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CDA R2應用於簽章簡介 教育訓練委員會 Education Technical Committees

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Presentation on theme: "CDA R2應用於簽章簡介 教育訓練委員會 Education Technical Committees"— Presentation transcript:

1 CDA R2應用於簽章簡介 教育訓練委員會 Education Technical Committees
版權所有:台灣健康資訊交換第七層協定協會 HL7 Taiwan 協會 秘書長 范士展 HL7 Taiwan Google論壇:

2 大綱 HL7 v3背景說明 CDA R2背景說明 CDA R2簽章說明 XML Signature

3 HL7 v3背景說明

4 RIM 2.20

5 靜態模型結構

6 RIM類別關係 Non Core Participation Entity Role Act Role_Link
participates in has plays Entity Role Act has target scopes has source has target has source Role_Link Act_Relationship

7 Roles與Entities之關聯 “Played and Scoped”
Downtown Hospital Uptown Hospital Scoped By Scoped By Joe Smith Doctor Patient Plays Plays

8 Acts與Roles之關聯 Relations and Participants
Participating Roles Related Acts Act Entities in Roles participate in acts via Participations. Acts are related to other acts via ActRelationShips.

9 RIM之編碼概念

10 RIM之限制式概念

11 以UML表達

12 與文字及多媒體有關的資料型態

13 與唯一辨識碼有關的資料型態

14 與臨床編碼有關的資料型態

15 CDA R2背景說明

16 Reference Information Model Hierarchical Description
How the CDA is developed and maintained: just enough HL7 Development Framework RMIM Reference Information Model subset of RIM tighten constraints 平面結構 巢狀結構 linearization additional constraints XML Schema algorithm Hierarchical Description

17 讀懂R-MIM 類別是複製與顏色編碼 Participations: Entities: Acts: Roles:
notificationContact attender consultant referrer subject location responsibleParty admitter ActRelationships: componentOf pertinentInformation2 Authorization pertinentInformation1 Reference sequelTo arrivedBy Entities: E_Organization E_Place Roles: R_NotificationParty R_AssignedPerson R_AssignedEntity R_Patient ServiceDeliveryLocation R_AssignedOrganization Acts: EncounterEvent A_Encounter ValuablesLocation A_Consent A_ObservationDx A_Account AccomodationEvent PatientTransportation All of the reading RMIM slides use the Active Emergency Encounter example.

18 CDA R-MIM CDA Body, CDA Header CDA Entries Section, and
Narrative Block CDA Entries Ext'l Refs

19 R-MIM 轉換成XML Schema 一個CDA 的XML Schema檔,應用於任何臨床文件。

20 CDA = header + body CDA Header CDA Body
Metadata required for document discovery, management, retrieval CDA Body Clinical report Discharge Summary Care Record Summary Progress Note H&P Public health report … any content that carries a signature

21 Sample CDA Header Body Readable: required Computable: optional
Animation The CDA XML and how it is rendered. Maybe launch the actual CDA sample in a browser (with/without stylesheets). Open one in FireFox and one in IE.

22 CDA Header The header describes:
The document itself (unique ID, document type classification, version) Participants (providers, authors, patients…) Document relationships (to orders, other documents…) Metadata sufficient for document management

23 CDA Header: Metadata Identify Sufficient for Patient Provider
Document type... Sufficient for Medical records management Document management Registry/repositoryg Record locator service Store, query, retrieve required Animation Note that human readable text is required.

24 XML Body: two types of markup
Human-readable “narrative block”, all that is required to reproduce the legal, clinical content Optional machine-readable CDA Entries, which drive automated processes

25 CDA Body: Human-readable report
Any type of clinical document H&P Consult Op note Discharge Summary... Format: tif, PDF, HTML, XML: Paragraph List Table Caption Link Content Presentation Animation Note that human readable text is required. required

26 CDA Body: Machine Processible
Model-based computable semantics: Observation Procedure Organizer Supply Encounter Substance Administration Observation Media Region Of Interest Act Optional Animation Machine processible data is optional.

