Report of the secretariat. CEN/TC 251 secretariat ACTION REQUIRED: For your information

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1 Secretariat: doc.nr. Vlinderweg 6 P.O. box 5059 CEN/TC 251 N AX Delft 2600 GB Delft date The Netherlands The Netherlands total pages 8 Secretary: Ms Shirin Golyardi Committee CEN/TC 251 Telephone: Fax: Health Informatics shirin.golyardi@nen.nl Assistant: Telephone: Fax: mary.vandenberg@nen.nl TITLE: SOURCE: ACTION REQUIRED: Report of the secretariat CEN/TC 251 secretariat For your information Telephone +31 (0) , Fax +31 (0) , Internet: 1

2 Report of the secretariat CEN/TC 251 "Health informatics February 2011 Ms. Shirin Golyardi 1. Chairman and secretary Chairman: Secretariat: Mr. Kees Molenaar (The Netherlands) Ms. Shirin Golyardi, NEN (The Netherlands) 2. Active Liaisons with CEN TC 251 ISO/TC 215 Health informatics Health Level 7 CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices COCIR Normapme epsos project Calliope network project 3. Constitution WG I Information models, Convener: Dr. Stephen Kay, United Kingdom WG II Terminology and Knowledge Representation, Convener: Dr. Magnus Fogelberg, Sweden WG III Security, safety and quality, Acting Convener: Mr. Luuc Posthumus, Netherlands WG IV Technology for Interoperability, Convener: Mr. Alpo Värri, Finland 4. Published standards CR 1350:1993 ENV 1613:1995 CR 12161:1995 CR 12587:1996 ENV 12388:1996 ENV 12018:1997 ENV :1997 ENV :1997 ENV 12610:1997 ENV 12611:1997 ENV 12612:1997 ENV 12924:1997 ENV 12443:1999 CR 13694:1999 Investigation of syntaxes for existing interchange formats to be used in health care Medical informatics - Messages for exchange of laboratory information A method for defining profiles for healthcare Medical Informatics - Methodology for the development of healthcare messages Medical Informatics - Algorithm for Digital Signature Services in Health Care Identification, administrative, and common clinical data structure for Intermittently Connected Devices used in healthcare (including machine readable cards) Medical informatics - Registration of information objects used for EDI in healthcare - Part 1: The Register Medical informatics - Registration of information objects used for EDI in healthcare - Part 2: Procedures for the registration of information objects used for electronic data interchange (EDI) in healthcare Medical informatics - Medicinal product identification Medical informatics - Categorial structure of systems of concepts - Medical devices Medical informatics - Messages for the exchange of healthcare administrative information Medical Informatics - Security Categorisation and Protection for Healthcare Information Systems Medical Informatics - Healthcare Information Framework (HIF) Health Informatics - Safety and Security Related Software Quality Standards for Healthcare (SSQS) Telephone +31 (0) , Fax +31 (0) , Internet: 2

3 ENV 13607:2000 ENV :2000 ENV :2000 ENV :2000 ENV :2000 ENV 13729:2000 ENV :2001 ENV :2002 CR 14301:2002 CR 14302:2002 EN 1828:2002 EN ISO 18812:2003 EN 14484:2003 EN 14485:2003 EN ISO 18104:2003 CEN/TS 14796:2004 Health informatics Messages for the exchange of information on medicine prescriptions Health informatics - Security for healthcare communication - Part 1: Concepts and terminology Health informatics - Security for healthcare communication - Part 2: Secure data objects Health informatics - Security for healthcare communication - Part 3: Secure data channels Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 2: Updating of medical laboratory-specific information Health informatics - Secure user identification - Strong authentication using microprocessor cards Health informatics - Blood transfusion related messages - Part 1: Subject of care related messages Healthcare Informatics - Blood transfusion related messages - Part 2: Production related messages (BTR-PROD) Health informatics - Framework for security protection of healthcare communication Health informatics - Framework for security requirements for intermittently connected devices Health informatics - Categorial structure for classifications and coding systems of surgical procedures Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003) Health informatics - International transfer of personal health data covered by the EU data protection directive - High level security policy Health informatics - Guidance for handling personal health data in international applications in the context of the EU data protection directive Health Informatics - Integration of a reference terminology model for nursing (ISO 18104:2003) Health Informatics - Data Types EN ISO :2004 Health informatics - Patient healthcard data - Part 1: General structure (ISO :2004) EN ISO :2004 Health informatics - Patient healthcard data - Part 2: Common objects (ISO :2004) EN ISO :2004 Health informatics - Patient healthcard data - Part 3: Limited clinical data (ISO :2004) EN 12251:2004 EN 12381: EN : EN : CEN/TS : EN 12264: Health informatics - Secure User Identification for Health Care - Management and Security of Authentication by Passwords Health informatics - Time standards for healthcare specific problems Health informatics - Service request and report messages - Part 1: Basic services including referral and discharge Health informatics - Messages for maintenance of supporting information in healthcare systems - Part 1: Updating of coding schemes Health informatics - General purpose information components - Part 4: Message headers Health informatics - Categorial structures for systems of concepts Telephone +31 (0) , Fax +31 (0) , Internet: 3

