For the Nineteenth Meeting of ISO TC215 Working Group 1, Data Structure. 1.0 Welcome and Introductions. (ISO/TC215/WG1, WG4, WG8 with CEN/TC251/WG1)

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1 Draft Minutes Date: Reference: ISO/TC215/ WG1/ N 040 Draft Minutes For the Nineteenth Meeting of ISO TC215 Working Group 1, Data Structure Held in conjunction with the Fourth Meeting of ISO TC215 Working Group 8, Electronic Health Record Requirements. Monday October 9, Welcome and Introductions. (ISO/TC215/WG1, WG4, WG8 with CEN/TC251/WG1) The Conveners, Don Newsham (ISO/WG1-Data Structure), Ross Fraser (ISO/WG4 - Security), David Rowlands (ISO/WG8 Business Requirements for Electronic Health Records) and Stephen Kay (CEN/WG1 Information Models) welcomed the experts and guests to the Joint Working Group sessions. Secretary s Note: All WG1 documents and presentations from the Geneva Meetings will be made available on the ISO/TC215/WG1 website. Convener, WG1 Vice-convener, WG1 Secretary, WG1 Don Newsham Ken Toyoda Andrea Ciemny donnewsham@sierrasystems.com Kent105@attglobal.net aciemny@infoway-inforoute.ca Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

2 JWG Attendance List, October 9-11, 2006 David Rowlands (Convener WG8) Australia Ock Mee Oh Korea Elizabeth Hanley (Secretary WG8) Australia Seung Jong Yu Korea Graham Grieve Australia Heather Grain Australia Young Hwan Choi Korea Richard Dixon Hughes Australia Yung Sik Kwak Korea Sam Heard Australia Albert de Roos Netherlands Jurgen Brandstaetter Austria Fritz Elferink Netherlands Wolfgang Dorda Austria Kees Molenaar Netherlands Alain Maskens Belgium Luuc Posthumus Netherlands Andrea Ciemny (Secretary WG1) Canada Shirin Golyardi (Secretary CEN/WG1) Netherlands Andrew Grant Canada Edgar Gluck Norway Don Newsham (Convener WG1) Canada Knut Lindelien Norway Garry Cruickshank Canada Torbjørn Nystadnes Norway Grant Gillis Canada Ivan Emelin Russia Marion Lyver Canada Olga Galinovskaya Russia Michael Hunt Canada Bostjan Bercic Slovenia Neil Gardner Canada Adolfo Munoz Spain Ross Fraser (Convener WG4) Canada Anders Thurin Sweden Pekka Ruotsalinen Finland Britt Lagerlund Sweden Laszlo Balkanyi EU Gunnar Klein Sweden Alice Rideau France Karin Kajbjer Sweden Charles Parisot France Per Torlof Sweden Dominique Lepère France Per-Arne Lundgren Sweden François Mennerat France Hilal Ince Turkey Hubert Mensch France Songul Dogan Turkey Bernd Blobel Germany Andrew Marr UK Christine Haas Germany Bryan Manning UK Heike Moser Germany Davd Lloyd UK Thomas Norgall Germany Dipak Kalra UK Wolfgang Leetz Germany Jeremy Thorp UK Alessandra Pastorino Italy Laura Sato UK Pier Angelo Sottile Italy Martin Strange UK Daigero Ebina Japan Nicholas Brown UK Daisuke Yamakata Japan Nigel Cox UK Hideshigi Hasegawa Japan Paul Budgen UK Hideyuki Miyohara Japan Paul Woolman UK Hiroshi Tanaka Japan Stephen Kay (Convener CEN/WG1) UK Ken Toyoda (Vice Convener WG1) Japan Steve Daniels UK Kouichi Kita (Secretary WG4) Japan Tim Buxton UK Masaaki Hirai Japan Chris Chute USA Masakatsu Imoto Japan Chuck Meyer USA Masayuki Ebina Japan Ed Hammond USA Mihoko Okada Japan Gary Dickinson USA Noriko Inaoka Japan Lori Reed-Fourquet USA Shinichico Nishida Japan LuAnn Whittenburg USA Tadao Ozaki Japan Mark Shafarman USA Tetsuro Kiyotani Japan Randy Levin USA DongHo Kim Korea Robert Owens USA Ein-Jeong Hwang Korea William (Ed) Hammond USA Hyun-Taek Shin Korea Marie Lindquist WHO Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

