1. HL7 Healthcare Device SIG Device Informatics Update to Government Projects SIG General Overview and IEEE PCD WG + IHE PCD Activities 2006 September 12 Todd Cooper ISO TC215 WG7, IEEE EMBS 11073, HL7 DEV SIG, IHE PCD, HITSP Board

2. 2 Session Overview DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper Topics to be discussed… IHE Patient Care Device (PCD) Domain Organizational & Project Overview Q & A IEEE Personal Health Device WG

3. 3 Foundational Concepts and Definitions DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper Vent Vital Signs Monitor Infusion Pumps Pulse Ox Dialysis Machine PoC Integration (X73) Device Data Manager Enterprise Integration (HL7, DICOM, X12,…X73) HISPACSCISPharmacyLAB Gateway Multi-vendor environment Requires both semantic & technical interoperability

4. 4 Foundational Concepts and Definitions DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper Key Benefits of PCD Interoperability: –Heterogeneity – Multiple manufacturers + multiple device modalities coexisting over a shared infrastructure –Semantic Interoperability ( comparability) – shared terminology and data models, interpret data based on the clinical context, compare information from different healthcare facilities, and interrogate systems across enterprises and regions. –Real-Time Availability – ability to provide data in a time frame appropriate to the physiologic function being measured, displayed or affected (controlled).

5. 5 Medical Device Informatics Standardization DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper IEEE EMBS 11073 CEN TC251 WG4 HL7 DEV & CBCC SIGs ISO TC215 WG7 Single set of Internationally Harmonized Medical Device Informatics & Interoperability Standards IHE Patient Care Devices Domain DICOM

6. 6 Medical Device Informatics Standardization DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper Cabled 11073-30200 e.g., RS-232C RS-422 (USB) ENet 11073-30400 [802.3] -20404 ID -20402 QoS Mngt -20403 Location IrDA 11073-30300 -20400 Network Services - Framework & Overview -20000 Application Profile – Framework & Overview wLAN 11073-30503 e.g., 802.11a 802.11b 802.11g -20401 IP protocol (applies only to ENet, wLAN) wPAN 11073 -30501 [BT / 802.15.1] -2040x BT Data wPAN 11073 -30502 [low- rate] 802.15.4 MICs / MedRadio wPAN 11073 -30503 [high- rate] e.g., UWB -2040? -30000 Transport Profile – Framework & Overview -30500 RF Wireless - Framework & Overview wMAN wRAN 11073 -30504 e.g., 802.16e 802.20 802.22 wWAN 11073 -30505 e.g., 2G 3G Mesh Networks 11073 -30507 WMTS 11073 -30508 -20500 Security – Framework & Overview -1yyzz Information Profiles -10101 Nomenclature -10201 Domain Info Model (DIM) -10316 Dialysis -10315 Scale -10313 Pulmonary -10312 Hemo -10311 Gas Anl -10310 Cardiac -10309 Airway -10308 Temp -10307 BP -10306 ECG -10305 Defib -10304 Pulse Ox -10303 Ventilator -10302 Vital Signs -10301 Infusion -5yyzz Internetworking Support -9yyzz Analytic Instruments – PoC Tests -6yyzz Application Gateway -0yyzz Guidelines / Technical Reports Information System Monitor/Manager Device ISO / OSI Model Framework HL7 / CEN/ISO/IEEE / POCT-1A Compatible WIREDWIRELESS -01010 RF Wireless -103xx / -104xx

7. 7 ISO/IEEE Standards DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper Published ISO/IEEE 11073 Standards… ISO/IEEE 11073-10201 Domain Information Model ISO/IEEE 11073-20101 Application Profile – Base Std. IEEE 1073 Framework & Overview (under revision) ISO/IEEE 11073-30200 Transport Profile – Cable Connected ISO/IEEE 11073-10101 Nomenclature / Terminology ISO/IEEE 11073-30300 Transport Profile – IR Wireless

8. 8 ISO/IEEE Standards DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper Active ISO/IEEE projects (partial) … -20103 Clinical Context Management (CCoM) -20301 Remote Control -10102 Annotated ECG Terminology -30400 Inter-LAN (IP protocol profiling) -10103 Implantable Device, Cardiac Terminology -30503 wLAN & -30505 wWAN

