استانداردهای تبادل الکترونیکی اطالعات پزشکی The Electronic Data Interchange Standards for Medical Data Dr. Ali M. Hadianfard Faculty member of AJUMS http://www.alihadianfard.info/download.html 2 Further reading • Biomedical informatics computer applications in health care and biomedicine (3rd edition), Edward H. Shortliffe, 2006 (chapter 7). • Principles of Health Interoperability HL7 and SNOMED, Tim Benson, 2010 (whole book). • From Patient Data to Medical Knowledge The Principles and Practice of Health Informatics, Paul Taylor, 2006 (chapter 9). • SNOMED user guide, http://www.ihtsdo.org/fileadmin/user_upload/doc/en_us/ug.html • HL7 organization, the official website, http://www.hl7.org/ • Medical imaging informatics, Alex A.T. Bui and Ricky K. Taira, 2010 (chapter 3). • PACS and Imaging Informatics Basic Principles and Applications, H. K. Huang, 2010 (chapter 9). 3 استاندارد در لغت به معنای قاعده یا اصل می باشد. هر چیزی که از طرف عموم ،سنت ،تصمیم سازمانی یا قرارداد بعنوان مبنا یا پیمانه ای برای اندازهگیری یا مقایسه پذیرفته شود. 4 اهمیت وجود استاندارد ایجاد سازگاری برقراری هماهنگی تضمین امنیت گسترش ارتباطات توسعه کمی و کیفی 5 توسعه استانداردها استانداردهای از طریق: – برآورده نمودن منافع مشترک افراد یا مؤسسات – غیر رسمی بوسیله شرکتها یا مؤسسات بزرگ – رسمی با تصویب قوانین و آئینامه ها بوسیله مراجع دولتی و قانونی – توافق بین افراد ،گروهها و مؤسسات محلی و بین املللی ایجاد و توسعه می یابد. 6 سطوح موسسات استاندارد National سطح ملی.I . به تصویب رسید1339 مؤسسه استاندارد و تحقیقات صنعتی ایران (ماتصا) در سال Institute of Standards and Industrial Research of Iran (ISIRI) American National Standards Institute (ANSI) Regional سطح منطقه ای.II European Committee for Standardization (CEN), Brussels, Belgium International International Organization for Standardization (ISO) (1947, Geneva, Switzerland) سطح جهانی.III 7 تبادل الکترونیکی داده ها )Electronic Data Interchange (EDI انتقال داده ها یا مستندات الکترونیکی از یک سیستم (کامپیوتر) به سیستم دیگر. بطور مثال انتقال داده ها با استفاده از شبکه های خصوص ی (VAN) Value Added Network و یا اینترنت. ASC X12مجموعه ای از استاندارهایی است که برای تبادل الکترونیکی داده های مستندات تجاری(معامالتی) نظیر فاکتورهای فروش ،بین شرکتها استفاده می شود و توسط مؤسسه استاندار ملی آمریکا پذیرفته شده است .در حال حاضر 300نوع سند در آن استاندارد شده است. 8 زیر ساختهای انتقال اطالعات پزشکی انتقال الکترونیکی اطالعات پزشکی نیاز به 4گروه زیر ساخت اصلی دارد: (1زیر ساختهای تکنولوژیک (فنی)؛ شامل تجهیزات پزشکی دیجیتال ،سخت افزار کامپیوتر ،شبکه های کامپیوتری ،سیستم های عامل و نرم افزارهای کاربردی (2استانداردهای لغات و واژگان پزشكي به طورمثال از طريق (3 )(Medical Vocabulary ؛ SNOMED CT استانداردهای تبادل اطالعات پزشکی؛ نظیر HL7 (4زیر ساختهای حفظ امنیت داده ها؛ شامل حفظ محرمانگی و جلوگیری از دسترس ی غیر مجاز نظیر استانداردهای )Secure Sockets Layer (SSL), Transport Layer Security (TLS البته سایر زیر ساختها نظیر زیر ساختهای فرهنگی ،اجتماعی ،اقتصادی و سیاس ی بطور غیر مستقیم مؤثر می باشند. 9 The standardization of medical terminology Clinicians and organizations use different clinical terms that mean the same thing. For example, the terms heart attack, myocardial infarction, and MI may mean the same thing to a cardiologist, but, to a computer, they are all different. There is a need to exchange clinical information consistently between different health care providers, care settings, researchers and others because medical information is recorded differently from place to place (on paper or electronically), a comprehensive, unified medical terminology system is needed as part of the information infrastructure. The terminology enables clinicians, researchers and patients to share comparable data. 10 SNOMED CT SNOMED CT is a comprehensive clinical terminology Originally created by the College of American Pathologists (CAP) and, as of April 2007, owned, maintained, and distributed by the International Health Terminology Standards Development Organization (IHTSDO, http://www.ihtsdo.org), a non-for-profit association in Denmark. The CAP continues to support SNOMED CT operations under contract to the IHTSDO and provides SNOMED-related products and services as a licensee of the terminology. 