27 Non-XML body

28 CDA R2文件版本控管說明 id:文件流水號 setId:文件序列號

29 CDA R2簽章說明

30 臨床文件的參與者 簽證者 服務執行者 法定簽證者 副本接收者 文件作者 資料輸入者 文件標的 (病患) 文件保管者 情報提供者

31 由情境決定角色如何參與(範例) 1. StaffPhysicianOne負責照護病患為會診者、病歷書寫與簽章者。
Author — StaffPhysicianOne Encounter Participant — StaffPhysicianOne (typeCode="CONS") Legal Authenticator — StaffPhysicianOne 2. StaffPhysicianOne照護病患與病歷書寫;StaffPhysicianTwo負責簽章。 Legal Authenticator — StaffPhysicianTwo 3. ResidentOne與StaffPhysicianOne共同照護病患。ResidentOne負責書寫病歷並簽章, StaffPhysicianOne負責共同簽章。 Author — ResidentOne Authenticator — ResidentOne Encounter Participant — StaffPhysicianOne (typeCode="ATND") 4. ResidentOne與StaffPhysicianOne共同照護病患。ResidentOne負責書寫病歷並簽章。由StaffPhysicianTwo負責共同簽章。

32 由情境決定角色如何參與(範例) 任何情境下,一定要有一個Legal Authenticator
5. ResidentOne與StaffPhysicianOne共同照護病患。ResidentOne負責書寫病歷,但休假。其病歷由ResidentTwo與StaffPhysicianOne簽章。 Author — ResidentOne Authenticator — ResidentTwo Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianOne 6. ResidentOne與StaffPhysicianOne共同照護病患。ResidentOne負責書寫病歷。之後由ResidentTwo由 StaffPhysicianTwo負責簽章。 Legal Authenticator — StaffPhysicianTwo 7. StaffPhysicianOne收到不正常檢驗報告,試聯絡病患未果。但他仍書寫與簽一份progress note。 Author — StaffPhysicianOne 8. ResidentSurgeonOne與StaffSurgeonOne共同執行一項手術。StaffSurgeonOne寫手術記錄並簽章之。 Author — StaffSurgeonOne Authenticator — null (need not be included) Legal Authenticator — StaffSurgeonOne Performer — StaffSurgeonOne (typeCode="PPRF") Performer — ResidentSurgeonOne (typeCode="SPRF") 任何情境下,一定要有一個Legal Authenticator

33 套用於國內時之考量 服務類別 單張類別(參考台北醫學大學 劉立教授) 門診 急診 住院 一人一次/一人多次/多人一次/多人多次

34 支援之欄位

35 Participation.signatureCode
Cocpet domain為ParticipationSignature,其Value Set: I (intended):參與者應提供簽章。 S(signed):參與者已簽章。其簽章的可能附加形式,寫在檔案中或附於Participation.signatureText內。 X (required):A signature for the service is required of this actor.此角色在此服務是需要簽章的。 若需存入一份未完成病歷時,參與者應標記為I。 也就是說,未標記為S者,皆為未完成病歷。

36 Participation.signatureText
其資料型態為ED (Encapsulated Data),且ED繼承於BIN(Binary Data),故可存放二元碼,也可存放類似XML-signatures 的資料。 只要於mediaType宣告清楚即可。