3 2.0 Split Session: Risk Management (with WG4) and Pharmacy Patient Record (with WG6) Joint WG1 and WG4 Session on Risk Management was led by Ross Fraser. The WG4 Convener, R. Fraser, highlighted the current items under consideration at WG4. It was agreed that a coherent approach to Risk Management across ISO/TC215/WGs is needed so that the message is consistent. The question posed to WG Experts was whether to address risk from a broader perspective or specifically by document. A number of Risk Management issues for consideration were acknowledged, including: the language; consistent use of nomenclature and measures; potential problems of context; the need for a data perspective scope; medical disciplines interactions understanding; effective communication with ISO/TC215/WG7 for consistency with medical device risk management ; the best approach for patient safety risk assessment methods and information security; the benefit of best practices learned from other industries (such as transport, and oil and gas); human factors of risk how information is interpreted and used; integration across the lifecycle (specification, implementation, etc.); and the review of other standards such as the ISO (Information Security) and ISO 9000 (Quality Management) series. Action Plan Developed from Discussion: 1. Healthcare specific guidance on existing ISO Risk Management standards will be developed, including: Data and Information Systems (ISO Information security risk management guidelines); and Patient Safety (Healthcare specific guidelines) 2. Specific subject area for focus: Identity management and business requirements from WG8 (Guidelines that fulfil these requirements from WG4) 3. Other subject areas: System Migration and Data Quality 4. Will start with Identity Management and work through Risk Management, then progress to other subject areas There was general agreement among WG experts on the proposed action plan. Also noted was: the liaison with the World Health Organization; the need to communicate and be consistent with CEN WG3 and; the scope of discussion (end product is patient safety). To coordinate this work with WG1, it was determined that Risk Management work can proceed in parallel with Identity Management activity. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

4 Pharmacy Patient Record -Overview of WG6 Agenda by Ian Shepherd I. Shepherd reviewed the WG6 Agenda and also indicated that WG6 and WG1 were working together to determine consistent data. Secretary s Note: Copies of the agenda and the WG6 Work Programme are available as N043 and N044 respectively. ISO/TR Pharmacy and Medication -Specification of a Pharmacy Patient Record was briefly reviewed, including: the scope of pharmacy records; the provider requirements of, and the potential iehr stakeholder interest in, pharmacy records. Additional discussion included: a suggestion that WG6 define a number of archetypes that reflect pertinent information and review supporting use cases; S. Kay suggested that WG6 concentrate on business requirements and relationships in this work item; it was also mentioned that knowledge representation databases already exist that can be learned from. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

5 Medical Devices Nomenclature -Presentation by Tom Marley Secretary s Note: A copy of the presentation is available as N045 S. Kay noted that if medical device nomenclature could be clarified, pharmacies could follow. It was asked how much Global Medical Device Nomenclature (GMDN) is used in medical practice. The response was that it is declared as the EU reference. The high level of collaboration between GMDN and ECRI was mentioned. It was stressed that terms such as adverse event, adverse reaction, adverse food reaction, etc. need to be clarified to avoid confusion as they have different legal implications. It was agreed that ISO/TC215/WGs 1 and 6 and CEN/WG1 need to communicate to leverage efforts on the work being done. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