11 SNOMED Predecessors • SNDO (Standard Nomenclature of Diseases and Operations) • • • • • • • • Academy of Medicine, 1961 SNOP (Systematic Nomenclature for Pathology)- 1965 SNOMED (Systematized Nomenclature of Medicine)- 1974 SNOMED II - 1979 SNOMED Version 3.0 (Systematized Nomenclature of Human and Veterinary Medicine) - 1993 LOINC (Logical Observation Identifiers Names and Codes) codes integrated into SNOMED - 1997 SNOMED Version 3.5 - 1998 SNOMED RT (Systematized Nomenclature of MedicineReference Terminology)- 2000 SNOMED CT (Systematized Nomenclature of Medicine-Clinical Terms) - First release January 2002 12 SNOMED CT - Continue SNOMED CT has been created by combining SNOMED RT and a computer based nomenclature and classification known as Clinical Terms Version 3 (CTV3 ) developed by the National Health Service of the United Kingdom, formerly known as Read Codes Version 3 Over a period of 40 years SNOMED has evolved from a pathology- centric terminology distributed and used in print format to a comprehensive clinical terminology, which is only available in electronic format and needs to be integrated with clinical applications software. 13 14 SNOMED CT - Continue SNOMED CT is A clinical healthcare terminology A resource with comprehensive, scientifically-validated content essential for electronic health records A terminology that can cross-map to other international standards already used in more than fifty countries SNOMED CT is both a coding scheme, identifying concepts and terms, and a multidimensional classification, enabling concepts to be related to each other, grouped, and analyzed according to different criteria. 15 SNOMED CT - Continue SNOMED CT provides the core general terminology for the electronic health record (EHR) and contains more than 311,000 active concepts with unique meanings and formal logic-based definitions organized into hierarchies, 990,000 English descriptions, and 1.38 million relationships. When implemented in software applications, SNOMED CT can be used to represent clinically relevant information consistently, reliably and comprehensively as an integral part of producing electronic health records. 16 SNOMED CT - Continue SNOMED CT is a systematically organized computer process able collection of medical terminology covering most areas of clinical information such as diseases, findings, procedures, microorganisms, pharmaceuticals and etc. It allows a consistent way to index, store, retrieve, and aggregate clinical data across specialties and sites of care. It also helps organizing the content of medical records, reducing the variability in the way data is captured, encoded and used for clinical care of patients and research. It is a mistake to assume that SNOMED CT applies to human medicine only. Many codes are applicable to both human and non-human subjects. Some codes are applicable to non-human subjects only, and these non-human codes are identified in the non-human subset provided with the International Release. 17 SNOMED CT components 1. Concept Codes: numerical codes that identify clinical terms, primitive or defined, organized in hierarchies. The SCTID (SNOMED CT Identifiers) is an integer between 6 and 18 digits long. The sequence of digits in a Concept Identifier does not convey any information about the meaning or nature of the Concept. The meaning of Concept is represented in human-readable forms by Descriptions and in a computer processable form by Relationships with other Concepts. For example 22298006 means myocardial infarction (MI). 2. Descriptions: textual descriptions of Concept Codes 3. Relationships: relationships between Concept Codes that have a related meaning Reference Sets: used to group Concepts or Descriptions into sets, including reference sets and cross-maps to other classifications and standards 18 Top Level Concepts • Clinical finding • Linkage concept • Procedure • Physical force • Observable entity • Event • Body structure • Environment or geographical location • Organism • Social context • Substance • Situation with explicit context • Pharmaceutical / biologic product • Staging and scales • Specimen • Physical object • Special concept • Qualifier value • Record artifact 19 Concepts 20 Example of descriptions Some of the Descriptions associated with ConceptId 22298006: Fully Specified Name: | Myocardial infarction (disorder) | DescriptionId 751689013 Preferred term: Myocardial infarction DescriptionId 37436014 Synonym: Cardiac infarction DescriptionId 37442013 Synonym: Heart attack DescriptionId 37443015 Synonym: Infarction of heart DescriptionId 37441018 Each of the above Descriptions has a unique DescriptionId, and all of these Descriptions are associated with a single Concept (and the single ConceptId 22298006). 