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

2. Back story X73 – Standards Development Update - 2008-01-17 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. PoC vs. Enterprise X73 – Standards Development Update - 2008-01-17 Vent Vital Signs Monitor Infusion Pumps Pulse Ox Dialysis Machine PoC Integration (X73) Device Data Manager Enterprise Integration (HL7, DICOM, X12,…) HISPACSCISPharmacyLAB Gateway

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

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

8. X73 to v3 X73 – Standards Development Update - 2008-01-17 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. Related Activities X73 – Standards Development Update - 2008-01-17 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. Project Planning X73 – Standards Development Update - 2008-01-17 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