ISO/TC215, Health Informatics Activity
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1 ISO/TC215, Health Informatics Activity Yun Sik Kwak, MD,PhD ISO TC 215 Dept Medical Informatics Kyungpook Nat l Univ Sch Med, Daegu, Republic of Korea Feb 2004 WSC WS Med Tech, Geneva 1
2 ISO TC 215 Health Informatics Chair : Yun Sik Kwak (Rep. of Korea) Secretariat : ANSI (USA) Secretary : Audrey Dickerson, RN (HIMSS; USA) Joyce Sensmier, RN (HIMSS) Scope : Standardization in field of information for health, health ICT to achieve compatibility and interoperability between independent systems. Also to ensure compatibility of data for comparative statistical purpose (eg, classifications), and to reduce duplication of effort and redundancies Feb 2004 WSC WS Med Tech, Geneva 2
3 ISO TC215 Structure Technical Committee WG 1 WG 2 WG 3 WG 4 WG 5 WG 6 Sub G 1 Sub G 2 Sub G 3 Sub G 4 TF e-health TF COPOLCO Feb 2004 WSC WS Med Tech, Geneva 3
4 ISO TC 215 Membership P' Member Bodies = 25 Africa : S Africa Kenya (2) N America : Canada USA (Secretariat) (2) S America : None Asia : Israel Japan Korea Turkey (4) Europe : Austria Belgium Denmark Finland France Germany Italy Netherlands Norway Poland Spain Sweden Serbia/Croatia Russian federation United Kingdom (15) Oceania : Australia New Zealand (2) Feb 2004 WSC WS Med Tech, Geneva 4
5 ISO TC 215 Membership 'O' Member Bodies = 13 Africa : Zimbabwe (1) N America : Ecuador (1) S America : Argentina (1) Asia : China India Mongolia Singapore Thailand (5) Europe : Czech Republic Hungary Ireland Portugal Switzerland (5) Feb 2004 WSC WS Med Tech, Geneva 5
6 ISO TC 215 WG 1 Health Records and Modelling Coordination Convenor : Don Newsham (Canada) Scope : To develop standards to facilitate the capturing, safe communications, and trusted management of information concerning the total health process applied to one subject of care for individual and public health purposes and, furthermore, to coordinate modelling of other relevant standards efforts such as those regarding terminology, messaging, and security &objAction=browse&sort=name Feb 2004 WSC WS Med Tech, Geneva 6
7 ISO TC 215 WG 2 Messaging and communications Convenor : Edward Hammond (USA) Scope :effort of the WG 2 is defined as follows: A general statement of the types of standards to be considered (for example, the functional purpose of the interchange and the circumstances in which the interchange should occur) The specific domains of activity (that is, clinical messaging, medical device communication, and business and financial messaging) A set of additional tasks or working principles that will guide the effort &objAction=browse&sort=name Feb 2004 WSC WS Med Tech, Geneva 7
8 ISO TC 215 WG 2 Messaging and communications(cont ) Scope : A means of implementing that interchange in one or more syntax or communication modalities. Specific Domains : Clinical messaging Medical device communication Business and financial messaging Feb 2004 WSC WS Med Tech, Geneva 8
9 ISO TC 215 WG 2 Messaging and communications(cont ) Sub-working Groups : 1. Architecture 2. Device interface 3. Methodology 4. DICOM persistent object Feb 2004 WSC WS Med Tech, Geneva 9
10 ISO TC 215 WG 3 Health Concept Representation Convenor : Christopher Chute (USA) Scope : To develop standards for representation of health concepts. These standards include formal models of representation and description of health concepts; principles of their organization within terminologies and their related systems (including controlled clinical terminologies and classifications); and issues concerning context of their use in electronic health records. =529136&objAction=browse&sort=name Feb 2004 WSC WS Med Tech, Geneva 10
11 ISO TC 215 WG 4, Security Convenor : Gunnar Klein (Sweden) Scope : Defining standards for technical measures to protect and enhance the confidentiality, availability, and integrity of health information, and also accountability for users, as well as guidelines for security management in healthcare. =529136&objAction=browse&sort=name Feb 2004 WSC WS Med Tech, Geneva 11