21 Relationships Each concept in SNOMED CT is logically defined through its relationships to other concepts. | is a | relationships are also known as "Supertype - Subtype relationships " or "Parent - Child relationships ". | is a | relationships are the basis of SNOMED CT 's hierarchies. A concept can have more than one | is a | relationship to other concepts. An attribute Relationship is an association between two concepts that specifies a defining characteristic of one of the concepts (the source of the Relationship). Each Attribute Relationship has a name (the type of Relationship) and a value (the destination of the Relationship) 22 Examples of relationships 23 SNOMED CT guides 1) The SNOMED CT User Guide 2) Technical Reference Guide(TRG) 3) Technical Implementation Guide (TIG) They are three key documents describing SNOMED CT in detail. 24 Standards Development Organizations (SDOs) ANSI-accredited SDOs have responsibility for: HL7 focuses on the domain of clinical and administrative data. Pharmacy (NCPDC) Medical devices (IEEE) Imaging (ACR/NEMA) Insurance (claims processing) transactions (X12) Dentistry (ADA) 25 HL7 ) :HL-7(Health Level 7در سال 1986در تالش ی گروهی توسط ارائه کنندگان مراقبت سالمت و ارائه کنندگان تکنولوژی ایجاد شد .استانداردی برای تبادل اطالعات بالینی و انواع دیگر اطالعات (پذیرش ،ترخیص ،انتقال ،دستورات پزشک ،اقدامات ،نتایج آزمایشات و اطالعات مالی) بین سیستمهای کامپیوتری است. (For Exchanging, Integrating, Sharing, and Retrieving electronic health )information. اکنون مورد توافق بیش از 55کشور از قبیل آمریکا ،کانادا ،استرالیا ،آملان ،هلند ،ژاپن ،نیوزیلند و ...می باشد. HL7در زمره موسسات استاندار ملی آمریکا می باشد. نام HL7بر گرفته از الیه هفتم مدل مرجع ISO/OSIاست. 26 مدل مرجع OSI Open System Interconnection Reference Model یک الگوی مرجع برای ایجاد شبکه و برقراری ارتباط بین کامپیوترها می باشد که توسط ISO توسعه یافته است .از هفت سطح (الیه) تشکیل شده است .الیه های زیرین جنبه سخت افزاری (فیزیکی) و الیه های باالتر جنبه نرم افزاری دارند .الیه های باالیی بر روی تبادل پیامها بین کاربران و برنامه های کاربردی متمرکز شده اند. اليه هفتم با سيستم عامل و يا برنامه هاي کاربردي ارتباط دارد .کاربران با استفاده از نرم افزارهاي کاربردي متفاوت قادر به انجام عمليات مرتبط با شبکه خواهند بود .اين اليه ،محتواي اطالعات را مشخص مي كند و انتقال آنها بین برنامه هاي كاربردي را فراهم میکند .مثال کاربران مي توانند اقدام به خواندن پيام ،ارسال پيام و ...نمايند .پروتکلهایی نظیر HTTP, FTP , HL7در این سطح قرار می گیرند. 27 OSI Model Data unit Function 7. Application Network process to application 6. Presentation Data representation, encryption and decryption 5. Session Inter host communication Segments 4. Transport End-to-end connections and reliability, Flow control Packet 3. Network Path determination and logical addressing Frame 2. Data Link Physical addressing Bit 1. Physical Media, signal and binary transmission Data Host layers Media layers Layer 28 HL7 standards HL7 develops: Conceptual Standards (e.g., HL7 RIM) Document Standards (e.g., HL7 CDA) Application Standards (e.g., HL7 CCOW) Messaging Standards (e.g., HL7 v2.x and v3.0) 29 HL7 ویرایشهای Version 2 (V2.x) : 2.1, 2.2, 2.3, 2.3.1, 2.4, 2.5, 2.5.1 and 2.6, 2.7 originally created in 1987. All 2.x versions are backwards-compatible with earlier versions. This means that an older application can receive and process messages from newer applications using newer HL7 versions. HL7 v2.x mostly uses a textual, non-XML encoding syntax. Version 3 (V3): 3.0, first released in late 2005. The V3 is not backwards compatible with V2. 