IEEE Development Program - Overview. d1jw

Transcription

1 IEEE Development Program - Overview d1jw

2 Contents Program management perspective Development phasing perspectives Functional Temporal Supporting perspectives (Appendices) A: Project/Program context B: Project status summary tables 1. Base 2. Nomenclature extensions 3. Application profile extensions 4. Support services and Transports C: Harmonization relationships D: Reuse relationships

3 Program Management Perspective A program management perspective is used due to multiple relationships of projects Architecturally (generally due to layering) Reusably (generally involving harmonizing with overlapping standards and underlapping standards organizations) Temporally (i.e. over time, generally in a phased, harmonization interstandard organization process) Main perspectives Functional: multi-track development model (IEEE, NIST, IHE) Temporal: project development over time Supporting perspectives (Appendices) Project/Program context Project status summaries Harmonization and Reuse relationships

4 Development phasing perspective functional The primary strategy is to parallel-track IEEE SDO-based standards and reusable artifacts, particularly involving IHE profiles and NIST tools. Tracking and phasing is characterized in the following diagram. Track IHE NIST IEEE [SDO] RTM [Rev q] Base Nomenclature PCD<nn> Profile[s] Base DIM RTMMS aecg Nomenclature User-class restricted use/access DB IDCO Nom. Export /Prepare UnLicensed Distribution Import /Prepare DB Media Format Licensed Distribution Document Format

5 Development phasing perspective - temporal Scope Std ID < > New 2014 Nomen clature Domain Info Model (DIM) Classic aecg IDCO ASN XML Appl. Profile Base Std Polling Mode Asynch Mode [Package] External Control Approved Ext(1) Ext(2) Generally, 2006 Ext(1) trying to align to common Completing 10 yr from Approved Ext(1) Ext(2) Base initial approval defer Approved Ext(1) Ext(2) 2006 Ext(1) Ext(2) 2006 Ext(1) Ext(2) 2006 defer Supporting Services & Transports Common Svcs 30400a LAN WLAN Approved defer 2006 Ext(1)

6 Appendix A. Project/Program context Particular standards are related in program subsets. In general, the Base standards are in the main subset to be extended, and others extend or support the Base (so-called Classic ). *Bold highlight implies revision/renewal phasing. Std Scope ID /Mnemonic Program Subset Nomenclature Classic X aecg X IDCO X Domain Info Model (DIM) ASN.1 X Base Extensions Supporting Services Nomen Appl n XML [X] Appl. Profile Baseline X Polling Mode X Asynchronous Mode X [Package] External Control X X Supporting Services Common *Internet+ Services X WLAN X

7 Appendix B-1. Status Summary Table Base This set concerns the base, initial (2004) standards set (aka Classic ). 1. The most complex of the standards is Nomenclature, involving several major moving parts (see Appendix B-2) and harmonization activities (see Appendix C), including tool development through NIST (see Appendix D) PAR # WG CHAIR TITLE TYPE EXP DATE CURRENT STATUS Intended for PSDO? ISO NOTES UL Wittenber ISO/IEEE :2004, Health informatics - Point-of-care medical device communication - Nomenclature 12/31/2010 Open for revision Yes Document under development - The ISO TC215/WG7 Secretary, informs: ISO TC215 Secretary, CEN TC251 Secretary, CEN TC251/WGiv Secretary, of PAR Submittal and Form 4 for registration as ISO and CEN (VA) prenwip, and for expert recruitment circulation. Published by ISO Nomenclature primarily supports (Domain Information Model [DIM]) and Medical Device Application Profiles, particularly , MDAP Base Standard, which has harmonization dependencies with CEN PAR # WG CHAIR TITLE TYPE EXP DATE CURRENT STATUS Intended for PSDO? ISO NOTES UL Wittenber ISO/IEEE :2004, Health informatics - Point-of-care medical device communication - Domain information model UL Wittenber ISO/IEEE :2004, Health informatics - Point-of-care medical device communication - Application profile - Base standard 12/31/2010 Open for revision 12/31/2010 Open for revision Yes Yes Document under development - The ISO TC215/WG7 Secretary, informs: ISO TC215 Secretary, CEN TC251 Secretary, CEN TC251/WGiv Secretary, of PAR Submittal and Form 4 for registration as ISO and CEN (VA) prenwip, and for expert recruitment circulation. Published by ISO 2004.

8 Appendix B-2. Status Summary Table Nomenclature Extensions This set concerns significant extensions to Nomenclature (-10101). 1. Annotated ECG (aecg): to be dual-tracked with (a) NIST RTMMS tooling and DB distribution, (b) copyrighting/licensing resolution and (c) editorial methods clarification concerning export from DB and inclusion in tabular form in standard specification. PAR # WG CHAIR TITLE TYPE EXP DATE CURRENT STATUS Intended for PSDO? ISO NOTES UL Schluter Standard for Health informatics - Point-of-care medical device communication - Nomenclature - Annotated ECG New 12/31/ /31/2011 Dev Yes Document under development - The ISO TC215/WG7 Secretary, informs: ISO TC215 Secretary, CEN TC251 Secretary, CEN TC251/WGiv Secretary, of PAR Submittal and Form 4 for registration as ISO and CEN (VA) prenwip, and for expert recruitment circulation. 2. Implantable Devices, Cardiac Observations: expected to be completed in 2011 and subsequently NIST RTMMS tooling ( ) UL Wittenber /Steblay Standard for Health informatics - Point-of-care medical device communication - Nomenclature - Implantable device, cardiac New (Mod) scope purpose 12/31/ /31/201 1 In cmt rez since 2/21/2011 Yes Document under development - The ISO TC215/WG7 Secretary, informs: ISO TC215 Secretary, CEN TC251 Secretary, CEN TC251/WGiv Secretary, of PAR Submittal and Form 4 for registration as ISO and CEN (VA) prenwip, and for expert recruitment circulation.