6 EHR Communication JWG session. Documents provided for review prior to the meeting include: pren Parts 1 to 4. An EHR Communication agenda overview was provided by the WG1 Convener, followed by presentations by Dipak Kalra including: an EHR Communication progress update; and summaries of both Archetypes and Exchange Models. Secretary s Note: Copies of the presentations are available as N046, N047, N048 and N049 D. Kalra led the discussions on the documents, including the following: Archetypes The intention is for ISO/WG1 to approve Part 2 and 3 as New Work Items for adoption as CD during the Geneva meetings is currently at CEN stage Final Vote 4 and ISO/WG4 is to review for input to the NWI in the October 18, 2006 meeting. A. Coenen raised a concern regarding unresolved issues of being addressed before it becomes an International Standard. D. Kalra noted that an opportunity to provide formal technical comments, and have a formal response to these comments, on all parts of is available through the ISO voting process. A question was posed regarding the feasibility of conformance testing of archetypes. D. Kalra responded that the workbench tool will validate archetypes and will show where breaks are. Another question was put forward regarding the international registry of archetypes. Sources of information noted included openehr and HL7. A point of clarification was provided: CEN members were also contributors to Detailed Clinical Models collaboration. Discussion on the number of archetypes available and appropriate use ensued and it was stated that the number of archetypes needed depends on the domain involved. (It was noted that there were less than 20 in practice and approximately 75 that have been considered) It was determined that will be updated with both CEN and ISO comments. Discussions on concluded with the work of Thomas Beale being acknowledged. Decision: It was agreed to move forward as a NWI for adoption as a CD through WG Reference Archetypes and Term Lists The following details were noted about : there are a series of term lists that refer to an attribute in the Part 1 model included in the Table of Contents; potential areas of harmonization were identified (e.g. Termlist mode Section 5) and; consistency with requirements was considered in creating term lists. A point of clarification was made regarding the CEN/ISO balloting process. CEN could approve the document and ISO could not approve the document, as these are independent votes. A primary goal is to receive comments on the document. Decision: It was agreed to bring forward as a NWI for adoption as a CD. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

7 Exchange Models There was a deliberation of concerns on the Implementation Guide for , particularly the appropriate level of computational modelling. D. Kalra highlighted the need to nominate experts to verify that the Exchange Model is compatible with other relevant standards (e.g. message standards) and provide advice on whether a computational viewpoint specification is realistic or useful to add. The aim is to have a draft document ready by the early part of next year. Implementation Guide An Implementation Guide will be created for all 5 parts of It will start as an HL7 deliverable, this experience will be learned from, and then it will be considered at ISO Harmonization Proposal Presented by Mark Shafarman Secretary s Note: A copy of the presentation is available as N050 A review of harmonization activity to date, considerations and next steps was provided. HL7 will be undertaking work on a HL7v3 Implementation Guide, covering all five parts of the standard, which will then be used as an exemplar for any other related Implementation Guides that are needed in the future. It was clarified that is not a standard for building an EHR, it is a system for communication. CEN and HL7 V3 Convergence Presentation by Graham Grieve G. Grieve provided a high level summary of CEN and outlined the path to 13606/HL7v3 convergence. He also indicated that the overlap between the models needs to be resolved in the review of reference models. Secretary s Note: A copy of the presentation is available as N051 The group discussed the gap between the HL7 template and an information model. S. Kay raised a concern regarding convergence being a work in progress. R. Dixon-Hughes asked about semantic interoperability and what aspects of reference models will be reviewed in this context? The response was that is aligned with domain models/meta domain models in HL7. The difference between the reference models is that the HL7 model has structure codes and has data structure. Another question raised was regarding the suppliers/developers engagement process. The response was that the engagement was through HL7v3 work and through the communication with vendors on the difficulty of v3 implementation. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

8 An SDO Harmonization Meeting of ISO/CEN/HL7 Officers took place (17:00-19:00) after the Working Group meetings were adjourned on October 9 th. Agreement was reached and signed by all three Chairs of ISO, CEN and HL7 to further coordinate and collaborate in delivering global standards that enable interoperable capabilities in the healthcare domain. This agreement was distributed to Working Group Experts at the meeting on Tuesday October 10, Secretary s Note: A copy of the agreement is available as N052 Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

9 Tuesday October 10, WG1 Opening and Welcome. The Convener welcomed the WG1 members and guests. 4.0 Identity Management. Documents provided for review prior to the meeting included, ISO vote results for ISO/DTS 22220, TS and ISO/JTC1/SC27/N5205. Subjects of Care Results of ISO vote on DTS Presented by Heather Grain Secretary s Note: A copy of the presentation is available as N053 Post Geneva discussions with H. Grain clarified timeframes indicated in her presentation. An FDIS ballot for a TS is not required. Given the consensus reached in Geneva, the document will be finalized for publication. H. Grain provided a status update and next steps in her presentation. Discussions proceeded on the unknown family name. A suggestion that was provided was to use unknown with a number. The main consideration was consistency. Two questions were posed to the WG experts: Are there any comments on unknown plus unique id? Are there preferred name suggestions? o No comments were put forward for either question. A request was made to bring unknown data types to HL7 for identification. The following decisions were made by the WG experts: Field length limitations would be removed Electronic Communication will be maintained HL7 Annex will be kept TS will progress to publication, subject to conclusion of disposition of comments # 1 Conclude disposition of comments on Subjects of Care DTS22220 and forward for publication. Action by: H. Grain Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

