ISO/TC 215 N N1576_RESOLUTIONS_ISOTC215_ Berlin_Germany_10_October_2014. Replaces: N Date of document:

Transcription

1 ISO/TC 215 N 1576 ISO/TC 215 Health informatics of secretary: lisa.spellman@ahima.org Secretariat: N1576_RESOLUTIONS_ISOTC215_ Berlin_Germany_10_October_2014 Replaces: N 1575 Document type: Resolution Date of document: Expected action: No. of pages: INFO 18, including cover Background: Committee URL:

2 N RESOLUTIONS 22 nd meeting of ISO/TC 215, Health Informatics 10 October 2014 Berlin, Germany RESOLUTION FROM ISO/TC215 COMMITTEE ADVISORY GROUP 2 (CAG02) 2014 Resolution 43 [CAG02-R01] CAG 02 Scope extension to address the need for domain standards To extend the scope of CAG 02 to clarify the process for managing the proposed development of normative standards ( meta- standards or master standards ) defining the application of published standards to various domains across the health system; ISO/TC215 resolves to approve: Modifying the scope of the CAG 2 Coordinating Group (CG) from: Scope: To prioritise new work item proposals (NPs) with the goal of harmonizing work within TC215 with the following objectives: (a) (b) (c) to: Scope: co-ordination of the development of health informatics standards; harmonisation of existing and emerging health informatics standards to establish a global framework of consistent and common standards for health systems and health data (together with CAG3); and development and maintenance of operational plans and the overseeing of their delivery; addressing TC logistics and expediting the standards development process, 1. To prioritise new work item proposals (NPs) with the goal of harmonizing work within TC 215 with the following objectives: (a) (b) (c) co-ordination of the development of health informatics standards; harmonisation of existing and emerging health informatics standards to establish a global framework of consistent and common standards for health systems and health data (together with CAG3); and development and maintenance of operational plans and the overseeing of their delivery; addressing TC logistics and expediting the standards development process, and 2. to create a framework of healthcare domains for which normative standards publications can be developed to define integrated systems of coherent and aligned health informatics standards from TC 215 and other Health Informatics SDOs to cover end-to-end management, interoperability, and use of health related data and information systems within each domain: 3. for each identified domain, to recommend to TC 215 a new or existing working group to undertake the development of such standard publications; and 4. to oversee and coordinate the process of developing such standards publications. DISCUSSION: Request from the UK to add the following wording into the minutes for Resolution 2014:43. "The UK was concerned about the risk that existing standards might be adopted in full without due attention to the appropriateness of scope for the domain in question. In response, the Chair confirmed the intention for relevant working groups to apply their judgment in the selection of standards or relevant parts of standards, sensitive to issues of contextual dependency." The UK approved with the additional wording as listed. Opposed: NONE Abstentions: NONE Motion: PASSES N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 1 of 17

3 RESOLUTIONS WG1: ARCHITECTURE, FRAMEWORKS AND MODELS BERLIN 2014 Resolution 44 [WG1-R1] EN ISO Parts 1-5: Approve restarting ISO revision of all five parts For EN ISO parts 1-5: EN ISO :2008, Health informatics -- Electronic health record communication -- Part 1: Reference model EN ISO : 2008, Health informatics -- Electronic health record communication -- Part 2: Archetype interchange specification EN ISO :2009, Health informatics -- Electronic health record communication -- Part 3: Reference archetypes and term lists EN ISO :2009, Health informatics -- Electronic health record communication -- Part 4: Security EN ISO :2010, Health informatics -- Electronic health record communication -- Part 5: Interface specification ISO/TC215 approves the recommendation of WG1 to revise all parts based on prior work on ISO and meeting the following required details: the scope of each part will remain the same; each with a timeframe of 36 months; re-start date: 11 October 2014 call for experts to join with the existing teams. Project Leader: Dr. Dipak Kalra - dipak.kalra@eurorec.org UK/BSI Request ISO/CS and TC215 Secretary to coordinate with CEN/TC251 on ballot planning and related actions Discussion: Netherlands (NEN): Mr. William Goossen (HOD) asked about how interested persons could better interact with this project in the future. WG1 Convenor Mr. Stephen Kay responded that one of the sub-points is a Call for Additional Experts. It is also in the WG1 Minutes that there will be the Call for Additional Experts and ensuring a better way of sharing in the future. Objections: NONE Abstentions: Switzerland Motion: PASSED UNANIMOUSLY BERLIN 2014 Resolution 45 [WG1-R2] addition of PWI for Meta Data for structured clinical genomic sequencing report in EHR system approves the WG1 recommendation that the above mentioned project be recorded to the internal TC 215 Program of Work as a Preliminary TS Work Item (PWI); instructs the TC 215 Secretary to add the project to the TC 215 Program of Work. Requests that the PWI be referred to JIC as a potential future JIC joint initiative Project Leader: Soo-Yong Shin - sooyong.shin@amc.seoul.kr Korea Discussion: WG1 Convenor Mr. Stephen Kay noted that the intention of this work is to be inclusive US commented that this work seems to be duplicative of work elsewhere so to please ensure that CAG02 is appropriately engaged with the activity to avoid overlap. Mr. Kay agreed that CAG02 will have a strong role to ensure that is not duplicative. Opposed: NONE Abstentions: Switzerland Motion: PASSED UNANIMOUSLY N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 2 of 17

