ISO/TC 215 N RESOLUTIONS ISO TC215 Liverpool 10 Nov 2017 v2. Date of document: Expected action: Background:

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1 ISO/TC 215 N 2473 ISO/TC 215 Health informatics of secretary: Diana.warner@ahima.org Secretariat: ANSI (United States) RESOLUTIONS ISO TC215 Liverpool 10 Nov 2017 v2 Document type: Resolution Date of document: Expected action: INFO Background: Committee URL:

2 Liverpool Resolutions P-MEMBERS Australia (SA), Brazil (ABNT), Canada (SCC),China (SAC), Denmark (DS), Finland (SFS), Germany (DIN), India (BIS), Ireland (NSAI), Italy (UNI), Japan (JISC), Republic of Korea (KATS), Malaysia (DSM), Netherlands (NEN), Norway (SN), Spain (AENOR), Sweden (SIS), Switzerland (SNV), United Kingdom (BSI), United States (ANSI) Resolutions Office of the ISO/TC215 Secretariat : ISO/TC215 extends its appreciation to Ms. Mary Lou Pelaprat for her dedication, significant contributions and years of service as Technical Programme Manager to ISO/TC : ISO/TC215 extends its appreciation to Ms. Sheryl Reyes for her dedication, significant contributions and years of service as secretary support to ISO/TC 215. Resolutions WG1: Architecture, Frameworks and Models : ISO/TC215 resolves to confirm 21667:2010 Health indicators conceptual framework : ISO/TC215 resolves to Approve ISO/NP Healthcare informatics service architecture -- Parts 1-3 to change to the 48 month standards development track : ISO/TC215 resolves to Approve under Vienna Agreement (ISO lead) ISO/DIS Electronic health record communication Part 1: Reference model to Skip FDIS and go to publication with WG1 approval after a 4 week CIB and CEN approval to skip the Formal Vote ballot. 1 P age

3 : ISO/TC215 resolves to Approve under Vienna Agreement (ISO lead) ISO/DIS Electronic health record communication Part 2: Archetype interchange specification to Skip FDIS and go to publication with WG1 approval after a 4 week CIB and CEN approval to skip the Formal Vote ballot : ISO/TC215 resolves to Approve under Vienna Agreement (ISO lead) ISO/DIS Electronic health record communication Part 3: Reference archetypes and term lists to Skip FDIS and go to publication with WG1 approval after a 4 week CIB and CEN approval to skip the Formal Vote ballot : ISO/TC215 resolves to Approve under Vienna Agreement (ISO lead) ISO/DIS Electronic health record communication Electronic health record communication -- Part 4: Security to Skip FDIS and go to publication with WG1 and WG4 approval after a 4 week CIB and CEN approval to skip the Formal Vote ballot : ISO/TC215 resolves to Approve under Vienna Agreement (ISO lead) ISO/DIS Electronic health record communication Part 5: Interface specification to Skip FDIS and go to publication with WG1 approval after a 4 week CIB and CEN approval to skip the Formal Vote ballot. Resolutions WG2: Systems and Device Interoperability : ISO/TC215 resolves to Approve ISO/ TR Health-related data which a person generates daily for an 8-week DTR ballot by 22 December A: ISO/TC215 resolves to Approve ISO/PWI Clinical genomics data sharing specification to be added to the WG2 program. Discussion: Duplicate Number, added an A to differentiate 2 P age

4 B: ISO/TC215 resolves to Approve ISO/PWI Registration of cardiology device and related data for research to be added to the WG2 program. Discussion: Duplicate Number, added a B to differentiate : ISO/TC215 resolves to Approve ISO/PWI Structured clinical gene fusion report in electronic health records for an 8-week NP ballot by 22 December : ISO/TC215 resolves to Approve ISO/PWI Medical waveform format Part 5: EEG for an 8-week NP ballot by 22 December Objections: Abstentions: Discussion: United Kingdom: Requests WG2 revisit the title in the next ballot to more closely align with the scope of the project. Consider including the term neurophysiology. Motion: : ISO/TC215 resolves to Approve ISO/PWI Ophthalmic examination device data for an 8-week NP ballot by 22 December : ISO/TC215 resolves to Approve ISO/PWI Endoscopy and related data for an 8-week NP ballot by 22 December : ISO/TC215 resolves to Approve ISO/PWI Quality control metrics for DNA sequencing for an 8-week NP ballot by 22 December : ISO/TC215 resolves to Approve ISO/PWI Reliability assessment criteria for highthroughput gene-expression data for an 8-week NP ballot by 22 December P age

5 Resolutions WG3: Semantic Content : ISO/TC215 resolves to Approve ISO/TS Terminology resource map quality measures (MapQual) for a 12-week DTS ballot by 11 November : ISO/TC215 resolves to Approve ISO/DIS Terminological Resources, Part 1: Characteristics for an 8-week FDIS ballot by 20 November : ISO/TC215 resolves to Approve ISO/TS Workforce roles and capabilities for terminology and terminology services for a 12-week DTS ballot by 30 November : ISO/TC215 resolves to Approve ISO/IS 17115:2007 Vocabulary for terminological systems for an 8-week CD ballot by 11 November 2017 and change the title to Representation of categorial structure of terminology (CatStructure). Resolutions WG4: Security, Safety and Privacy : ISO/TC215 resolves to approve that Alistair Donaldson discontinues as liaison to JTC1/SC : ISO/TC215 resolves to Approve PWI Application of privacy management to personal health information for an 8 week NP ballot 13 November P age