12 ISO TC 215 WG 5 Health Cards Convenor : Juergen Sembritzki (Germany) Scope : To develop standards in field of healthcare usage of machine readable cards compliant with physical characteristics, including dimensions defined in ISO/IEC 7810,Identification cards - Physical characteristics. The WG shall place special emphasis on standards on technology independent data structure leading to interoperability and compatibility including communication of data. jid=529136&objaction=browse&sort=name Feb 2004 WSC WS Med Tech, Geneva 12
13 ISO TC 215 WG 6 Pharmacy and Medication Convenor : Ray Rogers (UK) Scope : To develop standards in field of healthcare usage of pharmacy supply and medication related activities including e-prescription. =529136&objAction=browse&sort=name Feb 2004 WSC WS Med Tech, Geneva 13
14 ISO TC 215 Liaison International Council of Nurses - Category B IMIA WG Standard - A UN/EDIFACT D11 Healthcare EWG - A WHO - B World Wide Web Consortium - B Feb 2004 WSC WS Med Tech, Geneva 14
15 ISO/CS Support Sophie Clivio, ISO Programme Manager Central Secretariat Contact Coordinates ISO/CS resources for committee s use Procedural questions Work programme Balloting of DIS and FDIS Editing/publication Feb 2004 WSC WS Med Tech, Geneva 15
16 WEBSITE ISO General Site ISO/TC 215 Home Page (LiveLink): 36&objAction=browse&sort=nameStandards specific information Templates Directives Informative articles/communiqué Feb 2004 WSC WS Med Tech, Geneva 16
17 Interoperability Interoperability : ability of two or more system or components to exchange information and to use the information that has been exchanged. source : IEEE Standard Computer Dictionary : A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990 Functional interoperability Semantic interoperability Feb 2004 WSC WS Med Tech, Geneva 17
18 Use Case Descriptions Use Case Analysis Transactions / Interactions Actors Pilot Projects Tasks ICT Profile Statements Use Case Requirements ISO/IEEE/CEN X73 ISO TC215 CEN TC251 ASTM / NCCLS ITU-T JTC1 DICOM HL7... Clinical Information Communications Security QoS Economics Legal & Regulatory Feb 2004 WSC WS Med Tech, Geneva 18
19 ISO TC215 Health Informatics Focus is primarily on Level 7 Interope rability Medical Device Co mmunications cove rs all 7 layers. ISO/OSI Level 7: ISO/OSI Level 6: ISO/OSI Level 5: ISO/OSI Level 4: ISO/OSI Level 3: ISO/OSI Level 2: ISO/OSI Level 1: Application Presentation Session Transport Network Datalink Physical Feb 2004 WSC WS Med Tech, Geneva 19
20 Standards and/or Guides Published TS :2002 Health Informatics PKI framework and overview TS :2002 Health Informatics PKI certificate profile TS :2002 Health Informatics PKI management of certificate authority TS :2002 Health Informatics Controlled health term structure and high-level indicators ISO :2003 Health Informatics Integration of a reference terminology model for nursing Feb 2004 WSC WS Med Tech, Geneva 20
21 Standards and/or Guides Published TR 18307:2001 Health Informatics Interoperability and common messaging and communication standards key characteristics TS 18308:2004 Health Informatics Requirements for an electronic medical record architecture ISO :2003 Health Informatics Clinical analyser interfacing information system Feb 2004 WSC WS Med Tech, Geneva 21
22 Focused Activities 1. Medical Device Interface jointly with ISO/TC215, IEEE and CEN 2. Market Relevance HIMSS exhibit Feb 2004 WSC WS Med Tech, Geneva 22
23 Issues 1. Global relevance 2. Inclusiveness and exclusiveness 3. Timeliness of marketing Feb 2004 WSC WS Med Tech, Geneva 23
24 Where do we go for? 1. Inclusiveness of developing countries 2. Multi-cultural representation 3. Clinical user representation 4. Negotiated idealism and realism 5. Market relevance and timeliness 6. Harmonization - CEN and others Need your participation through your country member bodies! Feb 2004 WSC WS Med Tech, Geneva 24
25 Thank you Feb 2004 WSC WS Med Tech, Geneva 25