4 BERLIN 2014 Resolution 46 [WG1-R3] Removal of inactive project from the ISO/WG1 Work Program Due to lack of activity, agrees to remove the following open work item from the ISO/WG1 work program: ISO TS Health Informatics, Functional classification of health informatics standards Opposed: NONE Abstentions: NONE Motion: Passed unanimously N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 3 of 17

5 RESOLUTIONS WG2: SYSTEMS AND DEVICE INTEROPERABILITY 2014 Resolution 47 [WG2-R01] ISO/DTS , submission for TS publication For ISO /AWI/DTS , Health informatics, Medical waveform format part 2: Electrocardiography approves the recommendation of WG2 to proceed to Publication; instructs the PL to submit disposition of DTS comments, updated text and any revisable graphics to the WG2 secretary by 1 November 2014; instructs the WG2 secretary to provide these items to the TC215 secretary no later than 8 November 2014; instructs the TC215 Secretary to submit these items to ISO/CS 9 December Opposed: NONE Abstentions: Motion: PASSED UNANIMOUSLY 2014 Resolution 48 [WG2-R02] ISO/DTS , submission for TS publication For ISO /AWI/DTS , Health informatics, Medical waveform format part 3: Long Term Electrocardiography - approves the recommendation of WG2 to proceed to Publication; instructs the PL to submit disposition of DTS comments, updated text and any revisable graphics to the WG2 secretary by 1 November 2014; instructs the WG2 secretary to provide these items to the TC215 secretary no later than 8 November 2014; instructs the TC215 Secretary to submit these items to ISO/CS 9 December Opposed: NONE Abstentions: NONE Motion: PASSED UNANIMOUSLY 2014 Resolution 49 [WG2-R3] ISO/DTR submission for TR publication For ISO/DTR 17522, Health informatics, Provisions for Health Applications on Mobile/Smart Devices approves the recommendation of WG2 to proceed to submit for publication as a TR; instructs the PL to provide the disposition of the DTR comments, updated text and revisable files for any visuals to the WG2 secretary no later than 1 November-2014; instructs the WG2 secretary to provide these items to the TC215 secretary by 14 November 2014; instructs TC215 Secretary to submit to ISO/CS for publication no later than 15 December Opposed: NONE Abstentions: Motion: PASSED UNANIMOUSLY 2014 Resolution 50 [WG2-R04] ISO/DTR Change of Title For ISO/DTR 20055, Health informatics, Patient-owned Document Repository for PHR Applications and Health Information Exchange approves WG2 recommendation for a title change TO Health informatics, Person-owned Document Repository for PHR Applications and Health Information Exchange Opposed: NONE Abstentions: Italy, Switzerland Motion: PASSED N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 4 of 17