30 HL7 V2.x The HL7 Standard covers messages that exchange information in the general areas of: • Patient Demographics • Patient Charges and Accounting • Patient Insurance and Guarantor • Clinical Observations • Encounters including Registration, Admission, Discharge and Transfer • Orders for Clinical Service (Tests, Procedures, Pharmacy, Dietary and Supplies) • Observation Reporting including Test Results • The synchronization of Master Files between systems • Medical Records Document Management • Scheduling of Patient Appointments and Resources • Patient Referrals—Specifically messages for primary care referral • Patient Care and problem-oriented records. 31 HL7 V2.x Messaging HL7 v2.x messages use a human-readable (ASCII), non-XML encoding syntax based on segments (lines) and one-character delimiters. Segments have composites (fields) separated by the composite delimiter. A composite can have sub-composites (subcomponents) separated by the sub-composite delimiter, and sub-composites can have sub-sub-composites (subcomponents) separated by the sub-sub-composite delimiter. The default delimiters are vertical bar or pipe (|) for the field separator, caret (^) for the component separator, and ampersand (&) for the subcomponent separator. The tilde (~) is the default repetition separator. The first field (composite) in each segment contains the 3-character segment name. Each segment of the message contains one specific category of information. Every message has Message Header (MSH) as its first segment, which includes a field that identifies the message type. The message type determines the expected segment names in the message. The segment names for a particular message type are specified by the segment grammar notation used in the HL7 standards. 32 Example of HL7 V2.x Laboratory Message MSH|^~\&|GHH LAB|ELAB-3|GHH OE|BLDG4|200202150930||ORU^R01|CNTRL-3456|P|2.4<cr> PID|||555-44-4444||EVERYWOMAN^EVE^E^^^^L|JONES|19620320|F|||153 FERNWOOD DR.^ ^STATESVILLE^OH^35292||(206)3345232|(206)752-121||||AC555444444||67-A4335^OH^20030520<cr> OBR|1|845439^GHH OE|1045813^GHH LAB|15545^GLUCOSE|||200202150730||||||||| 555-55-5555^PRIMARY^PATRICIA P^^^^MD^^|||||||||F||||||444-44-4444^HIPPOCRATES^HOWARD H^^^^MD<cr> OBX|1|SN|1554-5^GLUCOSE^POST 12H CFST:MCNC:PT:SER/PLAS:QN||^182|mg/dl|70_105|H|||F<cr> The PID (Patient Identification) segment contains the demographic The Header) segmentsegment contains identifies the message type, The MSH OBR (Observation Request) the observation The OBX(Message (Observation) segment contains the results of in thethis case,as information of the patient. Eve E. Everywoman was born on 1962-03-20 and ORU^R01, which identifies message type and the trigger event. The sender it was orignally ordered:the 15545^GLUCOSE. The observation was observation: 182OH. mg/dl. lives in Statesville Her patient ID number (presumably assigned to her by is the GHH Lab in ELAB-3. The receiving is the OE system ordered by Particia Primary MD andapplication performed by GHH Howard the Good Health Hospital) is 555-44-4444. located in BLDG4. The message was sent on 2002-02-15 at 09:30. The MSH Hippocrates MD. segment is the initial segment of the message structure. 33 HL7 V3 HL7 Version 3 is mainly used in large interoperability projects, such as the National Health Service (NHS) Connecting for Health program in the UK, Health InfoWay in Canada, etc. HL7 messages are XML (extended markup language) documents, which look somewhat similar to HTML. 34 Why HL7 V3? HL7 V3 is designed to be Comprehensive in scope Complete in detail Extensible as requirements change Up-to-date Model-based Conformance testable Technology-independent 35 HL7 RIM The Reference Information Model (RIM) is the cornerstone of the HL7 Version 3 development process. The HL7 RIM specifies the grammar of HL7 messages and, specifically, the basic building blocks of the language and their permitted relationships. Structural attributes are used to specify more precisely what each RIM class means when used in a message. 