26 ISO/TC215 WG Activities Working Group 1 Designation ISO/DIS Health informatics - Country identifier mechanism in healthcare Designation ISO/DTS Health informatics - Requirements for the electronic health record reference architecture Designation ISO/DTS Health informatics - Health indicators conceptual framework Designation ISO/WDTR Health informatics - A general domain model for health information - profiling framework Designation ISO/PWI Health informatics - Emergency data set Feb 2004 WSC WS Med Tech, Geneva 26
27 ISO/TC215 WG Activities(cont ) Working Group 1 Designation ISO/PWI Health informatics - Health indicators definitions, attributes and relationships Designation ISO/PWI Health informatics - Essential principles of health care documentation Designation ISO/PWITR Health informatics - EHR definition, scope and context Working Group 2 ISO/TR Health informatics - Key characteristics for interoperability and compatibility in messaging and communications standards (Published in Jan 2002) Feb 2004 WSC WS Med Tech, Geneva 27
28 ISO/TC215 WG Activities(cont ) Working Group 2 ISO/IS Health informatics - Clinical analyzer interfaces to laboratory information systems - Use profiles (Published in Jan 2003) Designation ISO/WD Health informatics - Point-of-care medical device communications - Framework and overview Designation ISO/WD Health informatics - Point-of-care medical device communications - Nomenclature Designation ISO/DIS Health informatics - Point-of-care medical device communications - Domain information model Feb 2004 WSC WS Med Tech, Geneva 28
29 ISO/TC215 WG Activities(cont ) Working Group 2 Designation ISO/DIS Health informatics - Point-of-care medical device communication - Application profiles - Base standard Designation ISO/WD Health informatics - Point-of-care medical device communication - Application profiles - Polling mode Designation ISO/WD Health informatics - Point-of-care medical device communication - Application profiles - Baseline Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - Framework and overview Feb 2004 WSC WS Med Tech, Geneva 29
30 ISO/TC215 WG Activities(cont ) Working Group 2 Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - Infusion device Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - Vital signs monitor Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - Ventilator Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - Pulse oximeter Feb 2004 WSC WS Med Tech, Geneva 30
31 ISO/TC215 WG Activities(cont ) Working Group 2 Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - Defibrillator Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - ECG Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - Blood pressure Designation ISO/WD Health informatics - Point-of-care medical device communication - Device specialization - Temperature Feb 2004 WSC WS Med Tech, Geneva 31
32 ISO/TC215 WG Activities(cont ) Working Group 2 Designation ISO/WD Health informatics - Point-of-care medical device communication - Application profiles - MIB elements Designation ISO/DIS Health informatics - Point-of-care medical device communication - Transport profile - Infrared wireless Designation ISO/DIS Health informatics - Point-of-care medical device communication - Transport profile - Cable connected Designation ISO/WD Health informatics - Point-of-care medical device communication - Application profiles - Optional package, remote control Feb 2004 WSC WS Med Tech, Geneva 32
33 ISO/TC215 WG Activities(cont ) Working Group 2 Designation ISO/DTR Health informatics - Trusted end-to-end information flows Designation ISO/PWI Health informatics - Data types for use in healthcare data interchange Designation ISO/PWI Health informatics - Processes for developing and implementing a message standard Designation ISO/DTR Health informatics - Interoperability of telehealth systems and networks -Part 1: Introduction and definitions Designation ISO/DTR Health informatics - Interoperability of telehealth systems and networks - Part 2: Real-time systems Feb 2004 WSC WS Med Tech, Geneva 33