6 RESOLUTIONS WG3: SEMANTIC CONTENT 2014 Resolution 51 [WG3-R01]: ISO/IS NP submitted for a 2 month CD Ballot For ISO/IS NP Health informatics, Terminological Resources Part 1: Characteristics, approves the WG3 recommendation to progress for CD ballot; instructs PL to provide the disposition of comments and updated text to WG3 convenor and WG3 Secretary no later than 1 February 2015; instructs WG3 secretary forward to the TC215 Secretary no later than 4 February 2015; instructs the TC215 Secretary to launch a 2 month CD ballot no later than 10 February Opposed: NONE Abstentions: Italy, Switzerland Motion: PASSED UNANIMOUSLY Please note that Resolutions 52, 53, 54, 55 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Canada, Denmark, Switzerland, Sweden, Finland, Netherlands on Resolutions MOTION PASSSES: Resolutions passed Resolution 52 [WG3-R02]: ISO/DTS submitted for a 2 nd 2 month DTS Ballot For ISO/ AWI/DTS Health informatics, Categorial structure for representation of herbal medicaments in terminological systems approves WG3 recommendation to progress to a 2 nd 2 month DTS ballot; WG 6 is to provide comment to WG3 project lead by 7 November 2014 instructs the project leader to submit the disposition of comments, updated text to the WG3 convenor and secretary no later than 7 December; instructs the WG3 secretary to submit these items to the TC215 secretary no later than 8 December; instructs the TC215 Secretary to launch a DTS ballot no later than 11 December. Discussion: NONE Resolution 53 [WG3-R03]: ISO/IS CD submission for a 3-month New Work Item Proposal-DTS For ISO/TS , Health informatics, Categorial structure for representation of acupuncture Part 1: Acupuncture points - approves the WG3 recommendation to submit for NP ballot ISO/PWI/ , Categorial Structure for representation of acupuncture Part 1: Acupuncture Points; targeting a Technical Specification instructs the PL to provide complete form 4 and NP text to the WG3 convenor for review and approval no later than 17 th October 2014 instructs the WG3 convenor to provide these items to the TC215 secretary no later than 24th October 2014; instructs the TC215 Secretary to launch a 3-month NP-DTS ballot no later than 30 October Discussion: None N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 5 of 17

7 2014 Resolution 54 [WG3-R04] ISO/CD , submission for DTS ballot For ISO/ CD Health informatics, Categorial structure for representation of acupuncture Part 2: Needling - approves WG3 recommendation to progress to DTS ballot; instructs the PL to submit the disposition of comments, updated text to the WG3 convenor and secretary no later than 31 st October 2014 instructs the WG3 convenor to submit these items to the TC215 secretary no later than 5 November 2014; instructs the TC215 Secretary to launch a DTS ballot no later than 15 November Instructs the TC215 Secretary to forward documentation to TC249 for their comment no later than 15 November Resolution 55 [WG3-R05] ISO/PWI submission as a TS New Work Item Proposal (NP) For Health informatics, Categorial structure for representation of acupuncture -- Part 3: Moxibustion approves the WG3 recommendation to submit for NP ballot ISO/PWI/ Categorial Structure for representation of acupuncture -- Part 3: Moxibustion; targeting a TS; instructs the PL to provide complete form 4 and NP text to the WG secretary for review and approval no later than 31 st October 2014; instructs the WG3 secretary to provide these items to the TC215 secretary no later than 5 November 2014 instructs the TC215 Secretary to launch an NP ballot no later than 15 November 2014 Please note that Resolutions 52, 53, 54, 55 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Canada, Denmark, Switzerland, Sweden, Finland, Netherlands on Resolutions MOTION PASSSES: Resolutions passed Resolution 56 [WG3-R06]: Establish a new Traditional Medicine Work Group (WG) approves the WG3 recommendation to establish a domain specific work group for Traditional Medicine (TM) and it is recommended that this WG have a scope of traditional medicine of all types; the TMTF and WG3 are requested to review and discuss possible projects that might transfer if the new WG is created and if so, the ISO/TC215 Secretary will issue a Call for Additional Experts [if any existing projects are transferred] and a new Call for Experts if new work items are proposed and approved. Current experts must be appointed and registered into this new WG by their National Member Body (NMB); ideally, the review and recommended should be completed in time for review and discussion at the ISO/TC215 meeting in San Francisco April 2015 and no later than the 2 nd meeting of ISO/TC215 in Switzerland in October or November Appropriate NMB / liaison support is required for WG secretary, Convenor and Vice-convenor roles. The new WG will not be formed lacking this support. N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 6 of 17