36 The RIM structure The underlying structure of the RIM is based on six core classes: • Act: represents any action that occurs and is documented throughout the process as health care is managed and provided. • Entity: represents any physical thing and/or beings that are of interest to, and take part in health care. • Role: describes the task that Entities play/provide as they participate in health care acts. • Participation: refers to an association between a Role and an Act. • Act-relationship: is the association between a pair of Acts. • Role-link: is the connection that may exist between two roles that expresses a dependency between those roles. 37 Backbone Class: Act Structural attribute (Example) The structural attribute classCode determines whether an Act is an observation (such as tests, diagnoses, and examination findings), an encounter, or a procedure. moodCode indicates whether an Act has happened (an event), is a request for something to happen, a goal, or a criterion. For example, “weight = 100kg” is an observation event; “measure weight daily” is a request; “reduce weight to 80Kg” is a goal and “if weight is greater than 80Kg” is a criterion. Act: A record of something that is being done, has been done, can be done, or is intended or requested to be done. Act has the following sub-classes: Account ControlAct DeviceTask DiagnosticImage Diet FinancialContract FinancialTransaction InvoiceElement Observation Participation PatientEncounter Procedure PublicHealthCase SubstanceAdministration Supply WorkingList 38 Backbone Class: Entity Structural attribute (Example) Person has the attributes inherited from Entity and Living Subject as well as its own. name is an attribute of Entity, while sex (administrativeGenderCode), date of birth (birthTime), and date of death (deceasedTime) is each an attribute of LivingSubject. Entity: cover the whole universe of: • Living things such as people, animals, plants, and microorganisms • Nonliving things such as places, manufactured items, and chemical substances • Abstract things such as organizations Entity has the following sub-classes: Container Device LanguageCommunication LivingSubject ManufacturedMaterial Material NonPersonLivingSubject Organization Person Place 39 Backbone Class: Role Roles: Structural attribute (Example) A responsibility or part played by an entity (e.g. Person in a role of patient, employee, etc.). Attributes for person are patient, name, address, and patient id • People, such as patient, practitioner, or employee • Places, such as hospital, home, clinic, or place of birth • Organizations, such as care provider, employer, or supplier • Things, such as drug, instrument, or computer system • Responsible entities, such as parent, employer, or manufacturer There is a wide variety of Roles, which can be played by: Role has the following sub-classes: Access Employee LicensedEntity Patient 40 Backbone Class: ActRelationship Structural attribute (Example) typeCode describes the type of association between Acts: • Composition comprises entries • Discharge summary documents a hospital visit • Test report fulfills a test request • Discharge summary refers to a referral • Final report replaces a preliminary report ActRelationship: A directed association between a source Act and a target Act. A point from a later instance to a earlier instance OR point from collector instance to component instance. ActRelationship has no sub-classes. 41 Backbone Class: Participation Structural attribute (Example) Type Code describes the type of association between an Act and each participating Role: Performer of act (surgeons, observers, practitioners) Participation: An association between an Act and a Role with an Entity playing that Role. Participation has the following sub-class: ManagedParticipation 42 Backbone Class: RoleLink Example An employee of type "manager" may have authority over employees of type "analyst" which would be indicated by a role link for "direct authority". RoleLink: A connection between two roles expressing a dependency between those roles. RoleLink has no sub-classes. 43 Diagram Notation HL7 uses a special graphical notation: Each Act is represented as a red rectangle Role as a yellow rectangle Entity as a green rectangle ActRelationship is usually shown as pink (salmon), arrow-shaped pentagon Participation as a cyan (light blue) pentagon RoleLink as a light yellow pentagon. 