10 Providers of Care ISO/TS27527 draft Presented by H. Grain Secretary s Note: A copy of the presentation is available as N054 H. Grain provided an update on the document status, specifically: that the CD would be out for comment by November; for review and update to Plenary by early 2007; Committee ballot by May 2007; and review and preparation for the final publication by late Decision: Change the name of the TS A number of names are under consideration, one suggestion was for HC Provider and Service Identification. # 2 Provide ISO/TS draft to WG1 for comment by November and forward to WG4 for comments on security. Action by: H. Grain A discussion on the scope and objective of the standard followed, including issues such as the provider roles, services, license qualifications, organization and location identification. It was noted that the WG would need to have clarity on the business process(es) required and determine if there are other standards that help with identity management. Members identified two WG4 documents to review, including ISO TS Health informatics Directory services for security, communications, and identification of professionals and patients and ISO/PDTS Health informatics -Functional and structural roles. Both WGs agreed that a detailed standard on the identification of providers as individuals and organizations will be developed and then in the future structure related standards may be addressed and other issues identified. H. Grain outlined the document s next steps, as follows: the document is in initial draft stage with plans for circulation by end of the year and a draft ready for the Montreal Plenary Meeting. Additional comments on related activity included: CEN is working on Patient Identification and have noted issues on not using single identifiers e.g. cross border patients (it was noted that this work might coincide with a possible next stage in the Subjects of Care document s development); WG 7 is now considering how to safely and suitably relate patients and their medical devices. Bryan Manning volunteered to provide a business framework on identification (purpose is to identify where we need to work, what s missing, a report to generate discussion) # 3 Secretary to follow up with B. Manning regarding the scale, scope and timelines for the business framework for provider identification. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

11 Security and Identity Management Standards Presented by Bernd Blobel Secretary s Note: A copy of the presentation is available as N055 Biometrics is being addressed through other technical committees and has been referenced in the subject of care standard. Secretary s Note: The Convener invites members to consider the presentation and welcomes any comments or proposals for future work. 5.0 Split Session Patient Safety (with ISO/WG4) And, Semantic Harmonization (with ISO/WG3). Patient Safety (with ISO/WG1, WG4, WG6, WG8 and CEN/WG3) Discussion led be Ross Fraser Secretary s Note: A copy of the relevant WG4 Document List is available as N056 Issues for consideration identified by WG4: electronic reporting of adverse incidents involving health software products; a new standard (consistent with the work of: ISO/TMB Risk Management WG, ISO Medical devices Application of risk management to medical devices, and IEC Functional safety of electrical/electronic/programmable electronic safety-related) is needed specifically for health software products (this should have an accompanying Implementation Guide) and; standards for assuring the safety of health software in the user environment, should be addressed. Secretary s Note: Guide 73 Risk management Vocabulary Guidelines for use in standards is available for further consideration. A member of WG6 drew attention to the following developments: that the work item ISO Health informatics Electronic reporting of adverse drug reactions has expanded due to the impact of HL7 initiatives, and other requirements, including national legal requirements; WHO representatives in WG6 provide strong global input; the geographical/regional dimension is being considered (country legislation and reporting/monitoring); and, input has been sought from other organizations/sdos who have developed standards in this area. The Convener indicated that the WG1 primary interest is in safety issues of health software related to data structure. Other issues to consider: it was suggested to start with the lowest common denominator that everyone can agree on and progress from there; a proposal was offered that ISO/TC 215 lead the development and solicit ICH -International Conference on Harmonization (of technical requirements for Registration of Pharmaceuticals for Human Use), input (ICH is Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