8 Discussion: Edits from the floor to this Resolution and are reflected in this final approved version. The minutes of the discussion and original version detailed in N1577 MINUTES Closing Plenary ISOTC October 2014 Berlin Germany. Opposed: Germany, Italy, Norway, and Russia, Sweden Abstentions: Finland, United Kingdom Motion: Passed unanimously Please note that Resolutions 57, 58, 59, 60, 61, 62 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Denmark, Italy, Switzerland MOTION PASSSES: Resolutions passed Resolution 57 [WG3-R07]: Revision ISO/17115:2007 and CEN/EN combined For ISO/ 17115:2007 Health informatics -- Vocabulary for terminological systems accepts the WG3 recommendation that the ongoing revision of ISO and the existing work item en12264 be aggregated into one work item. Resolution 58 [WG3-R07]: Addition of Preliminary Work Item (PWI) Technical Specification (TS) to the ISOTC215 WG3 work program approves the WG3 recommendation that a PWI-TS entitled: ISO/DTS Health informatics, Maturity Levels for terminological resources in EHRs be established Resolution 59 [WG3-R08]: Addition of Preliminary Work Item (PWI) Technical Specification (TS) to the ISOTC215 WG3 work program approves the WG3 recommendation that a Preliminary Work Item-TS entitled: ISO/DTS Health informatics Metadata requirements in Healthcare be established Resolution 60 [WG3-R09]: Addition of Preliminary Work Item (PWI) Technical Specification (TS) to the ISOTC215 WG3 work program approves the WG3 recommendation that a PWI-TS entitled: ISO/DTS Health informatics, Terminology Capacity Assessment be established Resolution 61 [WG3-R010]: Addition of a planned revision - Preliminary Work Item (PWI) International Standard (IS) Revision to the ISOTC215 WG3 work program approves the WG3 recommendation that a PWI-IS planned revision entitled: ISO 13120:2013: Health informatics - Syntax to represent the content of healthcare classification systems -- Classification Markup Language (ClaML) N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 7 of 17

9 Resolution 62 [WG3-R11]: Addition of Preliminary Work Item (PWI) Technical Specification (TS) to the ISOTC215 WG3 work program ISO/TC215 approves the WG3 recommendation that a PWI-TS entitled: ISO/DTS Health informatics, Measurement of conformance in implementation of terminological resources be established Discussion: None Please note that Resolutions 57, 58, 59, 60, 61, 62 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Denmark, Italy, Switzerland MOTION PASSSES: Resolutions passed N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 8 of 17

10 RESOLUTIONS WG4: SECURITY, SAFETY AND PRIVACY 2014 Resolution 63 [WG4-R1]: ISO/DTR submitted for 2 nd DTR Ballot For ISO/DTR Health Informatics Components of education to ensure health information privacy, - Instructs Project Lead to provide the disposition of comments and updated text to WG4 convenor and Secretary no later than 3 December 2014; - Instructs WG4 secretary to post on WG4 Committee for a 1 one month review no later than 5 December 2014; - Instructs PL to update and submit the disposition of comments and updated text to WG4 convenor and - secretary no later than 5 January 2015; - approves WG4 recommendation to progress to 2 nd DTR ballot; - instructs the WG4 secretary to submit these items to the TC215 secretary no later than 7 January 2015; instructs the TC215 Secretary to launch a 2 month 2nd DTR ballot no later than 2015 January 28 Opposed: NONE Abstentions: Finland, Germany, Italy, Mexico, Netherlands, Norway, Sweden, Switzerland Motion: PASSES Please note that Resolutions 64, 65, 66, 67 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Italy, Switzerland MOTION PASSSES: Resolutions passed 2014 Resolution 64 [WG4-R2]: ISO/DTS submitted for 3rd DTS Ballot For ISO/DTS Health Informatics Principles and data requirements for consent in the collection, use or disclosure of personal health information, - approves WG4 recommendation to progress to 3 rd DTS ballot; - Instructs PL to update and submit the disposition of comments and updated text to WG4 convenor and secretary no later than 2014 November 12; - instructs the WG4 secretary to submit the disposition of comments and updated text to the TC215 secretary no later than 2014 November 12; - instructs the TC215 Secretary to launch a 2 month 3 rd DTS ballot no later than 2014 December 11 Discussion: NONE N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 9 of 17

11 2014 Resolution 65 [WG4 R3] ISO/PWI submission for NP Ballot For ISO/NP, Health informatics Framework of Event Data & Reporting Definitions for the Safety of Health Software, - approves WG4 recommendation to be submitted for NP ballot; - instructs the project lead to provide a complete and approved form 4, timeline and NP text to the WG4 secretary and convenor no later than 2014 October 31; - instructs the WG4 secretary to provide a complete and approved form 4, timeline and NP text to the TC215 Secretary no later than 2014 November 3; - instructs the TC215 Secretary to launch an NP ballot no later than 2014 December 8; - instructs the TC215 Secretary to send by 2014 December 8 to IEC/SC 62A and TC210 WG3 for review with a request for comments to be submitted through the national member bodies 2014 Resolution 66 [WG4 R4] ISO/PWI submission for NP Ballot For ISO/NP , Health informatics Public key infrastructure Part 5: Authentication using healthcare PKI credentials - approves WG4 recommendation to be submitted for NP ballot; - instructs the project lead to provide a complete and approved form 4, timeline and NP text to the WG4 secretary and convenor no later than 13 October 2014; - instructs the WG4 secretary to provide a complete and approved form 4, timeline and NP text to the TC215 Secretary no later than 14 October 2014; - instructs the TC215 Secretary to launch an NP ballot no later than 4 November 2014 Discussion: NONE 2014 Resolution 67 [WG4 R5] ISO/IS PWI - Aaddition of PWI to the ISO/TC215 WG4 work program - approves the WG4 recommendation to add ISO/IS PWI Health informatics, Principles and guidelines for protection of personal health information to the ISO/TC215 WG4 work program - Instructs the TC215 secretary to register the PWI with ISO/CS by 2014 October 31 Discussion: NONE Please note that Resolutions 64, 65, 66, 67 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Italy, Switzerland MOTION PASSSES: Resolutions passed N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 10 of 17

12 RESOLUTIONS WG6: PHARMACY AND MEDICINES BUSINESS 2014 Resolution 68 [WG6 R01] prcen ISO/DTS Title change For prcen ISO/DTS 19256, Health informatics Requirements for Medicinal Product Dictionaries, approves the change of name of this project TO ISO/DTS Health informatics Requirements for Medicinal Product Dictionaries for clinical care FROM:ISO/DTS Health informatics Requirements for Medicinal Product Dictionaries, instructs the TC 215 Secretary to inform the ISO/CS to adjust ISO Project portal accordingly. Discussion: U.S. Two points from the floor (a) We have some questions about matching between the scope and original form 4 for the word "dictionaries". It appears that there is some difference in what this means and suggests that perhaps "Knowledge resource" instead of Dictionary might be more appropriate. (b)please ensure that any scope shift is visible to the TC Response: Convenor Mr. Christian Hay: Indicated that it was not a scope change but an adjustment. It was requested this information be made clear on forthcoming DTS ballot. US: Noted that the US strongly supports the direction and just seeks clarification Opposed: NONE Abstentions: Australia Motion: Motion passes Please note that Resolutions 69, 70, 71, 72, 73 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Italy, Switzerland MOTION PASSSES: Resolutions passed 2014 Resolution 69 [WG6 R02] prcen ISO/DTS submission for a 2-month DTS ballot For prcen ISO/DTS 19256, Health informatics -- Requirements for Medicinal Product Dictionaries for clinical care, approves the recommendation of WG6 that this item progress to a DTS ballot; instructs the project lead to provide the text of prcen ISO/DTS and NP ballot reconciliation to the WG6 Secretary no later than 1 November 2014; instructs the TC 215 Secretary to launch a 2-month DTS ballot no later than 15 November 2014 and request that CEN/TC251 launch a parallel 2-month DTS ballot. N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 11 of 17

