariyanonNovember 2, 2014 46. 46Exchange StandardsMessage Exchange Goal: Specify formatfor exchange of data Internal vs. externalmessages Examples HL7 v.2 HL7 v.3 Messaging DICOM NCPDPDocument Exchange Goal: Specify formatfor exchange ofdocuments Examples HL7 v.3 Clinical DocumentArchitecture (CDA) ASTM Continuity of CareRecord (CCR) HL7 Continuity of CareDocument (CCD) 47. 47Exchange StandardsMessages Human Unreadable Machine ProcessableClinical Documents Human Readable (Ideally) MachineProcessable 48. 48Message ExchangeMessageMessageHospital A Hospital BClinic CGovernmentLab Patient at HomeMessageMessage Message 49. 49Clinical Document ExchangeMessage containingReferral LetterMessage containingClaims RequestMessage containingCommunicableDisease ReportHospital A Hospital BClinic CGovernmentLab Patient at HomeMessage containingLab ReportMessage containingPatient Visit Summary 50. 50What Is HL7 CDA? A document markup standard thatspecifies structure & semantics of clinicaldocuments for the purpose of exchange[Source: HL7 CDA Release 2] Focuses on document exchange, notmessage exchange A document is packaged in a messageduring exchange Note: CDA is not designed for documentstorage. Only for exchange!! 51. 51What is CDA? CDA is based on XML XML is eXtensible Markup Language In XML, structure & format are conveyedby markup which is embedded into theinformationSlide reproduced/adapted from Dr. Supachai Parchariyanon 52. 52Clinical DocumentsSlide reproduced/adapted from Dr. Supachai Parchariyanon 53. 53A Clinical Document (1) A documentation of clinical observationsand services, with the followingcharacteristics: Persistence - continues to exist in anunaltered state, for a time period defined bylocal and regulatory requirements Stewardship - maintained by an organizationentrusted with its care Potential for authentication - an assemblageof information that is intended to be legallyauthenticated Source: HL7 CDA R2 54. 54A Clinical Document (2) A documentation of clinical observationsand services, with the followingcharacteristics: Context - establishes the default context for itscontents; can exist in non-messaging contexts Wholeness - Authentication of a clinicaldocument applies to the whole and does notapply to portions of the document without fullcontext of the document Human readability - human readableSource: HL7 CDA R2 55. 55A Clinical Document (3) A CDA document is a defined & completeinformation object that can include Text Images Sounds Other multimedia contentSource: HL7 CDA R2 56. 56CDA & HL7 Messages Documents complement HL7 messagingspecifications Documents are defined and complete informationobjects that can exist outside of a messagingcontext A document can be encoded within an HL7messageSource: What is CDA R2? by Calvin E. Beebeat HL7 Educational Summit in July 2012 57. 57CDA & Message Exchange CDA can be payload (or content) in any kind ofmessage HL7 V2.x message HL7 V3 message EDI ANSI X12 message IHE Cross-Enterprise Document Sharing (XDS)message And it can be passed from one kind toanotherSource: What is CDA R2? by Calvin E. Beebeat HL7 Educational Summit in July 2012 58. 58CDA & Message ExchangeClinical Document(Payload)HL7 V3 Message(Message)HL7 V2 Message(Message)Source: Adapted from What is CDA R2? by Calvin E. Beebeat HL7 Educational Summit in July 2012 59. 59CDA As PayloadSource: From What is CDA R2? by Calvin E. Beebeat HL7 Educational Summit in July 2012 60. 60Major Components of aCDASlide reproduced/adapted from Dr. Supachai Parchariyanon 61. 61CDA ModelSource: From What is CDA R2? by Calvin E. Beebeat HL7 Educational Summit in July 2012 62. Human Readable PartMachine Processable Parts62A Closer Look at a CDA Document ... CDA Header ...... SingleNarrative Block ...............Source: HL7 CDA R2 63. 63Rendering CDA Documents (1)Source: From What is CDA R2? by Calvin E. Beebeat HL7 Educational Summit in July 2012 64. 64Rendering CDA Documents (2)Source: From What is CDA R2? by Calvin E. Beebeat HL7 Educational Summit in July 2012 65. 65CDA & Document Management CDA focuses on document exchange, notstorage or processing Clinical documents are used for various reasons Clinical care Medico-legal reasons (as evidence) Auditing Etc. Clinical documents may contain errors or needdata updates (e.g. preliminary lab results vs. finalresults) 66. 66CDA & Document Management CDA supports appending and replacement ofdocuments through use of Document ID, setID,versionNumber & parent document Supports version control of documents Both old (replaced) and new versions of documentscan be stored in and retrieved from documentmanagement systems depending on situation Addendum is possible through append Addendum itself can also be replaced with sameversion control mechanism Document management system (not CDA) isresponsible for keeping track of most up-to-datedocuments 67. 67Document Management ExamplesSource: From What is CDA R2? by Calvin E. Beebeat HL7 Educational Summit in July 2012 68. 68Some Possible Use Cases of CDA Intra-institutional Exchange of parts of medical records (scanned orstructured electronic health records) Lab/Imaging requests & reports Prescriptions/order forms Admission notes Progress notes Operative notes Discharge summaries Payment receipts Other forms/documents (clinical or administrative) 69. 69Some Possible Use Cases of CDA Inter-institutional Referral letters Claims requests or reimbursement documents External lab/imaging reports Visit summary documents Insurance eligibility & coverage documents Identification documents Disease reporting Other administrative reports 70. 70Achieving Interoperability CDA is a general-purpose, broad standard Use in each use case or context requiresimplementation guides to constrain CDA Examples Operative Note (OP) Consultation Notes (CON) Care Record Summary (CRS) Continuity of Care Document (CCD) CDA for Public Health Case Reports (PHCRPT) Quality Reporting Document Architecture (QRDA) 71. 71CDA Summary CDA is a markup standard for documentexchange Not message exchange CDA is a general-purpose standard Use in specific context requiresImplementation Guides (and possiblyExtensions) 72. 72CDA Summary CDA is XML-based and RIM-based CDA documents can be exchanged asencapsulated data (payload) in any message(HL7 V2, HL7 V3, etc.) CDA is not dependent on using HL7 V3messages Most likely early use cases for CDA Referrals Claims & Reimbursements Lab/imaging Reports Electronic Health Records Documents 73. 73Q/ASlide reproduced/adapted from Dr. Supachai Parchariyanon