4 EN 1068: CEN/TS : CEN/TR 15253: Health informatics - Registration of coding schemes Health informatics - Testing of physiological measurement software - Part 1: General Health Informatics - Quality of service requirements for health information interchange EN ISO : communications - Part 10101: Nomenclature EN ISO : communications - Part 10201: Domain information model EN ISO : communications - Part 20101: Application profiles - Base standard EN ISO : communications - Part 30300: Transport profile - IrDA based - Infrared wireless EN ISO : communications - Part 30200: Transport profile - IrDA based - Cable connected EN : Health informatics - General purpose information components - Part 1: Overview EN : Health informatics - General purpose information components - Part 2: Non-clinical EN : Health informatics - General purpose information components - Part 3: Clinical CEN/TR 15212:2006 EN 1614:2006 Health informatics - Vocabulary maintenance procedure for a web-based terms and concepts database Health informatics - Representation of dedicated kinds of property in laboratory medicine EN 12435:2006 CEN/TR 15299:2006 CEN/TR 15300:2006 CEN/TS 15260:2006 Health Informatics - Expression of the results of measurements in health sciences Health Informatics - Safety procedures for identification of patients and related objects Health Informatics - Framework for formal modelling of healthcare security policies Health informatics - Classification of safety risks from health information products CEN/TS 15211:2007 Health Informatics - Mapping of hierarchical message descriptions to XML EN :2007 Health informatics - Electronic health record communication - Part 1: Reference model EN ISO :2007 Health informatics - Patient healthcard data - Part 4: Extended clinical data EN ISO :2008 Health informatics Patient healthcard data Part 7: Electronic prescription (medication data) (ISO/DIS :2004) EN :2007 Health informatics - Electronic health record communication - Part 4: Security EN :2007 Health Informatics - System of concepts to support Continuity of care - Part 1: Basic concepts EN 1064:+A1:2007 Health informatics - Standard communication protocol - Computer-assisted electrocardiography Telephone +31 (0) , Fax +31 (0) , Internet: 4

5 CEN/TR 15640:2007 Health informatics Measures for ensuring the patient safety of health software EN :2007 Health informatics - Electronic health record communication - Part 2: Archetype interchange specification EN 15521:2007 Health informatics Categorial structure for terminologies of human anatomy EN 14463:2007 Health informatics A syntax to represent the content of medical classification systems ClaML EN :2008 EN ISO :2008 Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists Health informatics Patient healthcard data Part 5: Identification data EN ISO :2008 Health informatics Patient healthcard data Part 6: Administrative data EN ISO 27799:2008 Health informatics Information security management in health using ISO/IEC CEN/TS 15699:2009 EN ISO 10781:2010 EN ISO :2010 EN ISO :2010 Health informatics Clinical knowledge resources Metadata (MetaKnow) Health Informatics HL7 Electronic health record system functional model Health informatics Electronic health record communication Part 5: Interface specification Health informatics Patient healthcard data Part 8: Linkage and reference data 4.1. Withdrawn Standards and abandoned projects CR 12069:1995 Profiles for medical image interchange ENV 12381:1996 Health care informatics - Time standards for healthcare specific problems CR 12700:1997 Supporting document to ENV 1613:1994 Messages for Exchange of Laboratory Information ENV 12539:1997 Medical informatics - Request and report messages for diagnostic service departments ENV 12538:1997 Medical informatics - Messages for patient referral and discharge ENV 12264:1997 ENV 12017:1997 ENV 12623:1997 Medical informatics - Categorical structures of systems of concepts - Model for representation of semantics Medical Informatics - Medical Informatics Vocabulary (MIVoc) Medical Informatics - Media Interchange in Medical Imaging Communications (MI-MEDICOM) CR 13058:1997 ENV :1997 Medical data interchange - Mapping between the models specified in ENV 12539:1997 and NEMA PS3 Supplement 10 Medical Image Management - Part 1: Storage Commitment Service Class ENV :1998 ENV :1998 ENV 13735:2000 Medical informatics - Healthcare Information System Architecture (HISA) - Part 1: Healthcare Middleware Layer Medical informatics - Healthcare Information System Architecture (HISA) - Part 1: Healthcare Middleware Layer Health informatics Interoperability of patient connected medical devices Telephone +31 (0) , Fax +31 (0) , Internet: 5

6 ENV 13734:2000 Health informatics Vital signs information representation ENV 13939:2001 Health informatics Medical Data Interchange: HIS/RIS-PACS and HIS/RIS Modality Interface ENV 14032:2001 Health Informatics System of concepts to support nursing CR 14300:2002 Health Informatics Interoperability of healthcare multimedia report systems CEN/TS 14271:2003 Health informatics File exchange format for vital signs EN 12052:2004 Health informatics - Digital imaging - Communication, workflow and data management EN :2007 Health informatics Service architecture Part 1: Enterprise viewpoint EN :2007 Health informatics Service architecture Part 2: Information viewpoint EN :2007 Health informatics Service architecture Part 3: Computational viewpoint PrCEN/TR (2009) Health informatics - Overview of national health professional cards in the CEN member countries prcen TR (2009) pren ISO (2009) Health informatics The categorization and nomenclature of medical devices Requirements and analysis Health informatics Pharmacovigilance Controlled vocabularies for the reporting of laboratory results and clinical observations prcen/tr (2009) Health informatics Concurrent use of 13606, and pren rev (2010) Health informatics Categorial structure of systems of concepts Medical devices prcen ISO/TS prcen ISO/NP TR Health informatics Application of clinical risk management to the manufacture of health software Health informatics Guidance on the management of clinical risk relating to the deployment and use of health software systems 5. Current Work Program pren ISO pren ISO Health Informatics Data types for use in health care interchange Health informatics Identification of Medicinal Products Data Elements and Structure for the Exchange of regulated Product Information for Drug Dictionaries Publication: pren ISO Health informatics Identification of Medicinal Products Pharmaceutical Product Identifiers pren ISO Health informatics Identification of Medicinal Products Structures and Controlled Vocabularies for Ingredients and Substances pren ISO Health informatics Identification of Medicinal Products Structures and Controlled Vocabularies for Pharmaceutical Dose Form, Units of Presentation and Routes of Administration pren ISO Health informatics Identification of Medicinal Products Structures and Controlled Vocabularies for Units of Measurement Telephone +31 (0) , Fax +31 (0) , Internet: 6

7 pren ISO pren ISO pren ISO pren ISO Health informatics - Pharmacovigilance - Individual case safety report - Part 1: The framework for adverse event reporting Health informatics - Pharmacovigilance - Individual case safety report - Part 2: Human pharmaceutical reporting requirements for ICSR Health informatics Quality Requirements and Methodology for Detailed Clinical Models Health informatics Service architecture Part 1: Enterprise viewpoint Parallel FDIS ballot: Parallel FDIS ballot: Dispatch DIS / ENQ draft before: Publication: pren ISO Health informatics Service architecture Part 2: Information viewpoint Publication: pren ISO Health informatics Service architecture Part 3: Computational viewpoint Publication: prcen/tr Health informatics - Use Case Framework for use in M403 Dispatch DTR draft before: prcen/tr prcen/tr pren ISO 1828 review pren ISO pren Health informatics Roadmap for Health Record Information Models Health informatics Roadmap for Health Record Information Models Health informatics Categorial structure for classifications and coding systems of surgical procedures Health informatics System of concepts to support continuity of care Part 1: Basic concepts Health informatics System of concepts to support continuity of care Part 2: Workflow Dispatch DTR draft before: Dispatch DTR draft before: until Enquiry: until ENQ ballot between and pren ISO Health informatics Clinical knowledge resources Metadata until pren ISO pren ISO PrCEN/TR pren ISO pren ISO/TS ISO/NP pren ISO pren ISO ISO/NP Health informatics A syntax to represent the content of classification systems in health care Health informatics - Audit trails for electronic health records Health informatics - Guidance on Patient identification and Cross-referencing of identities Health informatics -- Directory services for health care providers, subjects of care, and other entities Health Informatics - Classification of purposes for processing personal health information communication - Part 20301: Application profile - Optional package, remote control communication - Part 00000: Framework and overview communication - Part 20202: Application profile - Baseline communication - Part 20201: Application profile - Polling mode * Transfer of VA lead to ISO * Next: parallel DIS ballot Parallel DIS/ENQ ballot: until To be submitted for publication 2 nd parallel DIS / ENQ: After publication in ISO, UAP ballot in CEN DIS ballot Q DIS ballot Q DIS ballot Q DIS ballot Q Telephone +31 (0) , Fax +31 (0) , Internet: 7

8 pren ISO/TS communication - Part 92001: Medical waveform format - Encoding rules (ISO/TS ) Systematic review closed on Next stage pren ISO Health Informatics - Personal Health Device Communication - Part 10404: Device Specialization - Pulse Oximeter pren ISO Health Informatics - Personal Health Device Communication - Part 10407: Device Specialization - Blood Pressure Monitor pren ISO Health Informatics - Personal Health Device Communication - Part 10408: Device Specialization - Thermometer pren ISO Health Informatics - Personal Health Device Communication - Part 10415: Device Specialization Weighting Scale pren ISO Health Informatics - Personal Health Device Communication - Part : Device Specialization Glucose Meter pren ISO Health Informatics - Personal Health Device Communication - Part : Device Specialization Independent Living Activity Hub pren ISO Health Informatics - Personal Health Device Communication - Part : Device Specialization Medication monitor pren ISO Health Informatics - Personal Health Device Communication - Part : Application Profile Optiomized Exchange Protocol Next stage is DIS ballot pren ISO Health informatics Digital imaging Communication, workflow and data management Publication: Next meetings - ISO/TC 215 and CEN/TC 251 will have joint WG meetings between 23 and 27 May 2011 in Kuopio, Finland Telephone +31 (0) , Fax +31 (0) , Internet: 8