34 ISO/TC215 WG Activities(cont ) Working Group 2 Designation ISO/DTS Health informatics - Interoperability of telelearning systems Designation ISO/WD Health informatics - Web access to DICOM persistent objects Designation ISO/PWI Health informatics - Stakeholder general purpose information component Designation ISO/PWI Health informatics - Methodology for documenting high-level flows (stakeholder to stakeholder) communications Designation ISO/PWI Health informatics - Requirements for interoperability and compatibility in messaging and communications standards Feb 2004 WSC WS Med Tech, Geneva 34
35 ISO/TC215 WG Activities(cont ) Working Group 2 Designation ISO/PWI Health informatics - Messages and communication - Procedure result data objects - Unique instance identifiers - Format Designation ISO/PNWI Health informatics - Interoperability guidelines for telehealth systems and networks Designation ISO/PNWI Health informatics - Quality indicators for health information made available on the Internet Designation ISO/PNWI Health informatics - Inventory of healthcare informatics related standards and works in progress Designation ISO/PNWI Health informatics - De-identification of health records Feb 2004 WSC WS Med Tech, Geneva 35
36 ISO/TC215 WG Activities(cont ) Working Group 3 ISO/TS Health informatics - Controlled health vocabularies - Vocabulary structure and high-level quality indicators (Published in Jan 2002) - revision proposed Designation ISO/CD Health informatics - Metavocabulary for terminologic systems Designation ISO/DIS Health informatics - Integration of a reference terminology model for nursing Working Group 4 ISO/TS Health informatics - Public key infrastructure - Part 1: Framework and overview (in Press) Feb 2004 WSC WS Med Tech, Geneva 36
37 ISO/TC215 WG Activities(cont ) Working Group 4 ISO/TS Health informatics - Public key infrastructure - Part 2: Certificate profile (in Press) ISO/TS Health informatics - Public key infrastructure - Part 3: Policy management of certification authority (in Press) Designation ISO/WD TS Health informatics - Security requirements for archiving and backup - Part 1: Archiving of health records Designation ISO/PWI Health informatics - Framework for health information security Designation ISO/WD TS Health informatics - Directory services for security, communications and identification of professionals and patients Feb 2004 WSC WS Med Tech, Geneva 37
38 ISO/TC215 WG Activities(cont ) Working Group 4 Designation ISO/DIS Health informatics - Guidelines on data protection to facilitate trans-border flow of personal health information Designation ISO/PWI TS Health informatics - Privilege management and access control Designation ISO/PWI Health informatics - Functional and structural roles Working Group 5 Designation ISO/DIS Health informatics - Patient healthcard data - Part 1: General structure Designation ISO/DIS Health informatics - Patient healthcard data - Part 2: Common objects Feb 2004 WSC WS Med Tech, Geneva 38
39 ISO/TC215 WG Activities(cont ) Working Group 5 Designation ISO/DIS Health informatics - Patient healthcard data - Part 3: Limited clinical data Designation ISO/CD Health informatics - Patient healthcard data - Part 7: Electronic prescription Designation ISO/PWI Health informatics - Patient healthcard data - Part 5: Identification data Designation ISO/PWI Health informatics - Patient healthcard data - Part 6: Administrative data Designation ISO/WD Health informatics - Patient healthcard data - Part 8: Links Designation ISO/WD Health informatics - Healthcards - General characteristics Feb 2004 WSC WS Med Tech, Geneva 39
40 ISO/TC215 WG Activities(cont ) Working Group 5 Designation ISO/WD Health informatics - Healthcards - Numbering system and registration procedure for issuer identifiers Working Group 6 e-pharmacy Task Force e-health Consumer policy Feb 2004 WSC WS Med Tech, Geneva 40
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