9 Appendix B-3. Status Summary Table Appl n Profile Extensions This set concerns Medical Device Application Profile (MDAP) extensions, supporting plug-and-play, including remote control, as such require significant industry-wide support. In general, these have been previously extended but require additional extension primarily due to resource limitations and harmonization or regulatory requirements (e.g. Integrating the Clinical Environment (ICE), an evolving ASTM standard*-series]. PAR # WG CHAIR TITLE TYPE EXP DATE CURRENT STATUS Intended for PSDO? ISO NOTES UL Wittenber Standard for Health informatics - Point-of-care medical device communication - Application Profile Polling Mode Profile Standard for Health informatics - Point-of-care medical device communication - Application Profile Asynchronous Mode Profile Standard for Health informatics - Point-of-care medical device communication - Application Profile - Optional package, remote control New 12/31/2011 Dev Yes 12/31/ /31/2011 Document under development - The ISO TC215/WG7 Secretary, informs: ISO TC215 Secretary, CEN TC251 Secretary, CEN TC251/WGiv Secretary, of PAR Submittal and Form 4 for registration as ISO and CEN (VA) prenwip, and for expert recruitment circulation.

10 Appendix B-4. Status Summary Table Support/Transport Services This set concerns supporting services or profiles to be reviewed for possible extension or deferral, scope and harmonization ( ). PAR # WG CHAIR TITLE TYPE EXP DATE CURRENT STATUS Intended for PSDO? ISO NOTES 1. Common [Internetworking] Services involve standards supporting device discovery, dynamic configuration, naming, object management, security, among others UL/LL [Schnell] Standard for Health informatics - Point-of-care medical device communication - Application Profile Common Services New 2. Wireless LAN (WLAN) is a strongly related Transport that has significant harmonization relationships (IEEE workshops, WiFi and Continua consortia) that tend to mitigate the need for a particular IEEE Transport. Scoping clarification is also needed w.r.t. hospital vs. home topologies (involving Wide Area Networking [WAN]) LL Clarke Standard for Health informatics - Point-of-care medical device communication - Transport profile - RF wireless - Local area network (wlan) New 12/31/201 Dev 1

11 Appendix C. Harmonization Relationships Significant harmonization relationships are required to provide for consistency and comprehensiveness of device standards, as characterized in the following table. [Std Org listing is alphabetical (bold highlight denotes MoU). Std Org Desc Project/Program relationships CEN European Committee for Standardization Nomen DIM Appl Profiles Support Svcs VITAL Standards harmonized through ISO e.g. CEN Continua Continua Health Alliance See IHE IEEE PHD WAN, WLAN HL7 Health Level Seven See IHE IAB Internet Architecture Board Common Svcs ICE Integrated Clinical Environment Semantics, esp. IEC Int l Electro-tech. Commission (TC121) Ventilator Device Models IHE Integrating the Healthcare Environment RTM PCD<nn> Profiles IHTSDO Int l Healthcare Terminology SDO SNOMED Plug-and-Play ; External Control ISO Healthcare Informatics (TC215) IEEE standards generally fast-tracked NIST National Inst.of Science and Technology Automation Tools, e.g. RTMMS ICS Generator PDU Validator

12 Appendix D. Reuse relationships Tooling, primarily Nomenclature and Conformance, is key to evolution of the standards set. NIST has been a principal stakeholder in several tools, in particular the Rosetta Terminology Mapping Management System (RTMMS) tool, which is strongly supported by the IHE Patient Care Devices RTM project. ISO/IEEE Project # Status Relationship to NIST RTMMS Project Project Title Revision Pre-Ballot Core terminology - represents the bulk of the informaiton that will be incorporated into the NIST tool. Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature Extends the base nomenclature to support annotated ECG concepts; normative content is complete, awaiting finalization Health informatics - Point-of-care medical of explanatory text; supports HL7 Annotated ECG standard device communication - Part 10102: (published many years ago); in wide use for clinical trial Nomenclature - Annotated ECG submissions to the FDA that include ECG data In Ballot Extends the base nomenclature with terms supporting implantable cardiac devices (e.g., pacemakers) Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, Cardiac Revision Pre-Ballot xx <all stages> Published Provides "syntax" needed to build statements using terms; includes terms that support the information model (Object Oriented partition). Used to support tools that use the Domain Information Model (10201) - may / may not be relevant to RTMMS Extends the base nomenclature to define normative terms for specific personal health device specializations Extends the base nomenclature to define normative terms for general use by personal health device specializations Health informatics - Point-of-care medical device communication - Part 10201: Domain information model Health informatics - Point-of-care medical device communication - Part 10202: Domain information model - XML schema format Health informatics - Personal health device communication - Part 104xx: Device specialization - <xyz> Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol