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Patient Care Devices Standards-Based Activities Overview for ISO TC121/SC3 2007-06-12 San Diego

Patient Care Devices Standards-Based Activities Overview for ISO TC121/SC3 2007-06-12 San Diego. Todd Cooper, Co-Chair, IHE PCD Domain Co-Chair, HL7 DEV SIG / ISO TC215 WG7 / IEEE 11073, ISO/IEC JWG7 President, Breakthrough Solutions, Inc. Presentation Overview.

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Patient Care Devices Standards-Based Activities Overview for ISO TC121/SC3 2007-06-12 San Diego

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  1. Patient Care Devices Standards-Based Activities Overviewfor ISO TC121/SC32007-06-12 San Diego Todd Cooper, Co-Chair, IHE PCD Domain Co-Chair, HL7 DEV SIG / ISO TC215 WG7 / IEEE 11073, ISO/IEC JWG7 President, Breakthrough Solutions, Inc.

  2. Presentation Overview • IOTA Overview & Update (slide set) • “X73” Device Standards Activities • ISO TC215 / WG7 Health Informatics - Devices • ISO/IEC JWG7 – RM for IT Nets Integrating MDs • IHE Patient Care Device Domain Overview (SLIDE SET)

  3. IOTA Overview & Update (see slides from IOTA-SNOMED 2007)

  4. IHE: A Framework for Interoperability State of open standards-based medical device connectivity? Nonexistent! Proprietary / semi-standard Interfaces + Partnerships = Security & lower risk for vendors Limitations & expense for providers & patients A business issue – not a lack of technology

  5. IHE: A Framework for Interoperability Dialysis Machine Vital Signs Monitor Infusion Pumps Vent Pulse Ox HIS PACS CIS Pharmacy LAB Device Data Manager Enterprise Integration (HL7, DICOM, X12,…X73) Gateway PoC Integration (X73) Multi-vendor environmentRequires both semantic & technical interoperability

  6. IHE: A Framework for Interoperability Device integration involves many levels… Device Interface Profile Semantics (alarms, RT waves, ID, …) Application Services (security, QoS) Transport Technologies (WiFi … Ethernet, simple serial…Bluetooth…) Standards-based interoperability profiles are required…from the transmitter to abstract semantics!

  7. Dain’s PnP Requirements MD interoperability should be… • Plug-n-Play • Real-time communication • Device Unique Identifiers & nomenclature • Open-source / license free resources • Support closed-loop control • Support EHR Integration • Support clinical DSS & A.I. applications • … for starters!

  8. IHE: A Framework for Interoperability ISO/IEEE 11073 purpose: Provide real-time plug-and-play interoperability for patient-connected medical devices and Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care, in all health care environments …leveraging off-the-shelf technologies, scaling across a wide range of system complexities, and supporting commercially viable implementations.

  9. IHE: A Framework for Interoperability Core set of standards in place… 11073-10101 Nomenclature / Terminology 11073-10201 Information model 11073-20101 Application Profile – Base Std. 11073-30200 Transport Profile: Cabled 11073-30300 Transport Profile: IR wireless Together these support connector-to-content interfaces!

  10. “X73” Device Standards Activities Single set of Internationally Harmonized Medical Device Informatics & Interoperability Standards IHE Patient Care Devices Domain ISO TC215 WG7 Other Standards • Other activities… • Continua Health Alliance • CIMIT Medical Device PnP IEEE EMBS 1073 CEN TC251 WGIV HL7 DEV SIG

  11. IHE: A Framework for Interoperability

  12. ISO/IEC JWG7 ISO TC 215 IEC SC 62A • JWG 7 – • Risk Management for I.T. Networks Integrating Medical Devices • IEC 80001 ISO TC 210

  13. IHE: A Framework for Interoperability Core set of X73 standards in place… 11073-10101 Nomenclature / Terminology 11073-10201 Information model 11073-20101 Application Profile – Base Std. 11073-30200 Transport Profile: Cabled 11073-30300 Transport Profile: IR wireless Together these support connector-to-content interfaces!

  14. IHE: A Framework for Interoperability Active terminology projects… 11073-10102 Annotated ECG (used by HL7 RCRIM) 11073-10103 Implantable Device, Cardiac 11073-10104 Virtual Attributes (control) 11073-10202 Information Model - Schema 11073-1030x Device Specializations 11073-1040x Personal Health Devices

  15. IHE: A Framework for Interoperability

  16. X73 Transport Projects IP Support Services Location services LDAP DHCP Net. capacity service Radius 802.1x “upper layers” NAT NTP Presence services SNMP 11073 assoc service 11073 config service DNS Interface to ‘upper layers” RTP TCP UDP SCTP TinyTP L4 - xport IP IrLMP L3 - net Serial port profile IP profile Serial port class drv ether class drv GPRS EDGE 1xRTT 802.3 802.11 IrLAP 802.16 L2 - link ZigBee Cellular Data USB USB BlueTooth BlueTooth ethernet 10/100/ 1000BT Wi-Max IR RS-232 RF RF RF L1 - phy Wi-Fi MICS WMTS current possible future short term possible future possible future point to point links IP centric links

  17. X73 Personal Health Device Projects

  18. IHE Patient Care Device Overview (see slides from HIMSS Showcase 2007)

  19. “X73” Standards-Based Activities Overview ISO/IEEE 11073 Nomenclature Part -1010x DIM Part -1020x Compare Devices HL7/OBXMapping(XML) Device UML Diagram DIMXSchema ICSGenerator

  20. “X73” Standards-Based Activities Overview WIRESHARK Validation Report NIST ICSGenerator NIST ValidatePDU Device Profile (XML) X73 APDU (MDER) X73 PDU PnP MD Manager Simulator PnP MD Agent Simulator PnP PoC RT 11073-30200 11073-30300(G) 11073-20101 11073-2020x

  21. IHE Patient Care Device Overview • http://www.ihe.net/Technical_Framework/index.cfm • PCD CoChairs: • Todd Cooper - t.cooper@ieee.org • Jack Harrington - jack.harrington@philips.com • Ray Zambuto - rzambuto@techmed.com • Other Contacts: • Manny Furst - efurst@imp-tech.com • Elliott Sloane - elliot.sloane@villanova.edu

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