6 : ISO/TC215 resolves to Approve the following title change: Guidance for an identification and authentication framework of networked personal health devices to Guidance for identification and authentication for connectable personal healthcare devices : ISO/TC215 resolves to Approve PWI Guidance for identification and authentication for connectable personal healthcare devices for an 8-week NP ballot 13 November : ISO/TC215 resolves to Approve under Vienna Agreement (ISO lead) to add ISO/IS 27789:2013 Audit trails for electronic health records for revision to the WG4 work program target date 36 months; the same scope; project lead: Mr Hideyuki Miyohara. Discussion: Canada: Ensure harmonization between others standards. US: Include Electronic Health Record-System Functional Model and Electronic Health Record Communication Part 4. It was agreed that this is important to identify other standards that need to be harmonized. WG4 was commended for this. TC215 needs to continue to look at this type of harmonization. The CAG02 will be a good place to review the maintenance of standards as new ones are proposed : ISO/TC215, instructs the TC 215 Secretary to request DICOM to initiate a Change Proposal that will add to their DICOM Standard the following: Add into DICOM Part 15 PatientRecord Event Message 2 items: o PurposeOfUse and o ParticipantObjectPolicySet Add into DICOM Part 15 Query Event Message allowance to use UUID Add to DICOM Part 16 a new PurposeOfUse definition into the Content Mapping Resource that corresponds to ISO Classification of purposes for processing personal health information So that ISO can be revised. Discussion: WG4: IHE refers to part 15 and part 16 of the DICOM standards and these is the implementation issue that needs to be addressed. Australia: Support for this coordination and harmonization to keep standards in sync is very important. This is also important from a JIC perspective. 5 P age

7 Withdrawn: : ISO/TC215 resolves to Approve to add ISO/TS Security and privacy requirements for compliance testing of EHR systems -- Part 1: Foundation, for revision to the WG4 work program; target date 36 months; the same scope; project lead: Marcelo Carvalho. Objections: Abstentions: Discussion: Motion: : ISO/TC215 resolves to Approve ISO NP , Information security management for remote maintenance of medical devices and medical information systems -- Part 1: Requirements and risk analysis for an 8-week DTS ballot 8 December Resolutions WG6: Pharmacy & Medicines Business : ISO/TC215 resolves to Approve New Work Item Proposal for Requirements for accessing digital medicinal products information by using the existing data carrier for an 8-week NP ballot under Vienna Agreement-ISO lead 21 November : ISO/TC215 resolves to Approve ISO/ TR Identification of medicinal products (IDMP) Core principles for Maintenance of Identifiers and Terms for an 8-week DTR ballot by 20 December : ISO/TC215 resolves to Approve to revise ISO/TS Requirements for international machine-readable coding of medicinal product package identifiers, keeping the same scope, with Mr Christian Hay as project leader and a target date 24 months : ISO/TC215 resolves to Approve the registration as the Preliminary Work Item for ISO to target as a TS Implementation guide for ISO/TS Requirements for medicinal product dictionary systems for health care. Abstentions: United Kingdom Discussion: Edited the wording to clarify this work item is added to the work program only, not added as a DTS. 6 P age

8 : ISO/TC215 resolves to Approve the following amended scope statement of WG6 as followed: Standardisation related to the application of information and communication technology in the domain of pharmacy and medication. This, includes standardisation to improve patient safety and the efficiency and interoperability of information systems such as those used in researching, developing, regulating, supplying, prescribing, dispensing, administering and monitoring medicinal and pharmaceutical products, and documentation supporting implementation. Discussion: Edited the wording from the initial submission to ensure the scope in not opened ended. Ended the sentence after medication and added This includes. such as those : ISO/TC215 resolves to Approve the withdrawal of the technical report ISO/TR 25257:2009 Business requirements for an international coding system for medicinal products. Resolutions JWG1: Informatics aspects of Traditional Chinese Medicine - jointly with ISO/TC : ISO/TC215 resolves to Approve ISO/NP TS Classification of Traditional Chinese Medicine datasets for an 8-week DTS ballot by 22 December : ISO/TC215 resolves to Approve the following title change: Categorial structures for representation of combination of Chinese medicine to Information model of combination of decoction pieces in Chinese medicine : ISO/TC215 resolves to Approve ISO/TS Information model of combination of decoction pieces in Chinese medicine for an 8-week DTS ballot by 28 January P age

9 : ISO/TC215 resolves to Approve the following title change: Categorial structures for representation of processing Chinese materia medica to Information Model of processing Chinese materia medica : ISO/TC215 resolves to Approve ISO/TS Information Model of processing Chinese materia medica for an 8-week DTS ballot by 28 January : ISO/TC215 resolves to Approve Categorial structures for representation of pharmaceutical technology of Chinese materia medica for an 8-week NP ballot by 22 December Resolutions JWG7: Safe, Effective and Secure Health Software and Health IT Systems, including those incorporating Medical Devices : ISO/TC 215 welcomes the appointment of Georg Heidenreich by IEC/SC 62A as the new IEC co-convener of IEC/SC 62A-ISO/TC 215 JWG7. Discussion: add co- to convener to clarify the role : ISO/TC215 resolves to Approve a parallel ISO and IEC circulation of IEC/CD (2 nd ed.) Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software -- Part 1: Application of risk management for a 12-week CD ballot by 22 December P age

10 : ISO/TC215 resolves to Approve a parallel ISO and IEC circulation of ISO/CD Health software and health IT systems safety, effectiveness and security -- Part 1: Foundational principles, concepts, and terms for a 12-week CD ballot by 22 December P age