37 code name status definition text/plain  Plain Text  required  For any plain text. This is the default and is equivalent to a character string (ST) data type.  text/x-hl7-ft  HL7 Text  recommended  For compatibility, this represents the HL7 v2.x FT data type. Its use is recommended only for backward compatibility with HL7 v2.x systems.  text/html  HTML Text  For marked-up text according to the Hypertext Mark-up Language. HTML markup is sufficient for typographically marking-up most written-text documents. HTML is platform independent and widely deployed.  application/pdf  PDF  The Portable Document Format is recommended for written text that is completely laid out and read-only. PDF is a platform independent, widely deployed, and open specification with freely available creation and rendering tools.  text/xml  XML Text  indifferent  For structured character based data. There is a risk that general SGML/XML is too powerful to allow a sharing of general SGML/XML documents between different applications.  text/rtf  RTF Text  The Rich Text Format is widely used to share word-processor documents. However, RTF does have compatibility problems, as it is quite dependent on the word processor. May be useful if word processor edit-able text should be shared.  application/msword  MSWORD  deprecated  This format is very prone to compatibility problems. If sharing of edit-able text is required, text/plain, text/html or text/rtf should be used instead.  audio/basic  Basic Audio  This is a format for single channel audio, encoded using 8bit ISDN mu-law [PCM] at a sample rate of 8000 Hz. This format is standardized by: CCITT, Fascicle III.4 -Recommendation G.711. Pulse Code Modulation (PCM) of Voice Frequencies. Geneva, 1972.  audio/mpeg  MPEG audio layer 3  MPEG-1 Audio layer-3 is an audio compression algorithm and file format defined in ISO and ISO MP3 has an adjustable sampling frequency for highly compressed telephone to CD quality audio.  audio/k32adpcm  K32ADPCM Audio  ADPCM allows compressing audio data. It is defined in the Internet specification RFC 2421 []. Its implementation base is unclear.  image/png  PNG Image  Portable Network Graphics (PNG) [] is a widely supported lossless image compression standard with open source code available.  image/gif  GIF Image  GIF is a popular format that is universally well supported. However GIF is patent encumbered and should therefore be used with caution.  image/jpeg  JPEG Image  This format is required for high compression of high color photographs. It is a "lossy" compression, but the difference to lossless compression is almost unnoticeable to the human vision.  application/dicom  DICOM  Digital Imaging and Communications in Medicine (DICOM) MIME type defined in RFC3240 [].  image/g3fax  G3Fax Image  This is recommended only for fax applications.  image/tiff  TIFF Image  Although TIFF (Tag Image File Format) is an international standard it has many interoperability problems in practice. Too many different versions that are not handled by all software alike.  video/mpeg  MPEG Video  MPEG is an international standard, widely deployed, highly efficient for high color video; open source code exists; highly interoperable.  video/x-avi  X-AVI Video  The AVI file format is just a wrapper for many different codecs; it is a source of many interoperability problems.  model/vrml  VRML Model  This is an openly standardized format for 3D models that can be useful for virtual reality applications such as anatomy or biochemical research (visualization of the steric structure of macromolecules) 

38 CDA R2對執行簽章說法 簽章應由文件(病歷)管理系統負責處理。

39 XML Signature

40 Schema解析 - Signature SignedInfo: 簽章相關資訊。 根元素
SignatureValue: 密文資料,以base64方式編碼。 KeyInfo: 私密金鑰。用來驗證簽章。 Object: 任意資料,可能是MIME Type資料。

41 Schema解析 - SignedInfo CanonicalizationMethod : 摘要處理方法 簽章相關資訊
SignatureMethod : 簽章處理方法 Reference : 簽章參考位置,可重複多次。

42 Schema解析 - KeyInfo 私密金鑰

43 最簡結構 <Signature ID?> <SignedInfo>
<CanonicalizationMethod/> <SignatureMethod/> (<Reference URI? > (<Transforms>)? <DigestMethod> <DigestValue> </Reference>)+ </SignedInfo> <SignatureValue> (<KeyInfo>)? (<Object ID?>)* </Signature> 注意:三種簽章類型,會用到不同的Tag。 ? : zero or one + : one or more * : zero or more

44 範例

45 XML Signature三種類型 Detached Enveloped Enveloping 簽章在文件之外。 XML簽章在文件之內。
可只簽文件的部分。 一份文件可以有好幾個簽章 Enveloping 被簽的文件在XML簽章中。 <signature> <Reference>…</Reference> </signature> <ClinicalDocument>…</ClinicalDocument> <ClinicalDocument> <signatureText <signature>….</signature> </signatureText> </ClinicalDocument> <signature> <ObjectID> <ClinicalDocument>….</ClinicalDocument> </ObjectID> </signature>

46 與CDA R2之配合 Detached Enveloped Enveloping
在簽章XML檔中,透過<Reference>指向外部的CDA R2臨床文件。 因<Reference>可重複,適用於批次臨床文件簽章。如健保上傳。 Enveloped 簽章資料放在CDA R2臨床文件中。 適合一份文件許多人簽。 但CDA R2並不建議如此做。 Enveloping 是將CAD R2的XML資料放在<Object>中。 <Object>可重複,故可同時簽多份臨床文件。

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