12 seeking active participation on geographical issues at ISO); CEN is undertaking patient safety work (collaborating with WG4); WG8 has no work items on patient safety directly, however, the Convener noted that they will be reviewing patient safety on a generic level. Comment: It is important to add to the dialogue that ISO is performing the task of bringing together global experts for a global solution. This should be recognized as a positive step forward. Semantic Harmonisation Session (WG1and 3) Discussions took place regarding decisions and next steps for semantic harmonisation. It was noted that, while work on this front is already well advanced via TermInfo and DCM (Detailed Clinical Model), it was not yet clear that the subject is mature enough to support development of a standards solution. The dominance of archetypes over templates was observed as signifying that the focus and requirements are changing. It was noted that, at the next meeting in March 2007, D. Kalra would present on semantic interoperability and whether a work item is needed. He suggested an ongoing agenda item (a watching brief of semantic harmonization issues) and that WG3 manage a list of experts, including: Alan Rector, Craig Parker, Sam Heard, Ross Fraser, Dipak Kalra, Chris Chute, and Terminfo experts. Secretary s Note: The above discussion is derived from notes kindly provided by E. Hanley. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

13 6.0 Health Summary Records (with WG8). Secretary s Note: Details of the discussions for these presentations are available in the WG8 Draft Minutes. Copies of the presentations are available as N057, N058 and N059. WG8 Requirements for Health Summary Reports (HSRs) and EHRs presented by David Rowlands D. Rowlands reviewed the history and progress of this work item. Key points of HSR Document (TR): Health informatics Requirements and specifications of common essential information for health summary records Presented by Marion Lyver The lack of response/participation on HSR was noted, thus the question was posed: Is there support from WG8 to move forward with the TR or should this work item be cancelled? Overall support was shown for continuing with this initiative. Issues for consideration and an outline of next steps were included in the presentation. # 4 Members to comment on HSR Part 1, including: the TR scope and approach, the proposed definition and the focus for an HSR standard (common content) Members to comment on HSR Part 2, including: Updates to the Environmental Scan and Additional sample datasets Action by: WG1 and WG8 Members. 7.0 EHR Standards Map (JWG ISO WG1/WG8 and CEN WG1) The title of the work item has been changed to EHR Standards Classification Framework. Secretary s Note: Details of the discussions for this presentation are available in the WG8 Draft Minutes. For the information of WG1, the following notes have been highlighted. Standards Knowledge Management Tool (SKMT) Overview by Andrew Grant A comprehensive demonstration of the SKMT was provided by A. Grant. Next steps were identified as: stabilize and populate SKMT, review the process for updating the resource and demonstrate the utility of the tool. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

14 Wednesday, October 11, Health Information Services Architecture (HISA ) -with CEN WG1 HISA Part 1 (pren Health Informatics Service architecture Part 1: Enterprise viewpoint) by Frederick Endsleff HISA Part 2 (Health informatics Service architecture - Part 2: Information viewpoint) Presented by Pier Angelo Sotille Secretary s Note: Copies of the presentations are available as N060 and N061 Members received the two presentations on the respective parts of the proposed HISA standard. Concerns were raised regarding the level of alignment/harmonization with published and in-development ISO standards. D. Kalra suggested that it would be beneficial to cross reference with ISO/TS and ISO/TR 20514, as well as the HL7 Functional Model for EHR specific details and the HL7 Services Oriented Architecture, with a view to ascertaining how the four, do now or might yet, relate to the HISA parts in their respective current forms. The Convener noted that Canadian reference architecture and other national reference architectures should also be reviewed for alignment with these documents. Consideration for adding the document as an ISO NWI was provided at the formal meeting of WG1. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

15 9.0 Clinical Data Warehouse (CDW)/ Health Information Data Warehouse ISO NWIP Draft Status Update Presented by Andrew Grant Secretary s Note: A copy of the presentation is available as N062 Andrew's presented the NWI, highlighting its three sections: Conditions for deployment of a CDW; Data aggregation and data modelling; and Architecture and analysis. Next steps were identified as preparation of the NWI submission, contact experts interested in participating in the work, and establish preliminary timelines. Discussion on the relationship between CDR (Clinical Data Repository) and EHR took place, including the potential for redundancy of the CDR. A. Grant noted that it is viewed as a spectrum and that there is a change that takes place with large amounts of data. J. Thorp indicated that the basic purpose of a CDW is different from an EHR, therefore the underlying architecture is different. E. Hammond stressed that the set of functionalities of a CDW needs to be agreed upon. D. Kalra noted that openehr was being used to build research repositories. Lessons learned should be applied to a good CDW. The differences and similarities between CDW and EHR need to be highlighted in the document. It was also strongly endorsed that the CDW needs to interface well with EHR. The Convener asked Andrew if he would consider adding the CDW/EHR similarities and differences to the documentation and Andrew agreed. A. Grant and a smaller group of experts interested in participating further had additional discussions online with M. Fuller regarding the future work at the break. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