13 2014 Resolution 70 [WG6 R03] prcen ISO/DTS submission for 2-month DTS ballot For prcen ISO/DTS 19844, Health informatics -- Identification of medicinal products (IDMP) Implementation Guide for EN ISO for Data Elements and Structures for the Unique Identification and Exchange of Regulated Information on Substances, approves the recommendation of WG6 that this item progress to a DTS ballot; instructs the project lead to provide the text of prcen ISO/DTS and NP ballot reconciliation to the WG6 Secretary no later than 1 November 2014; instructs the TC 215 Secretary to launch a 2-month DTS ballot no later than 15 November 2014 and request that CEN/TC251 launch a parallel 2-month DTS ballot Resolution 71 [WG6-R04] prcen ISO/TS/NP submission for NP/DTS ballot For prcen ISO/TS/NP, Health Informatics Identification of medicinal products (IDMP) Implementation Guide for EN ISO Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, ISO/ TC215; approves the recommendation of WG6 that this item be submitted for an NP/DTS ballot, in parallel in CEN/TC 251 to establish Vienna Agreement; instructs the project lead to provide a completed form 4 and text to the WG6 secretary no later than 21 October 2014; instructs the TC215 Secretary to launch a 2-month NP ballot no later than 15 November 2014 and request that CEN/TC251 launch a parallel 2-month NP ballot. NOTE: ISO/CS is requested to assign a new and unique standard reference number to this NP Resolution 72 [WG6-R05] prcen ISO/TS/NP submission for NP/DTS ballot For prcen ISO/TS/NP, Health Informatics Identification of medicinal products (IDMP) Implementation Guide for EN ISO Data elements and structures for the unique identification and exchange of regulated medicinal product information, approves the recommendation of WG6 that this item be submitted for an NP/DTS ballot, parallel in CEN/TC 251 to establish Vienna Agreement; instructs the project lead to provide a completed form 4 and text to the WG6 secretary no later than 21 October 2014; instructs the TC215 Secretary to launch a 2-month NP ballot no later than 15 November 2014 and request that CEN/TC251 launch a parallel 2-month NP ballot. NOTE: ISO/CS is requested to assign a new and unique standard reference number to this NP to avoid past numbering confusion with these Guides supporting the work item. The Guide should not be numbered ISO please assign a new ISO number. N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 12 of 17

14 2014 Resolution 73 [WG6-R06] prcen ISO/TS/NP submission for NP/DTS ballot For prcen ISO/TS/NP, Health Informatics Identification of medicinal products (IDMP) Implementation Guide for EN ISO Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information, ISO/ TC215; approves the recommendation of WG6 that this item be submitted for an NP/DTS ballot, parallel in CEN/TC 251 to establish Vienna Agreement; instructs the project lead to provide a completed form 4 and text to the WG6 secretary no later than 21 October 2014; instructs the TC215 Secretary to launch a 2-month NP ballot no later than 15 November 2014 and request that CEN/TC251 launch a parallel 2-month NP ballot. NOTE: ISO/CS is requested to assign a new and unique standard reference number to this NP to avoid past numbering confusion with these Guides supporting the work item. The Guide should not be numbered ISO please assign a new ISO number. Please note that Resolutions 69, 70, 71, 72, 73 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Italy, Switzerland MOTION PASSSES: Resolutions passed Please note that Resolutions 74 and 75 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on Resolutions ABSTENTIONS: Italy, Switzerland MOTION PASSSES: Resolutions 74 and 75 passed 2014 Resolution 74 [WG6 R07] prcen ISO/DTS submission for DTS ballot For prcen ISO/DTS 17251, Health informatics - Business requirements for the exchange of structured dose instructions for medicinal products, approves the recommendation of WG6 for this item to be submitted for a DTS ballot; instructs the project lead to provide the text of prcen ISO/DTS and NP ballot reconciliation to the WG6 Secretary no later than 1 November 2014; instructs the TC 215 Secretary to launch a 2-month DTS ballot no later than 15 November 2014 and request that CEN/TC251 launch a parallel 2-month DTS ballot Resolution 75 [WG6 R08] pren ISO withdraw from work programme For prcen ISO/DTS 19294, Health informatics -- Data elements and structures for identification of extemporaneous and magistral (compound) pharmaceutical preparations without marketing authorisation, approves the recommendation of WG6 to withdraw this work item from its work programme; instructs the TC 215 Secretary to inform the ISO/CS to adjust ISO Project portal accordingly. Please note that Resolutions 74 and 75 were voted as a block DISCUSSION or OBJECTIONS: No Discussion or Objections on any of the Resolutions ABSTENTIONS: Italy, Switzerland MOTION PASSSES: Resolutions 74 and 75 passed N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 13 of 17

15 RESOLUTIONS FROM ISO/TC215 JWG1: INFORMATICS OF TRADITIONAL CHINESE MEDICINE (PROVISIONAL) 2014 Resolution 76 [JWG1- R01] ISO/AWI/DTS submission for TS publication For ISO/AWI/DTS , Health informatics -- Profiling Framework and Classification for Traditional Medicine informatics standards development -- Part 1: Traditional Chinese Medicine, approves the recommendation of JWG 1 to submit ISO/DTS for TS publication; instructs the project leader to provide the updated text and revisable figure files of ISO/DTS to the TC 215 Secretary no later than 10 Dec 2014; instructs the TC 215 Secretary to submit TS materials to ISO/CS for publication no later than 25 December Opposed: NONE Abstentions: NONE Motion: PASSES UNANIMOUSLY 2014 Resolution 77 [JWG1- R02] ISO/PWI/ for assessment as potential JWG1 project For ISO/PWI/ , Health informatics, Categorial structure for representation of acupuncture, part 3: Moxibustion, approves the recommendation of JWG 1 to assess ISO/PWI/ as a potential JWG1 project. approves ISO/PWI/ to be a joint work item with ISO/TC215 administrative lead subject to ISO/TC215 review and approval of NP result of voting Opposed: NONE Abstentions: NONE Motion: PASSES UNANIMOUSLY 2014 Resolution 78 [JWG1- R03] ISO/PWI/ for assessment as potential JWG1 project For ISO/PWI/ , health informatics: Categorial structures for representation of acupuncture, Part 4: Meridian and collateral channels. approves the recommendation of JWG 1 to assess ISO/PWI/ as a potential JWG1 project. approves ISO/PWI/ to be a joint work item with ISO/TC215 administrative lead subject to ISO/TC215 review and approval of NP result of voting Opposed: NONE Abstentions: NONE Motion: PASSES UNANIMOUSLY Please note that Resolutions 79, 80, 81 were voted as a block DISCUSSION: Approved with language as amended on Resolution 81 OBJECTIONS: NONE ABSTENTIONS: Canada, Denmark, Finland, Italy, Norway, Netherlands, Norway, Russia, Sweden, Switzerland MOTION PASSSES: Resolutions passed as amended N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 14 of 17

16 2014 Resolution 79 [JWG1- R04] ISO/CD/ Review and scope clarification ISO/TC249 lead For ISO/CD , Coding System of Chinese Medicine -- Part 1: Coding Rules for Decoction Pieces - ISO/TC249 as administrative lead Instructs the project leader clarify the definition of Chinese Medicines no later than 20 October 2014 and provide this definition to the JWG1 secretary for circulation to JWG1 Instructs the project leader provide an updated text for ISO/CD to the JWG1 secretary and circulate the text in ISO/TC215 and ISO/TC249 before 30 October 2014 ISO/TC 215 agrees to the recommendation by JWG 1 co-convenors that the domains of Kampo medicine, Korean medicine and other traditional medicines are not within the scope of this part Resolution 80 [JWG1- R05] ISO/CD/ Review and scope clarification ISO/TC249 lead For ISO/AWI Coding System of Chinese Medicine -- Part 2: Codes of decoction pieces. ISO/TC249 as administrative lead - Instructs the project leader clarify the definition of Chinese Medicines no later than 20 October 2014 and provide this definition to the JWG1 secretary for circulation to JWG1 Instructs the project leader provide an updated text for ISO/CD to the JWG1 secretary and circulate the text in ISO/TC215 and ISO/TC249 before 30 October 2014 ISO/TC 215 agrees to the recommendation by JWG 1 co-convenors that the domains of Kampo medicine, Korean medicine and other traditional medicines are not within the scope of this part Resolution 81 [JWG1- R06] ISO/CD/ Review and Scope clarification ISO/TC249 lead For ISO/ AWI , Coding System of Chinese Medicine Part 3: Coding Rules for Chinese Medicines in Supply Chain Management. ISO/TC249 as administrative lead Instructs the project leader clarify the definition of Chinese Medicines no later than 20 October 2014 and provide this definition to the JWG1 secretary for circulation to JWG1 ISO/TC 215 agrees to the recommendation by JWG 1 co-convenors that the domains of Kampo medicine, Korean medicine and other traditional medicines are not within the scope of this part. Discussion: Several NMBs noted that they found the title unclear. Matter was discussed and it was agreed to modify the proposed title as listed below. Revise FROM 2014 Resolution 81 [JWG1- R06] ISO/CD/ out of JWG1 Scope ISO/TC249 lead TO 2014 Resolution 81 [JWG1- R06] ISO/CD/ Review and Scope clarification ISO/TC249 lead Please note that Resolutions 79, 80, 81 were voted as a block DISCUSSION: Approved with language as amended on Resolution 81 OBJECTIONS: NONE ABSTENTIONS: Canada, Denmark, Finland, Italy, Norway, Netherlands, Norway, Russia, Sweden, Switzerland MOTION PASSSES: Resolutions passed as amended N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 15 of 17