9. 9 IEEE 11073 Personal Health Device WG DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper SerialIrDABluetoothUSBZigBee Consistent Data/Command Framework Transport Layers 1-6 Layer 7 OSI Pulse Oximeter Blood PressureGlucosePulseWeight Spiro- meter … Device Specializations Technical Report PAR PAR for –2yyzz series work PAR(s) for –1yyzz series work

10. 10 IEEE 11073 Personal Health Device WG Proposed key milestones 08/04 06Project Approval Request (PAR) submission deadline –Requires Phase I device specialization selection 09 06Early draft specs available for November prototype testing 09/12 or 09/13 Data work group face to face meeting in Boca Raton with report out to ISO/IEEE 11073 general committee 09/14 11/12 or 11/13 Data work group face to face in Zurich (just prior to Medica in Düsseldorf) 12 06Document updated based on prototype discovery 02/10 07Bluetooth unplugfest to ratify nearly final specs 03 07Final specification completed DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

11. 11 IHE Patient Care Device Domain DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper 5 Technical Frameworks 39 Integration Profiles, Testing at Multiple Connectathons Annually IHE EHR- Longitudinal Record IHE Cardiology IHE Laboratory IHE Radiology New IHE Domains Patient Care Coordination IHE IT Infrastructure 16 Integration Profiles 5 Integration Profiles 4 Integration Profiles 13 Integration Profiles 1 Integration Profile 2 Integration Profiles Patient Care Devices Expanding Reach

12. 12 IHE Patient Care Device Domain DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper IHE-PCD Charter The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging. The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging.

13. 13 IHE Patient Care Device Domain DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper PCD Roadmap… Year 1: Enterprise sharing of Patient Care Data Initial device classes – vital sign monitors, infusion pumps, ventilators … and possibly others

14. 14 IHE Patient Care Device Domain DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper Year 2++ Point-of-Care Device PnP Connectivity Home Health / Personal Care Devices Emergency Care Real-time data archiving and communication PCD Alarm Management + smart alarms & interlocks Medication Management Device Control (e.g., Hospital Bed–Blood Pressure Coordination) Mobile, enterprise-wide, reliable vital signs monitoring … many more!

15. 15 IHE Patient Care Device Domain DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper 2006 Development Schedule: 2006 Development Schedule: Planning Committee decision:mid-January Planning Committee decision:mid-January Issue Public Comment version: June 2006 Issue Public Comment version: June 2006 Public Comment Due:July 2006 Public Comment Due:July 2006 Issue Trial Implementation version: August 8, 2006 Issue Trial Implementation version: August 8, 2006 IHE Connectathon: January 2007 IHE Connectathon: January 2007 HIMSS Demo: February 2007 HIMSS Demo: February 2007

16. 16 IHE Patient Care Device Domain DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper

17. 17 IHE Patient Care Devices Domain DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper n Testing Framework HL7v2.x Standard IHE/PCD Technical Framework (vol 2) (Transactions) Message Profile xml ICS-Generator ICS XML File -Attribute ID, Term codes, value ranges, qualifiers… -Object Containment Tree 11073 Standards (DIM + Terms) IEEE 11073 Standard IHE-ITI Patient Administration P11073-60101 HL7 V2.x ORI (gateway) IHE Message Profile IHE Message Profile (XSLT) NIST Test Framework …

18. 18 IHE Patient Care Devices Domain DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper 2006 Development Schedule: 2006 Development Schedule: Planning Committee decision:mid-January Planning Committee decision:mid-January Issue Public Comment version: June 2006 Issue Public Comment version: June 2006 Public Comment Due:July 2006 Public Comment Due:July 2006 Issue Trial Implementation version: August 2006 Issue Trial Implementation version: August 2006 IHE Connectathon: January 2007 IHE Connectathon: January 2007 HIMSS Demo: February 2007 HIMSS Demo: February 2007

19. 19 DEV SIG – Update to the Government Projects SIG – 2006-09-12 – Boca Raton – Todd Cooper Q & A