44 HL7 CDA The CDA (Clinical Document Architecture) provides an exchange model for clinical documents (such as discharge summaries and progress notes) and brings the healthcare industry closer to the realization of an electronic medical record. By leveraging the use of XML, the HL7 RIM and coded vocabularies, the CDA makes documents both machine readable and human readable. Release 1, published in 2000, is a simple standard, describing a header and body. Only the header is based on the HL7 V3 RIM, while the body uses a variety of human-readable non-XML formats such as text or images. Release 2, published in 2005, is more complex and both the header and the body are based on the HL7 V3 RIM, allowing fine granularity of structured data. The body may be non-XML (providing backward compatibility to Release 1) or it may be organized into one or more sections, which may have structured entries. 45 The properties of document The CDA defines a clinical document as having the following characteristics: − Persistence: While it exists, it remains a single coherent whole. − Stewardship: At any time, some body or organization is responsible for looking after it. − Authentication: Each document may be signed, physically or electronically. − Context and Wholeness: : Each document is complete and whole in itself, including context information, such as who created it, when, where, and for what purpose. − Human readability: Meaning, as perceived by the human reader, is paramount. 46 HL7 CCOW Clinical Context Object Workgroup (CCOW), more commonly known as Clinical Context Management or Health Level Seven Context Management Standard (CMS) , is an interoperability specification for visual integration of applications that allows users to experience an integrated computer-user session on the desktop. The CCOW standard provides a mechanism for applications to share information so that they appear to behave as a single system. This shared information is known as the context. The CCOW is a standard protocol designed to enable disparate applications to share user context and patient context in real-time, and at the user-interface level. To allow clinical applications to share information at the point of care. This means that when a clinician signs onto one application within a CCOW environment, and selects a patient, that same sign-on is simultaneously executed on all other applications within the same environment, and the same patient is selected in all the applications, saving clinician time and improving efficiency. The CCOW offers a series of recommendations that, when followed by application developers will produce a cohesive and uniform set of CCOW-compliant behaviors. 47 An example of using the HL7-CCOW Here would be a step-by-step example of a CCOW exchange: 1) The computer boots up and the medical applications load. 2) Each application logs into CCOW using its secret passcode (and unique application name). 3) The compliant application displays a login prompt, and the user logs in as “Mary Jane”. 4) Mary Jane has a “CCOW ID”. Let us assume that her CCOW ID is “MJane”. 5) The compliant application notifies the CCOW vault that “MJane” is now logged in. 6) Once CCOW verifies that “MJane” is a valid CCOW user, the vault notifies all the other applications that “MJane” is logged in. 7) All of the other applications realize that the CCOW ID “MJane” is referring to “Mary Jane” (because they have been configured as such). They login “Mary Jane” automatically. 8) The transaction is complete. All of the applications running on the machine have been automatically logged in as “Mary Jane”. 48 . منتشر شد1993 توسط کالج رادیولوژی آمریکا و انجمن ملی سازندگان ابزار الکترونیک در سالDICOM (American College of Radiology, ACR and National Electrical Manufacturers Association, NEMA) ذخیره و انتقال انواع،این استاندارد جهت انتقال داده های مربوط به تصاویر دیجیتالی پزشکی است و شامل دستیابی .