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San Antonio – 2008-01-17

HL7 DEV WG ISO TC215 WG7 IEEE EMBS 11073. San Antonio – 2008-01-17. Health Informatics – Devices Update to HL7 Structured Documents. Todd Cooper Chair, ISO/IEEE 11073; Co-Chair HL7 DEV WG. X73 – Standards Development Update - 2008-01-17. Back story.

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San Antonio – 2008-01-17

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  1. HL7 DEV WG ISO TC215 WG7 IEEE EMBS 11073 San Antonio – 2008-01-17 Health Informatics – Devices Update to HL7 Structured Documents Todd Cooper Chair, ISO/IEEE 11073; Co-Chair HL7 DEV WG

  2. X73 – Standards Development Update - 2008-01-17 Back story • Mapping from X73 information to HL7 v3 … • Discussed in the JWG meetings for many years – never any traction • Part of the DEV WG Mission when formed 2 years ago + • Included in the HL7 – IEEE EMBS MoU • CDA representation has motivated the needed participation to move forward on X73 => v3 Mapping and prototyping • In IHE, exchange of device information via XDS motivates a CDA-device content profile • Anesthesia records – inconsistent & non-comparable device-related information (same parameter name – different measurement methods) • Event investigations – detailed device information during and around an adverse event • Medical Device Report (MDRs) CDA profile now being discussed • … many many more on the horizon!

  3. Dialysis Machine Vital Signs Monitor Infusion Pumps Vent Pulse Ox HIS PACS CIS Pharmacy LAB Device Data Manager X73 – Standards Development Update - 2008-01-17 PoC vs. Enterprise Enterprise Integration (HL7, DICOM, X12,…) Gateway PoC Integration (X73)

  4. X73 – Standards Development Update - 2008-01-17 HL7 DEV WG HL7 DEV WG Vision To facilitate integration of health care device information throughout the health care enterprise, enabling more efficient and accurate processing of device-related data and ultimately resulting in improved patient safety and quality of care. HL7 DEV WG Relationships Sponsor: Orders & Observations Coordinating: Vocabulary, Patient Care, CBHS, EHR, GAS Transitioning: Expert Domain Steering Division

  5. X73 – Standards Development Update - 2008-01-17 HL7 DEV WG HL7 DEV SIG Mission • To facilitate the integration of health care device information at the enterprise level by: • Establishing standardized version 2.x and version 3 messaging profiles to support health care device interoperability at the enterprise level • Harmonizing device data models between HL7 and other organizations including ISO/IEEE 11073 • Harmonizing and coordinating device terminology usage within HL7 components • Support revision and harmonization of the Clinical and Laboratory Standards Institute (CLSI – formerly NCCLS) Point of Care Test (POCT) and laboratory automation standards • General coordination and harmonization between HL7 and other national and international organizations involved in health care device informatics and interoperability

  6. X73 – Standards Development Update - 2008-01-17 SDOs IHE Patient Care Device Domain ISO TC215 WG7 Single set of Internationally Harmonized Medical Device Informatics & Interoperability Standards IEEE EMBS 11073 CEN TC251 WGIV HL7 DEV SIG

  7. X73 – Standards Development Update - 2008-01-17 Broad Focus

  8. X73 – Standards Development Update - 2008-01-17 X73 to v3 • Mapping from X73 semantics to HL7 v3 … • Continuity with v2.x mapping • X73 terminology usage • Parameter containment information • Device Identification & System information • Data types: Numerics, enumerations, wave snippets, trends, alarms, etc. • Language specific text labeling • Key Issues: Level of Detail + Textual Rendering Requirements

  9. X73 – Standards Development Update - 2008-01-17 Related Activities • Other v3 device oriented projects … • Annotated ECG (aECG) / RCRIM for FDA drug study submissions • Medical Waveform Encoding Rules (MFER) – CDA • Implantable Devices, Cardiac (IDC) workflow • Dialysis treatment summary report • IHE PCD v3/CDA profiling (incl. KP/Hendler prototyping) • Continua reports containing 11073-originated device data • …

  10. X73 – Standards Development Update - 2008-01-17 Project Planning • Current HL7 DEV WG plans … • Formally initiate a Project to produce a consistent HL7 v3 device representation based on ISO/IEEE 11073 semantics • Formally initiate a Project to extend this device information representation to include CDA-based documents • Coordinate with IHE PCD and other groups as appropriate to ensure continuity with related projects and activities

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