International Standards Health Informatics. Audrey Dickerson, RN, MS ISO/TC 215 Secretary

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1 International Standards Health Informatics Audrey Dickerson, RN, MS ISO/TC 215 Secretary

2 Objectives To appreciate the global role of standards in our lives To understand the role of international HIT standards in the US To appreciate the value for HIMSS with international HIT standards

3 Standards all around us Construction: Electrical: Manufactured: Currency: Environmental: Food: Sanitation: Transportation: Buildings, roads Wiring, bulbs, outlets Refrigerators, etc Material and sizes Air and water How food is grown and processed Processing plants Automobiles, trains and planes (Not limited to these topics)

4 Healthcare Standards Two main types: Clinical Quality accreditation process>>> Ex: JCAHO Standards of Care developed from Best Practices Information Technology Messaging communication between IT systems Messaging between medical devices Messaging between devices and systems

5 Healthcare is a Global business HIT Standards Provide: Support for dynamic development of e-business Paradigm changing to support e-business Including healthcare manufacturing and service vendors Ensure consistent manufacturing processes The global supply chain from supplier to consumer Suppliers & Consumers are global (not only from the US) Throughout the lifecycle of products and systems Lifecycle/version and updates of products and systems Standards Drive Business Processes!

6 What is an HIT Standard A standard specifies a well-defined approach that supports a business process and: (1) has been agreed upon by a group of experts; (2) has been publicly vetted; (3) provides rules, guidelines, or characteristics; (4) helps to ensure that materials, products, processes, and services are fit for their intended purpose; (5) is available in an accessible format; and (6) is subject to an ongoing review and revision process. (HITSP definition ) Example: ISO#18104 Integration of a reference terminology model for nursing -An essential first step in creating comparable nursing data across settings and countries. (ex: B/P)

7 What Health Information Technology Standards Do: Critical to Healthcare Delivery Beginning the work to establish a common terminology (Semantic Content) Facilitate interoperability and integration of data across time and settings Create structured information models for data and message interchange Enhance security and privacy Develop data sets and clinical models into a specific format allowing many settings and cultures to use the same data set or clinical model

8 ISO/TC 215 Health Informatics Chair : Yun Sik Kwak, MD, PhD (Korea/USA) Secretariat : ANSI (USA) Delegated to HIMSS Secretary : Audrey Dickerson, MS, RN (HIMSS, USA) Scope : Standardization in the field of information for health, and Health Information and Communications Technology (ICT) to achieve compatibility and interoperability between independent systems. Also, to ensure compatibility of data for comparative statistical purposes (e.g. classifications), and to reduce duplication of effort and redundancies.

9 Definitions used in the TC Technical committee (TC) : International group unified with specific knowledge of the core elements related to a specific topic. This TC is: Health Informatics Working group: Division within the TC working in one topic area (TC 215 has 9) Example: Security Project leader: Assigned for coordination during development for each new work item

10 ISO Deliverables IS International Standard Used for RFP references Governmental regulations Used in Manufacturing specifications TS Technical Specification Used when agreement for IS is not possible TR Technical Report Information on a single topic Guide for implementation of a standard

11 ISO/TC 215 Officer Structure Chairman: Responsible for the overall management of the TC, including working groups; works closely with secretary to ensure management of the work programme Secretariat: Responsible for project management, timely progress and general advice for the work program and adherence to ISO directives

12 ISO/TC 215 WG Leadership Working Group (WG) Convener: Responsible for the progress of the work items within their respective working group Vice-Convener of Working Group Assists the Convener Political position to give additional countries leadership positions Working Group secretary Manages WG documents except ballots

13 ISO TC 215 Membership P' (Participating) Member Bodies = 24 Africa : South Africa N America : Canada USA (Secretariat) S America : Brazil Asia Europe : Austria Belgium Denmark Czech Republic Finland : Japan Korea Malaysia Turkey France Germany Italy Netherlands Norway Russian Federation Serbia Sweden United Kingdom Oceania : Australia New Zealand

14 ISO TC 215 Membership 'O' (Observing) Member Bodies = 21 Africa : Kenya Zimbabwe Central America: None South America : Argentina Equador Asia : China India Mongolia Singapore Thailand Europe : Bulgaria Croatia Cyprus Hungary Iran Ireland Israel Poland Portugal Slovakia Spain Switzerland

15 ISO TC 215 WG 1 Data Content Convenor : Grant Gillis (Canada) EHR architecture Requirements standards EHR content Definition, scope and content Provider/Patient ID Identification of providers and patients Data Mining Clinical Data Warehouse data source

16 ISO TC 215 WG 2 Data Interchange Convenor :Mike Glickman (US) Clinical Genomics Coordinated work with HL7 SIG Clinical Genomics Health Informatics Methodology Data Types (Harmonized standard development) Adoption of IHE, HL7 and DICOM standards into ISO standards IHE framework profiles HL7 ANSI approved standards DICOM Web access standard

17 ISO TC 215 WG 3 Semantic Content Convenor : Heather Grain (Australia) Terminology standards for EHR HL7 Terminology standard for EHR Glossary for ISO/TC 215 Harmonizing terminologies for use in multinational countries Principles and guidelines documents on harmonized terminologies for use in HIT standards Beginning work on Oriental Medicine terminologies

18 ISO TC 215 WG 4 Security Convenor : Ross Fraser (Canada) Security for EHR s Specific standards for EHR security Pseudonymisation Secure archiving of EHR s Security for Health Informatics Risk Management for Health Software Classification of Safety risks for health software Measures for assuring patient safety Privilege Management and Access Control Public Key Infrastructure

19 ISO TC 215 WG 5 Health Cards Convenor : Franz Van Bommel (Netherlands) Health cards used in Europe with the governmental health programs. Not the same as the smart cards used by the US military with their EHR US does not participate with this work group

20 ISO TC 215 WG 6 Pharmacy and Medication Convenor : Ian Shepherd (UK) Drug Trial standards for use globally Japan UK US Individual Case Safety Report Identification for Medicinal Products Business requirements for pharmacies

21 ISO/TC 215 WG 7 Devices Convener: Todd Cooper (US) Messaging standards used for communication between all types of medical devices Bringing IEEE medical device standards into ISO/TC 215 Harmonizing work between International Electrical Commission medical devices and ISO/TC 215 New task group for personal medical device standards

22 ISO/TC 215 WG 8 Business Requirements for an EHR Acting Convener: Marion Lyver (Canada) Business requirements for an EHR EHR Maps HL7 Functional EHR model on ballot now in ISO/TC 215

23 Value to HIMSS HIMSS strategy: To provide a platform for knowledge exchange for all stakeholders and build a community of professionals to advance the development and application of healthcare IT. HIMSS Influence Spreads Globally 2003 Acceptance of ISO secretariat 2004 First ISO booth at HIMSS AC 2005 Global Summit Series begins 2006 WHIT and Global Summit together 2007 Asia-Pac >>> ISO/TC 215 Chair is the Organizing Committee Chair 2008 Global Summit topic: Consumer Health

24 Questions Contact: Audrey Dickerson, TC 215 Secretary at Secretary Support Michael Kroll at

International standards used locally worldwide ISO/TC 67

/ International standards used locally worldwide ISO/TC 67 International standardization for materials, equipment and offshore structures for the petroleum, petrochemical and natural gas industries Cecilie