مختلف داده های تصویری و داده های همراه با تصاویر پزشکی می باشد . را فراهم می نمایدPACS دایکام امکان ذخیره تصاویر در سیستم . و پس از آن بطور پیوسته به روز می شود1993 – 3 ویرایش - 1988 -2 ویرایش- 1985 – 1 ویرایش DICOM (Digital Imaging and Communications in Medicine) is a standard for handling, storing, printing, and transmitting information in medical imaging. It includes a file format definition and a network communications protocol that uses TCP/IP to communicate between systems. DICOM is known as NEMA standard PS3. 49 The usage of DICOM 1. A set of protocols for network communication followed by devices conformance to the DICOM standard. 2. A syntax and semantics for commands and associated information that can be exchanged using these protocols. 3. A set of media storage services to be followed by standard compliant devices, as well as a file format and a directory structure to facilitate access to images, waveform data, and related information. 50 The current DICOM standard (V3.0 in year 2008) includes 16 parts 3.9: Point-to-Point Communication Support for Message Exchange (Retired) 3.13: Print Management Point-to-Point Communication Support (Retired) Medical imaging informatics, Alex A.T. Bui and Ricky K. Taira, 2010 (page 122). 51 The fundamental components of DICOM Object Class Service Class 52 The fundamental components of DICOM Object Class In DICOM, all data is represented within an information object class. Thus, any entity such as a patient’s demographics, image acquisition variables, and the image data itself is specified by an object class. DICOM distinguishes between normalized object classes (which basically are atomic entities) versus composite objects that are constructed from two or more normalized classes 53 PACS and Imaging Informatics Basic Principles and Applications, H. K. Huang, 2010 (page 277). 54 The fundamental components of DICOM - Service Class A service class refers to a process upon which data is generated, operated (transformed), or communicated. Examples of services are storage, querying, retrieval, and printing of images. Like its object class counterpart, services classes are divided between normalized and composite services. Service classes consider the role of a device in a requested operation: for example, is the device invoking the service, or is the device performing the operation? The former is referred to as a service class user (SCU), the latter a service class provider (SCP).For a given service class, a device may be capable of acting as the SCU, the SCP, or both dependent on its function in an overall PACS. 55 PACS and Imaging Informatics Basic Principles and Applications, H. K. Huang, 2010 (page 277). 56 A service is built on top of a set of “DICOM message service elements” (DIMSEs). These DIMSEs are computer software programs written to perform specific functions. PACS and Imaging Informatics Basic Principles and Applications, H. K. Huang, 2010 (page 281). 57 A service is built on top of a set of “DICOM message service elements” (DIMSEs). These DIMSEs are computer software programs written to perform specific functions. PACS and Imaging Informatics Basic Principles and Applications, H. K. Huang, 2010 (page 281). 58 The fundamental components of DICOM Service-Object Pairs (SOPs) The service classes and information object classes are combined to form the fundamental units of DICOM, called Service-Object Pairs (SOPs). The interchange of data in DICOM is governed by the concept of service-object pair (SOP) classes. SOP classes are defined for transmission and storage of documents that describe or refer to the images or waveforms or the features they contain. 59 DICOM file format • A file format is a standard way that information is encoded for storage in a computer file. It specifies how bits are used to encode information in a digital storage medium. File formats may be either proprietary or free and may be either unpublished or open. • The DICOM file starts with header (the DICOM file meta information) that is optional, followed by the bit stream of data set, and ends with the image pixel data if it is a DICOM image file. • The DICOM file meta information includes file identification information. • A Data Set represents an instance of a real world Information Object. • DICOM provides a mechanism for supporting the use of JPEG Image Compression. • DICOM files typically have a .dcm file extension 60 New Features in DICOM 1) Visible Light (VL) Image: The visible light (VL) image information object definition (IOD) for endoscopy, microscopy, and photography has become available. 2) Mammography CAD (Computer-Aided Detection): It uses the mammography CAD output for analysis of mammographic findings. 3) Waveform IOD: It was mainly developed for imaging cardiac waveforms, for example, ECG and cardiac electrophysiology (EP). 4) Structured Reporting (SR) Object: Structured reporting is for radiologists to shorten their reporting time. SR SOP classes provide the capability to record the structured information to enhance the precision and value of clinical documents and enable users to link the text data to particular images or waveforms. The DICOM standard allows different patterns of an SR report, called SR templates 5) Content Mapping Resource: This defines the templates and context groups used in other DICOM parts. 61 The base hierarchy of patient and imaging data concepts, which is often referred to as DICOM’s “model of the real-world.” Medical imaging informatics, Alex A.T. Bui and Ricky K. Taira, 2010 (page 123). 62 EDIFACT Administration, For Interchange Data (Electronic EDIFACT )Commerce and Transport در سال 1986برای تبادل داده های الکترونیکی اداری ،تجاری و حمل و نقل ارائه شد. عالوه بر آن بخش سالمت و مراقبتهای بهداشتی را نیز در بر می گیرد. در اروپا توسعه بیشتری یافته است. 63 Using an EDIFACT message, An example • For example: You order a particular product from your supplier using an EDIFACT message (ORDERS). The recipient of the products can now automatically process your data in its in-house system. Many of the factors required for delivery of the product (e.g. product, delivery date, delivery address, customer name, etc.) are already available. • The goods are transferred to the carrier with a transport order (IFTMIN). The consignee receives notification of delivery (INSDES) at the same time. Both the consignor and consignee can track the consignment and retrieve useful information (e.g. estimated date of arrival, current location of the consignment, etc.). A status report (IFTSTA) from the carrier automatically informs the consignor and consignee of any delays. • Notification of arrival is automatically generated (IFTMAN) when the goods arrive at the destination station. When the consignee confirms receipt of the goods, the transport invoice (IFTFCC) is issued to the consignor or consignee, depending on the payment method. 64 استانداردهای رایج تبادل اطالعات پزشکی – استانداردهای اروپایی CEN/TC251 ( European Committee for Standardization [1961] / Technical Committee 251) is a workgroup within the European Union working on standardization in the field of Health Technology (HICT). Information and Communications 65 The Workgroups in CEN/TC251 • Information models (WG I) Development of European standards to facilitate communication between independent information systems within and between organisations. • Terminology and knowledge representation (WG II) Semantic organisation of information and knowledge so as to make it of practical use in the domains of health informatics and telematics. Provision of information and criteria to support harmonisation in health care and terminological consistency within TC251. • Security, Safety and Quality (WG III) Techniques for technical protection of confidentiality, integrity, availability and accountability as well as guidelines for security management. • Technology for Interoperability (WG IV) Work on middleware and most of the work on medical imaging and multimedia (although the focus in this area is on international standards) and medical device communication in integrated healthcare. 66 CEN/TC251 نمونه ای از مستندات • ENV 1613: Medical informatics - Messages for exchange of laboratory information – 1995 [WG I] • ENV 12017 : Medical Informatics - Vocabulary - 1997 [WG II] • ENV 12388: Medical Informatics - Algorithm for Digital Signature Services in Health Care – 1996 [WG III], used for digital signatures in medicine information exchange. • ENV 13734 : Health Informatics -Vital signs information representation – 1999 [WG IV] , Used in Medical device communication.