16 10.0 Formal Meeting 10.1 Convenor s and Secretary s Reports The Convener presented the report, including the following points: 1. The Global Summit Meeting took place on Sunday, October 8, 2006 Another summit is being planned, perhaps end user/provider focussed 2. The Executive of TC215 met on Sunday, October 8, 2006 Reviewed details on health informatics SDO business planning and harmonization of HL7, CEN/TC 251, and ISO/TC 215 work programmes 3. Future joint approach to business planning and work programme harmonization among SDOs. SDO Harmonization Meeting on Monday, October 9, 2006 (17:00-19:00) o The resulting CEN/ISO/HL7 Agreement was provided to members o Requested that delegates advise member bodies of the agreement o Work on harmonization is underway, specific plans will be provided at Montreal Meeting Andrea Ciemny (the new ISO/TC215/WG1 Secretary) provided an update on the TC215/WG1 web site, noting that the TC215 Secretary has indicated it should be available in 1-2 weeks and it will work similarly to the previous ISO Livelink site. More details to follow as provided by A. Dickerson Review and Approval of the Draft Minutes of Meeting No. 18, April 2006, Jeju, Korea. No comments or questions on the Minutes were provided. Minutes were approved. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

17 10.3 Actions from the last meeting. The s, as outlined in document WG1/N28R were discussed and updated as follows: # Action Geneva Discussion/Update 1 To liaise with WG3 re terms and definitions. Status update: A trial harmonization effort will be undertaken; arising (terms) issues need to be reviewed; will then produce a glossary document and use with a webbased tool (SKMT) 2 To collate existing WG1 and WG8 (published and Drafts developed developed) definitions into a glossary. 3 To use the above glossary to populate the SKMT tool. Addressed and updated in Item A.7 of Agenda (October 10, 2006 discussions) 4 To report on research into the country code change request. No new information on country code changes. Convenor to follow-up with D. Dobson 5 To comment on the approved WG1 Scope. Completed 6 For WG4 to send Functional and Structural Roles (latest All documents have been circulated document) to WG1/8. 7 To send a copy of document ISO/IEC JTC1/SC27 N4721, The document has been circulated Identity Management to WG4/5. 8 To send the combined comments on Identity Management to ISO/IEC JTC1/SC27 with copy to WG1/4/5/8. No new information on JTC1 9 For Identification of Providers of Care to be developed as a result of the approved NWIP ballot. 10 To prepare DTS ballot for ISO 22220, Identification of Subjects of Care document prior to ballot. 11 To include the implementation question with the DTS ballot for For the CEN Secretary to send the CEN document on Services Architecture to the WG1 Secretary for circulation. 13 To complete final edit for publication of ISO/TR 22221, Principles and Practices for a Clinical Data Warehouse. 14 To prepare an ISO form 4 on Clinical Data Warehouse to summarize parts of the Technical Report (TR) that should be considered for advancement to a Technical Specification (TS). 15 To forward a copy of ISO 22220, Subjects of Care to the HL7 technical committee on medical records, requesting feedback. 16 To follow up with Dipak Kalra on the pre-ballot check of ISO/ To advise on possibilities for completing Form 4s for and -3. Discussed in Item A.4 of Geneva Agenda (October 10, 2006) Update provided in Item A.4 of Geneva Agenda (October 10, 2006) Completed. The document has been circulated Final edits completed Form 4s for CDW completed Copy sent to HL7 for input DIS is at ballot, and is scheduled to close March 5, 2007 pren and -3 have been distributed Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