17 RESOLUTIONS JWG 7 HEALTH INFORMATICS AND ELECTRICAL EQUIPMENT IN HEALTHCARE Please note that Resolutions 82 and 83 were voted as a block 2014 Resolution 82 [JWG7-R01] IEC/TR submission for DTR for ballot For IEC/TR , Health informatics, Application of risk management for IT-networks incorporating medical devices -- Part 2-8: Application guidance Guidance on standards for establishing the security capabilities identified in IEC/TR , approves the JWG7 recommendation to proceed to DTR ballot (after the close of ballot of ISO/DIS 27799); instructs the JWG7 secretary to coordinate the schedule [as needed] with the IEC primary point of contact; in schedule coordination with IEC, instructs the PL to provide the disposition of CD comments and DTR text to the JWG7 secretary no later than 10 March 2015; instructs the JWG7 secretary to provide these items to the TC 215 Secretary and IEC SC 62A Secretary no later than 17 March 2015; instructs the TC 215 Secretary and IEC SC 62A Secretary to circulate the DTR for ballot no later than 1 April Discussion: See discussion notes below 2014 Resolution 83 [JWG7-R02] ISO/TR x submission for NP ballot For ISO/TR x, Application of risk management for IT-networks incorporating medical devices Part 2-x: Application guidance Guidance for use of security assurance cases to demonstrate confidence in IEC/TR security capabilities, approves the JWG 7 recommendation to proceed to NP ballot with an IEC lead; instructs the JWG7 secretary to coordinate the schedule with the IEC primary point of contact; instructs the PL to provide the complete form 4 and draft text to the JWG 7 secretary no later than 15 October 2014; instructs the JWG 7 secretary to provide these items to the TC 215 Secretary and IEC no later than 1 November 2014; instructs the TC 215 Secretary, in coordination with the IEC/SC 62A Secretary, to launch the respective NP ballots no later than 11 November Administrative note: If a part cannot be assigned a number, it cannot be registered by ISO CS so the item may only be listed on the internal ISO/TC215 tracking work program and not on the ISO database. This is called out because ISO and IEC handle work item numbering processes differently and as a result, the numbering of the items in the ISO and IEC databases occasionally get out of synch. DISCUSSION: See discussion notes below Please note that Resolutions 82 and 83 were voted as a block DISCUSSION: Canada: Asked if the US and Project leader were comfortable that these are taking into consideration the Ad Hoc TF Report for all of these recommendations? US: Replied in the affirmative. OBJECTIONS: Germany opposed Resolutions 82 and 83 ABSTENTIONS: Italy, Switzerland MOTION: MOTION PASSES N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 16 of 17

18 2014 Resolution 84 [JWG7-R03] IEC , submission for parallel ISO and IEC Enquiry ballots For IEC , Health software -- Part 1: General requirements for product safety, approves the JWG 7 recommendation to proceed to parallel ISO and IEC Enquiry ballots with an IEC lead; instructs the JWG7 secretary to coordinate the schedule with the IEC primary point of contact; instructs the PL to provide the disposition of CD.2 comments and Enquiry text to the JWG 7 secretary no later than 15 January 2015; instructs the JWG 7 secretary to provide these items to the TC 215 Secretary and IEC no later than 28 January 2015; instructs the TC 215 Secretary, in coordination with the IEC/SC 62A Secretary, to submit the document to ISO and IEC for parallel Enquiry ballots no later than 15 February Opposed: NONE Abstentions: NONE Motion: PASSES UNANIMOUSLY N1576_RESOLUTIONS_ISOTC215_Berlin_Germany_10_October_2014.docx Page 17 of 17