18 10.4 Disposition of Comments on ISO/DTS 22220, Identification of Subjects of Healthcare. Motion was passed to approve the disposition of comments and move the DTS to publication, subject to the incorporation of final edits. Motion passed Liaison Updates. There were no new liaisons, no new information on other WGs and no liaison reports from external TCs to report. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

19 10.6 WG1 Work Program Review. The members reviewed ISO/TC215/WG1/N039 and the following updates were developed: Preliminary Items (not yet ready for NWIP Ballot) o EHR System Functional Model is still on the preliminary list o EHR Definition, Scope and Context to be removed from preliminary list and transferred to WG8 list o EHR Glossary work is being subsumed by the WG Terms and Definitions Glossary related work item o NWI Identity Management Framework A request to pass a motion for a task group on Identity Management Framework was led by B. Manning Motioned by D. Rowlands and seconded by G. Gillis Motion passed # 5 Task group led by B. Manning to bring forward a report of status and document development to next WG1 meeting Action by: B. Manning o Semantic Linkages between Information Models and Terminologies D. Kalra reported previously and was thanked for his work Agreed that the field is moving too fast for a TR. Will have a joint WG1/WG3 meeting with regular updates on Semantic Linkages # 6 Watching brief agenda item for the next joint WG1/3 Meeting. Action by: D. Kalra Active Items After NWIP Approval o Provider Identification ISO/TS draft will be available in January o Identification of Subjects of Care ISO/TS TS22220 Vote taken at meeting No negative ballots received, 3 abstentions DIS and FDIS Ballots o EHR Communication Part 1: DIS is out for a 5 month ballot (closing date March 5, 2007) Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

20 Published Items (5 standards published in 2004 and 2005) o ISO Requirements for EHR reference architecture o ISO Health Indicators for Conceptual Framework o ISO TS Health Informatics: Country Identifier Standards o ISO TR EHR Definition, Scope and Context o ISO Health Informatics: Profiling Framework o ISO TR Health Informatics -Good Principles and Practices for a Clinical Data Warehouse # 7 For 2007 meetings: WG1 to review published items and begin discussion on carrying forward items Secretary s Note: ISO TR Health Informatics -Good Principles and Practices for a Clinical Data Warehouse was published after the Geneva JWG Meetings. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

21 10.7 New Work Items. The Convener reminded the Working Group of the following work items for consideration: EHR Blueprint Definition EHR Glossary o The EHR Glossary work is being subsumed by the Working Group Terms and Definitions related work item The Convener introduced the following documents for consideration EHR Communication Parts 2 and 3 It was explained that the WG was voting on balloting each of these documents as separate NWIs for approval as a CD with a 3 month ballot. The Form 4s and drafts are scheduled to be completed for circulation by November. Comments to be provided by February and the document to be ready for the Montreal meeting. A motion to accept Part 2 and 3 as separate NWIs for approval as a CD was proposed by D. Rowlands, the motion was seconded by G. Klein and approved. # 8 Form 4s to be completed for EHR Communication and to be balloted as NWIs for approval as a CD. Action by: D. Kalra Clinical Data Warehouse Parts 1-3 It was clarified that the WG would be voting on one NWI. A motion to accept CDW as a NWI for approval was proposed by H. Grain, the motion was seconded by D. Kalra and approved. # 9 Form 4 to be completed for Clinical Data Warehouse to be balloted as a NWI. Action by: A. Grant Health Informatics Service Architecture (HISA) Parts 1-3 (pren 12967) The documents are currently balloting at CEN. G. Dickinson indicated that the U.S. can t support the documents at this time, as the national group hasn t reviewed them yet. D. Kalra suggested an informative Annex on standards cross referencing. A motion for presenting HISA as NWIs was proposed by D. Rowlands, the motion was seconded by A. Grant. There was one abstention and the motion was approved. # 10 Form 4s to be completed for each HISA , 2 and 3 and each to be balloted as a NWI as a new project. Revised drafts, including additions from Geneva discussions to be provided. Action by: G. Klein 10.8 Other Business. Nothing further was discussed. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

22 10.9 Next Meeting. It was agreed that the next WG1 meeting would take place in Montreal, Canada on March 25-29, 2007 in conjunction with the ISO/TC215 Plenary Meeting. Future meetings include Brisbane, Australia (August 27-29, 2007), and Sweden and Istanbul in More information to follow. Overview of Work of HL7 EHR Technical Committee EHR Interoperability Project Team Presented by Gary Dickinson Secretary s Note: A copy of the presentation is available as N Formal Meeting Adjournment. The Convener thanked the participants for the productive sessions held in Geneva. Thanks were also given to SNV, IATA, ANSI and HIMSS for the excellent hosting of our meetings. Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

23 Consolidated List. Note: The following information is available in ISO/TC215/WG1 N XX. # # 1 # 2 # 3 # 4 # 5 # 6 # 7 # 8 # 9 # 10 Action Conclude disposition of comments on Subjects of Care DTS22220 (Subjects of Care) and forward for publication. Action by: H. Grain Provide ISO/TS (Providers of Care) draft to WG1 for comment by November and forward to WG4 for comments on security. Action by: H. Grain Secretary to follow up with B. Manning regarding the scale, scope and timelines for the business framework for provider identification. Members to comment on HSR Part 1, including: the TR scope and approach, the proposed definition and the focus for an HSR standard (common content) Members to comment on HSR Part 2, including: Updates to the Environmental Scan and Additional sample datasets Action by: WG1 and WG8 Members. Task group led by B. Manning to bring forward a report of status and document development to next WG1 meeting Action by: B. Manning Watching brief agenda item for the next joint WG1/3 Meeting. Action by: D. Kalra For 2007 meetings: WG1 to review published items and begin discussion on carrying forward items Form 4s to be completed for EHR Communication and to be balloted as NWIs for approval as a CD. Action by: D. Kalra Form 4 to be completed for Clinical Data Warehouse to be balloted as a NWI. Action by: A. Grant Form 4s to be completed for HISA , 2 and 3, each to be balloted as a NWI as a new project. Revised drafts, including additions from Geneva discussions to be provided. Action by: G. Klein Due December 2006 November 2006 November 2006 January 2007 January 2007 Montreal Plenary 2007 Ongoing November 2006 November 2006 November 2006 # 11 s Carried over from Jeju Meeting To liaise with WG3 re terms and definitions. Status update: A trial harmonization effort will be undertaken; arising (terms) issues need Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

24 to be reviewed; will then produce a glossary document and use with a webbased tool (SKMT) # 12 # 13 # 14 To collate existing WG1 and WG8 (published and developed) definitions into a glossary. To use the above glossary to populate the SKMT tool. To report on research into the country code change request. Drafts developed Addressed and updated in Item A.7 of Agenda (October 10, 2006 discussions) No new information on country code changes. Convenor to follow-up with D. Dobson Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October

25 List of WG1 Geneva JWG Meeting Documents and Presentations TC215/WG1 N Doc # Source/Author Subject Source Doc Type 043 I. Shepherd Pharmacy Patient Record -Overview of.pdf WG6 Agenda 044 I. Shepherd WG6 Work Programme.pdf 045 T. Marley Medical Devices Nomenclature.pdf 046 D. Newsham EHR Communication Agenda.pdf 047 D. Kalra EHR Communications Progress.pdf Update 048 D. Kalra Archetypes.pdf 049 D. Kalra Exchange Models.pdf 050 M. Shafarman Harmonization Proposal.pdf 051 G. Grieve CEN and HL7 V3 Convergence.pdf 052 D. Newsham SDO Harmonization Agreement.pdf 053 H. Grain Subjects of Care Results of ISO vote.pdf on DTS H. Grain Providers of Care.pdf -ISO/NP TS Bernd Blobel Security and Identity Management.pdf Standards 056 R. Fraser WG4 Document List.pdf 057 D. Rowlands WG8 Business Requirements for EHR.pdf 058 D. Rowlands WG8 Requirements for Health Summary.pdf Reports 059 M. Lyver Key points of HSR Document (TR).pdf 060 F. Endsleff HISA Part 1 Computational Viewpoint.pdf 061 P. A. Sotille HISA Part 2 Information Viewpoint.pdf 062 A. Grant ISO CDW NWIP Draft Status Update.pdf 063 G. Dickinson Overview of Work of HL7 EHR TC/EHR Interoperability Project Team.pdf Draft Minutes for the ISO/TC215/WG1 JWG Meeting held in Geneva, October